[Federal Register Volume 63, Number 71 (Tuesday, April 14, 1998)]
[Rules and Regulations]
[Pages 18260-18287]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-9397]



[[Page 18259]]

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Part II





Department of Commerce





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National Institute of Standards and Technology



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15 CFR Part 280



Procedures for Implementation of the Fastener Quality Act; Final Rule

  Federal Register / Vol. 63, No. 71 / Tuesday, April 14, 1998 / Rules 
and Regulations  

[[Page 18260]]



DEPARTMENT OF COMMERCE

National Institute of Standards and Technology

15 CFR Part 280

[Docket Number: 970724177-8057-02]
RIN 0693-AB43


Procedures for Implementation of the Fastener Quality Act

AGENCY: National Institute of Standards and Technology, United States 
Department of Commerce.

ACTION: Final rule and extension of implementation date.

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SUMMARY: The Director of the National Institute of Standards and 
Technology (NIST), United States Department of Commerce, and the Under 
Secretary of the Bureau of Export Administration (BXA), United States 
Department of Commerce (collectively referred to as the Department), 
are today issuing a final rule based on comments received in response 
to the notice of proposed rulemaking published in the Federal Register 
on September 8, 1997 (62 FR 47240-47260) (1997)) amending regulations 
found at 15 CFR part 280 implementing the Fastener Quality Act (the 
Act). This final rule establishes the procedures for registration of 
in-process inspection activities of qualifying manufacturing facilities 
that use Quality Assurance Systems (QAS), revises definitions and 
related sections for clarity, and corrects editorial errors. These 
changes will facilitate the implementation of the Act and will better 
accommodate modern industry practices by incorporating these practices 
into the certification process of fasteners covered by the Act. This 
rule also extends the implementation date of the Fastener Quality Act 
by sixty days to July 26, 1998.

DATES: This rule is effective May 14, 1998. The date of implementation 
of the Act is July 26, 1998.

FOR FURTHER INFORMATION CONTACT: Dr. Subhas G. Malghan, FQA Program 
Manager, Technology Services, National Institute of Standards and 
Technology, Building 820, Room 306, Gaithersburg, MD 20899, telephone 
number (301) 975-5120.

SUPPLEMENTARY INFORMATION:

Extension of Implementation Date

    The final rule implementing the Fastener Quality Act became 
effective on November 25, 1996, and was to apply to fasteners 
manufactured on or after May 27, 1997, the ``implementation date''. On 
April 18, 1997, as permitted by section 15 of the Act, NIST announced a 
one year delay of the implementation date of the regulations because 
there were an insufficient number of accredited laboratories to conduct 
the volume of inspection and testing required by the Act and 
regulations (62 FR 19041 (1997)). Currently, NVLAP and the NIST-
recognized private accreditation bodies have received applications from 
approximately 430 testing laboratories, a sufficient number for 
implementation of the Act. Of these, approximately 130 testing 
laboratories have been accredited and are listed on the NIST Accredited 
Laboratory List. Although NVLAP and the private accreditation bodies 
have been working diligently to complete accreditation of these 
laboratories, it seems unlikely that the necessary 425 laboratories 
will be accredited by May 26, 1998. Therefore, to ensure that there are 
a sufficient number of accredited laboratories to conduct the 
inspection and testing required by the Act, pursuant to section 15 of 
the Act, NIST is extending the implementation date of the Act by sixty 
days to July 26, 1998.

Background--Final Rule

    The Fastener Quality Act (the Act) protects the public safety by: 
(1) Requiring that certain fasteners which are sold in commerce conform 
to the specifications to which they are represented to be manufactured; 
(2) providing for accreditation of laboratories and registration of 
manufacturing facilities engaged in fastener testing; and (3) requiring 
inspection, testing and certification, in accordance with standardized 
methods, of fasteners covered by the Act.
    The Secretary of Commerce, acting through the Director of NIST, 
published final regulations implementing the Act on September 26, 1996. 
Those regulations established procedures under which: (1) Laboratories 
in compliance with the Act may be listed; (20 laboratories may apply to 
NIST for accreditation; (3) private laboratory accreditation entities 
(bodies) may apply to NIST for approval to accredit laboratories; and 
(4) foreign laboratories accredited by their governments or by 
organizations recognized by the NIST Director under section 6(a)(1)(C) 
of the Act can be deemed to satisfy the laboratory accreditation 
requirements of the Act. The regulation also established, within the 
Patent and Trademark Office (PTO), a recordation system to identify the 
manufacturers or distributors of covered fasteners to ensure that the 
fasteners may be traced to their manufacturers or private label 
distributors. In addition, the regulations contained provisions on 
testing and certification of fasteners, sale of fasteners subsequent to 
manufacture, recordkeeping, applicability of the Act, enforcement, 
civil penalties, and hearing and appeal procedures.
    Those regulations became effective on November 25, 1996, and were 
to apply to fasteners manufactured on or after May 27, 1997, the 
``implementation date''. On April 18, 1997, as permitted by section 15 
of the Act, NIST announced a one year delay of the implementation date 
of the regulations because there were an insufficient number of 
accredited laboratories to conduct the volume of inspection and testing 
required by the Act and regulations (62 FR 19041 (1997)).
    Following issuance of the final regulations on September 26, 1996, 
the automobile industry approached the Department and expressed its 
concern that the Act and the implementing regulations did not recognize 
the use of modern manufacturing methods using prevention-based quality 
assurance systems employing statistical process controls (SPC). On 
February 4, 1997, a Public Workshop was held at NIST to solicit 
information from all interested parties, including the automobile, 
aerospace, construction, and fastener industries on the use of 
prevention-based quality assurance systems employing SPC in the 
manufacture of fasteners. The Department published a notice of proposed 
rule making in the Federal Register on September 8, 1997, seeking 
public comments on proposed amendments to the regulations that 
recognize the use of prevention-based quality assurance systems under 
the Act.
    To incorporate Quality Assurance Systems/Statistical Process 
Control (QAS/SPC) into the regulations, the Department proposed adding 
Sec. 280.104, Accreditation of Certain Manufacturing Facilities as 
Laboratories; subpart I, Special Rule for the Accreditation of Certain 
Fastener Manufacturing Facilities, Whose Implemented Fastener Quality 
Assurance Systems Meet Defined Requirements, as Laboratories; subpart 
J, Recognition of Foreign Registrar Accreditation Bodies; subpart K, 
Requirements for Registrar Accreditation Bodies (Accreditors); and 
subpart L, Requirements for Registrars. In addition, the Department 
proposed adding a definition of Fastener Quality Assurance System 
(FQAS) and defining the terms Accreditor, Registrar, and Facility. The 
Department also proposed amendments to section 280.6, Laboratory Test 
Reports and Sec. 280.10, Sampling, to specify requirements for 
facilities.

[[Page 18261]]

Summary of Public Comments Received by the Department in Response 
to the September 8, 1997 Request for Public Comments, and the 
Department's Response to the Comments

    As noted above, on September 8, 1997, the Department published in 
the Federal Register (62 FR 47240-47260) (1997) (Sept. 8, 1997) a 
proposed rule to amend 15 CFR part 280. The Department received 125 
responses to the request for comments. Twenty-five comments were 
received from fastener manufacturers, twenty domestic and five foreign; 
twenty-five were from associations, twenty domestic and five foreign; 
thirteen were from consultants; ten were from fastener distributors; 
eight were from entities involved in laboratory accreditation/facility 
registration, three laboratory assessors, two fastener testing 
laboratories, one laboratory accreditor, one foreign QAS registrar, and 
one foreign registration accreditation body; eight were manufacturers 
of products that incorporate fasteners, five from the aerospace 
industry, two from the automobile industry (one domestic and one 
foreign), and one foreign equipment manufacturer; eight were from 
government agencies; six were from importers of fasteners; one was from 
a foreign exporter of fasteners; one was from a raw material 
manufacturer; and twenty were from other interested parties, fifteen 
domestic and five foreign. Of the some 125 commenters, 69 commented on 
the issue of incorporating SPC/QAS into the FQA regulations. A detailed 
analysis of the comments follow.
    As explained in detail below, based on the comments received, the 
Department has included all the proposed changes, with some editorial 
corrections and clarifications, in the final rule. For further 
clarification, the Department also has included definitions for 
recognized accreditor, accredited registrar, registered facility, and 
authorized representative, and has amended the definition of consensus 
standards organization to clarify that it is NIST that will identify 
such organizations.

Comments on the Overall Effectiveness of the Proposed QAS 
Regulation

    Of the 125 commenters, 69 commented on the issue of incorporating 
SPC/QAS into the FQA regulations; 44 favored the incorporation of SPC/
QAS into the FQA regulations, and 25 were opposed.
    Of the 44 commenters who favored the incorporation of SPC/QAS into 
the FQA regulations, thirteen were fastener manufacturers, ten domestic 
and three foreign; thirteen were trade associations, ten domestic and 
three foreign; six were manufacturers of products that incorporate 
fasteners, three aerospace manufacturers, two automobile manufacturers 
(one domestic and one foreign), and one foreign equipment manufacturer; 
three were fastener distributors; three were consultants; one was a 
government agency; one was a foreign QAS registrar; and four were other 
interested parties, two domestic and two foreign.
    Of the 25 commenters opposed to the incorporation of SPC/QAS into 
the FQA regulations, four were consultants; four were laboratory 
accreditors/accessors; three were domestic fastener manufacturers; two 
were fastener distributors; three were government agencies; one was a 
raw material manufacturer; and seven were other interested parties.
    Comment: Support for the proposed incorporation of QAS/SPC into the 
regulation was widespread, although many raised questions on details of 
the regulation, as is explained more fully elsewhere in this document. 
However, a substantial minority of the commenters, twenty-five, 
expressed the concern that without final testing, the QAS/SPC scheme 
proposed by NIST would not ensure the quality of fasteners covered by 
the regulations, and would fail to protect the public safety.
    Response: The decision by the Department to include QAS/SPC into 
the regulations as an alternative to end-of-line sampling and testing 
is based upon strong evidence that QAS/SPC reduces the defect rate in 
the fastener manufacturing process. A lower defect rate means that 
fewer fasteners are manufactured that fail to comply with relevant 
standards and specifications, and thus that fewer defective fasteners 
will enter into commerce. Public safety is preserved and enhanced. 
Furthermore, the Department has structured the regulation to provide 
checks and balances to ensure that this is the case.
    The administrative record for this rule-making contains strong 
evidence that QAS/SPC systems utilizing continuous monitoring and 
control in the manufacturing process yields a substantially lower 
defect rate than do traditional manufacturing techniques that rely 
solely upon end-of-line sampling and testing. Testimony at the Public 
Workshop of February 7, 1997 indicates that the use of QAS/SPC may 
reduce the defect rate from the range of thousands or tens of thousands 
parts-per-million experienced by traditional manufacturing techniques 
to approximately 100 parts-per-million. The improved manufacturing 
techniques embedded in QAS/SPC thus improve the quality of fasteners by 
reducing the portion of each lot that fails to meet standards and 
specifications. The regulations being issued today offer the benefits 
of QAS/SPC manufacturing to consumers in this country. But consistent 
with the FQA, these regulations also mandate in-process inspection and 
testing of fasteners manufactured under QAS/SPC systems, to verify that 
the promise of QAS/SPC is the reality.
    As a means of providing checks and balances to the process controls 
that underlie the QAS/SPC methodology, the regulations mandate in-
process inspection and testing of fasteners to assure the quality of 
fasteners, and thus the protection of public safety. Process controls 
in QAS/SPC facilities are required by the regulation to be augmented by 
all testing required by the standards and specifications that the 
manufacturer holds out that a given lot meets. The general rule is set 
out in Sec. 280.104(a), which states that registration of a fastener 
manufacturing facility employing a fastener quality assurance system 
(FQAS) shall be deemed to meet the requirements of accreditation of a 
laboratory under the FQA. This general rule is amplified in Sec. 280.2, 
which defines the term FQAS, and Sec. 280.10, which sets out 
requirements for sampling methods to be followed by QAS/SPC facilities.
    These sections of the regulation address three issues in the regime 
required of QAS/SPC facilities:
     What is the sampling methodology required of QAS/SPC 
facilities as part of their responsibility to conduct in-process 
testing and inspection?
     What specific tests and testing techniques must QAS/SPC 
facilities apply to the samples that are to be tested?
     Where must these tests be performed?
    Sampling is a concept that will not always be relevant in the QAS/
SPC environment. The definition of FQAS speaks about ``process 
inspection embodied in a comprehensive and written control plan for 
product/process characteristics, process controls (including 
statistical process control), tests, and measurement systems that will 
occur during mass production.'' The Department recognizes that under 
QAS/SPC, some tests and inspections will be conducted on every fastener 
in the lot. That is, the test sample will be one hundred percent of the 
fastener lot. Section 280.10(c), as it has been revised as a result of 
the public comment

[[Page 18262]]

process, makes this point clear by stating, as one alternative, that 
``a manufacturer operating a Registered Facility may elect to conduct 
inspections and tests upon all of the fasteners within a specified lot, 
provided that this election is documented in the control plan of its 
Fastener Quality Assurance System.'' Otherwise, the sample size is 
governed by the general rule in Sec. 280.10(a), which states that 
``[f]or tests conducted either in a laboratory on the Accredited 
Laboratory List or in a Registered Facility, if a manufacturer 
represents that the fasteners in a particular sample have been 
manufactured to a standard or specification which provides for the 
size, selection or integrity of the sample to be inspected and tested, 
the sample shall be determined in accordance with that standard or 
specification''; or the first alternative in Sec. 280.10(c) ``For tests 
conducted in a Registered Facility, and not in a laboratory on the 
Accredited Laboratory List, if a manufacturer represents that the 
fasteners in a particular sample have been manufactured to a standard 
or specification which does not provide for the size, selection or 
integrity of the sample to be inspected and tested, the sample for 
inspections and tests by the Facility shall be determined by the 
sampling plan provided by its Fastener Quality Assurance System or by 
standards and specifications intended for use with a Fastener Quality 
Assurance System, as appropriate.''
    Tests are as required in the relevant standards and guidelines.
    Where testing occurs in the QAS/SPC regime is governed by 
Sec. 280.104(b) of the regulations, which requires that all in-process 
laboratory inspection and testing must be performed in laboratories 
accredited under the FQA; and Sec. 280.104(d), which requires that the 
chemical composition of all fastener lots manufactured under QAS/SPC 
must be conducted in laboratories accredited under the FQA. In-process 
testing and inspection may occur within Registered Facilities.
    In the view of the Department, these requirements meet the 
statutory mandates of the FQA, and protect the public safety.

280.2  Definitions

    Comment: Eight commenters addressed the issue of whether 
subcontracted processes required final testing by an accredited 
laboratory or whether they could be performed by another Facility.
    Response: In Sec. 280.2, the definition of Facility has been 
expanded to include a facility performing subcontracted processes such 
as electroplating and heat treating, provided that they too are listed 
on NIST's Facilities list. In addition, Sec. 280.807 allows 
subcontracting to other Facilities listed on the Facilities list.
    Comment: Eight commenters suggested that Quality Assurance Systems 
are not equivalent, and that they do not define which characteristics 
to measure and how to measure them.
    Response: No changes have been made to the regulations based on 
these comments because the QAS facilities must meet equally rigorous 
standards to maintain their registration by an accredited Registrar.
    Comment: Two commenters requested that the regulations be amended 
to allow QAS in lieu of metal testing by a metal manufacturer.
    Response: No changes were made to the regulations because to the 
Department's knowledge, chemistry of metal is obtained by testing it in 
a laboratory. Therefore, chemical analysis by QAS is not an acceptable 
testing method.
    Comment: Ten commenters suggested deleting references to ISO-9000 
in the definition of Fastener Quality Assurance System because it lacks 
quality details and does not contain the details of ISO-25. In 
addition, three of these commenters stated that the proposed rule does 
not satisfy the intent of the Congress and will have a serious effect 
on the laboratory accreditation, and that a final inspection should be 
still required.
    Response: No changes were made to the regulations based on these 
comments. The regulations are clear on laboratory accreditation and 
registration of fastener manufacturing facilities. The laboratory 
accreditation is performed in accordance with ISO Guides 58 and 25, and 
specific requirements of the Act and the regulations. Registration of 
fastener manufacturing facilities is carried out in accordance with the 
ISO Guides 61, 62 and the specific requirements of the Act and the 
regulations. The revised rule accommodating QAS facilities is fully 
within the intent of the Act because under QAS, fasteners are produced 
to stringent standards that yield fasteners of at least as good quality 
as end-of-line laboratory testing can assure. Since the two programs, 
accreditation and registration, are treated separately, the Department 
does not believe that laboratory accreditation will be seriously 
affected.
    Comment: Two commenters suggested that the Department specify a 
level of revision of ISO Guides referred to in the QAS regulations that 
will assure the Department that the QAS approved today will remain 
compliant in the future.
    Response: No changes were made to the regulations based on these 
comments. As they currently exist, the ISO Guides referenced in the QAS 
regulations fulfill the needs of the Act and the regulations. The 
regulations are sufficiently flexible to accommodate moderate change in 
these standards.
    Comment: One commenter remarked that the parameters of a control 
plan are not discussed in the proposed rule.
    Response: No changes were made to the regulations based on this 
comment because the Department has decided that the broad parameters 
described in Sec. 280.2 are sufficient.
    Comment: One commenter suggested clarifying the meaning of 
``documented criteria of a QAS.''
    Response: No changes were made to the regulations based on this 
comment because the definition of QAS describes specific criteria to be 
met by the QAS facility.
    Comment: One commenter suggested adding a requirement that 
personnel who collect data pursuant to the operation of a QAS be held 
to the same standards of training, experience and competency as 
laboratory personnel.
    Response: No changes were made to the regulations based on this 
comment. The processes involved in laboratory testing differ from those 
in a QAS facility. Requirements for personnel performing tasks involved 
in these processes differ. The requirements for laboratory personnel 
are described in ISO Guide 25. The requirements for QAS facility 
personnel are described, in general, in the fastener QAS followed by 
that QAS facility.
    Comment: One commenter remarked that QAS plans should be required 
to measure all characteristics called for in the standard and 
specification, rather than just those that the manufacturer finds 
appropriate for product functionality.
    Response: The Department agrees. Changes were made to the 
regulations in Sec. 280.2 under the definition of Fastener Quality 
Assurance System in (2)(v). To improve clarity, this section is amended 
to read as follows: ``a requirement that the in-process control plan 
include those characteristics specified by the QAS standard, 
characteristics specifically indicated by the applicable fastener 
standards and specifications, and those characteristics as designated 
by the end user for evaluating product functionality.''
    Comment: One commenter asked if a fastener standard does not accept 
SPC as an alternative to the final testing, then can the SPC be used.

[[Page 18263]]

    Response: No changes were made to the regulations based on this 
comment. If a fastener standard does not accept SPC, SPC may not be 
used to meet the requirements of that standard.
    Comment: One commenter requested amending Sec. 280.5 to confer upon 
the major end user the responsibility of specifying how a lot of 
fasteners is to be tested, including in accordance with major end users 
in-house publication or in accordance with QAS, rather than in 
accordance with the embedded standards and specifications.
    Response: No changes were made to the rule based on this comment 
because section 5(b)(1) of the Act requires that a manufacturer have 
lot samples tested to determine whether the lot conforms to the 
standards and specifications to which the manufacturer represents it 
has been manufactured. The Act does not offer the flexibility of 
delegating this responsibility to the end user.
    Comment: One commenter suggested adding a definition of major end 
user to the rule.
    Response: The Department has not made any changes to the 
regulations based on this comment. A definition of major end user is 
not necessary because the term major end user does not appear in the 
regulations.
    Comment: One commenter remarked that NIST overlooked the basis of 
its Malcolm Baldrige award, and NIST should practice its quality 
outreach program by reissuing regulations to encompass ISO-9002 and QS-
9000 and state of the art quality programs.
    Response: No changes were made to the regulations based on this 
comment. ISO-9002 and QS-9000 are used worldwide while the Malcolm 
Baldrige criteria are familiar only to United States firms. Since 
fasteners to which the Act and the regulations apply are produced 
worldwide, international standards are more appropriate.

280.5  Certification of Fasteners

    Comment: One commenter proposed an amendment to Sec. 280.5 of the 
rule to clarify that a manufacturer that follows QAS is in compliance 
with the Act.
    Response: No changes were made based on this comment because 
Sec. 280.5(a) states the rule for inspecting, testing, and 
certification of covered fasteners, and Sec. 280.104(a) brings 
registered QAS facilities under this general rule, and therefore, in 
compliance with the Act.

280.6  Laboratory Test Reports

    Comment: Nine commenters stated that manufacturers registered to 
QAS should not have to prepare test reports as proposed in Sec. 280.6 
(b) and that requirement would make the QAS program unworkable. These 
commenters stated that amendments to proposed Sec. 280.6(b) would be 
necessary. In addition, two additional commenters requested that the 
Department reduce the contents of the test reports for QAS facilities 
since it is unnecessary and burdensome, limit requirements to those of 
the Act and require just a statement that fasteners conform to the QAS 
plan on the report.
    Response: The requirement for a test report is mandated by sections 
5 and 7 of the Act. However, based on these comments, amendments have 
been made to Sec. 280.6(b) of the regulations by deleting certain 
reporting requirements. Also, similar amendments were made in 
Sec. 280.6(a) to simplify laboratory test report requirements for both 
laboratories and Facilities. Further, Sec. 280.7 was amended to 
accommodate amendments made to Sec. 280.6.
    Comment: Two commenters asked whether imported fasteners produced 
under QAS must be accompanied by a certificate and laboratory testing 
report.
    Response: No changes were made to the regulations because there is 
no exception that states that imported fasteners produced under QAS 
need not be accompanied by a certificate and laboratory test report. 
Section 280.13 describes the requirements for imported fasteners, which 
include a manufacturer's certificate of conformance and an original 
laboratory test report.
    Comment: One commenter suggested that a ``synopsis'' of the test 
report would not provide assurances for end user.
    Response: In response to this comment, the word, ``synopsis'' has 
been deleted from Sec. 280.6(b) to clarify that registered facilities 
must include test results in their reports rather than a synopsis of 
their test results. The reporting of actual test results will provide 
assurances for the end user.
    Comment: Two commenters asked that QAS reports include basic and 
unique identification information to tie a particular fastener lot with 
the report and control plan.
    Response: In response to this comment, the Department has amended 
Sec. 280.6(b)(2) to require that test reports include: ``Unique 
identification of the test report, including date of issue and serial 
number, or other appropriate means, including reference to the control 
plan identification.''
    Comment: Three commenters suggested allowing facilities to make a 
certified statement that fasteners with a specific lot number are 
fulfilling the requirements of stated standards and specifications, in 
place of a detailed test report as required by Sec. 280.6(b).
    Response: No changes were made to the regulations based on this 
comment because a certified statement will not satisfy the requirements 
of sections 5 and 7 of the Act. An original laboratory testing report 
and a manufacturer's conformance certificate are required.
    Comment: One commenter asked how he should report QAS test results 
in accordance with the regulations.
    Response: No changes were made to the regulations based on this 
comment because Sec. 280.6 describes procedures for reporting QAS test 
results.

280.10  Sampling

    Comment: Two commenters addressed a conflict between Sec. 280.10, 
which pertains to sampling, and one of the goals of QAS. According to 
these commenters, Sec. 280.10 appears to permit a plan provided by a 
Fastener QAS only when the standards and specifications do not provide 
for size, selection and integrity of the sample. However, one of the 
goals of QAS is to have a control plan which describes a sampling plan. 
Therefore, these commenters requested guidance on which sampling plan 
should they follow. Another commenter requested allowing sampling plans 
specified by the customer in a QAS control plan.
    Response: Section 280.10 has been rewritten in response to these 
concerns to clarify sampling requirements under the FQA and these 
regulations. Section 5(b)(2) of the Act restricts the authority of the 
Department to prescribe sampling procedures for fastener testing to 
those instances where the standards and specifications relevant to a 
fastener lot are silent on sampling. This is why revised Sec. 280.10(a) 
states ``For tests conducted either in a laboratory on the Accredited 
Laboratory List or in a Registered Facility, if a manufacturer 
represents that the fasteners in a particular sample have been 
manufactured to a standard or specification which provides for the 
size, selection or integrity of the sample to be inspected and tested, 
the sample shall be determined in accordance with that standard or 
specification''.
    However, in response to these comments, the Department has included 
Sec. 280.10(c) to clarify sampling procedures in the QAS/SPC setting. 
Section 280.10(c) sets out procedures to be followed when 
Sec. 280.10(a) does not apply: ``For tests conducted in a Registered 
Facility, and not in a laboratory on the Accredited Laboratory List, if 
a manufacturer represents that the fasteners in a particular sample 
have been manufactured to a standard or

[[Page 18264]]

specification which does not provide for the size, selection or 
integrity of the sample to be inspected and tested, the sample for 
inspections and tests by the Facility shall be determined by the 
sampling plan provided by its Fastener Quality Assurance System or by 
standards and specifications intended for use with a Fastener Quality 
Assurance system, as appropriate. Or, a manufacturer operating a 
Registered Facility may elect to conduct inspections and tests upon all 
of the fasteners within a specified lot, provided that this election is 
documented in the control plan of its Fastener Quality Assurance 
System.''
    The last sentence in Sec. 280.10(c) has been added because sampling 
is a concept that will not always be relevant in the QAS/SPC 
environment. The definition of FQAS speaks about ``process inspection 
embodied in a comprehensive and written control plan for product/
process characteristics, process controls (including statistical 
process control), tests, and measurement systems that will occur during 
mass production.'' The Department recognizes that under QAS/SPC, some 
tests and inspections will be conducted upon every fastener in the lot. 
That is, the test sample will be one hundred percent of the fastener 
lot. The last sentence in Sec. 280.10(c), as it has been revised as a 
result of the public comment process, makes this point clear by stating 
that ``[A] manufacturer operating a Registered Facility may elect to 
conduct inspections and tests upon all of the fasteners within a 
specified lot, provided that this election is documented in the control 
plan of its Fastener Quality Assurance System''.
    Comment: Three commenters remarked that the default sampling plans 
prescribed in the regulations are overly restrictive. One commenter 
cited the example of sampling plans restricting lot size to 250,000 
pieces while manufacturing lots may be larger.
    Response: No changes were made to the regulations based on this 
comment. Section 5(b)(2)(B) of the Act provides that default sampling 
plans prescribed by the Secretary must, to the extent practicable, use 
consensus testing standards and related materials. Sampling plans are 
prescribed by these standards and specifications. NIST does not have 
the authority to change those standards.

280.12  Applicability

    Comment: Eighteen commenters stated that the planned implementation 
date of May 26, 1998 will not allow enough time for NIST to approve 
Accreditors, for Accreditors to accredit Registrars, and for the 
Registrars to register fastener manufacturing facilities. Suggested 
approaches were: (1) To delay implementation date of the Act until a 
sufficient number of facilities are registered, (2) to grant 
provisional approval of current QAS-registered facilities and begin 
audit in six months, (3) to convene a meeting of all interested parties 
to establish a reasonable time line for industry compliance.
    Response: The Department has studied these comments and assessed 
the registration requirements of the fastener industry. To accommodate 
the industry needs, the Department has developed the following plan, 
codified in Sec. 280.810(c)(3), to provisionally approve current QAS-
registered facilities so that commerce in fasteners is unaffected as a 
result of the July 26, 1998 implementation date.
    If a Facility intends to be listed in accordance with 
Sec. 280.810(c)(1) but the registration process will not be completed 
by July 26, 1998, the Facility may be provisionally listed on the 
Facilities List by providing the following to NIST on or before 
September 30, 1998:
    1. Certification that: (a) The Facility is registered to QS-9000 or 
an equivalent by a quality systems registrar; (b) the Facility conforms 
to all other requirements of the Act and the regulations at the time of 
certification; (c) if the Facility ceases to be registered to QS-9000 
or an equivalent by an accredited Registrar and/or ceases to conform to 
any other requirement of the Act and the regulations at any time during 
the provisional listing period, it will notify NIST of that fact within 
three working days; and (d) if the Facility fails to apply to an 
accredited Registrar for registration under the FQA within 30 days of 
the time the Registrar is accredited by a NIST-approved Accreditor, an 
authorized representative of the Facility will immediately notify NIST. 
(If the Facility's current Registrar decides not to seek accreditation 
under the FQA, it is the Facility's responsibility to apply to another 
Registrar that has been approved by NIST-ABEP.);
    2. A list of fasteners produced or processed by the Facility, 
identified by either a part number or a specification number;
    3. A list of standards included in the Facility's registration;
    4. A copy of the Facility's registration certificate; and
    5. The listing fee established by NIST.
    The Facility must meet all the requirements of the Act and the 
regulations by May 25, 1999. If the Facility fails to receive FQA 
registration by May 25, 1999, it will be removed from the Facilities 
List.
    Comment: Six commenters requested delaying the implementation date 
(for example, one more year) so that outstanding questions can be 
interpreted and lead time provided to get ready for implementation of 
the Act.
    Response: Changes were made to the regulations based on these 
comments. As described earlier, the Department has developed a 
procedure, based on industry input, by which manufacturing Facilities 
in the QS-9000 system may ``self-certify'' for one year. The Department 
is also delaying the implementation date from May 26, 1998 to July 26, 
1998, following the Department's determination that there will be an 
insufficient number of accredited laboratories to perform the volume of 
inspections and testing required on May 26, 1998.
    Comment: Three commenters, including a U.S. government agency, 
requested delaying the implementation date until a detailed regulatory 
flexibility analysis is conducted and published for public comment. 
They claim the proposed regulations will have a significant negative 
impact on fastener distributors and manufacturers because of the cost 
of inventory scrapped, the cost of accrediting laboratories, the loss 
of potential market share because of exemption of fasteners in free 
trade zones, the disruption in supply and resulting loss of business to 
OEM customers, the disproportionate cost of laboratory accreditation on 
QAS registered facilities, and the disproportionate cost to certify raw 
materials.
    Response: A detailed regulatory flexibility analysis was conducted 
and published as part of the final regulations on September 26, 1996, 
which considered almost all issues raised by these commenters. The 
remaining issues related to QAS regulations were addressed as part of 
the proposed rule on September 8, 1997. As noted above, the Department 
has delayed the implementation date until July 26, 1998.
    Comment: An agency of the U.S. Government commented that the 
proposed rule does not provide a meaningful regulatory alternative to 
small businesses because of the short deadline of May 26, 1998, and 
does not address economic impact on affected sectors.
    Response: The Department has addressed the issue of the short 
deadline for registering a sufficient number of facilities before the 
July 26, 1998 implementation date by adding Sec. 280.810(c)(3), which 
allows

[[Page 18265]]

provisional approval of current QAS-registered facilities if they meet 
certain requirements.
    The Department certified, under 5 U.S.C. 605(b), that the proposed 
rule would not have a significant economic impact on a substantial 
number of small entities. The factual basis for this certification was 
published with the proposed rule. The Department does not agree with 
the commenter's conclusion that the proposed rule does not afford a 
meaningful alternative to small businesses as no preference is given to 
large manufacturers and registrars over small industry participants. 
This methodology would be available to any business, large or small, 
that employs QAS of manufacturing. Moreover, whether small or large, 
businesses are not forced to adopt QAS. The amended rule would 
establish a second option for those manufacturers interested and 
qualified to use the QAS of manufacturing.
    On the issue of cost of inventory produced before the 
implementation date, the industry has long recognized this problem and 
has had adequate time to react appropriately. This issue has been 
discussed several times since the 1992 comment process. In its January 
10, 1995, report and recommendations for amending the Act, the Public 
Law Task Force, the fastener industry coalition, recommended that 
fasteners manufactured before the implementation date not be allowed to 
be certified as conforming fasteners under the Act. This recommendation 
was endorsed by the Fastener Advisory Committee in letters to Congress 
dated February 9, 1995. Other cost elements were addressed in the 
September 26, 1996 notice of final rulemaking.

280.104  Accreditation of Certain Manufacturing Facilities as 
Laboratories

    Comment: Four commenters stated that the requirement that in-
process testing be done by a laboratory on the Accredited Laboratory 
List would require a costly additional evaluation of the laboratory by 
an accreditation body. In addition, one suggested that the QS-9000 
registration process should include accreditation of the Facility's 
laboratory.
    Response; No changes were made to the regulations based on this 
comment. The requirement that in-process testing be performed by a 
laboratory on the Accredited Laboratory List is included in the 
regulations because registration of a QAS facility under ISO Guide 9001 
or 9002 or QS-9000 does not include evaluation of technical credibility 
and validity of test results from an accredited laboratory.
    Comment: One commenter stated that having to be assessed by a body 
approved by NIST is just as onerous a burden as getting laboratory 
accreditation.
    Response: No changes were made to the regulations because section 6 
of the Act mandates that laboratory accreditation be performed by 
accreditation bodies recognized by NIST. Facilities are brought into 
the FQA regime under Sec. 280.104(a) of the regulations, which deems 
registration of Facilities to meet the requirements of laboratory 
accreditation. Therefore, the Act's requirements for laboratory 
accreditation apply to the registration of Facilities, as well.
    Comment: One commenter suggested clarifying the phrase ``any in-
process inspection and testing,'' because it does not include all in-
process testing at a QAS facility.
    Response: Based on this comment, the Department revised 
Sec. 280.104(d) of the regulations to clarify which tests must be 
performed by a laboratory on the Accredited Laboratory List.
    Comment: Three commenters suggested making laboratories used by QAS 
registered facilities meet ISO Guide 25 and proficiency testing 
requirements so that QAS registered facilities provide consistency in 
accreditation of laboratories.
    Response: Since these requirements are already present in the 
revised regulations, no changes were made.
    Comment: One commenter suggested that since laboratories must 
comply with stricter standards (ISO-25, EN-45001, etc) than 
manufacturers, the Department should allow laboratories owned by 
distributors to use the same standards as manufacturers.
    Response: No changes have been made to the regulations because 
manufacturers follow QAS standards defined under Sec. 280.2 of the 
regulations to qualify as a QAS facility. Distributors are not 
manufacturers manufacturing, hence they cannot follow the same 
standards as the manufacturers. However, irrespective of the ownership 
of the laboratory, the laboratory has to meet the same requirements.
    Comment: One commenter stated that recognizing SPC as an 
alternative to final testing inspection is unlikely to benefit the 
aerospace industry because aerospace industry specifications 
specifically do not allow SPC.
    Response: No changes were made to the regulations based on this 
comment because the incorporation of fastener specific QAS standards is 
an essential element of the QAS requirements. If the aerospace industry 
requires final testing and inspection, it will not be affected by the 
addition of the QAS option.
    Comment: One commenter suggested that if a chemical laboratory is 
included in the registration of a QAS registered facility, there is no 
need to go to an accredited laboratory for testing.
    Response: No changes were made based on this comment. Section 
280.104(d) requires that chemical testing be performed by a laboratory 
on the Accredited Laboratory List. Section 280.104(b) allows that such 
a laboratory may be located on the same premises as a fastener 
manufacturing facility if the laboratory is separately accredited 
pursuant to a provision of the regulations other than Sec. 280.104(a). 
Therefore, a chemical laboratory cannot be accredited through 
registration process.
    Comment: One commenter requested providing clarification as to when 
a QAS Facility does testing and when an accredited laboratory does 
testing.
    Response: In response to this comment, Sec. 280.104(d) has been 
amended to clarify the requirements for laboratory tests.

Subparts I-L: Accreditation of Manufacturing Facilities; Foreign 
Accreditors; Accreditors; Registrars

    Comment: Two commenters requested amending Sec. 280.800 to allow 
the use of QAS facilities registration by another agency, in addition 
to NIST.
    Response: No changes were made to the regulations based on this 
comment. NIST is the only government agency allowed to carry out 
laboratory accreditation under section 6 of the Act.
    Comment: Three commenters suggested recognizing accreditation 
bodies that have been recognized by organizations other than NIST. Two 
commenters mentioned recognizing accreditation bodies accessed under 
the International Accreditation Forum. One commenter suggested that if 
one accreditation body is recognized in Europe under the Act and the 
regulations, NIST should recognize all other bodies that are part of 
multilateral agreements to which the recognized accreditation body is a 
party.
    Response: No changes were made to the rule based on this comment. 
Section 6 of the Act allows FQA accreditation only by bodies recognized 
by NIST. Under this regulatory program, each accreditation body must 
apply to NIST directly and be individually evaluated to obtain 
recognition. Blanket accreditation under a multilateral agreement or 
under an international forum would not allow NIST to ensure that each 
accreditation body meets all

[[Page 18266]]

requirements of the Act and the regulations.
    Comment: One commenter asked if the Registrars will be required to 
evaluate the substantive content of control plan.
    Response: Under the definition of a Fastener QAS in Sec. 280.2, one 
of the elements of a QAS is a requirement that a fastener manufacturer 
fully document a detailed control plan. Therefore, it is the 
responsibility of the manufacturer to develop and maintain a detailed 
control plan. However, as part of the registration process, a Registrar 
is required to evaluate the contents of the control plan.
    Comment: One commenter stated that in Japan, a government body 
approves QAS registered fastener manufacturing facilities as JIS 
Marking factories. In this situation, the commenter asked, how will the 
proposed system of registration work.
    Response: No changes were made to the regulations based on this 
comment because the system of registration in the current regulations 
is based on internationally accepted procedures. The system proposed by 
the commenter is different from the internationally accepted standards 
procedures. The commenter has two options to comply with the 
regulations: 1. Separation of registration and accreditation 
activities; or 2. Use of a private registrar to register facilities.
    Comment: One commenter asked if the United Kingdom Accreditation 
Service (UKAS) can accredit Registrars for QAS assessments.
    Response: No changes were made to the regulations based on this 
comment because the procedures for seeking recognition by NIST-ABEP are 
described in the ABEP handbook. If interested in engaging in the 
acceditation of Registrars, UKAS must apply to NIST-ABEP for 
recognition.
    Comment: One commenter inquired whether approving Registrars will 
require additional resources for NIST. According to the commenter, if 
NIST approves registrars, it will be perceived as expansion of 
government into a role previously performed by the private sector. If 
that is the case, the commenter asked, why not rely on the private 
sector.
    Response: No changes were made to the regulations based on this 
comment because the revised regulations clarify that NIST will not 
directly accredit Registrars. NIST will rely on NIST-approved private 
sector Registrar Accreditation Bodies to perform Registrar 
accreditation. There will be no additional resources required for NIST 
because section 6(d)(2) of the Act specifies that accreditation 
activities performed by NIST will be on a reimbursable basis.
    Comment: One commenter asked how NIST-ABEP will assure that a 
manufacturer is competent to conduct fastener testing if the criteria 
is based on ISO-9000 series.
    Response: No changes were made to the regulations based on this 
comment. Registering a fastener manufacturing facility to ISO-9000 does 
not indicate that the facility is competent to perform laboratory 
tests. Any laboratory tests performed during in-process inspection and 
testing must be performed by a laboratory on the Accredited Laboratory 
List.
    Comment: One commenter commented that elements (ii), (iv), and (v) 
in proposed Sec. 280.1010(d)(5) are not related to quality elements.
    Response: No changes have been made to the regulations as a result 
of this comment. Section 280.1010(d)(5) details the requirements for a 
quality manual, which necessarily must contain administrative 
information as well as quality elements. The same information is 
required by ISO Guide 61, so these requirements are familiar to the 
industry.
    Comment: One commenter asked for clarification of terms used in 
Secs. 280.1010 and 280.1011: ``appropriate international 
documentation'' in Sec. 280.1010(d)(5)(xiv); ``informed'', ``corrective 
action'', and ``timely and appropriate'' in Sec. 280.1010(f); 
``appropriate international documentation'', ``technical experts'', 
``assessment of familiarity'' and others in Sec. 280.1011. Similarly, 
this commenter suggested that subparts K and L need to be reworked to 
eliminate vague terms.
    Response: No change was made to the regulations. The ABEP handbook 
will provide guidance for interpreting these terms.
    Comment: One commenter mentioned that Sec. 280.1010(i)(2), the 
prohibition on disclosure of information about an accreditation body 
without its written consent, could interfere with the responsibilities 
of end-users to control the quality of their suppliers in quality 
management.
    Response: No changes were made to the regulations based on this 
comment. Section 280.1010(i)(2) refers to confidentiality of 
information obtained by the Accreditor concerning the applicant 
Registrars. The Department feels that this provision is required to 
safeguard confidentiality of the information provided by the Registrar 
to its Accreditor. The regulations do not prevent the end user from 
getting the quality management-related information of its Registrar 
from the Registrar itself or from the Accreditor with the Registrar's 
written permission.
    Comment: One commenter stated that there is a high probability of 
inconsistent requirements under various registration systems. This 
commenter specifically asked how NIST will assure that NIST and 
Registrar Accreditation Body recognition requirements are equivalent.
    Response: No changes have been made to the regulations in response 
to this comment. Subparts I through L describe the criteria by which 
Registrar Accreditation Bodies will be approved and by which Registrars 
will be accredited by the approved bodies. NIST plans to closely adhere 
to these requirements to maintain uniformity among the Registrars 
accredited by various bodies.
    Comment: One commenter asked if auditors will be approved for 
appropriate standard industrial codes. The commenter also asked if 
auditors will be required to be experts in both QAS and fastener 
technology.
    Response: No changes were made to the regulations based on this 
comment. Approval of auditors will be the responsibility of accredited 
Registrars under subpart L, which is based on ISO Guide 62. Auditors 
will be required to be competent in both QAS and fastener technology. 
Additional requirements specific to the fastener technology will be 
described in the ABEP Handbook.
    Comment: One commenter requested that NIST function as a Registrar 
Accreditation Body if no accreditation body seeks NIST's approval.
    Response: No changes were made to regulations based on this comment 
because NIST does not foresee such a problem. The industry has 
indicated that accreditation bodies are ready to apply once the 
regulations take effect.
    Comment: One commenter suggested that all Registrars currently 
approved by Registrar Accreditation Bodies should be automatically 
approved by NIST and all companies with QAS systems accredited by those 
Registrars should be deemed to have approved QAS.
    Response: No changes were made to the regulations based on this 
comment. Recognition of Accreditation Bodies, accreditation of 
Registrars, and registration of Facilities under the Act and the 
regulations include meeting requirements specific to the Act and 
regulations. Therefore, prior recognition, accreditation, or 
registration, based on different requirements, are insufficient to meet 
the requirements of the Act and the regulations.

[[Page 18267]]

    Comment: One commenter suggested appointing the major users of QS-
9000 as registrars.
    Response: The requirements for an organization to qualify as a 
registrar are outlined in subpart L. If a major user wants to become a 
registrar, it must meet those requirements and must apply to a 
recognized registrar accreditation body to become an accredited 
registrar.
    Comment: One commenter requested that the Act should merely require 
that certification (recognition of accreditation bodies and 
accreditation of registrars) be made in accordance with applicable 
standards because existing certification practices are sufficient to 
meet the purposes of the Act.
    Response: No changes were made to the regulations based on this 
comment because existing practices do not require that accreditation 
bodies and registrars meet the specific requirements of the Act and its 
implementing regulations and, therefore, are insufficient for these 
purposes.
    Comment: One commenter suggested modifying Sec. 280.1010(e)(1) by 
replacing ``partially or in total, for all or part of the accreditation 
body's scope of accreditation'' with ``for FQA.''
    Response: No changes were made to the regulations based on this 
comment. The regulations apply only to FQA accreditations, not all 
accreditations. Therefore, the current language of Sec. 280.1010(e) 
refers only to partial or total suspension or withdrawal of 
accreditation under the FQA.
    Comment: One commenter suggested modifying Sec. 280.1012(c)(2)(iii) 
by replacing ``product categories'' with ``Fasteners.''
    Response: The Department has accepted the suggestion and modified 
Sec. 280.1012(c)(2)(iii) by replacing ``product categories'' with 
``fasteners covered by the Act.''
    Comment: One commenter requested deleting the requirement for 
accreditors in Sec. 280.1010(b)(17) that they must have a structure 
where members are chosen to provide a balance of interest, where no 
single interest predominates.
    Response: The Department has not made any changes to 
Sec. 280.1010(b)(17) based on this comment because a balance of 
interest is required to maintain objectivity in making decisions 
related to accreditation.
    Comment: One commenter requested deleting Sec. 280.1010(b)(18), 
which is a requirement for accreditors that offer other products, 
processes or services not to compromise confidentiality or the 
objectivity or impartiality of its accreditation process and decisions.
    Response: No changes were made to the regulations based on this 
comment because, according to ISO Guide 61, this is a necessary 
condition that assures a fair decision making process in granting 
accreditations.
    Comment: One commenter suggested the following changes to the 
proposed regulations: replace ``international documentation'' in 
Sec. 280.1010(d)(5)(xiv), Sec. 280.1010(b)(2), and Sec. 280.1010(b)(3) 
with ``ISO Guide 10011-1.''
    Response: No changes were made to the proposed regulations based on 
this comment. The Department deliberately used the term ``international 
documentation'' rather than referring to an existing document so as not 
to restrict the interpretation of that term. The Department notes that 
Secs. 280.1010(b)(2), and 280.1010(b)(3) do not include the words 
``international documentation.''
    Comment: Two commenters requested changing the reassessment period 
for accreditors, registrars, and QAS manufacturing facilities from two 
years to three years to be consistent with the policies of the 
International Accreditation Forum.
    Response: No changes were made to the regulations based on this 
comment. The Department has decided to retain the two year reassessment 
period in order to be consistent with the laboratory accreditation 
reassessment period under the Act and the regulations.
    Comment: Three commenters requested that NIST should have an 
oversight role on the Registrar activities to assure uniformity.
    Response: No changes were made to the regulations based on this 
comment. Detailed descriptions of oversight roles will appear in the 
ABEP Handbook.

Part 2: Summary of Comments Received on Six Proposed Amendments

    Six issues were addressed in the proposed amendments with a request 
for public comment. A discussion of the comments received, and the 
actions taken by the Department as a result of these comments follows:

1. Significant Alterations of Fasteners

    Of the 125 commenters, 15 commented on the issue of significant 
alteration of fasteners; eight favored the proposed changes to the FQA 
regulations, and seven others offered different issues in the area of 
significant alteration. Of the eight commenters who favored the 
proposed changes regarding the significant alteration of fasteners, 
four were trade associations, three domestic and one foreign; two were 
fastener manufacturers, one domestic and one foreign; one was a 
fastener distributor; and one was an other interested party. Of the 
seven commenters who proposed changes regarding the significant 
alteration of fasteners, three were government agencies; two were 
aerospace manufacturers; and two were consultants.
    In the notice of proposed rulemaking, the Department proposed 
changes to the definition of ``significantly alter'' in Sec. 280.2 and 
to Sec. 280.11(b) to correct editorial errors in the reference to 
Rockwell C hardness in these sections. These changes have been adopted 
into the final rule.
    Comment: One aerospace manufacturer, one professional organization 
and one consulting organization commented that other alterations such 
as application of adhesives, locking elements and cutting off of 
finished fasteners should be considered significant alterations.
    Response: Based upon advice from the Fastener Advisory Committee, 
the Department has determined that application of adhesives, locking 
elements, and cutting off of finished fasteners are not significant 
alterations because they do not weaken or otherwise materially affect 
the performance or capabilities of fasteners as they were originally 
manufactured, grade or property class marked, tested, or represented. 
This language appears in the current definition of ``significantly 
alter.'' Therefore, no changes were made based on these comments.
    Comment: One distributor commented that clarification is needed as 
to whether ``coating'' a fastener with a Rockwell hardness of C32 or 
above is a significant alteration.
    Response: The definition of ``alter'' as contained in the Act lists 
only through-hardening, electroplating, and machining as forms of 
alteration. The regulations do not expand upon this definition. 
Therefore, ``coating'' other than electroplating is not a significant 
alteration under the Act and the regulations.
    Comment: The Department received three comments, two from 
distributors and one from an equipment manufacturer, requesting that 
the regulations be revised to allow alterers who electroplate the 
option of either testing or warning rather than requiring them to test 
to the plating specifications.
    Response: Based upon advice from the Fastener Advisory Committee, 
which deliberated this issue at great length during the initial review 
of the regulations implementing the Act and recommended the requested 
option not

[[Page 18268]]

be offered for electroplating due to concerns about hydrogen 
embrittlement as a result of electroplating, the Department has made no 
changes to the rule.
    Comment: One distributor suggested deleting all references to 
adhesives and sealants from the regulations and workshop materials and 
requested that the Department issue a clarifying statement that these 
issues are not covered by the Act.
    Response: No changes have been made to the rule based on this 
comment. The definition of ``significantly alter'', as it appears in 
the regulations, specifically states that ``[t]he term does not include 
the application of adhesives or sealants * * *.'' The Department feels 
that retaining this definition clarifies what processes are not 
considered significant alterations for purposes of the Act and the 
regulations.

2. Removal of Head Markings

    Of the 125 commenters, 18 commented on the proposed amendment to 
allow the removal of head markings for decorative purposes and to meet 
customer needs; eight favored the proposed changes, and 10 were 
opposed. Of the eight commenters who favored the proposed changes 
regarding the removal of head markings, five were trade associations; 
three domestic and two foreign; one was a foreign equipment 
manufacturer; one was a foreign fastener manufacturer; and one was a 
foreign other interested party. Of the 10 commenters who opposed the 
proposed changes regarding the removal of head markings, four were 
government agencies; two were fastener distributors; two were fastener 
manufacturers, one domestic and one foreign; one was a trade 
association; and one was an aerospace manufacturer. In all of these 
comments, it was noted that the proposed amendments did not contain the 
statement, ``fasteners are to be manufactured according to the OEM or 
major end user standard which does not require head marking'' though 
the same was found in the preamble. This statement was included in the 
preamble in error. Some of these commenters noted that removal of head 
markings would not have adverse implications.
    The proposed rule included a proposed new Sec. 280.11(c) to allow a 
fastener user or purchaser to special order fasteners covered under the 
Act and regulations without the required manufacturer or grade 
identification markings under certain conditions. Based on comments 
received, the Department has excluded this section from the final rule.
    Comment: Two commenters suggested that the head marking exclusion 
be moved to Sec. 280.700(b).
    Response: No changes have been made based on this proposal. Since 
the Department has decided not to adopt the proposed change, it will 
not appear in either section.
    Comment: Several commenters stated that the proposal to remove head 
markings is contrary to the intent of the Act, and that markings are 
vital for informing the user of strength levels and traceability. These 
commenters emphasized that the removal of head markings does not 
conform with the purpose of the Act that fasteners conform with 
standards to which they were represented to have been manufactured. One 
commenter from a trade association stated that removal of markings 
promotes unsafe alteration of fasteners. Three commenters (a 
manufacturer and two trade associations) noted that allowing the 
removal of markings could lead to misapplication, misrepresented 
fasteners, entry of substandard fasteners into commerce, and 
significant equipment failures. These commenters stated that if the end 
users want fasteners without markings, they can contract to have them 
made that way. One manufacturer stated that no sales should be allowed 
without the markings. Two commenters from U.S. Government agencies 
stated that the removal of head markings would hinder investigations 
and reduce accountability; therefore, it should not be allowed.
    Response: Based on comments, the Department has decided not to 
adopt the proposed change but to retain the existing rule.

3. Supplying Originals vs Copies of Test Reports

    Of the 125 commenters, 18 commented on the issue of originals vs. 
copies of test reports; 13 favored the proposed changes, and five were 
opposed. Of the 13 commenters who favored the proposed changes 
regarding originals vs. copies of test reports, five were trade 
associations, two domestic and three foreign; four were fastener 
manufacturers, three domestic and one foreign; three were consultants; 
and one was a government agency. Of the five commenters opposed to the 
proposed changes, two were government agencies; two were fastener 
manufacturers, one domestic and one foreign; and one was a raw material 
manufacturer.
    The proposed rule included a proposed amendment to the definition 
of ``original laboratory testing report'' in Sec. 280.2 to allow metal 
manufacturers, as well as laboratories, to certify copies of laboratory 
testing reports of chemical characteristics. Based on comments 
received, the new definition has been included in the final rule. In 
addition, the Department has added a definition of ``certified copy'' 
to further clarify the issue.
    Comment: Two foreign equipment manufacturers commented that the 
proposed rule does not allow a fastener manufacturer to test his own 
fasteners rather than rely on the metal manufacturer's chemical 
analysis of the metal.
    Response: The Department has determined that the proposed rule does 
not prevent fastener manufacturers who choose to adopt QAS from 
obtaining chemical analysis, provided that the fastener manufacturers 
obtain such analysis from an accredited laboratory.
    Comment: A manufacturer proposed an approach in which the fastener 
manufacturer keeps the actual test report of material chemistry and 
transfers only the data from the raw material test report.
    Response: The Department has determined that this approach is not 
consistent with section 5 of the Act, according to which the entire 
chemical test report is necessary for traceability purposes.
    Comment: One commenter recommended that the term ``certified copy 
of test report'' be explained or defined.
    Response: The Department concludes that it would be useful to 
provide guidance as to what constitutes a certified copy. Therefore, 
this final rule amends Sec. 280.2 to add a definition to read as 
follows: ``Certified Copy (of a laboratory testing report) means a 
complete and accurate copy of the original laboratory testing report, 
which contains a statement describing it as an accurate and complete 
copy of the original and which is signed by an authorized 
representative of the accredited laboratory issuing the report or, in 
the case of metal chemistry testing reports, an authorized 
representative of the metal manufacturer.''
    Comment: One consulting firm recommended that the Department repeal 
Sec. 280.15(d) of the regulations because it allows the fastener 
manufacturer to use tests performed on the raw materials by the metal 
manufacturer; however, the fastener manufacturer cannot prove that 
fasteners came from the same coil or heat as required by 
Sec. 280.15(d).
    Response: The Department has determined that repeal of this section 
is not appropriate at this time. Allowing chemical testing of raw 
material by the

[[Page 18269]]

metal manufacturer to be sufficient for meeting the requirements of 
chemical certification of fasteners was one of several options 
recommended by a large segment to the industry as part of the 1996 
amendments to the Act. The Fastener Advisory Committee supported this 
amendment.

4. Laboratory Test Reports

    Of the 125 commenters, seven commented on the issue of laboratory 
test reports; all favored the proposed changes. Of the seven 
commenters, three were trade associations, two domestic and one 
foreign; two were foreign fastener manufacturers; and one was a 
consultant.
    Based on these comments, the Department has adopted the proposed 
amendments dealing with a discrepancy in the language used in reporting 
of alternative chemical characteristics. Following the amendments, 
Sec. 280.6(b)(5)(ii), which is redesignated as Sec. 280.6(c)(5)(ii), 
reads as follows:

    Test results for such coil or heat number chemical 
characteristics.

5. New Definition of Lot Number

    Of the 125 commenters, 18 commented on the new definition of lot 
number; four were in favor of the proposed changes, and 14 were 
opposed. Of the four commenters who favored the proposed changes, two 
were trade associations, one domestic and one foreign; one was a 
fastener distributor; and one was a consultant. Of the 14 commenters 
who opposed the proposed changes, five were fastener manufacturers, 
four domestic and one foreign; three were domestic trade associations; 
three were government agencies; one was a fastener distributor; one was 
a fastener testing laboratory; and one was an other interested party.
    The proposed rule included a proposed amendment to the definition 
of ``lot number'' in Sec. 280.2 to include a number assigned by a 
manufacturer, importer, distributor, or significant alterer to the lot. 
Based on comments received, the Department has excluded the proposed 
definition of lot number and retained the original definition of lot 
number in the final rule. Based on the comments, for purposes of the 
Act and the regulations, there is only one lot number that is assigned 
by the manufacturer of fasteners or significant alterers, i.e., the lot 
number is unique to the manufacturer or significant alterer. 
Distributors and importers may use ``tracking numbers''; however, if 
the tracking number is used for lot identification, both lot number and 
tracking number must be used. Therefore, the Department has decided not 
to adopt the proposed change but to retain the existing rule, under 
which the ``Lot number means a number assigned by a manufacturer to the 
lot.''
    The following issues were highlighted by those that opposed the 
adoption of the new definition of lot number:

--Allowing distributors and importers to designate lot numbers will 
make it impossible for users to verify that the test report relates to 
the fasteners they receive, possibly requiring them to engage in costly 
retesting,
--The proposed rule would thwart enforcement efforts by creating gaps 
in the paper trail,
--The proposed rule would conflict with published consensus standards,
--The proposed rule would conflict with numerous Federal and State 
codes,
--The proposed rule would prevent product recalls,
--The proposed rule would make counterfeiting easier.

    These commenters suggested that the original manufacturer's lot 
number and any number assigned by an importer or distributor should be 
sent to the end user. Otherwise, merely requiring that a subsequent lot 
number be traceable to a manufacturer's lot number creates too great a 
possibility that traceability will be lost. These comments suggested 
that the lot number should be reserved for the number assigned to a lot 
by the manufacturer; distributors and importers may assign their own 
inventory number or tracking number or traceability number.
    Comment: One commenter suggested allowing alterers to deliver only 
the new lot number assigned by the alterer so long as it is traceable 
to the manufacturer's lot number.
    Response: The Department does not consider this to be an 
appropriate change because traceability would be questionable.
    Comment: A common theme among those who supported this proposed 
change in the definition of lot number is that distributors and 
importers that use their own lot numbers should be able to prove that 
those lot numbers link to manufacturer's lot numbers all the way back 
to ladle analysis, and there should be no provision allowing the 
fasteners to be sold without the manufacturer's original lot number.
    Response: No changes were made to the regulations based on these 
comments because importers and distributors can use a trace number to 
avoid confusion with the lot number that is assigned by manufacturers.
    Comment: One commenter asked how the two numbers should be 
identified.
    Response: The Department recommends that both numbers, the lot 
number assigned by the manufacturer and the trace number assigned by 
the distributor or importer, appear on the package and wherever the 
trace number appears.

6. Grandfathered Fasteners Issue

    In response to the notice of proposed rulemaking, NIST received 28 
comments on the issue of grandfathering, i.e., representing that 
fasteners produced prior to the implementation date of May 26, 1998 are 
in compliance with the Act and the regulations. Of the seven commenters 
that opposed any form of grandfathering, three were agencies of the 
U.S. Government, two were domestic fastener manufacturers, and one was 
a domestic trade association. Of the 21 commenters who suggested that 
grandfathering of different degrees should be allowed, 10 were fastener 
manufacturers, nine domestic and one foreign; five were domestic trade 
associations; three were fastener distributors; one was a foreign 
automobile manufacturer; and one was an other interested party.
    In the notice of proposed rulemaking, the Department proposed 
amending section 280.12(c) of the regulations by moving the last 
sentence of that section, which states that fasteners manufactured 
prior to the implementation date of the Act may not be represented as 
being in conformance with the Act or the regulations, to Sec. 280.602, 
Violations. Based on the comments and because as a prohibition on 
certain specific conduct, the language more appropriately belongs in 
the Violations section, the Department has included this change in the 
final rule, with appropriate modification to reflect the changes made 
to Sec. 280.12 that are described below.
    Although the commenters supported the proposed change, the comments 
NIST received offered a wide variety of alternative grandfathering 
solutions. The Department considered each of these, as well as other 
regulatory alternatives.
    The first and most crucial ``regulatory'' alternative for the 
disposition of pre-existing inventory is found in section 15 of the Act 
itself, which provides that the requirements of the Act apply only to 
fasteners manufactured after the implementation date of the regulation, 
now set at July 26, 1998. Thus, the sale of pre-existing inventory 
after the regulation becomes effective is legal, and the fasteners may 
properly be held out as complying with relevant standards and 
specifications.

[[Page 18270]]

    Five other regulatory alternatives have been considered by the 
Department during the current rulemaking. The genesis of the 
Department's consideration of the pre-existing inventory or 
``grandfathering'' issue, however, predates the promulgation of the 
final rule implementing the FQA on September 26, 1996. (See 61 FR 
50538.) During that rulemaking, NIST sought the advice of the Fastener 
Advisory Committee on the grandfathering issue, noting that the Act 
prohibited all parties from holding out fasteners in the pre-existing 
inventory as being compliant without the various lots of fasteners 
being retested. The Fastener Advisory Committee responded that 
fasteners in the pre-existing inventory, if not held out as FQA 
compliant, could still be sold after the implementation of the Act, 
meaning that the companies would suffer no economic loss on these 
fasteners. The Committee, also, however, recommended to NIST that 
finished fasteners manufactured prior to the implementation date be 
permitted to be retested to be in compliance with the FQA provided that 
all the associated requirements of law could be met for the lot of 
fasteners in question, such as the presence of the original set of 
certifications. The Committee also recommended a one year moratorium on 
the retesting of these fasteners to avoid shortages in the pipeline 
that could occur if pre-implementation material was put up for 
retesting at the same time as new complying material was put up for 
initial testing. There also was discussion of placing a time limit, 
i.e., three years or five years, on retesting of pre-implementation 
fasteners, but no conclusion was reached on this issue. The Fastener 
Advisory Committee reemphasized that if the holders of pre-existing 
inventory did not wish to incur the cost of the retesting after the 
proposed moratorium, the product would still be saleable in commerce 
under section 15 of the Act.
    Due to concerns about lot integrity and falsification of 
certification documents for pre-implementation fasteners, and the 
``bottle-necking'' concerns raised by the Fastener Advisory Committee, 
in the final regulations of September 26, 1996, NIST made no provision 
for the retesting of the pre-existing inventory. This effectively meant 
that the fasteners in the pre-existing inventory, when sold after the 
effective date of the regulations, could not be held out as FQA 
compliant.
    Following the September 8, 1997 notice of proposed rulemaking, the 
Department has considered the following alternative solutions to the 
grandfathering issue, each of which was supported by one or more 
comments:
    (1) Seven of the comments opposed any regulatory change that would 
permit fasteners manufactured before the effective date of the 
regulation to be held out as complying with the FQA. The Department 
views this as essentially a reaffirmation of the proposed change. Among 
the reasons stated for this position were: The inability of a procurer 
of fasteners to determine whether the fasteners were manufactured pre- 
or post-FQA; possible hindrance of the Government's ability to 
prosecute defective or counterfeit fastener cases currently being 
investigated; enforcement problems; the additional cost and demand on 
laboratories that retesting would cause; and the inability to 
``upgrade'' lots of fasteners produced to previous revisions of 
consensus standards to certify that they conform to the requirements of 
the current revisions.
    (2) One comment suggested that NIST permit new fasteners tested in 
a duly accredited FQA laboratory prior to the effective date of the 
regulation be permitted to be held out as FQA compliant. NIST deemed 
this alternative to be permissible under the FQA since the requirement 
of testing in a FQA accredited laboratory has been met.
    (3) Two comments suggested that the regulation be amended to permit 
fasteners to be held out as FQA compliant if they are included in lots 
of fasteners manufactured before the effective date of the regulation 
but subsequently tested or retested after the effective date of the 
regulation in FQA accredited laboratories. NIST deemed this alternative 
to be permissible under the FQA since the FQA requirement of testing in 
an FQA accredited laboratory has been met.
    (4) Eight comments suggested that since fasteners are manufactured 
to high standards, NIST should permit all fasteners manufactured prior 
to the effective date of the regulation to be held out as FQA 
compliant, regardless of whether the fasteners were ever tested in a 
laboratory, accredited or otherwise. NIST has rejected this alternative 
because the FQA requires that fasteners must be tested by an accredited 
laboratory to be deemed FQA compliant. Hence, this alternative is not 
permissible by law, since it does not require testing.
    (5) Six comments suggested that fasteners manufactured prior to the 
effective date be deemed to be FQA compliant after a ``paperwork'' 
review of laboratory records. NIST has rejected this alternative 
because the FQA requires that fasteners must be tested by an FQA 
accredited laboratory to be deemed FQA compliant. Hence, this 
alternative is not permissible by law, since the tests being reviewed 
were not conducted by FQA accredited laboratories.
    (6) The recommendation of the Fastener Advisory Committee received 
no comment, but is the sixth alternative considered by NIST.
    Thus, NIST was left with four lawful alternatives, options (1), 
(2), (3), and (6) above. Based upon the public comments, NIST believes 
that the weight of the evidence supports the view that some form of 
grandfathering beyond option (1) is appropriate. Accordingly, NIST has 
decided to proceed immediately with option (2) and has included this 
option in the final rule in Secs. 280.12 (d) and (e). Section 280.12(d) 
allows that ``fasteners manufactured on or after May 14, 1998 may be 
represented, sold, or offered for sale as complying with the Act and 
these regulations if they are tested and certified by a laboratory 
appearing on the Accredited Laboratory List * * * and meet all other 
requirements of the Act and this part.'' Section 280.12(e) allows that 
``fasteners manufactured on or after May 14, 1998 by a Facility listed 
on the Facilities List may be represented, sold, or offered for sale as 
complying with the Act and regulations'' if the Facility meets the 
requirements of Sec. 280.810(c)(3).
    NIST does not believe that the existing record permits it to 
endorse either option (3) or (6).

7. Paperwork Reduction Act and Regulatory Flexibility Act

    Various commenters questioned the statements made in the preamble 
to the proposed rule regarding the Paperwork Reduction Act or the 
Regulatory Flexibility Act or both. In general, these commenters stated 
that the Department understated the cost to industry to comply with the 
Act and regulations and the impact that those costs would have on small 
businesses. The costs cited in these comments included the costs of 
scrapping inventories and disruptions to supply because customers would 
not accept preimplementation fasteners on or after the implementation 
date, the costs of obtaining laboratory accreditation or using an 
accredited laboratory, the costs of testing small lots, the costs of 
added paperwork and storage of records. Two specific proposals were 
made in regard to this issue. One proposal was to form a joint 
government-industry task force to measure the costs of compliance. The 
other proposal was to conduct an in-

[[Page 18271]]

depth analysis of the negative impact on distributors and manufacturers 
under the Regulatory Flexibility Act and publish it for public comment. 
Several commenters recommended delaying implementation of regulations 
because of the costs to industry. The Department notes that all of the 
concerns cited above relate to the cost of complying with the existing 
rule. The final rule creates an option for fastener manufacturers to 
use, in certain instances, instead of the existing rule. Any costs 
associated with developing a registered fastener QAS would not be 
affected by the costs of complying with the existing rule. Therefore, 
the Department is not delaying the implementation of the regulations 
due to this issue.
    Comment: Two trade organizations commented that the cost of raw 
material analysis obtained by coil analysis is disproportionately high 
for small producers.
    Response: No change is made based on this comment. The requirements 
for raw material analysis and reports under the Act are the same for 
large producers and small producers. Under the revised regulations, 
small firms may obtain raw material analysis reports from either the 
laboratory that conducted the tests or from the metal manufacturer.

Part 3: Comments Received Regarding Issues Not Presented for Public 
Comment in the Notice of Proposed Rulemaking

    The Department received many comments on issues that were not 
presented for public comment in the notice of proposed rulemaking. 
These issues included: Repeal the Fastener Quality Act, amend the 
Fastener Quality Act, deem compliance with other regulations to be 
compliance with the Fastener Quality Act, create exemptions to the 
coverage of the Act and regulations, and define more terms. The 
Department will not respond to these comments at this time because they 
were not presented for public comment in the notice of proposed 
rulemaking but will retain these comments for possible action at a 
later date.

Additional Information

Executive Order 12866

    This rule has been determined not to be significant under section 
3(f) of Executive Order 12866.

Executive Order 12612

    This rule does not contain policies with Federalism implications 
sufficient to warrant preparation of a Federalism assessment under 
Executive Order 12612.

Regulatory Flexibility Act

    The Assistant General Counsel for Legislation and Regulation of the 
Department of Commerce certified to the Chief Counsel for Advocacy of 
the Small Business Administration that this rule will not have a 
significant economic impact on a substantial number of small entities. 
NIST received one comment, addressed above, regarding this 
certification. This comment did not cause a change in the determination 
regarding the certification. As a result, no final regulatory 
flexibility analysis was prepared.

Paperwork Reduction Act

    Notwithstanding any other provision of the Act, no person is 
required to respond to, nor shall any person be subject to a penalty 
for failure to comply with a collection-of-information, subject to the 
requirements of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., 
unless that collection of information displays a currently valid Office 
of Management and Budget (OMB) control number.
    This rule contains collections of information subject to the 
requirements of the Paperwork Reduction Act that have been cleared 
under OMB Control Nos. 0693-0015 and 0693-0026. The public reporting 
burden for the self-certification of QAS fastener manufacturing 
facilities is approximately four hours: The provisional registration is 
estimated at three hours, and one hour for the associated recordkeeping 
requirements. Send comments regarding these burden estimates or any 
other aspect of the data requirements, including suggestions for 
reducing the burden to the Office of Information and Regulatory 
Affairs, Office of Management and Budget, Washington, DC 20230 
(Attention: NIST Desk Officer) and to NIST (Attention: FQA Program 
Manager, NIST, Building 820, Room 306, National Institute of Standards 
and Technology, Gaithersburg, MD 20899).

National Environmental Policy Act

    This rule will not significantly affect the quality of the human 
environment. Therefore, an environmental assessment or Environmental 
Impact Statement is not required to be prepared under the National 
Environmental Policy Act of 1969.

List of Subjects in 15 CFR Part 280

    Business and industry, Fastener industry, Imports.

    Dated: April 3, 1998.
Robert E. Hebner,
Acting Deputy Director, National Institute of Standards and Technology.

    Dated: April 3, 1998.
William A. Reinsch,
Under Secretary for Export Administration.

    For reasons set forth in the preamble, Title 15 of the Code of 
Federal Regulations part 280 is amended as follows:

PART 280--FASTENER QUALITY

    1. The authority for part 280 continues to read as follows:

    Authority: Sec. 13 of the Fastener Quality Act (Pub. L. 101-592, 
as amended by Pub. L. 104-113).

    2. Section 280.1 is amended by adding paragraph (d) to read as 
follows:


Sec. 280.1  Purpose/description of rule.

* * * * *
    (d) Delegations of authority. The Secretary of Commerce has 
delegated authority to the Director, National Institute of Standards 
and Technology to promulgate regulations in this part under sections 5 
through 8 of the Fastener Quality Act (15 U.S.C. 5404-5407). In 
addition, the Secretary of Commerce has delegated concurrent authority 
to the Under Secretary for Export Administration to amend the 
regulations issued under sections 5 through 7 of the Act, regarding 
enforcement. The Secretary of Commerce has also delegated concurrent 
authority to amend the regulations issued under section 8 of the Act, 
regarding recordal of insignias, to the Assistant Secretary and 
Commissioner of Patents and Trademarks.
    3. Section 280.2 is amended by revising the definitions for 
accreditation, consensus standards organization, and original 
laboratory testing report, and adding the remaining definitions as set 
forth below:


Sec. 280.2  Definitions.

* * * * *
    Accreditation for purposes of the Act and this part means 
accreditation of a testing laboratory or the registration of a fastener 
manufacturing facility employing a quality assurance system (a 
Facility).
* * * * *
    Accredited registrar means a registrar, as defined in this part, 
that is accredited by a recognized accreditor and appears on the 
Registrars List described in section 280.810(b).
* * * * *

[[Page 18272]]

    Accreditor means a Registrar accreditation body that meets the 
requirements of subpart K of this part.
* * * * *
    Authorized representative means an employee of an organization who 
is authorized by that organization to speak on its behalf for purposes 
of the Act and this part.
* * * * *
    Certified Copy (of a laboratory testing report) means a complete 
and accurate copy of the original laboratory testing report, which 
contains a statement describing it as an accurate and complete copy of 
the original and which is signed by an authorized representative of the 
accredited laboratory issuing the report or, in the case of metal 
chemistry testing reports, an authorized representative of the metal 
manufacturer.
* * * * *
    Consensus standards organization means the American Society for 
Testing and Materials (ASTM), American National Standards Institute 
(ANSI), American Society of Mechanical Engineers (ASME), Society of 
Automotive Engineers (SAE), or any other consensus standards setting 
organization (domestic or foreign) publicly identified by NIST as 
having comparable knowledge, expertise, and concern for the health and 
safety in the field for which such organization purports to set 
standards.
* * * * *
    Facility means a fastener manufacturing facility, or a facility 
performing subcontracted processes for a fastener manufacturing 
facility, implementing a fastener quality assurance system as defined 
in this part.
* * * * *
    Fastener Quality Assurance System (QAS). (1) Fastener Quality 
Assurance System (QAS) means a fastener manufacturing system that has 
as a stated goal the prevention of defects through continuous 
improvement, and which seeks to attain that goal by incorporating:
    (i) Advanced quality planning;
    (ii) Monitoring and control of the manufacturing process;
    (iii) Process inspection embodied in a comprehensive and written 
control plan for product/process characteristics, process controls 
(including statistical process control), tests, and measurement systems 
that will occur during mass production; and
    (iv) The creation, maintenance, and retention of electronic, 
photographic, or paper records, available for inspection during the 
periods required by section 10 of the Act and Sec. 280.7 of this part, 
regarding the inspections, tests, and measurements required by or 
performed pursuant to the control plan.
    (2) A Fastener Quality Assurance System contains the following 
elements at a minimum:
    (i) A documented quality management system that satisfies the 
requirements of ISO-9001 ``Quality Systems--Model for quality assurance 
in design, development, production, installation and servicing,'' ISO-
9002 ``Quality Systems--Model for quality assurance in production, 
installation and servicing,'' or other quality system standards that 
incorporate ISO-9001 or ISO-9002 (e.g. QS-9000, AS-9000, etc.);
    (ii) A requirement that raw material certification supplied to the 
fastener manufacturer shall be traceable to that of a mill heat of 
material that has been tested by a laboratory on the Accredited 
Laboratory List;
    (iii) A requirement that subcontracted processes, including plating 
and heat treating, are controlled by the manufacturer, to avoid product 
lot contamination, and that finished lots of fasteners shall be 
traceable to subcontracted processes performed by a registered Facility 
on the Facilities List described in Sec. 280.810 of tested by a 
Laboratory on the Laboratories List described in Sec. 280.101;
    (iv) A requirement that the fastener manufacturer fully document 
fastener sampling and inspection points and an in-process control plan 
that emphasizes defect prevention, relates frequency of inspection, 
corrective action for nonconforming characteristics, and sampling 
frequency and sample size; a requirement that the control plan be made 
available to the customer upon request and shall identify those 
standards and specifications upon which the plan is based; and
    (v) A requirement that the in-process control plan include those 
characteristics specified by the QAS standard, characteristics 
specifically indicated by applicable fastener standards and 
specifications, and those characteristics as designated by the end user 
for evaluating product functionality.
* * * * *
    Original laboratory testing report means: (1) In general, a 
laboratory testing report which is originally signed by an approved 
signatory or is a copy thereof, certified by the laboratory that 
conducted the test; or
    (2) For purposes of the alternative procedures for chemical 
characteristics described in section 5(d) of the Act and Sec. 280.15 of 
this part only, a laboratory testing report which is originally signed 
by an approved signatory or is a copy thereof, certified by the 
laboratory that conducted the test or by the metal manufacturer.
* * * * *
    Recognized accreditor means an accreditor, as defined in this part, 
that is recognized by NIST and appears on the Accreditors List 
described in Sec. 280.810(a).
* * * * *
    Registered facility means a facility, as defined in this part, that 
is registered by an accredited registrar and appears on the Facilities 
List described in Sec. 280.810(c).
* * * * *
    Registrar means a quality systems Registrar that meets the 
requirements of subpart L of this part.
* * * * *
    Registration means evaluation and certification of a manufacturing 
facility as competent to carry out and conforming to the applicable 
requirements of a Fastener Quality Assurance System when such 
evaluation and certification is performed by a Registrar as defined in 
this part.
* * * * *
    Significantly alter means to alter or take any other action which 
could weaken or otherwise materially affect the performance or 
capabilities of the fastener as it was originally manufactured, grade 
or property class marked, tested, or represented. The term does not 
include the application of adhesives or sealants, locking elements, 
provisions for lock wires, coatings and platings of parts having a 
minimum specified Rockwell C hardness of less than 32, or cutting off 
of fasteners. The cutting of finished threaded rods, bars or studs to 
produce individual smaller length threaded studs for resale is not a 
significant alteration. However, cut threaded studs, rods, and bars 
offered for sale shall be individually marked with the grade or 
property class identification marking appearing on or accompanying the 
original threaded studs, rods, and bars from which the fasteners were 
cut.
* * * * *
    4. Section 280.6 is revised to read as follows:


Sec. 280.6  Laboratory test reports.

    (a) When performing tests for which they are accredited under this 
part, each laboratory accredited under subparts C, D, or E of this part 
and currently listed in the Accredited Laboratory List shall issue test 
reports of its work which accurately, clearly, and unambiguously 
present the test conditions, test set-up,

[[Page 18273]]

test results, and all information required by this section. All reports 
must be in English or be translated into English, must be signed by an 
approved signatory, must be protected by a tamper resistant system, and 
contain the following information:
    (1) Name and address of the laboratory;
    (2) Unique identification of the test report including date of 
issue and serial number, or other appropriate means;
    (3) Name and address of client;
    (4) Fastener Description, including:
    (i) Manufacturer (name and address);
    (ii) Product family (screw, nut, bolt, washer, or stud), drive and/
or head configurations as applicable;
    (iii) Date of manufacture;
    (iv) Head markings (describe or draw manufacturer's recorded 
insignia and grade identification or property class symbols);
    (v) Nominal dimensions (diameter; length of bolt, screw or stud; 
thickness of load indicating washer); thread form and class of fit;
    (vi) Product standards and specifications related to the laboratory 
in writing by the manufacturer, importer or distributor;
    (vii) Lot number;
    (viii) Specification and grade of material;
    (ix) Coating material and standard and specification as applicable;
    (5) Sampling information:
    (i) Standards and specifications or reference for sampling scheme;
    (ii) Final manufacturing lot size;
    (6) Test Results:
    (i) Test results for each sample;
    (ii) All deviations from the test method;
    (iii) All other items required on test reports according to the 
test method;
    (iv) Where the report contains results of tests performed by sub-
contractors, these results shall be clearly identified along with the 
name of the laboratory and accreditation information listed in 
paragraph (a)(10) of this section.
    (v) A statement that the samples tested either conform or do not 
conform to the fastener standards and specifications and identification 
of any nonconformance, except as provided for in Secs. 280.13 and 
280.14;
    (7) A statement that the report must not be reproduced except in 
full;
    (8) A statement to the effect that the test report relates only to 
the item(s) tested;
    (9) Name, title and signature of approved signatory accepting 
technical responsibility for the tests and test report;
    (10) The name of the body which accredited the laboratory for the 
specific tests performed which are the subject of the report, and code 
number assigned to the laboratory by the accreditation body, and the 
expiration of accreditation.
    (b) When performing tests for which they are registered under this 
part, each facility registered under subpart I or J of this part and 
currently listed in the Facilities List shall issue test reports of its 
work which accurately, clearly, and unambiguously present test results, 
and all information required by this section. In addition, the 
facilities shall attach reports of chemical characteristics and any 
report of the tests conducted in a laboratory under the accredited 
laboratories list. All reports must be in English or be translated into 
English, must be signed by an approved signatory, must be protected by 
a temper resistant system, and contain the following information:
    (1) Name and address of the facility;
    (2) Unique identification of the test report, including date of 
issue and serial number, or other appropriate means including 
references to control plan identification;
    (3) Name and address of client, if applicable;
    (4) Fastener Description, including:
    (i) Manufacturer (name and address);
    (ii) Product family (screw, nut, bolt, washer, or stud), drive and/
or head configurations as applicable;
    (iii) Date of manufacture;
    (iv) Head markings (describe or draw manufacturer's recorded 
insignia and grade identification or property class symbols);
    (v) Nominal dimensions (diameter; length of bolt, screw or stud; 
thickness of load bearing washer); thread form and class of fit;
    (vi) Product standards and specifications related to the facility 
in writing by the manufacturer, importer or distributor;
    (vii) Lot number;
    (viii) Specification and grade of material;
    (ix) Coating material and standard and specification as applicable;
    (5) Sampling information:
    (i) Standards and specifications or reference for sampling scheme;
    (ii) Final manufacturing lot size;
    (iii) Identification of control plan governing production of the 
lot to which the test report is applicable;
    (6) Test Results:
    (i) Test results of actual tests required by applicable fastener 
standards and specifications, and characteristics designated by the end 
user;
    (ii) All deviations from the test method;
    (iii) All other items required on test reports according to the 
applicable fastener standards and specifications, and characteristics 
designated by the end user;
    (iv) Where the report contains results of tests performed by sub-
contractors, these results shall be clearly identified along with the 
name of the laboratory/facility and accreditation/registration 
information listed in paragraph (b)(9) of this section.
    (v) Where all processes under the applicable QAS were found to be 
in accordance with the inspections, tests and measurements required by 
the standards and specifications and the QAS and characteristics 
designated by the end user, a statement that the samples tested conform 
to the applicable fastener standards and specifications;
    (vi) Where any process under the applicable QAS was found not to be 
in accordance with the inspections, tests, or measurements required by 
such QAS, a statement that the samples tested do not conform to the 
applicable fastener standards and specifications and identification of 
any nonconformance;
    (7) A statement that the report must not be reproduced except in 
full;
    (8) Name, title and signature of approved signatory accepting 
technical responsibility for the tests and test report;
    (9) The name of the registrar which registered the facility, and 
code number assigned to the facility by the registrar, and the 
expiration of registration.
    (c) For alternative chemical tests carried out under Sec. 280.15 of 
this part, each laboratory accredited under subparts C, D, or E of this 
part and currently listed in the Accredited Laboratory List shall 
provide to the fastener manufacturer, either directly or through the 
metal manufacturer, a written inspection and testing report containing 
all required information. All reports must be in English or be 
translated into English, must be signed by an approved signatory, must 
be protected by a tamper resistant system, and contain the following 
information:
    (1) Name and address of the laboratory;
    (2) Unique identification of the test report including date of 
issue and serial number or other appropriate means;
    (3) Name and address of client;
    (4) Coil or heat number of metal being tested;
    (5) Test Results:
    (i) Actual tests required by the standards and specifications;
    (ii) Test results for such coil or heat number chemical 
characteristics;
    (iii) All deviations from the test method;
    (iv) All other items required on test reports according to the test 
method;

[[Page 18274]]

    (v) Where the report contains results of tests performed by sub-
contractors, these results shall be clearly identified along with the 
name of the laboratory and accreditation information listed in 
paragraph (c)(9) of this section.
    (vi) A statement that the samples tested either conform or do not 
conform to the metal standards and specifications and identification of 
any nonconformance;
    (6) A statement that the report must not be reproduced except in 
full;
    (7) A statement to the effect that the test report relates only to 
the item(s) tested;
    (8) Name, title and signature of approved signatory accepting 
technical responsibility for the tests and test report;
    (9) The name of the body which accredited the laboratory for the 
specific tests performed which are the subject of the report, and code 
number assigned to the laboratory by the accreditation body, and the 
expiration of accreditation.
    (d) The laboratory shall issue corrections or additions to a test 
report only by a further document suitably marked, e.g., ``Supplement 
to test report serial number * * *.'' This document must specify which 
test result is in question, the content of the result, the explanation 
of the result, and the reason for acceptance of the result.
    (e) For tests carried out by a Facility registered pursuant to 
subpart I or J of this part, the Facility shall maintain laboratory 
test reports in the forms of electronic, photographic, or paper 
records, available for inspection during the periods required by 
section 10 of the Act and Sec. 280.7 of this part, regarding the 
inspections, tests, and measurements required or performed pursuant to 
the QAS control plan.
    5. Section 280.7 is amended by revising paragraph (a) to read as 
follows:


Sec. 280.7  Recordkeeping requirements.

    (a) Each laboratory accredited under subparts C, D, or E or 
Sec. 280.104 of this part shall retain for 5 years after the 
performance of a test all records pertaining to that test concerning 
the inspection and testing, and certification, of fasteners under the 
Act and this part. The final test report or the test records maintained 
by the laboratory shall contain sufficient information to permit the 
test to be repeated at a later time if a retest is necessary. The 
laboratory shall maintain the test report and a record of all original 
observations, calculations, and derived data. The records shall include 
the identity of personnel performing the testing. Procedures for 
storage and retrieval of records must be documented and maintained in 
the laboratory's quality manual.
* * * * *
    6. Section 280.10 is revised to read as follows:


Sec. 280.10  Sampling.

    (a) For tests conducted either in a laboratory on the Accredited 
Laboratory List or in a Registered Facility, if a manufacturer 
represents that the fasteners in a particular sample have been 
manufactured to a standard or specification which provides for the 
size, selection or integrity of the sample to be inspected and tested, 
the sample shall be determined in accordance with that standard or 
specification.
    (b) For tests conducted in a laboratory on the Accredited 
Laboratory List, if a manufacturer represents that the fasteners in a 
particular sample have been manufactured to a standard or specification 
which does not provide for the size, selection or integrity of the 
sample to be inspected and tested, the sample shall be determined in 
accordance with the sampling plan provided by ASME/ANSI B18.18.2M, 
Inspection and Quality Assurance For High-Volume Machine Assembly 
Fasteners; ASME/ANSI B18.18.3M, Inspection and Quality Assurance for 
Special Purpose Fasteners; or ASME/ANSI B18.18.4M, Inspection and 
Quality Assurance for Highly Specialized Engineering Applications--
Fasteners.
    (c) For tests conducted in a Registered Facility, and not in a 
laboratory on the Accredited Laboratory List, if a manufacturer 
represents that the fasteners in a particular sample have been 
manufactured to a standard or specification which does not provide for 
the size, selection or integrity of the sample to be inspected and 
tested, the sample for inspections and tests by the Facility shall be 
determined by the sampling plan provided by its Fastener Quality 
Assurance System or by standards and specifications intended for use 
with a Fastener Quality Assurance System, as appropriate. Or, a 
manufacturer operating a Registered Facility may elect to conduct 
inspections and tests upon all of the fasteners within a specified lot, 
provided that this election is documented in the control plan of its 
Fastener Quality Assurance System.
    7. Section 280.11 is amended by revising paragraph (b) to read as 
follows:


Sec. 280.11  Significant alterations of fasteners.

* * * * *
    (b) If the significant alteration is only electroplating of 
fasteners having a minimum specified Rockwell C hardness of 32 or 
above, the requirements set forth in paragraphs (a)(2) and (a)(3) of 
this section shall not apply, but the alterer shall assign a new lot 
number as set forth in paragraph (a)(1) of this section and shall test 
the electroplated fasteners as required by the plating standards and 
specifications.
* * * * *
    8. Section 280.12 is revised to read as follows:


Sec. 280.12  Applicability.

    (a) The requirements of the Fastener Quality Act and this part 
shall be applicable only to fasteners manufactured on or after July 26, 
1998.
    (b) Metal manufactured prior to July 26, 1998 may not be used to 
manufacture fasteners subject to the Act and this part unless the metal 
has been tested for chemistry pursuant to Sec. 280.15 of this part by a 
laboratory accredited under the Act and this part and the chemical 
characteristics of the metal conform to those required by the standards 
and specifications.
    (c) Nothing in the Act and this part prohibits selling finished 
fasteners manufactured prior to July 26, 1998 or representing that such 
fasteners meet standards and specifications of a consensus standards 
organization or a government agency.
    (d) Fasteners manufactured on or after May 14, 1998, may be 
represented, sold, or offered for sale as complying with the Act and 
these regulations if they are tested and certified by a laboratory 
appearing on the Accredited Laboratory List described in Sec. 280.101, 
and meet all other requirements of the Act and this part.
    (e) Fasteners manufactured on or after May 14, 1998, by a Facility 
listed on the Facilities List may be represented, sold, or offered for 
sale as complying with the Act and these regulations upon NIST's 
acknowledgment of receipt of the items required in Sec. 280.810(c)(3).
    9. Section 280.104 is added to subpart B to read as follows:


Sec. 280.104  Accreditation of certain manufacturing facilities as 
laboratories.

    (a) Subject to the limitations contained in paragraphs (b), (c), 
and (d) of this section, registration of a fastener manufacturing 
facility employing a fastener quality assurance system shall be deemed 
to meet the requirements of accreditation of a laboratory for purposes 
of the Act and this part. The independent third-party Registrar 
registering such facility under this section shall comply with all 
procedures set forth in subparts I through L of this part. Records

[[Page 18275]]

documenting the inspection and testing of a lot of fasteners performed 
by such an accredited laboratory shall be maintained by the facility in 
accordance with the requirements of Secs. 280.6, 280.808, and 280.809 
of this part.
    (b) In any instance where a Facility accomplishes any in-process 
inspection and testing by performing laboratory tests on a sample of 
fasteners at any stage in the manufacturing process, those tests must 
be conducted by a laboratory on the Accredited Laboratory List. Such a 
laboratory may be located on the same premises as a fastener 
manufacturing facility if the laboratory is separately accredited 
pursuant to a provision of this part other than Sec. 280.104(a).
    (c) Any laboratory tests performed outside the Facility's in-
process inspection and testing must be conducted by a laboratory on the 
Accredited Laboratory List.
    (d) Chemical and raw material testing must be performed by a 
laboratory on the Accredited Laboratory List.
    10. Section 280.602 is amended by revising paragraphs (e)(2), (h), 
and (j) and adding paragraphs (k), (l), (m), (n), and (o) to read as 
follows:


Sec. 280.602  Violations.

* * * * *
    (e) Misrepresentation and concealment of facts. * * *
    (2) In connection with the preparation, submission, use, or 
maintenance of a laboratory test report, certificate of conformance as 
described in Secs. 280.5 and 280.6 of this part, or any quality 
assurance system document required by this part or;
* * * * *
    (h) Falsification of documents relating to accreditation of 
laboratories or registrars or approval or recognition of accreditors or 
accreditation bodies. No person shall falsify or make any false or 
misleading statement on or in connection with any document relating to 
laboratory accreditation or approval or recognition of accreditation 
bodies, Accreditors or Registrars as required by section 6(a) or 6(b) 
of the Act or this part.
* * * * *
    (j) Falsification of laboratory accreditation, accreditation body 
or accreditor. No person shall falsely claim to be an accredited 
laboratory or approved or recognized accreditation body or Accreditor 
as described in section 6 of the Act or subparts B, C, D, E, I and J of 
this part.
    (k) Sale of fasteners manufactured prior to the implementation date 
as compliant with the Act. No person shall represent, sell, or offer 
for sale fasteners manufactured prior to July 26, 1998 as being in 
conformance with the Act or this part except as provided for in 
Sec. 280.12(d) or (e) of this part.
    (l) Failure to assign lot number traceable to manufacturer's 
single, unique lot number. No importer, distributor, or significant 
alterer shall assign a lot number unless the assigned lot number is 
traceable to a manufacturer's single, unique lot number.
    (m) Falsification of documents relating to the registration of 
fastener manufacturing facilities as accredited laboratories, 
accreditation of registrars or recognition of accreditors. No person 
shall falsify or make any false or misleading statement on or in 
connection with any document relating to the registration of Fastener 
Manufacturing Facilities as accredited laboratories, accreditation of 
Registrars or recognition of Accreditors as required by subparts I, J, 
K, and L of this part.
    (n) False claim of registration of fastener manufacturing 
facilities as accredited laboratories, accreditation of registrars, and 
recognition of accreditors. No person shall falsely claim to be a 
registered Fastener Manufacturing Facility, an accredited Registrar, or 
a recognized Accreditor as described by subparts I, J, K, and L of this 
part.
    (o) Falsification of documents relating to the certification of FOA 
compliance required for provisional listing on the Facilities List. No 
person shall falsify or make any false or misleading statement on or in 
connection with any document relating to the certification of FQA 
compliance required for provisional listing on the Facilities List 
pursuant to Sec. 280.810(c)(3).
    11. Subparts I through L are added to read as follows:

Subpart I--Special Rule for the Accreditation of Certain Fastener 
Manufacturing Facilities, Whose Implemented Fastener Quality Assurance 
Systems Meet Defined Requirements, as Laboratories

Sec.
280.800  Introduction.
280.801  Application.
280.802  Review and decision process.
280.803  Criteria for recognition.
280.804  Maintaining recognized status.
280.805  Voluntary termination of recognition.
280.806  Involuntary termination of recognition by NIST.
280.807  Subcontracting.
280.808  Reports.
280.809  Record keeping.
280.810  Listing of recognized accreditors, accredited Registrars, 
and registered facilities.
280.811  Removal from a list.
280.812  Appeal.

Subpart I--Special Rule for the Accreditation of Certain Fastener 
Manufacturing Facilities, Whose Implemented Fastener Quality 
Assurance Systems Meet Defined Requirements, as Laboratories


Sec. 280.800  Introduction.

    (a) This special rule applies to those fastener manufacturers, 
employing a fastener quality assurance system (QAS) as defined in this 
part, who wish to seek accreditation of the particular manufacturing 
facility employing the QAS as a laboratory within the meaning of the 
Act. This rule consists of this subpart, and subparts J, K and L of 
this part. The rule adopts the view that a fastener manufacturing 
facility is deemed to be an accredited laboratory for purposes of the 
Act and this part if such facility employs a fastener quality assurance 
system (QAS) that has been formally registered by a NIST-recognized 
quality systems Registrar. The rule applies only to facilities 
manufacturing fasteners; raw materials for fastener manufacture must be 
tested and certified by a laboratory listed on the Accredited 
Laboratory List. This Subpart sets out the full process that NIST 
requires for the accreditation of a fastener manufacturing facility 
employing a QAS in the United States: A fastener manufacturing facility 
employing a QAS (a ``Facility'') will be deemed to be an accredited 
laboratory if it is registered by a Quality Systems Registrar (a 
``Registrar'') that in turn has been accredited by a Registrar 
Accreditation Body (an ``Accreditor'') that has been recognized by 
NIST. Subpart J provides for foreign Accreditors to be recognized and 
to recognize Registrars under the same procedures.
    (b) A chain is thus established to assure the proper regulation of 
Facilities: NIST recognizes Accreditors that meet the requirements of 
subpart K of this part, which is based upon ISO Guide 61; the NIST-
recognized Accreditors may in turn accredit Registrars that meet the 
requirements of subpart L of this part, which is based upon ISO Guide 
62. The Registrars, in turn, may register Facilities that satisfy the 
elements of a fastener quality assurance system (QAS), as defined in 
this part.
    (c) Within this subpart, Secs. 280.801 through 280.809 contain the 
procedures that NIST uses to process requests from Accreditors for 
recognition by NIST.

[[Page 18276]]

Section 280.810 establishes three lists that NIST will maintain: 
Section 280.810(a) provides for a list of Accreditors that have been 
recognized by NIST; Sec. 280.810(b) provides for a list of Registrars 
that have been accredited by Accreditors listed according to 
Sec. 280.810(a); and Sec. 280.810(c) provides for a list of Facilities 
that have been registered by Registrars listed according to 
Sec. 280.810(b). The remainder of this subpart, Secs. 280.811 and 
280.812, contain procedural provisions related to the lists established 
by Sec. 280.810.


Sec. 280.801  Application.

    (a) Application must be made by Accreditors to NIST for recognition 
to accredit Registrars under the Act. Upon request, NIST will provide 
application forms and instructions. The applicant shall complete the 
application in English and may provide whatever additional enclosures, 
attachments or exhibits the applicant deems appropriate.
    (b) Application packages may be obtained from: Manager, FQA 
Accreditation Body Evaluation Program, NIST, Bldg. 820, Room 282, 
Gaithersburg, Maryland 20899. Requests may be made by mail or by FAX 
to: (301) 963-2871.
    (c) The applicant shall reimburse NIST for all costs incurred in 
the evaluation of its accreditation program and subsequent costs 
incurred in ensuring the continued compliance of its program. 
Reimbursement shall be in accordance with the fee schedule established 
by NIST for this purpose.
    (d) An application may be revised by an applicant at any time prior 
to the final decision by NIST. An application may be withdrawn by an 
applicant, without prejudice, at any time prior to the final decision 
by NIST.


Sec. 280.802  Review and decision process.

    (a) Applications submitted by Accreditors will be accepted by NIST 
and their receipt acknowledged in writing. The applications will be 
reviewed by NIST against the criteria specified in this subpart and in 
subpart K of this part. NIST may request additional information as 
needed from the applicant.
    (b) NIST shall conduct on-site assessments of the facilities of the 
applicant including all of the applicant's organizational units and 
locations covered by the application.
    (c) If the applicant's program is deemed by NIST to have met the 
requirements for recognition, the applicant shall be notified by NIST 
in writing. The recognition notice shall include the date when the 
recognition begins and the scope of the recognition. The recognition 
period shall be for as long as the Accreditor continues to satisfy the 
requirements of Sec. 280.803. As part of maintaining its approved 
status, each Accreditor shall agree to be reassessed by NIST every two 
years following its initial notice of recognition. NIST will maintain 
and make available to the public a list of recognized Accreditors.
    (d) If the applicant does not meet the requirements for 
recognition, the applicant shall be notified in writing, listing the 
specific requirements from this subpart and subpart K of this part 
which the applicant's program has not met. After receipt of such a 
notification, and within the response period provided by NIST, the 
applicant may:
    (1) Submit additional information for further review. Reviewing the 
new submission may involve additional on-site visits by NIST personnel. 
Additional fees may be required. Or,
    (2) Submit a request that the original application be reconsidered, 
including a statement of reasons why the applicant should have been 
recognized.


Sec. 280.803  Criteria for recognition.

    An applicant for NIST recognition must demonstrate the ability to 
operate a registrar accreditation program consistent with the 
requirements of this subpart and subparts A and K of this part, and 
accredit registrars of Facilities to requirements set out in subpart L 
of this part.


Sec. 280.804  Maintaining recognized status.

    (a) Accreditors shall continue to satisfy all the requirements of 
recognition during the recognition period.
    (b) Upon request, recognized Accreditors shall make available to 
NIST and/or BXA all records and materials pertaining to the program.
    (c) NIST has the right to participate as an observer during any on-
site visit to a Registrar being audited by a NIST-recognized 
Accreditor, or a Facility being audited by an accredited Registrar, or 
it may perform its own surveillance visit of such bodies at its 
discretion.
    (d) Neither the Accreditor, nor any Registrar it accredits, nor any 
Facility registered under the Act and this part shall take any action 
which states or implies the approval, or endorsement by NIST or any 
other agency of the U.S. Federal Government of any product or report 
pertaining to a product associated with any activities carried out 
under the recognition. None of these entities may take any action which 
states or implies that they are recognized or authorized by NIST to act 
or perform in any area(s) beyond that which was specified in their 
recognition under this part.


Sec. 280.805  Voluntary termination of recognition.

    An Accreditor may voluntarily terminate its recognition by giving 
written notice to NIST and to all Registrars accredited by that body 
under its accreditation program. The written notice shall state the 
date on which the termination will take effect.


Sec. 280.806  Involuntary termination of recognition by NIST.

    (a) NIST may terminate or suspend its recognition of an Accreditor 
if such an action is deemed to be in the public interest.
    (b) Before terminating the recognition of an Accreditor, NIST will 
notify the Accreditor in writing, giving it the opportunity to rebut or 
correct the stated reasons for the proposed termination. If the 
problems are not corrected or reconciled within 30 days, or such longer 
time as NIST in its sole discretion may grant, the termination shall 
become effective.
    (c) An Accreditor may appeal a termination to the Director by 
submitting a statement of reasons why the recognition should not be 
terminated. NIST may, at its discretion, hold in abeyance the 
termination action pending a final decision by the Director. Within 60 
days following receipt of the appeal, the Director shall inform the 
Accreditor in writing of his or her decision.
    (d) Registrars and registered organizations which have been listed 
by NIST in accordance with this Subpart, based on their accreditation 
by an Accreditor whose recognition has been terminated, shall be 
removed from the list, unless an exception is granted by NIST.


Sec. 280.807  Subcontracting.

    If a recognized Accreditor, an accredited Registrar, or a 
registered Facility subcontracts any of its functions to another entity 
it must place the work with another recognized Accreditor, accredited 
Registrar, or registered Facility; inform the client, before the fact, 
that subcontracting will be necessary, and clearly indicate in all 
appropriate records, and reports to the client, specifically what 
functions were subcontracted.


280.808  Reports.

    Reports and records shall be maintained in such a manner to 
preserve original data, and be collected as required into a final form, 
sufficient to satisfy customer and legal

[[Page 18277]]

requirements. Such reports shall be provided upon request to the Bureau 
of Export Administration, to the National Institute of Standards and 
Technology, or to any other agency of the federal government authorized 
to obtain such records under this part.


Sec. 280.809  Recordkeeping.

    Each recognized Accreditor, accredited Registrar, or fastener 
manufacturer whose Facility has been registered shall retain all 
applicable records required under the Act and this part for 5 years. 
All records are subject to the requirements in Sec. 280.7 of this part.


Sec. 280.810  Listing of recognized accreditors, accredited registrars, 
and registered facilities.

    (a) List of Accreditors. NIST shall prepare and maintain a list of 
Accreditors recognized under this subpart and subpart J of this part.
    (b) List of Registrars. NIST shall prepare and maintain a list of 
Registrars accredited by Accreditors listed in accordance with 
Sec. 280.810(a).
    (1) Names and information regarding accredited Registrars may only 
be included on the list from information submitted to NIST by an 
Accreditor listed in accordance with Sec. 280.810(a) that submits the 
listing fee established by NIST and the following information, in 
English:
    (i) The name of the Accreditor which granted the accreditation;
    (ii) The name and address of the Registrar affected by the 
accreditation action;
    (iii) The nature of the accreditation action (e.g., initial 
accreditation, renewal of accreditation, etc.);
    (iv) A copy of the Registrar's accreditation certificate and a 
scope of accreditation which states the quality system standard(s) for 
which the Registrar has been accredited for purposes of assessing and 
registering a fastener manufacturer's Facility; and
    (v) The name and telephone number of the accredited Registrar's 
authorized representative(s), and information concerning the physical 
locations of all organizational units involved in the accreditation 
activities.
    (2) All Accreditors listed by NIST in accordance with 
Sec. 280.810(a) shall promptly notify NIST of each accreditation action 
taken. Accreditation actions include initial accreditations, denials of 
accreditation, renewals, suspensions, terminations, and changes in 
scope. Notifications shall be filed with: Fastener Quality Act Program 
Manager, Office of Standards Services, National Institute of Standards 
and Technology, Gaithersburg, Maryland 20899.
    (c) List of Facilities. NIST shall prepare and maintain a list of 
Facilities registered by Registrars listed in accordance with 
Sec. 280.810(b).
    (1) Names and information regarding registered Facilities may only 
be included on the list from information submitted to NIST by 
accredited Registrars listed in accordance with Sec. 280.810(b) that 
submit the listing fee established by NIST, through their Accreditors, 
and the following information:
    (i) The name of the fastener manufacturer and the address of the 
registered Facility;
    (ii) The name of the authorized representative of the fastener 
manufacturer whose Facility is registered;
    (iii) The scope of the registration, stating the quality system 
standard(s) to which the Facility has been registered; and
    (iv) The effective dates of the registration.
    (2) All Registrars listed by NIST in accordance with 
Sec. 280.810(b) shall promptly notify NIST of each registration action. 
Registration actions include initial registrations, denials of 
registration, renewals, suspensions, terminations, and changes in 
scope. Notifications shall be filed with: Fastener Quality Act Program 
Manager, Office of Standards Services, National Institute of Standards 
and Technology, Gaithersburg, Maryland 20899.
    (3)(i) If a Facility intends to be listed in accordance with 
Sec. 280.810(c)(1) but the registration process will not be completed 
by July 26, 1998, the Facility may be provisionally listed on the 
Facilities List by providing the following to NIST on or before 
September 30, 1998:
    (A) Certification that:
    (1) The Facility is registered to QS-9000 or an equivalent by a 
quality systems registrar;
    (2) The Facility conforms to all other requirements of the Act and 
these regulations at the time of certification;
    (3) If the Facility ceases to be registered to QS-9000 or an 
equivalent by an accredited Registrar and/or ceases to conform to any 
other requirement of the Act and these regulations at any time during 
the provisional listing period, it will notify NIST of that fact within 
three working days; and
    (4) If the Facility fails to apply to an accredited Registrar for 
registration under the FQA within 30 days of the time the Registrar is 
accredited by a NIST-approved Accreditor, an authorized representative 
of the Facility will immediately notify NIST. (If the Facility's 
current Registrar decides not to seek accreditation under the FQA, it 
is the Facility's responsibility to apply to another Registrar that has 
been approved by NIST-ABEP.);
    (B) A list of fasteners produced or processed by the Facility, 
identified by either a part number or a specification number;
    (C) A list of standards included in the Facility's registration;
    (D) A copy of the Facility's registration certificate; and
    (E) The listing fee established by NIST.
    (ii) The Facility must meet all the requirements of the Act and 
these regulations by May 25, 1999. If the Facility fails to receive FQA 
registration by May 25, 1999, it will be removed from the Facilities 
List.
    (d) These lists will be readily accessible to the public. Only 
entities listed by NIST are authorized to offer services which comply 
with the Act and this part. NIST shall revise as appropriate all 
listings when notified of applicable actions and shall take appropriate 
steps to make changes promptly available to the public.


Sec. 280.811  Removal from a list.

    NIST may remove from a list any listed entity if NIST deems such 
action to be in the public interest. An entity may appeal the removal 
or proposed removal from a list to the Director by submitting a 
statement of reasons why it should remain on the list. NIST may, at its 
discretion, hold in abeyance a removal action pending a final decision 
by the Director. The Director shall inform the entity in writing of the 
decision within sixty days following receipt of the appeal.


Sec. 280.812  Appeal.

    An applicant Accreditor, Registrar, or fastener manufacturer whose 
Facility has been registered may appeal the removal or proposed removal 
from the Accreditors list, the Registrars list, or the Facilities list, 
to the Director.

Subpart J--Recognition of Foreign Registrar Accreditation Bodies

Sec.
    280.900  Introduction.
    280.901  Recognition of foreign entities.

Subpart J--Recognition of Foreign Registrar Accreditation Bodies


Sec. 280.900  Introduction.

    In accordance with section 6(a)(1)(C) of the Act, this subpart sets 
forth the conditions under which the recognition of foreign entities by 
their governments,

[[Page 18278]]

by organizations acting on behalf of their governments, or by 
organizations recognized by the Director shall be deemed to meet the 
requirements of the Act.


Sec. 280.901  Recognition of foreign entities.

    Foreign Accreditors wishing to be recognized to accredit Registrars 
must submit an application for evaluation to NIST according to subpart 
I of this part. NIST recognition is limited to bodies that accredit 
Registrars which register Facilities producing fasteners covered by the 
Act. To be recognized by NIST, Accreditors must meet conditions set out 
in subparts I and K of this part and accredit Registrars of Facilities 
to conditions set out in subpart L of this part.

Subpart K--Requirements for Registrar Accreditation Bodies 
(Accreditors)

General

280.1000  Introduction.
280.1001  Scope.

Requirements for Accreditors

280.1010  Accreditors.
280.1011  Accreditor personnel.
280.1012  Decision on accreditation.
280.1013  References to accredited status.
280.1014  Change in the accreditation.
280.1015  Appeals, complaints and disputes.
280.1016  Access to records of appeals, complaints and disputes.

Requirements for Assessment

280.1020  Application for accreditation.
280.1021  Preparation for assessment.
280.1022  Assessment.
280.1023  Assessment report.
280.1024  Surveillance and reassessment procedures.

Subpart K--Requirements for Registrar Accreditation Bodies 
(Accreditors)

General


Sec. 280.1000  Introduction.

    This subpart sets out organizational, operational and other 
requirements that must be met by all Accreditors recognized by NIST 
under subpart I or J of this part. This subpart also sets out the 
requirements against which an Accreditor assesses the competence of an 
applicant Registrar.


Sec. 280.1001  Scope.

    These are general requirements for an Accreditor to follow if it is 
to be recognized as competent and reliable in assessing and 
subsequently accrediting Registrars.

Requirements for Accreditors


Sec. 280.1010  Accreditors.

    (a) General provisions. (1) The policies and procedures under which 
the Accreditor operates shall be non-discriminatory, and they shall be 
administered in a non-discriminatory manner. Procedures shall not be 
used to impede or inhibit access by applicant bodies other than as 
specified in this part.
    (2) The Accreditor shall make its services accessible to all 
applicants whose activities fall within its declared field of 
operation. There shall not be undue financial or other conditions. 
Access shall not be conditional upon the size of the applicant body or 
membership of any association or group, nor shall accreditation be 
conditional upon the number of bodies already accredited.
    (3) The accreditation criteria against which the competence of a 
Registrar is assessed shall be those outlined in subpart L of this 
part. If an explanation is required as to the application of these 
documents to a specific accreditation program, it shall be formulated 
by relevant and impartial committees or persons possessing the 
necessary technical competence, and published by the Accreditor.
    (4) The Accreditor shall confine its requirements, assessment and 
decisions on accreditation to those matters specifically related to the 
scope of the accreditation being considered.
    (b) Organization of a recognized Accreditor. The structure of the 
Accreditor shall be such as to give confidence in its accreditations. 
In particular, the Accreditor shall:
    (1) Be impartial;
    (2) Be responsible for its decisions relating to the granting, 
maintaining; extending, reducing, suspending and withdrawing of 
accreditation;
    (3) Identify the management (committee, group or person) which will 
have overall responsibility for all of the following:
    (i) Performance of assessment and accreditation as defined in this 
part;
    (ii) Formulation of policy matters relating to the operation of the 
Accreditor;
    (iii) Decisions on accreditation;
    (iv) Supervision of the implementation of its policies;
    (v) Supervision of the finance of the Accreditor; and
    (vi) Delegation of authority of committees or individuals, as 
required, to undertake defined activities on its behalf;
    (4) Have documents which demonstrate that it is a legal entity;
    (5) Have a documented structure which safeguards impartiality, 
including provisions to assure the impartiality of the operations of 
the Accreditor; this structure shall enable the participation of all 
parties significantly concerned in the development of policies and 
principles regarding the content and functioning of the accreditation 
system;
    (6) Ensure that each decision on accreditation is taken by a person 
or persons different from those who carried out the assessment;
    (7) Have rights and responsibilities relevant to its accreditation 
activities;
    (8) Have adequate arrangements to cover liabilities arising from 
its operations and/or activities;
    (9) Have financial stability and resources required for the 
operation of an accreditation system;
    (10) Employ a sufficient number of personnel having the necessary 
education, training, technical knowledge and experience for performing 
accreditation functions relating to the type, range and volume of work 
performed, under a responsible senior executive;
    (11) Have a quality system, as outlined in paragraph (d) of this 
section, giving confidence in its ability to operate an accreditation 
system for registration bodies;
    (12) Have policies and procedures that distinguish between 
accreditation and any other activities in which the Accreditor is 
engaged;
    (13) Together with its senior executive and staff, be free from any 
commercial, financial and other pressures which might influence the 
results of the accreditation process;
    (14) Have formal rules and structure for the appointment and 
operation of any committees which are involved in the accreditation 
process; such committees shall be free from any commercial, financial 
and other pressures that might influence decisions;
    (15) Ensure that activities of related bodies do not affect the 
confidentiality, objectivity or impartiality of its accreditations and 
shall not offer or provide, directly or indirectly, those services that 
accredit others to perform, consulting services to obtain or maintain 
accreditation, or services to design, implement or maintain a 
certification scheme;
    (16) Have policies and procedures for the resolution of complaints, 
appeals and disputes received from bodies or other parties about the 
handling of accreditation of any related matters;
    (17) Have a structure where members are chosen to provide a balance 
of

[[Page 18279]]

interest, where no single interest predominates; and
    (18) Assure that other products, processes or services that may be 
offered, directly or indirectly, do not compromise confidentiality or 
the objectivity or impartiality of its accreditation process and 
decisions.
    (c) Subcontracting. (1) When an Accreditor decides to subcontract 
work related to accreditation (e.g. audits) to an external body or 
person, a properly documented agreement covering the arrangements, 
including confidentiality and conflict of interest, shall be drawn up. 
The Accreditor shall:
    (i) Take full responsibility for such subcontracted work and 
maintain its responsibility for granting, maintaining, extending, 
reducing, suspending or withdrawing accreditation;
    (ii) Ensure that the subcontracted body or person is competent and 
complies with the applicable provisions of this part, including section 
280.807, and is not involved, either directly or through its employer, 
with the design, implementation or maintenance of a registration scheme 
in such a way that impartiality could be compromised; and
    (iii) obtain the consent of the applicant or accredited body.
    (2) Requirements in paragraphs (c)(1) (i) and (ii) of this section 
are also relevant, by extension, when an Accreditor uses, for granting 
its own accreditation, work provided by another Accreditor with which 
it has signed an agreement.
    (d) Quality system. (1) The management of the Accreditor with 
executive responsibility for quality shall define and document its 
policy for quality, including objectives for quality and its commitment 
to quality. The management shall ensure that this policy is understood, 
implemented and maintained at all levels of the organization.
    (2) The Accreditor shall operate a quality system in accordance 
with the relevant elements of this part and appropriate to the type, 
range and volume of work performed. This quality system shall be 
documented, and the documentation shall be available for use by the 
staff of the Accreditor.
    (3) The Accreditor shall ensure effective implementation of the 
documented quality system procedures and instructions.
    (4) The Accreditor shall designate a person with direct access to 
its highest executive level who, irrespective of other 
responsibilities, shall have defined authority to ensure that a quality 
system is established, implemented and maintained in accordance with 
this part, and report on the performance of the quality system to the 
management of the Accreditor for review and as a basis for improvement 
of the quality system.
    (5) The quality system shall be documented in a quality manual and 
associated quality procedures, and the quality manual shall contain or 
refer to at least the following:
    (i) A quality policy statement;
    (ii) A brief description of the legal status of the Accreditor, 
including the names of its owners, if applicable, and, if different, 
the names of the persons who control it;
    (iii) The names, qualifications, experience and terms of reference 
of the senior executive and other accreditation personnel influencing 
the quality of the accreditation functions;
    (iv) An organization chart showing lines of authority, 
responsibility and allocation of functions stemming from the senior 
executive and, in particular, the relationship between those 
responsible for the assessment and those making decisions regarding 
accreditation;
    (v) A description of the organization of the Accreditor, including 
details of the management (committee, group or person), its 
constitution, terms of reference and rules of procedure;
    (vi) The policy and procedures for conducting management reviews;
    (vii) Administrative procedures including document control;
    (viii) The operational and functional duties and service pertaining 
to quality, so that the extent and limits of each person's 
responsibility are known to all concerned;
    (ix) The policy and procedures for the recruitment and training of 
Accreditor personnel (including auditors) and monitoring their 
performance;
    (x) A list of its subcontractors and details of the procedures for 
assessing, recording and monitoring their competence;
    (xi) Its procedures for handling nonconformities and for assuring 
the effectiveness of any corrective actions taken;
    (xii) The policy and procedures for implementing the accreditation 
process, including:
    (A) The conditions for issue, retention and withdrawal of 
accreditation documents;
    (B) Checks of the use and application of documents used in the 
accreditation;
    (C) The procedures for assessing and accrediting applicants; and
    (D) The procedures for surveillance and reassessment of accredited 
bodies.
    (xiii) The policy and procedures for dealing with appeals, 
complaints and disputes; and
    (xiv) The procedures for conducting internal audits based on 
appropriate international documentation.
    (e) Conditions for granting, maintaining, extending, reducing, 
suspending and withdrawing accreditation. (1) The Accreditor shall 
specify the conditions for granting, maintaining, extending and 
reducing accreditation, and the conditions under which accreditation 
may be suspended or withdrawn, partially or in total, for all or part 
of the accredited body's scope of accreditation. In particular, the 
Accreditor shall require the accredited body to notify it promptly of 
any intended changes to the quality system or other changes which may 
affect conformity.
    (2) The Accreditor shall have procedures to grant, maintain, 
withdraw and suspend accreditation; to extend or reduce the scope of 
accreditation; and to conduct reassessment in the event of changes 
significantly affecting the activity and operation of the accredited 
body (such as change of ownership, changes in personnel or equipment), 
or if analysis of a complaint or any other information indicates that 
the accredited body no longer complies with the requirements of the 
Accreditor.
    (f) Internal audits and management reviews. (1) The Accreditor 
shall conduct periodic internal audits covering all procedures in a 
planned and systematic manner, to verify that the quality system is 
being implemented and is effective. The Accreditor shall ensure that 
personnel responsible for the area audited are informed of the outcome 
of the audit; corrective action is taken in a timely and appropriate 
manner; and the results of the audit are documented.
    (2) The top management of the Accreditor shall review its quality 
system at defined intervals sufficient to ensure its continuing 
suitability and effectiveness in satisfying the requirements of this 
part and the stated quality policy and objectives. Records of such 
reviews shall be maintained.
    (g) Documentation. (1) The Accreditor shall document, update at 
regular intervals, and make available (through publications, electronic 
media or other means), on request:
    (i) Information about the authority under which the Accreditor 
operates;
    (ii) A documented statement of its accreditation system, including 
its rules and procedures for granting, maintaining, extending, 
reducing, suspending and withdrawing accreditation;
    (iii) Information about the assessment and accreditation process;

[[Page 18280]]

    (iv) A description of the means by which the Accreditor obtains 
financial support, and general information on the fees charged to 
applicants and accredited bodies;
    (v) A description of the rights and duties of applicants and 
accredited bodies, as specified, including requirements, restrictions 
or limitations on the use of the Accreditor's logo and on the ways of 
referring to the accreditation granted, in conformance with 
Sec. 280.804(d); and
    (vi) Information on procedures for handling complaints, describing 
the scope of accreditation granted to each.
    (2) The Accreditor shall establish and maintain procedures to 
control all documents and data that relate to its accreditation 
functions. These documents shall be reviewed and approved for adequacy 
by appropriately authorized and competent personnel prior to issuing 
any documents following initial development or any subsequent amendment 
or change being made. A listing of all appropriate documents with the 
respective issue and/or amendment status identified shall be 
maintained. The distribution of all such documents shall be controlled 
to ensure that the appropriate documentation is made available to 
personnel of the Accreditor, or applicants and accredited bodies, when 
required to perform any function relating to the activities of 
applicants and accredited bodies.
    (h) Records. (1) The Accreditor shall maintain a record system to 
suit its particular circumstances and to comply with this part. The 
records shall demonstrate that accreditation procedures have been 
effectively fulfilled, particularly with respect to application forms, 
assessment reports, and other documents relating to granting, 
maintaining, extending, reducing, suspending or withdrawing 
accreditation. The records shall be identified, managed and disposed of 
in such a way as to ensure the integrity of the process and 
confidentiality of the information. The records shall be kept for a 
period of five years.
    (2) The Accreditor shall have a policy and procedures for retaining 
records for a period of five years. The Accreditor shall have a policy 
and procedures concerning access to these records consistent with 
paragraph (h)(1) of this section.
    (i) Confidentiality. (1) The Accreditor shall have adequate 
arrangements, consistent with applicable laws, to safeguard 
confidentiality of the information obtained in the course of its 
accreditation activities at all levels of its organization, including 
committees and external bodies or individuals acting on its behalf.
    (2) Except as required in this part, information about a particular 
body shall not be disclosed to a third party without the written 
consent of the body.


Sec. 280.1011  Accreditor personnel.

    (a) General provisions. (1) The personnel of the Accreditor 
involved in accreditation shall be competent for the functions they 
perform.
    (2) Information on the relevant qualifications, training and 
experience of each member of the personnel involved in the 
accreditation process shall be maintained by the Accreditor. Records of 
training and experience shall be kept up to date.
    (3) Clearly documented instructions shall be available to the 
personnel describing their duties and responsibilities. These 
instructions shall be maintained up to date.
    (b) Qualification criteria for auditors and technical experts. (1) 
In order to ensure that assessments are carried out effectively and 
uniformly, the minimum relevant criteria for competence shall be 
defined by the Accreditor.
    (2) Auditors shall meet the requirements of the appropriate 
international documentation.
    (3) Technical experts are not required to comply with the 
requirements for auditors, and guidance on their personal attributes 
may be obtained from appropriate international documentation.
    (c) Selection procedure. (1) The Accreditor shall have a procedure 
for selecting auditors and, if applicable, technical experts on the 
basis of their competence, training, qualifications and experience, and 
for initially assessing the conduct of auditors and technical experts 
during assessments, and subsequently monitoring the performance of 
auditors and technical experts.
    (2) When selecting the audit team to be appointed for a specific 
assessment, the Accreditor shall ensure that the skills brought to each 
assignment are appropriate. The team shall:
    (i) Be familiar with the Act and this part, accreditation 
procedures and accreditation requirements;
    (ii) Have a thorough knowledge of the relevant assessment method 
and assessment documents;
    (iii) Have appropriate technical knowledge of the fastener 
technology for which accreditation is sought and, where relevant with 
associated procedures and their potential for failure (technical 
experts who are not auditors may fulfill this function);
    (iv) Have a degree of understanding sufficient to make a reliable 
assessment of the competence of the accredited body to operate within 
its scope;
    (vi) Be free from any interest that might cause team members to act 
in other than an impartial or non-discriminatory manner, for example,
    (A) Audit team members or their organization shall not have 
provided consulting services to the applicant or accredited body which 
compromise the accreditation process and decision; and
    (B) In accordance with the directives of the Accreditor, the audit 
team members shall inform the Accreditor, prior to the assessment, 
about any existing, former or envisaged link between themselves or 
their organization and the body to be assessed.
    (d) Contracting of assessment personnel. The Accreditor shall 
require the personnel involved in the assessment to sign a contract or 
other document by which they commit themselves to comply with the rules 
defined by the Accreditor, including those relating to confidentiality 
and those relating to independence from commercial and other interest, 
and any prior and/or present link with the bodies to be assessed. The 
Accreditor shall ensure that, and document how, any subcontracted 
assessment personnel satisfy all the requirements for personnel 
outlined in this subpart.
    (e) Assessment personnel records. (1) The Accreditor shall possess 
and maintain up-to-date records on personnel conducting assessments, 
consisting of:
    (i) Name and address;
    (ii) Affiliation and position held in the organization;
    (iii) Educational qualifications and professional status;
    (iv) Experience and training in each field of competence of the 
Accreditor;
    (v) Date of most recent updating of record; and
    (vi) Performance appraisal.
    (2) The Accreditor shall ensure, and verify, that any subcontracted 
body maintains records, which satisfy the requirements of this part, of 
assessment personnel who are subcontracted to the Accreditor.
    (f) Procedures for assessment teams. Assessment teams shall be 
provided with up-to-date assessment instructions and all relevant 
information on accreditation arrangements and procedures.


Sec. 280.1012  Decision on accreditation.

    (a) The decision whether or not to accredit a body shall be made on 
the basis of the information gathered during the accreditation process 
and any other relevant information. Those who make

[[Page 18281]]

the accreditation decision shall not have participated in the audit.
    (b) The Accreditor shall not delegate authority for granting, 
maintaining, extending, reducing, suspending or withdrawing 
accreditation to an outside person or body.
    (c) The Accreditor shall provide to each of its accredited bodies 
accreditation documents such as a letter outlining the scope of 
accreditation and a certificate signed by an officer who has been 
assigned such responsibility. These accreditation documents shall 
identify, for the body and each of its sites covered by the 
accreditation:
    (1) The name and address;
    (2) The scope of the accreditation granted, including as 
appropriate:
    (i) The type of registration scheme;
    (ii) The standards and/or other normative documents and regulatory 
requirements against which products, services or systems are 
registered; and
    (iii) Fasteners covered by the Act.
    (3) The effective date of accreditation and, as applicable, the 
term for which the accreditation is valid.
    (d) In response to an application for an amendment to the scope of 
an accreditation already granted, the Accreditor shall decide what, if 
any, assessment procedure is appropriate to determine whether or not 
the amendment should be granted and shall act accordingly.


Sec. 280.1013  References to accredited status.

    (a) An Accreditor which is proprietor or licensee of a symbol or 
logo, intended for use under its accreditation program, shall have a 
policy governing its use. It shall normally allow an accredited body to 
refer to its accreditation in certificates, reports, and stationery and 
publicity material relating to accredited activities.
    (b) The Accreditor shall not allow use of its mark or logo in any 
way which implies that the Accreditor itself approved a product, 
service or system registered by an accredited body. Where a Facility is 
registered only with respect to its quality assurance system, the 
symbol or logo shall not be used on a product or in any other way that 
may be interpreted as denoting product conformance, as required by 
Sec. 280.804(d).
    (c) The Accreditor shall take suitable action to deal with 
incorrect reference to the accreditation system, or misleading use of 
accreditation logos found in advertisements, catalogues, etc. Such 
action could include corrective action, withdrawal of certificate, 
publication of the transgression and, if necessary, other legal action.


Sec. 280.1014  Change in the accreditation.

    The Accreditor shall give due notice of any changes it intends to 
make in its requirements for accreditation. It shall take account of 
views expressed by interested parties before deciding on the precise 
form and effective date of the changes. Following a decision on, and 
publication of, the changed requirements, it shall verify that each 
accredited Registrar carries out any necessary adjustments to its 
procedures within such time as, in the opinion of the Accreditor, is 
reasonable.


Sec. 280.1015  Appeals, complaints and disputes.

    The Accreditor shall keep a record of all appeals, complaints and 
disputes, and remedial actions relative to accreditation; take 
appropriate corrective and preventive action; and document the actions 
taken and assess their effectiveness.


Sec. 280.1016  Access to records of appeals, complaints and disputes.

    The Accreditor shall require each applicant and accredited 
Registrar to make available to it, when requested, the records of all 
complaints, appeals and disputes, and subsequent actions.

Requirements for Assessment


Sec. 280.1020  Application for accreditation.

    (a)(1) As specified in Sec. 280.1010(g)(1) of this part, the 
Accreditor shall maintain up-to-date detailed descriptions of the 
assessment and accreditation procedure, the documents containing the 
requirements for accreditation, and documents describing the rights and 
duties of accredited Registrars, and shall provide them to applicants 
and accredited Registrars. The Accreditor shall require that an 
accredited Registrar.
    (i) Always complies with the relevant provisions of this part;
    (ii) Makes all necessary arrangements for the conduct of the 
assessment, including provision for examining documentation and the 
access to all areas, records (including internal audit reports) and 
personnel for the purposes of assessment, surveillance, reassessment 
and resolution of complaints;
    (iii) Only claims that it is accredited with respect to those 
activities for which it has been granted accreditation;
    (iv) Does not use its accreditation in such a manner as to bring 
the Accreditor into disrepute, and does not make any statement 
regarding its accreditation which the Accreditor may consider 
misleading or unauthorized;
    (v) Upon suspension or withdrawal of its accreditation, 
discontinues use of all advertising matter that contains any reference 
thereto and returns any accreditation documents as required by the 
Accreditor;
    (vi) Does not allow the fact of its accreditation to be used to 
imply that a product, process, system, or person is approved by the 
Accreditor, as required by Sec. 280.804(d);
    (vii) Ensures that no accreditation document, mark or report, or 
any part thereof, is used in a misleading manner; and
    (viii) In making reference to its accreditation status in 
communication media such as documents, brochures or advertising, 
complies with the requirements of the Accreditor.
    (2) When the desired scope of accreditation is related to a 
specific program any necessary explanation shall be provided to the 
applicant. If requested, additional application information shall be 
provided to the body.
    (b) The Accreditor shall require an official application form, duly 
completed and signed by a duly authorized representative of the 
applicant, in which or attached to which:
    (1) The scope of the desired accreditation is defined; and
    (2) The applicant agrees to comply with the requirements for 
accreditation and to supply any information needed for its evaluation.
    (c) At least the following shall be provided by the applicant prior 
to the on-site assessment:
    (1) The general features of the applicant body, such as corporate 
entity, name, address, legal status and, where relevant, human and 
technical resources;
    (2) General information concerning the body covered by the 
application, such as its functions, and its relationship in a larger 
corporate entity, and its physical locations;
    (3) A description of the systems or products it registers and the 
standards or other normative documents applicable to each; and
    (4) A copy of its quality manual and, where required, the 
associated documentation.


Sec. 280.1021  Preparation for assessment.

    (a) Before proceeding with the assessment, the Accreditor shall 
conduct, and maintain records of, a review of the request for 
accreditation to ensure that:
    (1) The requirements for accreditation are clearly defined and 
documented;
    (2) Any difference in understanding between the Accreditor and the 
applicant is resolved; and

[[Page 18282]]

    (3) The Accreditor has the capability to perform the accreditation 
service with respect to the scope of the accreditation sought, the 
location of the applicant's operations, and any special requirements 
such as the language used by the applicant.
    (b) The Accreditor shall prepare a plan for its assessment 
activities to allow for the necessary arrangements to be made.
    (c) The Accreditor shall nominate a qualified audit team to 
evaluate all material collected from the applicant and to conduct the 
audit on its behalf. Experts in the areas to be assessed may be 
attached to the Accreditor's team as advisers.
    (d) The applicant shall be informed of the names of the members of 
the audit team who will carry out the assessment, with sufficient 
notice to appeal against the appointment of any particular auditors or 
experts.
    (e) The audit team shall be formally appointed and provided with 
the appropriate working documents. The plan for and the date of the 
audit shall be agreed upon with the applicant. The mandate given to the 
audit team shall be clearly defined and made known to the applicant, 
and shall require the audit team to examine the structure, policies and 
procedures of the applicant, and confirm that these meet all the 
requirements relevant to the scope of accreditation, and that the 
procedures are implemented and are such as to give confidence in the 
registrations of the applicant.


Sec. 280.1022  Assessment.

    (a) The audit team shall assess all services of the applicant 
covered by the defined scope against all applicable accreditation 
requirements.
    (b) The Accreditor shall witness fully the on-site activities of 
one or more assessments or audits conducted by an applicant before an 
initial accreditation is granted for any function requiring on-site 
activity by the applicant.


Sec. 280.1023  Assessment report.

    (a) The Accreditor may adopt reporting procedures that suit its 
needs but, as a minimum, these procedures shall ensure that:
    (1) A meeting takes place between the audit team and the 
applicant's management prior to leaving the premises, at which the 
audit team provides a written or oral indication on the conformity of 
the applicant with the particular accreditation requirements and 
provides an opportunity for the applicant to ask questions about the 
findings and their basis;
    (2) The audit team provides the Accreditor with a report of its 
findings as to the applicant's conformity to all of the accreditation 
requirements;
    (3) A report on the outcome of the assessment is promptly brought 
to the applicant's attention by the Accreditor, identifying any 
nonconformity to be discharged in order to comply with all of the 
accreditation requirements;
    (4) The Accreditor shall invite the applicant to comment on the 
report and to describe the specific actions taken, or planned to be 
taken within a defined time, to remedy any nonconformity with the 
accreditation requirements identified during the assessment, and shall 
inform the applicant of the need for full or partial reassessment or 
whether a written declaration to be confirmed during surveillance will 
be considered adequate;
    (5) The report shall contain as a minimum:
    (i) The date(s) of the audit(s);
    (ii) The name(s) of the person(s) responsible for the report;
    (iii) The names and addresses of all sites audited;
    (iv) The assessed scope of accreditation or reference thereto;
    (v) Comments on the conformity of the applicant with the 
accreditation requirements and, where applicable, any useful 
comparisons with the results of previous assessment of the applicant; 
and
    (vi) An explanation of any differences from the information 
presented to the applicant at the closing meeting.
    (b) If the final report authorized by the Accreditor differs from 
the report referred to in paragraphs (b) (3) and (5) of this section, 
it shall be submitted to the applicant with an explanation of any 
differences from the previous report. The report shall take into 
consideration:
    (1) The qualification, experience and authority of the staff 
encountered;
    (2) The adequacy of the internal organization and procedures 
adopted by the applicant to give confidence in the quality of its 
services; and
    (3) The actions taken to correct identified nonconformities 
including, where applicable, those identified at previous assessments.


Sec. 280.1024  Surveillance and reassessment procedures.

    (a) The Accreditor shall have an established documented program, 
consistent with the accreditation granted for carrying out periodic 
surveillance and reassessment at sufficiently close intervals to verify 
that its accredited Registrar continues to comply with the 
accreditation requirements.
    (b) Surveillance and reassessment procedures shall be consistent 
with those concerning the assessment of the applicant as described in 
this part.
    (c)(1) The Accreditor shall have arrangements to ensure that an 
accredited Registrar informs it without delay of changes in any aspects 
of its status or operation that affect its:
    (i) Legal, commercial or organizational status;
    (ii) Organization and management, for example key managerial staff;
    (iii) Policies or procedures, where appropriate;
    (iv) Premises; and
    (v) Personnel, equipment, facilities, working environment or other 
resources, where significant.
    (2) The accredited Registrar shall also inform the Accreditor of 
other such matters that may affect activities, or conformance with the 
requirements, or any other relevant criteria of competence specified by 
the Accreditor.

Subpart L--Requirement for Registrars

General

Sec.
280.1100  Introduction.
280.1101  Scope.

Requirements For Registrars

280.1110  Registrars
280.1111  Registrar personnel.
280.1112  Changes in the registration requirements.
280.1113  Appeals, complaints and disputes.

Requirements For Registration

280.1120  Application for registration.
280.1121  Preparation for assessment.
280.1122  Assessment.
280.1123  Assessment report.
280.1124  Decision on registration.
280.1125  Surveillance and reassessment procedures.
280.1126  Use of certificates and logos.
280.1127  Access to records of complaints to fastener manufacturers.

Subpart L--Requirements for Registrars

General


Sec. 280.1100  Introduction.

    This subpart sets out organizational, operational and other 
requirements that must be met by all Registrars accredited under 
subparts I or J of this part.


Sec. 280.1101  Scope.

    These are general requirements that must be met by a third-party 
body registering Facilities.

    Note: In some countries, the bodies which verify conformity of 
quality systems to specified standards are called ``certification 
bodies,'' in others ``registration bodies,'' in others ``assessment 
and registration bodies''

[[Page 18283]]

or ``certification/registration bodies,'' and in still others 
``registrars.'' Reference to such bodies as ``Registrars'' should 
not be understood to be limiting.

Requirements for Registrars


Sec. 280.1110  Registrars.

    (a) General provisions. (1) The policies and procedures under which 
the Registrar operates shall be non-discriminatory, and they shall be 
administered in a non-discriminatory manner. Procedures shall not be 
used to impede or inhibit access by applicants other than as specified 
in this part.
    (2) The Registrar shall make its services accessible to all 
applicants. There shall not be undue financial or other conditions. 
Access shall not be conditional upon the size of the applicant body or 
membership of any association or group, nor shall registration be 
conditional upon the number of Facilities already registered.
    (3) The criteria against which the quality assurance system of an 
applicant is assessed shall be those outlined in the quality system 
standards or other normative documents relevant to the function 
performed. If an explanation is required as to the application of these 
documents to a specific registration program, it shall be formulated by 
relevant and impartial committees or persons possessing the necessary 
technical competence, and published by the Registrar.
    (4) The Registrar shall confine its requirements, assessment, and 
decision on registration to those matters specifically related to the 
scope of the registration being considered.
    (b) Organization of a registrar. The structure of the Registrar 
shall be such as to give confidence in its registrations. In 
particular, the Registrar shall:
    (1) Be impartial;
    (2) Be responsible for its decisions relating to the granting, 
maintaining, extending, reducing, suspending and withdrawing of 
registration;
    (3) Identify the management (committee, group, or person) which 
will have overall responsibility for each of the following:
    (i) Performance of assessment and registration as defined in this 
part;
    (ii) Formulation of policy matters relating to the operation of the 
Registrar,
    (iii) Decisions on registration;
    (iv) Supervision of the implementation of its policies;
    (v) Supervision of the finances of the Registrar; and
    (vi) Delegation of authority to committees or individuals, as 
required, to undertake defined activities on its behalf.
    (4) Have documents which demonstrate that it is a legal entity;
    (5) Have a documented structure which safeguards impartiality, 
including provisions to assure the impartiality of the operations of 
the Registrar, this structure shall enable the participation of all 
parties significantly concerned in the development of policies and 
principles regarding the content and functioning of the registration 
system;
    (6) Ensure that each decision on registration is taken by a person 
or persons different from those who carried out the assessment;
    (7) Have rights and responsibilities relevant to its registration 
activities;
    (8) Have adequate arrangements to cover liabilities arising from 
its operations and/or activities;
    (9) Have the financial stability and resources required for the 
operation of a registration system;
    (10) Employ a sufficient number of personnel having the necessary 
education, training, technical knowledge, and experience for performing 
registration functions relating to the type, range, and volume of work 
performed, under a responsible senior executive;
    (11) Have a quality system, as outlined in paragraph (d) of this 
section, giving confidence in its ability to operate a registration 
system for Facilities;
    (12) Have policies and procedures that distinguish between 
registration and any other activities in which the Registrar is 
engaged;
    (13) Together with its senior executive and staff, be free from any 
commercial, financial, and other pressures which might influence the 
results of the registration process;
    (14) Have formal rules and structures for the appointment and 
operation of any committees which are involved in the registration 
process; such committees shall be free from any commercial, financial, 
and other pressure that might influence decisions;
    (15) Ensure that activities of related bodies do not affect the 
confidentiality, objectivity, or impartiality of its registrations and 
shall not offer or provide, directly or indirectly, those services that 
it registers others to perform, consulting services to obtain or 
maintain registration, or services to design, implement, or maintain 
quality systems;
    (16) Have policies and procedures for the resolution of complaints, 
appeals, and disputes received from fastener manufacturers or other 
parties about the handling of registration or any other related 
matters;
    (17) Have a structure where members are chosen to provide a balance 
of interests, where no single interest predominates; and
    (18) Assure that the other products, processes, or services that 
may be offered, directly or indirectly, do not compromise 
confidentiality or the objectivity or impartiality of its registration 
process and decisions.
    (c) Subcontracting. (1) When a Registrar decides to subcontract 
work related to registration (e.g. audits) to an external body or 
person, a properly documented agreement covering the arrangements, 
including confidentiality and conflicts of interest, shall be drawn up. 
The Registrar shall:
    (i) Take full responsibility for such subcontracted work and 
maintain its responsibility for granting, maintaining, extending, 
reducing, suspending, or withdrawing registration;
    (ii) Ensure that the subcontracted body or person is competent and 
complies with the applicable provisions of this part, including 
Sec. 280.7, and is not involved, either directly or through its 
employer, with the design, implementation, or maintenance of a quality 
system in such a way that impartiality could be compromised; and
    (iii) Obtain the consent of the applicant or fastener manufacturer 
whose Facility is registered.
    (2) Requirements in paragraphs (c) (1) and (2) of this section are 
also relevant, by extension, when a Registrar uses, for granting its 
own registration, work provided by another Registrar with which it has 
signed an agreement.
    (d) Quality system. (1) The management of the Registrar with 
executive responsibility for quality shall define and document its 
policy for quality, including objectives for quality and its commitment 
to quality. The management shall ensure that this policy is understood, 
implemented, and maintained at all levels of the organization.
    (2) The Registrar shall operate a quality system in accordance with 
the relevant elements of this part and appropriate to the type, range, 
and volume of work performed. This quality system shall be documented 
and the documentation shall be available for use by the staff of the 
Registrar.
    (3) The Registrar shall ensure effective implementation of the 
documented quality system procedures and instructions.
    (4) The Registrar shall designate a person with direct access to 
its highest executive level who, irrespective of other 
responsibilities, shall have defined authority to ensure that a quality 
system is established, implemented, and maintained in accordance with 
this part, and report on

[[Page 18284]]

the performance of the quality system to the management of the 
Registrar for review and as a basis for improvement of the quality 
system.
    (5) The quality system shall be documented in a quality manual and 
associated quality procedures and the quality manual shall contain or 
refer to at least the following:
    (i) A quality policy statement;
    (ii) A brief description of the legal status of the Registrar, 
including the names of its owners, if applicable, and, if different, 
the names of the persons who control it;
    (iii) The names and qualifications, experience, and terms of 
reference of the senior executive and other certification/registration 
personnel, affecting the quality of the certification/registration 
function;
    (iv) An organization chart showing lines of authority, 
responsibility, and allocation of functions stemming from the senior 
executive and, in particular, the relationship between those 
responsible for the assessment and those taking decisions regarding 
registration;
    (v) A description of the organization of the registration body, 
including details of the management (committee, group, or person), its 
constitution, terms of reference and rules of procedure;
    (vi) The policy and procedures for conducting management reviews;
    (vii) Administrative procedures including document control;
    (viii) The operational and functional duties and services 
pertaining to quality, so that the extent and limits of each person's 
responsibility are known to all concerned;
    (ix) The policy and procedures for the recruitment and training of 
registration body personnel (including auditors) and monitoring their 
performance;
    (x) A list of its subcontractors and details of the procedure for 
assessing, recording, and monitoring their competence;
    (xi) Its procedures for handling nonconformities and for assuring 
the effectiveness of any corrective actions taken;
    (xii) The policy and procedures for implementing the registration 
process, including:
    (A) The conditions for issue, retention, and withdrawal of 
registration documents;
    (B) Checks of the use and application of documents used in the 
registration of quality systems;
    (C) The procedures for assessing and registering fastener 
manufacturers' quality systems as employed in particular Facilities; 
and
    (D) The procedures for surveillance and reassessment of registered 
Facilities.
    (xiii) The policy and procedures for dealing with appeals, 
complaints, and disputes; and
    (xiv) The procedures for conducting internal audits based on the 
provisions described in appropriate international documentation.
    (e) Conditions for granting, maintaining, extending, reducing, 
suspending, and withdrawing registration. (1) The Registrar shall 
specify the conditions for granting, maintaining, reducing, and 
extending registration and the conditions under which registration may 
be suspended or withdrawn, partially or in total, for all or part of 
the Facility's scope of registration. In particular, the Registrar 
shall require the fastener manufacturer to notify it promptly of any 
intended changes to the quality assurance system or other changes which 
may affect conformity.
    (2) The Registrar shall require the fastener manufacturer to have a 
documented quality system which conforms to applicable quality system 
standards or other normative documents.
    (3) The Registrar shall have procedures to grant, maintain, 
withdraw and, if applicable, suspend registration; to extend or reduce 
the scope of registration; and to conduct reassessment in the event of 
changes significantly affecting the activity and operation of the 
Facility (such as change of ownership, changes in personnel or 
equipment), or if analysis of a complaint or any other information 
indicates that the registered fastener Facility no longer complies with 
the requirements of the Registrar.
    (4) The Registrar shall have documented procedures which shall be 
made available on request for:
    (i) Initial assessment and for the surveillance and reassessment of 
a fastener manufacturer's quality assurance system as employed in a 
particular Facility;
    (ii) Continuing conformity with relevant requirements; and for 
verifying and recording that a fastener manufacturer takes corrective 
action on a timely basis to correct all nonconformities; and
    (iii) Identifying and recording nonconformities and the need for 
corrective action by fastener manufacturers on a timely basis for such 
items as incorrect references to the registration or misleading use of 
registration information.
    (f) Internal audits and management reviews. (1) The Registrar shall 
conduct periodic internal audits covering all procedures in a planned 
and systematic manner, to verify that the quality assurance system is 
implemented and is effective. The Registrar shall ensure that personnel 
responsible for the area audited are informed of the outcome of the 
audit; corrective action is taken in a timely and appropriate manner; 
and the results of the audit are recorded.
    (2) The top management of the Registrar shall review its quality 
system at defined intervals sufficient to ensure its continuing 
suitability and effectiveness in satisfying the requirements of this 
part and the stated quality policy and objectives. Records of such 
reviews shall be maintained.
    (g) Documentation. (1) The Registrar shall document, update at 
regular intervals, and make available through publications, electronic 
media, or other means), on request;
    (i) Information about the authority under which the Registrar 
operates;
    (ii) A documented statement of its registration system including 
its rules and procedures for granting, maintaining, extending, 
reducing, suspending, and withdrawing registration;
    (iii) Information about the assessment and registration process;
    (iv) A description of the means by which the Registrar obtains 
financial support, and general information on the fees charged to 
applicants and fastener manufacturers whose Facilities have been 
registered;
    (v) A description of the rights and duties of applicants and 
fastener manufacturers whose Facilities have been registered, including 
requirements, restrictions, or limitations on the use of the 
Registrar's logo and on the ways of referring to the registration 
granted;
    (vi) Information on procedures for handling complaints, appeals and 
disputes; and
    (vii) A directory of registered Facilities, including their 
locations, describing the scope of registration granted to each.
    (2) The Registrar shall establish and maintain procedures to 
control all documents and data that relate to its registration 
functions. These documents shall be reviewed and approved for adequacy 
by appropriately authorized and competent personnel prior to issuing 
any documents following initial development or any subsequent amendment 
or change being made. A listing of all appropriate documents with the 
respective issue and/or amendment status identified shall be 
maintained. The distribution of all such documents shall be controlled 
to ensure that the appropriate documentation is made available to 
personnel of the Registrar or of the fastener manufacturer whose 
Facility is registered, when

[[Page 18285]]

 required to perform any function relating to the activities of an 
applicant or registered Facility.
    (h) Records. (1) The Registrar shall maintain a record system to 
suit its particular circumstances and to comply with this part. The 
records shall demonstrate that the registration procedures have been 
effectively fulfilled, particularly with respect to application forms, 
assessment reports, and other documents relating to granting, 
maintaining, extending, reducing, suspending, or withdrawing 
registration. The records shall be identified, managed and disposed of 
in such a way as to ensure the integrity of the process and 
confidentiality of the information. The records shall be kept for a 
period of five years.
    (2) The Registrar shall have a policy and procedures for retaining 
records for a period of five years. The Registrar shall have a policy 
and procedures concerning access to these records consistent with 
paragraph (h)(1) of this section.
    (i) Confidentiality. (1) The Registrar shall have adequate 
arrangements, consistent with applicable laws to safeguard 
confidentiality of the information obtained in the course of its 
registration activities at all levels of its organization, including 
committees and external bodies or individuals, acting on its behalf.
    (2) Except as required in this part, information about a particular 
product, quality assurance system, Facility, or fastener manufacturer 
shall not be disclosed to a third party without the written consent of 
the fastener manufacturer.


Sec. 280.1111  Registrar personnel.

    (a) General provisions. (1) The personnel of the Registrar involved 
in registration shall be competent for the functions they perform.
    (2) Information on the relevant qualifications, training and 
experience of each member of the personnel involved in the registration 
process shall be maintained by the Registrar. Records of training and 
experience shall be kept up to date.
    (3) Clearly documented instructions shall be available to the 
personnel describing their duties and responsibilities. These 
instructions shall be maintained up to date.
    (b) Qualification criteria for auditors and technical experts. (1) 
In order to ensure that assessments are carried out effectively and 
uniformly, the minimum relevant criteria for competence shall be 
defined by the Registrar.
    (2) Auditors shall meet the requirements of the appropriate 
international documentation. For the assessment of a quality system, 
the relevant guidelines for auditing and the criteria for auditors are 
those defined in the appropriate international documentation.
    (3) Technical experts are not required to comply with the 
requirements for auditors, and guidance on their personal attributes 
may be obtained by the appropriate international documentation.
    (c) Selection procedure. (1) The Registrar shall have a procedure 
for selecting auditors and, if applicable, technical experts on the 
basis of their competence, training, qualifications, and experience, 
and for initially assessing the conduct of auditors and technical 
experts during assessment and subsequently monitoring the performance 
of auditors and technical experts.
    (2) When selecting the audit team to be appointed for a specific 
assessment, the Registrar shall ensure that the skills brought to each 
assignment are appropriate. The team shall:
    (i) Be familiar with the Act and this part, registration procedures 
and registration requirements;
    (ii) Have a thorough knowledge of the relevant assessment method 
and assessment documents;
    (iii) Have appropriate technical knowledge of the fastener 
technology for which registration is sought and where relevant with 
associated procedures and their potential for failure (technical 
experts who are not auditors may fulfill this function);
    (iv) Have a degree of understanding sufficient to make a reliable 
assessment of the competence of the Facility to provide products, 
processes or services in its registered scope;
    (v) Be able to communicate effectively, both in writing and orally, 
in the required languages;
    (vi) Be free from any interest that might cause team members to act 
in other than an impartial or non-discriminatory manner, for example:
    (A) Audit team members or their organization shall not have 
provided consulting services to the applicant or fastener manufacturer 
whose Facility is registered which compromise the registration process 
and decision; and
    (B) In accordance with the directives of the Registrar, the audit 
team members shall inform the Registrar, prior to the assessment, about 
any existing, former or envisaged link between themselves or their 
organization and the fastener manufacturer whose Facility is to be 
assessed.
    (d) Contracting of assessment personnel. The Registrar shall 
require the personnel involved in the assessment to sign a contract or 
other document by which they commit themselves to comply with the rules 
defined by the Registrar, including those relating to confidentiality 
and those relating to independence from commercial and other interests, 
and any prior and/or present link with the fastener manufacturers whose 
Facilities are to be assessed. The Registrar shall ensure that, and 
document how, any subcontracted assessment personnel satisfy all the 
requirements for assessment personnel outlined in this Subpart.
    (e) Assessment personnel records. (1) The Registrar shall possess 
and maintain up-to-date records on assessment personnel, consisting of:
    (i) Name and address;
    (ii) Affiliation and position held in the organization;
    (iii) Educational qualifications and professional status;
    (iv) Experience and training in each field of competence of the 
Registrar;
    (v) Date of most recent updating of records; and
    (vi) Performance appraisal.
    (2) The Registrar shall ensure and verify that any subcontracted 
body maintains records which satisfy the requirements of this part, of 
assessment personnel who are subcontracted to the Registrar.
    (f) Procedures for audit teams. Audit teams shall be provided with 
up-to-date assessment instructions and all relevant information on 
registration arrangements and procedures.


Sec. 280.1112  Changes in the registration requirements.

    The Registrar shall give due notice of any changes it intends to 
make in its requirements for registration. It shall take account of 
views expressed by the interested parties before deciding on the 
precise form and effective date of the changes. Following a decision 
on, and publication of, the changed requirements, it shall verify that 
each fastener manufacturer whose Facility is registered carries out any 
necessary adjustments to its procedures within such time as, in the 
opinion of the Registrar, is reasonable.


Sec. 280.1113  Appeals, complaints and disputes.

    Appeals, complaints and disputes brought before the Registrar by 
fastener manufacturers or other parties shall be subject to the 
procedures of the Registrar. The Registrar shall keep a record of all 
appeals, complaints and disputes, and remedial actions relative to 
registration; take appropriate

[[Page 18286]]

corrective and preventive action; and document the actions taken and 
assess their effectiveness.

Requirements for Registration


Sec. 280.1120  Application for registration.

    (a)(1) As specified in Sec. 280.1110(g)(1) of this part, the 
Registrar shall maintain up-to-date a detailed description of the 
assessment and registration procedure, the documents containing the 
requirements for registration and documents describing the rights and 
duties of fastener manufacturers whose Facilities are registered, and 
shall provide them to applicants and those fastener manufacturers. The 
Registrar shall require that a fastener manufacturer whose Facility is 
registered:
    (i) Always complies with the relevant provisions of this part;
    (ii) Makes all necessary arrangements for the conduct of the 
assessment, including provision for examining documentation and the 
access to all areas, records (including internal audit reports) and 
personnel for the purposes of assessment, surveillance, reassessment, 
and resolution of complaints;
    (iii) Only claims that its Facility is registered with respect to 
those activities for which it has been granted registration;
    (iv) Does not use the registration in such a manner as to bring the 
Registrar into disrepute, and does not make any statement regarding its 
registration which the Registrar may consider misleading or 
unauthorized;
    (v) Upon suspension or withdrawal of the registration (however 
determined), discontinues use of all advertising matter that contains 
any reference thereto and returns any registration documents as 
required by the Registrar;
    (vi) Uses registration only to indicate that the quality assurance 
system as employed in its Facility is in conformity with specified 
standards or other normative documents, and does not use the 
registration to imply that a product or service is approved by the 
Registrar, as required by Sec. 280.804;
    (vii) Ensures that no registration document, mark or report, or any 
part thereof, is used in a misleading manner; and
    (viii) In making reference to the registration in communication 
media such as documents, brochures, or advertising, complies with the 
requirements of the Registrar.
    (2) When the desired scope of registration is related to a specific 
program, any necessary explanation shall be provided to the fastener 
manufacturer. If requested, additional application information shall be 
provided to the fastener manufacturer.
    (b) The Registrar shall require an official application form, duly 
completed and signed by a duly authorized representative of the 
applicant fastener manufacturer in which or attached to which:
    (1) The scope of the desired registration is defined; and
    (2) The applicant agrees to comply with the requirements for 
registration and to supply any information needed for its evaluation.
    (c)(1) At least the following information shall be provided by the 
applicant prior to the on-site assessment:
    (i) The general features of the applicant, such as corporate 
entity, name, addresses, legal status and, where relevant, human and 
technical resources;
    (ii) General information concerning the quality system and the 
activities it covers;
    (iii) A description of the systems to be registered and the 
standards or other normative documents applicable to each; and
    (iv) A copy of its quality manual and, where required, the 
associated documentation.
    (2) The information gathered from the application documentation and 
the quality manual review may be used for the preparation of the on-
site assessment and shall be treated with appropriate confidentiality.


Sec. 280.1121  Preparation for assessment.

    (a) Before proceeding with the assessment the Registrar shall 
conduct, and maintain records of, a review of the request for 
registration to ensure that:
    (1) The requirements for registration are clearly defined, 
documented, and understood;
    (2) Any difference in understanding between the Registrar and the 
applicant is resolved; and
    (3) The Registrar has the capability to perform the registration 
service with respect to the scope of the registration sought, the 
location of the applicant's operations, and any special requirements 
such as the language used by the applicant.
    (b) The Registrar shall prepare a plan for its assessment 
activities to allow for the necessary arrangements to be made.
    (c) The Registrar shall nominate a qualified audit team to evaluate 
all material collected from the applicant and to conduct the audit on 
its behalf. Experts in the areas to be assessed may be attached to the 
Registrar's team as advisers.
    (d) The fastener manufacturer shall be informed of the names of the 
members of the audit team who will carry out the assessment, with 
sufficient notice to appeal against the appointment of any particular 
auditors or experts.
    (e) The audit team shall be formally appointed and provided with 
the appropriate working documents. The plan for and the date of the 
audit shall be agreed to by the fastener manufacturer. The mandate 
given to the audit team shall be clearly defined and made known to the 
fastener manufacturer, and shall require the audit team to examine the 
structure, policies, and procedures of the Facility and the quality 
assurance system it employs, and confirm that these meet all the 
requirements relevant to the scope of registration, and that the 
procedures are implemented and are such as to give confidence in the 
products, processes, or services of the Facility being evaluated.


Sec. 280.1122  Assessment.

    The audit team shall asses the quality assurance system, employed 
in the Facility being evaluated, covered by the defined scope against 
all applicable registration requirements.


Sec. 280.1123  Assessment report.

    (a) The Registrar may adopt reporting procedures that suit its 
needs but, as a minimum, these procedures shall ensure that:
    (1) A meeting takes place between the audit team and the fastener 
manufacturer's management prior to leaving the premises, at which the 
audit team provides a written or oral indication regarding the 
conformity of the quality assurance system, as employed in particular 
Facility, with the particular registration requirements and provides an 
opportunity for the fastener manufacturer to ask questions about the 
findings and their basis;
    (2) The audit team provides the Registrar with a report of its 
findings as to the conformity of the quality assurance system, as 
employed in the particular Facility, with all of the registration 
requirements;
    (3) A report on the outcome of the assessment is promptly brought 
to the fastener manufacturer's attention by the Registrar, identifying 
any nonconformity to be discharged in order to comply with all of the 
registration requirements;
    (4) The Registrar shall invite the fastener manufacturer to comment 
on the report and to describe the specific actions taken, or planned to 
be taken within a defined time, to remedy any nonconformity with the 
registration

[[Page 18287]]

requirements identified during the assessment of its quality assurance 
system, as employed in the particular Facility, and shall inform the 
fastener manufacturer of the need for full or partial reassessment of 
its quality assurance system or whether a written declaration to be 
confirmed during surveillance will be considered adequate;
    (5) The report shall contain as a minimum:
    (i) The date(s) of the audit(s);
    (ii) The name(s) of the person(s) responsible for the report;
    (iii) The names and addresses of the Facility audited;
    (iv) The assessed scope of registration or reference thereto, 
including reference to the standard(s) applied;
    (v) Comments on the conformity of the quality assurance system, as 
employed in the particular Facility, with the registration 
requirements, with a clear statement of nonconformity and, where 
applicable, any useful comparison with the results of previous 
assessments of the quality assurance system, as employed in that 
particular Facility; and
    (vi) An explanation of any differences from the information 
presented to the body at the closing meeting.
    (b) If the final report authorized by the Registrar differs from 
the report referred to in paragraphs (a)(3) and (5) of this section, it 
shall be submitted to the fastener manufacturer with an explanation of 
any differences from the previous report. The report shall take into 
consideration:
    (1) The qualification, experience, and authority of the staff 
encountered.
    (2) The adequacy of the internal organization and procedures 
adopted by the applicant body to give confidence in the quality 
assurance system, as employed in the particular Facility; and
    (3) The actions taken to correct identified nonconformities 
including, where applicable, those identified at previous assessments.


Sec. 280.1124  Decision on registration.

    (a) The decision whether or not to register a fastener Facility 
shall be taken by the Registrar on the basis of the information 
gathered during the registration process and any other relevant 
information. Those who make the registration decision shall not have 
participated in the audit.
    (b) The Registrar shall not delegate authority for granting, 
maintaining, extending, reducing, suspending, or withdrawing 
registration to an outside person or body.
    (c) The Registrar shall provide to each fastener manufacturer whose 
Facility is registered, registration documents such as a letter or a 
certificate signed by an officer who has been assigned such 
responsibility. These documents shall identify, for the fastener 
manufacturer and the particular Facility covered by the registration:
    (1) The name and addresses;
    (2) The scope of registration granted, including as appropriate:
    (i) The quality system standards and/or other normative documents 
to which quality systems are registered;
    (ii) The product, process, or service categories; and, if 
appropriate,
    (iii) Regulatory requirements, product standards, or other 
normative documents against which products are supplied.
    (3) The effective date of registration and the term for which the 
registration is valid.
    (d) Any application for amendment to the scope of a previously 
granted registration shall be processed by the Registrar. The Registrar 
shall decide what, if any, assessment procedure is appropriate to 
determine whether or not the amendment should be granted and shall act 
accordingly.


Sec. 280.1125  Surveillance and reassessment procedures.

    (a) The Registrar shall carry out periodic surveillance and 
reassessment at sufficiently close intervals to verify that its 
registered Facilities continue to comply with the registration 
requirements. The period involved cannot be greater than one year.
    (b) Surveillance and reassessment procedures shall be consistent 
with those concerning the assessment of the Facility as described in 
this part.


Sec. 280.1126  Use of certificates and logos.

    (a) The Registrar shall exercise proper control over ownership, use 
and display of its quality system registration mark and logos.
    (b) If the registrar confers the right to use a symbol or logo to 
indicate registration of a Facility, the fastener manufacturer may use 
the specified symbol or logo only as authorized in writing by the 
Registrar. This symbol or logo shall not be used on a product or in a 
way that may be interpreted as denoting product conformity.
    (c) The Registrar shall take suitable action to deal with incorrect 
references to the registration system or misleading use of certificates 
and logos found in advertisements, catalogs, etc. Such action could 
include corrective action, withdrawal of certificate, publication of 
the transgression and, if necessary, other legal action.


Sec. 280.1127  Access to records of complaints to fastener 
manufacturers.

    The Registrar shall require each fastener manufacturer whose 
Facility is registered to make available to the Registrar, when 
requested, the records of all complaints and corrective action taken in 
accordance with the requirements of the quality system standards or 
other normative documents.

[FR Doc. 98-9397 Filed 4-13-98; 8:45 am]
BILLING CODE 3510-13-M