[Federal Register Volume 62, Number 173 (Monday, September 8, 1997)]
[Proposed Rules]
[Pages 47240-47260]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-23613]



[[Page 47239]]

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Part II





Department of Commerce





_______________________________________________________________________



National Institute of Standards and Technology



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15 CFR Part 280



Procedures for Implementation of the Fastener Quality Act; Proposed 
Rule

  Federal Register / Vol. 62, No. 173 / Monday, September 8, 1997 / 
Proposed Rules  

[[Page 47240]]



DEPARTMENT OF COMMERCE

National Institute of Standards and Technology

15 CFR Part 280

[Docket No: 970724177-7177-01]


Procedures for Implementation of the Fastener Quality Act

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

ACTION: Notice of proposed rulemaking; request for comments.

-----------------------------------------------------------------------

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, United States 
Department of Commerce, request comments on proposed changes to the 
regulations found at 15 CFR part 280 pertaining to implementation of 
the Fastener Quality Act (the Act). The proposed changes allow 
accreditation of in-process inspection activities of qualifying 
statistical process control manufacturing facilities, address the issue 
of passing laboratory inspection and testing reports along the supply 
chain to the fastener manufacturer, address the issue of significant 
alteration by removal of manufacturer or grade identification markings 
for decorative purposes at the customer's request, address the issue of 
grandfathering fasteners, and revise definitions and related sections 
for clarity and to correct editorial error. The proposed changes will 
facilitate the implementation of the Act and regulations and will 
better accommodate modern industry practices by incorporating them into 
the Fastener Quality Act certification process.

DATES: Comments must be received no later than November 7, 1997.

ADDRESSES: Comments on the proposed revisions must be submitted to: 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.

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:

Background

    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 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 the 
National Institute of Standards and Technology (NIST), published final 
implementing regulations on September 26, 1996, establishing 
procedures, under which: (1) Laboratories in compliance with the Act 
may be listed; (2) 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, record keeping, 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, pursuant to Section 15 of 
the Fastener Quality Act, NIST announced a one year extension in the 
implementation date of the regulations on grounds that there were an 
insufficient number of accredited laboratories to conduct the volume of 
inspection and testing required by the Act and regulations (62 Fed. 
Reg. 19041 (1997)). NIST believes that it will have completed the 
approval/accreditation of a sufficient number of accreditation bodies/
laboratories to implement the Act by May 26, 1998.
    Following issuance of the final regulations on September 26, 1996, 
the automobile industry approached the Department and expressed its 
concerns that the Act and implementing regulations do not recognize the 
use of modern manufacturing methods using prevention-based quality 
assurance systems employing statistical process controls (SPC). During 
the period of September 1996 to January 1997, the Department worked 
with the automobile industry (domestic and foreign) to develop further 
information about the extent of the problem. On February 4, 1997, a 
Public Workshop was held at the National Institute of Standards and 
Technology (NIST) to solicit information from the automobile, 
aerospace, construction, and fastener industries on the use of 
prevention-based quality assurance systems employing SPC in the 
manufacture of fasteners. On the basis of this meeting and many 
discussions with the concerned industries, the Department is proposing 
amendments to the implementing regulations that will recognize the use 
of prevention-based quality assurance systems under the Act and 
regulations. These amendments are discussed in detail in Part 1 of this 
proposed rule.
    In addition to the above, the Department collaborated with industry 
in conducting eleven Fastener Quality Act Workshops in various parts of 
the United States, Europe, and Asia during the period from September 
1996 to February 1997. The workshops attracted over 2,500 industry 
participants who asked hundreds of questions of the Department on the 
Act and regulations. As a result of those workshops and the great deal 
of information provided by the industry participants on the impact of 
the Act and regulations, the Department assembled evidence of need for 
several possible amendments to the regulations. These amendments are 
discussed in detail in Part 2 of this proposed rule.

Part 1: Summary of Proposed Amendments on Statistical Process Control

Background & Definition of the Issue

    Ford, General Motors, and Chrysler Corporation established a 
Supplier Quality Requirements Task Force in the 1980s to develop 
quality system requirements (QS-9000) for their suppliers of materials 
and parts. Initially, each company developed its own expectations for 
supplier quality systems. In 1988, emphasis was placed on standardizing 
the requirements, and in 1992 this was largely accomplished. The goal 
of QS-9000 is the development of fundamental quality assurance systems 
(QAS) that provide for continuous improvement, emphasizing

[[Page 47241]]

defect prevention and the reduction in variation and waste in the 
supply chain.
    QS-9000 employs statistical process control (SPC) in ensuring the 
quality of parts. Suppliers must demonstrate process capabilities which 
will yield a given quantity of parts with a minimum specified number of 
defects. Depending upon the fastener type and auto maker, the maximum 
allowable defective Parts Per Million (PPM) ranges between 15 and 125 
PPM.
    The heart of the QS-9000 system is the Control Plan which each 
company must develop and have approved by Ford, GM, or Chrysler as part 
of their adherence to QS-9000. The Control Plan is a comprehensive 
documentation of product/process characteristics, process controls, 
tests, and measurement systems that will occur during mass production. 
It will normally also specify how much in-process or final testing and 
inspection will be carried out by the supplier company. This 
determination is based upon demonstrated process capabilities, 
experience with the supplier, etc. QS-9000 implies that, through 
continuous improvement, a supplier company may ultimately be able to 
demonstrate a capability of producing millions of parts with zero 
defects by continuously monitoring and controlling the production 
process rather than relying upon the inspection and testing of the 
physical attributes of the manufactured product. Given the above, the 
automotive industry asserts that the Fastener Quality Act's reliance on 
lot control and final inspection of fasteners does not recognize the 
reality of modern mass production using statistical process control.
    As present, the FQA and implementing regulations, rely on the use 
of accredited laboratories for inspection, testing, and certification 
of fasteners to applicable standards and specifications. Sections 5 of 
the Act and 280.5 of the regulations are very specific that a 
manufacturer of a lot of fasteners shall cause a representative sample 
of the fasteners in the lot to be inspected and tested by an accredited 
laboratory, and a test report must be produced which indicates that the 
fasteners tested are in conformance with all of the provisions of the 
standards and specifications used by the manufacturer in the production 
of the fasteners. The end result, and the cornerstone on which the Act 
is based, is that every lot of fasteners is certified by the 
manufacturer as conforming to a given standard and specification, and 
the paperwork relating to such certification (e.g., certificates of 
conformance and test reports) is maintained on file and available at 
the purchaser's request.
    In the case of fastener manufacturers supplying the automobile 
industry, Ford, GM, and Chrysler, as major end users of the fasteners, 
have established QS-9000 as a means of achieving the same end. Their 
suppliers are required to: (1) Establish a control plan under which 
they will produce fasteners to the auto industries standards and 
specifications; (2) submit evidence in the form of production data that 
they can produce fasteners under a specified defect rate; and (3) 
perform continuous monitoring and tests to maintain control of the 
production process and to assure that the final product will be in 
conformance with fastener standards and specifications. The difference 
between the previously published regulation and the QS-9000 approach is 
that the regulation assures end users that fasteners meet standards and 
specifications by relying upon the inspection and testing of fasteners 
by accredited laboratories. Under QS-9000, the end users (Ford, GM, and 
Chrysler) recognize the fastener manufacturer's entire production 
process as a means of ensuring conformance to these end users standards 
and specifications. Consequently, ensuring adherence to standards and 
specifications, is equivalent under the QS-9000 approach to end product 
testing. However, the automobile industry believes that reliance on QS-
9000, which is based upon continuous monitoring and improvement of the 
manufacturing process, is more efficient and cost effective than 
traditional manufacturing regimens of final inspection and testing of 
the end product, and represents the direction in which manufacturing 
technology is evolving in this country and abroad.
    Parallels to QS-9000 are being used in other countries including 
Japan, and in other industries. For example, the U.S. aerospace 
industry employs statistical process control in much the same way that 
the automobile industry does. That is, major end users of aerospace 
fasteners are beginning to require their fastener suppliers to comply 
with comparable quality assurance programs as a condition to supplying 
them.
    When the Fastener Quality Act was signed into law in 1990, QS-9000 
was in the early stages of development, and its full implication for 
the industry was not well known. There is some evidence in the history 
of the Act that Congress was informed of the need to consider OEM based 
quality assurance systems for procuring fasteners (e.g., Statement of 
Donald Keil, Assistant Director of Quality, Caterpillar Inc., during 
the Hearing on H.R. 3000 before the Committee on Commerce, Science, and 
Transportation, United States Senate, S.Hrg. 101-509, November 20, 
1989). However, the Act did not directly recognize major end user 
quality system requirements for satisfying testing, inspecting and 
certification provisions under section 5 of the Act. Similarly, in 
August 1992, NIST published draft implementing regulations for public 
comment. As a result of the public comment process, letters were 
received from General Motors and Nissan Corporation calling attention 
to quality assurance programs they had in place to qualify fastener 
suppliers; they indicated that the Act would require some redundant 
testing. However, no recommendations were made at that time to permit 
recognition of QS-9000 type systems.
    The discussions about the use of statistical process control within 
the automobile industry, did not lead to specific recommendations for 
treating SPC under the Act or regulations. However, the issue was 
raised at a meeting of the Fastener Advisory Committee in May 1996. At 
that meeting a member of the Advisory Committee raised the issue of 
problems that fastener suppliers would face in meeting the inspection, 
testing, and certification requirements of the Act and regulations. 
Accordingly, a proposal was introduced to exempt from the regulations 
the automotive fasteners produced to the standards of a major end user 
such as GM, Ford, and Chrysler. Since May of 1996, the Department has 
had many discussions of these issues with representatives of the 
automobile industry (U.S. and foreign) and with fastener manufacturers 
who supply such industries. On February 4, 1997, NIST held an open 
meeting to solicit industry views on the use of SPC in the manufacture 
of fasteners under the Act. The purpose of the meeting, attended by 
some 150 industry representatives and Department officials, was to 
determine the impact that inspection, testing, and certification 
requirements of the Act and regulations would have on fastener 
manufacturers who use SPC and to identify ways in which the 
requirements of the Act and regulations might be met by prevention-
based QAS using SPC.
    A report of the meeting was published in April 1997, NISTIR 6001--
``Summary of Public Meeting, Use of Quality Assurance Systems in the 
Fastener Industry,'' and may be obtained from NIST. The report included 
proposed regulatory language being considered at that time by the 
Department for resolving the issues identified during the meeting. As 
part of the report, the

[[Page 47242]]

Department invited industry to provide input on the suggested 
regulatory approach. Some 30 letters were received by NIST, commenting 
on the report and the proposed regulatory language. The vast majority 
of these focused on the SPC issue, suggesting solutions ranging from 
exempting the automobile industry from the Act and regulations to 
incorporating SPC in the regulatory scheme. Many proposed specific 
amendments to the regulations that would incorporate SPC. The 
Department appreciates the spirit with which the automobile industry 
has responded and had considered all comments received. It is believed 
that the amendments proposed in this notice best achieve the 
incorporation of SPC in the regulatory scheme.

The Proposed Solution to the QAS/SPC Issue

    The Director of NIST is today proposing that a fastener 
manufacturing facility employing a fastener quality assurance system 
(QAS) as defined in the regulations may be deemed to be an accredited 
laboratory for purposes of the Act and regulations if such facility has 
been formally registered by a NIST-recognized quality systems 
registrar.
    NIST wishes to make it clear that recognition of facilities that 
employ fastener QAS as accredited laboratories within the meaning of 
the Act and regulations is an alternative to final inspection and 
testing of fasteners that is still carried out by many fastener 
manufacturers. Both approaches to meeting the requirements of the Act 
and regulations are equally valid. Adoption of these proposed 
amendments will enable the use of QAS in fastener manufacturing in a 
manner consistent with the requirements of the Act by ensuring that 
every lot of fasteners is sampled and examined to ensure conformance 
with applicable standards and specifications. Manufacturers must follow 
the requirements of the fastener standards and specifications, as 
published by a consensus standards organization or a major end user. 
For example, a fastener manufacturer cannot unilaterally decide to 
replace final inspection and testing with a QAS unless the designated 
standards or specifications provide for this as an alternative to final 
inspection and testing.
    A definition of ``Fastener Quality Assurance System (QAS)'' is 
proposed as part of the amendments. In developing the QAS definition, 
NIST feels it is important to provide guidance to the industry as to 
the minimum elements a fastener manufacturer's QAS should contain to be 
eligible for recognition as an accredited laboratory within the meaning 
of the Act and regulations. These elements have been included in the 
definition.
    The Department believes that the proposed amendments resolve 
industry's concerns that the Act and regulations should recognize the 
use of modern manufacturing methods. Proposed procedures for applying 
for NIST/ABEP recognition of registrar accreditation bodies that 
accredit quality systems registrars, which are based upon international 
standards, are included as subparts I through L.

Part 2: Summary of All Other Proposed Amendments

    Since September 1996, eleven Fastener Quality Act Workshops have 
been conducted in seven cities in the U.S. (Chicago [2], Cleveland, 
Columbus, Houston, Newark, Atlanta, and Los Angeles), and in Taiwan and 
the U.K. (two were held in London). Over 2,500 industry participants 
attended the workshops. These included fastener manufacturers, 
distributors, and importers, and representatives of industries such as 
automotive, aerospace, construction, heavy machinery, etc., that 
purchase and use high strength fasteners. At the workshops, 
representatives of BXA, NIST, and the Patent and Trademark Office (PTO) 
presented information on the Act and implementing regulations. In 
addition, members of the Public Law Task Force (PLTF), a nine member 
industry committee representing fastener manufacturers, distributors, 
and importers, provided an industry perspective on the impact of the 
Act and regulations. Over the course of the workshops some 450 
questions from the participants were documented by the Department, with 
the understanding that answers would be published as interpretive 
opinions of the Department as soon as practicable.
    During the course of the workshops a great deal of practical 
information was exchanged among the participants on the impact of the 
Act and regulations on daily commerce in fasteners. This information 
has been analyzed by the Department and translated into proposed 
amendments which are discussed below. Comments from the public are 
requested on these proposed amendments.

1. Significant Alterations of Fasteners

    Under section 280.2 of the regulations, ``significantly alter'' 
means to alter a fastener in a manner 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 specified Rockwell C hardness of less than 
32, or cutting off of fasteners. In the reference to Rockwell C 
hardness, an editorial error was made in the September 26, 1996 
issuance of the final regulations in that the word ``minimum'' was to 
appear before the word ``specified'' so that it reads ``minimum 
specified Rockwell C hardness of less than 32 * * * '' in section 280.2 
and in section 280.11 (b) of the regulations. The Department proposes 
amendments to these sections to correct this error.

2. Removal of Head Markings

    Questions were raised during each of the workshops about specialty 
fasteners and the practice of shaving or polishing of fastener heads to 
remove all markings for decorative purposes. The cases mentioned were 
of manufacturers of motorcycles and pianos which frequently special 
order fasteners that will be subject to the Act and regulations without 
any head markings on them because they do not want the markings to show 
in the final product. However, the Department also recently received a 
letter from the Association of International Automobile Manufacturers 
(AIAM) indicating that some of its members produce company standards 
which may reference consensus standards for certain requirements for 
fasteners but which do not reference requirements for including the 
manufacturer's insignia on the head of the fastener. AIAM asserts that 
such practice is consistent with the Act and regulations and that the 
manufacturer of the fastener may supply the fasteners to these 
automobile manufacturers without any head markings. The issue is 
whether a fastener manufacturer is in violation of the Act and 
regulations if he/she fills such an order from a customer. Put another 
way, how much flexibility does a customer have in requesting that 
covered fasteners be supplied to them without the required headmarkings 
if they are going to use the fasteners in their products and possibly 
even sell them for repair and replacement parts?
    The Department has studied this issue and is proposing to amend the 
regulations by adding a new section 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. The existing sections

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280.11(c) and (d) are proposed to be redesignated as sections 280.11(d) 
and (e). The new section 280.11(c) requires that: (1) The fasteners be 
manufactured to an OEM or major end-user standard which does not 
require such markings; or (2) the customer request in writing that 
manufacturer or grade identification markings be removed for decorative 
purposes and certifies that such fasteners will not be held out or sold 
as meeting the requirements of a consensus standard which requires 
manufacturer or grade identification markings.

3. Supplying Originals vs Copies of Test Reports

    In all of the workshops, especially those held in Asia and in 
Europe, concerns were expressed about the potential paperwork burden on 
raw materials manufacturers in meeting the requirements of section 
280.15 of the regulations. Raw materials manufacturers (domestic and 
foreign) assert that the requirement for ``originally signed'' test 
reports to accompany shipments of raw materials and finished fasteners 
will be a significant burden to them.
    In the case of raw material suppliers, the raw material purchased 
by the fastener manufacturer typically goes through as many as four 
processors, each performing a different operation that does not affect 
the steel's chemical characteristics. In addition, distributors may be 
involved in these transactions. Under one scenario, the following 
successive processors/distributors transform the ingot/bloom to 
fasteners:

Steel mill or melter or ingot producer irod produceri wire or rod 
produceri distributori fastener producer

    Current industry practice is that the steel mill is the primary 
source at which the chemical characteristic certification is produced 
and passed down to the first processor or distributor to whom it sells 
the steel. All other subsequent processors, distributors and fastener 
manufacturers in the above mentioned chain, produce their own 
certification based on the results contained in the original chemical 
certificate of the steel mill. This certificate consists of relevant 
information such as the name of steel melter, steel mill 
identification, heat number, and chemical analysis data. Therefore, 
current industry practice is for everyone in the chain except the 
original steel melter to reference the original chemical certification 
data instead of passing on a certified copy of the chemical 
characteristics certificate down the chain to the fastener 
manufacturer. The primary reason for this practice is that from a 
single heat number of steel, thousands of lots of fasteners can be 
manufactured by an unknown number of fastener manufacturers. Moreover, 
the steel mill would not know in advance the name of fastener 
manufacturers who would purchase steel from a given heat number or the 
number of certificates required from a heat number of the steel.
    To comply with the Act and current regulations, either copies of 
the laboratory report of chemical characteristics, certified by the 
laboratory, must be passed down the supply chain ``through the metal 
manufacturer'' or the fastener manufacturer must be responsible for 
contacting the laboratory that performed the chemical tests to obtain a 
certified copy directly. Since the metal manufacturers do not know how 
many fastener manufacturers will acquire part of a particular heat or 
coil, they do not know how many certified copies to request from the 
laboratory at the time they obtain the original test report. The 
fastener manufacturers feel it is burdensome for them to obtain 
certified copies from the laboratories, and it is extremely burdensome 
for the laboratories to have to retrieve reports and create certified 
copies whenever requested by fastener manufacturers.
    A solution that works for both fasteners of foreign origin and 
domestically-produced fasteners is to allow copies of laboratory 
testing reports of chemical characteristics only to be certified by 
either the laboratory or the metal manufacturer. The definition of 
``original laboratory testing report'' in section 280.2 is proposed to 
be amended to allow metal manufacturers, as well as laboratories, to 
certify copies of laboratory testing reports of chemical 
characteristics.

4. Laboratory Test Reports

    Several steel producers raised another issue with respect to the 
chemistry certificate during the workshops. It deals with a discrepancy 
in the language used in reporting of alternative chemical 
characteristics, as follows:
    1. Section 5(d)(3)of the Act requires reporting the, ``chemical 
characteristics of such coil or heat number;''
    2. Section 280.6(b)(5)(ii) of the regulations requires, ``test 
results for each sample;'' and
    3. Section 280.15(b) returns to the requirement for reporting, 
``chemical characteristics of such coil or heat number.''
    The chemical characteristics data required to be reported in 
section 280.6(b)(5)(ii) is not the same as the other two sections 
mentioned above. Currently, steel manufacturers use test reporting 
methods that conform to section 5(d) of the Act, and section 280.15 of 
the regulations. The reporting of the ``heat number analysis'' is well 
defined in existing steel making practices and consensus standards. A 
``heat number analysis'' consists of derived values for each element 
from one or more samples taken from either molten metal or solid steel. 
Overall, this method best describes the chemical characteristics of the 
steel.
    If section 280.6(b)(5)(ii) is not changed to make it in agreement 
with other sections of the Act and regulations, several problems may 
occur:
    1. Steel suppliers will be forced to use their best judgement in 
interpreting the Act, and proper methods of reporting of chemical 
analysis;
    2. Variations in interpretations will lead to serious disputes 
between steel suppliers and their customers; and
    3. Steel suppliers will be forced to change reporting methods to 
those described in section 280.6(b)(5)(ii), which will result in 
unnecessary costs to the industry.
    Accordingly, the Department is proposing for public comment an 
amendment to section 280.6(b), which is proposed to be redesignated as 
section 280.6(c), which requires the reporting of test results for such 
coil or heat number chemical analysis.

5. New Definition of ``Lot Number''

    It was pointed out during the workshops that ``lot number'' as 
defined in section 280.2 of the definitions means a number assigned to 
the lot by a manufacturer, and that it is fairly common for 
distributors and importers to assign their own unique lot number to 
fasteners in addition to the number assigned by the manufacturer. 
Further, section 280.11 of the regulations dealing with significant 
alterations requires that significant alterors assign their lot numbers 
to significantly altered fasteners. Accordingly, the Department is 
proposing to amend the definition of lot number found in section 280.2 
to include a number assigned by a manufacturer, importer, distributor, 
or significant alterer to the lot. The amendment further stipulates 
that a lot number assigned by an importer, distributor, or significant 
alterer shall be traceable to a manufacturer's single, unique lot 
number.

6. Grandfathered Fasteners Issue

    Section 15 of the Act provides that the Act is applicable only to 
fasteners manufactured after the implementation date of the Act. 
Section 280.12(c) of the

[[Page 47244]]

regulations further states that nothing in the Act or in the 
regulations prohibits selling finished fasteners manufactured prior to 
the implementation date of the Act, or representing that such fasteners 
meet standards and specifications of a consensus standards organization 
or a government agency. Additionally, this section of the regulations 
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.
    It is clear that Congress, in enacting section 15 of the Act, 
intended only to cover those fasteners produced after the 
implementation date of the Act so as not to impose a hardship on the 
industry by having existing product retested and certified. However, 
representatives of the fastener industry met in January 1997 with 
representatives of NIST and proposed that section 280.12(c) of the 
regulations be amended by moving the last sentence of the 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 section 280.602, Violations. This sentence 
is moved to the violations section because as a prohibition on certain 
specific conduct, it more appropriately belongs there.
    Request for Public Comment: Persons interested in commenting on the 
proposed regulations should submit their comments in writing to the 
above address. All comments received in response to this notice will 
become part of the public record and will be available for inspection 
and copying at the Department of Commerce Central Reference and Records 
Inspection facility, room 6228, Hoover Building, Washington, DC 20230.

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

Regulatory Flexibility Analysis of Procedures for Implementation of the 
Fastener Quality Act
    This proposed rule has been determined to be not significant for 
the purposes of E.O. 12866.
    The Assistant General Counsel for Legislation and Regulation of the 
Department of Commerce certified to the Chief Counsel for Advocacy, the 
Small Business Administration that this proposed rule, if adopted, 
would not have a significant economic impact on a substantial number of 
small entities as follows:
    The proposed rule includes changes that allow accreditation of in-
process inspection activities of qualifying statistical process control 
(SPC) manufacturing facilities, address the issue of passing laboratory 
inspection and testing reports along the supply chain to the fastener 
manufacturer, address the issue of significant alteration by removal of 
manufacturer or grade identification markings for decorative purposes 
at the customer's request, address the issue of grandfathering 
fasteners, and revise definitions and related sections for clarity and 
to correct editorial error. The proposed changes will facilitate the 
implementation of the Fastener Quality Act (FQA) and regulations and 
will better accommodate modern industry practices by incorporating them 
into the FQA certification process. However, of all these proposed 
changes, the major change covered here is that which allows 
accreditation of in-process inspection activities of qualifying 
statistical process control manufacturing facilities. The remaining 
changes are relevant to the existing regulations that became effective 
on November 25, 1996, and their impact on the fastener industry already 
has been presented. Therefore, in this analysis, the issues relevant to 
manufacturing of fasteners using only SPC or quality assurance systems 
(QAS) are covered.
    As presently constructed, the FQA and implementing regulations, 
rely on the use of accredited laboratories for inspection, testing, and 
certification of fasteners to applicable standards and specifications. 
Sections 5 of the Act and 280.5 of the regulations are very specific 
that a manufacturer of a lot of fasteners shall cause to be inspected 
and tested a representative sample of the fasteners in the lot by an 
accredited laboratory, and a test report must be produced which 
indicates that the fasteners tested are in conformance with all of the 
provisions of the standards and specifications used by the manufacturer 
in the production of fasteners. The end result, and the cornerstone on 
which the law is based, is that every lot of fasteners is certified by 
the manufacturer as conforming to a given standard and specification, 
and the paperwork relating to such certification (e.g., a certificate 
of conformance and test reports) is maintained on file and available at 
the purchaser's request.
    In the case of fastener manufacturers supplying the automobile 
industry, the industry has established QS-9000 as a means of achieving 
the same end. That is, they qualify their suppliers by requiring them 
to: (1) Establish a control plan under which they will produce 
fasteners to their standards and specifications; (2) submit evidence in 
the form of production data that they can produce fasteners under a 
specified defect rate; and (3) perform continuous monitoring and tests 
of the production process to maintain control of the process and to 
assure that the final product will be in conformance with fastener 
standards and specifications. The difference between the regulation as 
it exists and the QS-9000 approach is that the regulation assures end 
users that fasteners meet standards and specifications by relying upon 
the inspection and testing of fasteners by accredited laboratories. 
Under QS-9000, the end users (Ford, GM, and Chrysler) recognize the 
fastener manufacturer's entire production process as a means of 
assuring conformance to their standards and specifications. The end 
result, that of assuring adherence to standards and specifications, is 
the same under the QS-9000 approach as with end product testing. 
However, the automobile industry believes that reliance on QS-9000, 
which is based upon continuous monitoring and improvement of the 
manufacturing process, is more efficient and cost effective than 
traditional manufacturing regimens of final inspection and testing of 
the end product, and represents the direction in which manufacturing 
technology is evolving in this country and abroad.
    To the extent the FQA permits flexibility in developing these draft 
regulations, the Department has sought advice from the fastener and 
end-user industries (automotive, aerospace, etc.) to maximize the cost-
effectiveness of the proposed rule. Those recommendations presented by 
the industry at the February 4, 1997 meeting and at site visits to 
industry have been incorporated in this proposed rule to assist 
industry in implementing this rule, if accepted, in a cost-effective 
manner.
    It is difficult to estimate the total number of fastener 
manufacturers in the U.S. because there are too many that do not belong 
to any professional organization and operate very small shops. Some 
estimate this number to be in excess of one thousand. However, based on 
an estimate from the Industrial Fastener Institute, 80% of the U.S. 
fastener production capacity is served

[[Page 47245]]

by approximately 120 major manufacturers. Of these, nearly 50%, or 60 
manufacturers, supplying fasteners to the auto and aerospace industries 
could be using the QAS included in this rule. A large majority of these 
60 manufacturers could be classified as small businesses employing less 
than 750 employees (as defined at 13 CFR 121.201).

    We believe the overall effect on the fastener industry of 
adopting this proposed rule will be highly beneficial. No negative 
effects are envisioned at this time. In fact, as we look into the 
future, we believe market forces (improved quality and decreased 
cost) will push the remaining manufacturers not currently using QAS 
to adopt the QAS standards. This proposed rule, if adopted, would 
allow these manufacturers to do so without incurring additional 
costs to comply with the FQA. We believe this proposed rule, if 
adopted, would benefit the industry in, at least, the following 
ways:
    1. Ability to use modern manufacturing technology to conform 
with the law without a need to make any changes;
    2. Ability to use just-in-time delivery and other advancements 
to avoid production delays and reduce inventory costs; and
    3. Overall improvement in the fastener quality at a lower 
production cost.
    Registration cost per facility will vary with scope (the number 
of procedures and products, the number of sampling locations, etc.) 
as in the case of laboratory accreditation. Based on the laboratory 
accreditation carried out by NVLAP during the past nine months, we 
estimate the annual cost of registration will run between $5,000 and 
$15,000 per facility which is the same as the cost of laboratory 
accreditation. Since most facilities are likely to adopt one of the 
approaches, this will not be an additional cost. Moreover, most 
facilities seeking registration have already obtained registration 
under either ISO-9000 or QS-9000. Therefore, additional cost savings 
may result because fastener manufacturers do not have to spend 
resources solely for conforming with the FQA.
    It is not expected that any manufacturing facility practicing 
QAS will cease to operate; suffer a significant loss in gross 
revenue; or have increased compliance costs because of this proposed 
rule, if adopted.
    We seek public comment providing data on impact for use in 
determining the appropriateness of this certification for purposes 
of a final rule. Moreover, within one to two years of the initial 
implementation period, if adopted, we should have sufficient data to 
assess impact for purposes of determining the necessity for review 
under 5 U.S.C. Sec. 610(c).
    The requirements for laboratory accreditation and registration 
of manufacturing facilities under this rule are in accordance with 
the established international standards, thus promoting uniformity 
in the evaluation process. The rule allows the fastener manufacturer 
and testing laboratories to decide which approach to choose for 
seeking accreditation.
    This rule contains a collection-of-information requirement 
subject to the Paperwork Reduction Act. However, that requirement 
involves paperwork already being produced by fastener manufacturers. 
The only additional requirement is to prepare a synopsis of the 
testing and inspection results in the form of a test report. This 
requirement is proposed to facilitate enforcement actions of the 
Bureau Of Export Administration (BXA), which has the enforcement 
authority granted under the Fastener Quality Act.
    As a result, no initial regulatory flexibility analysis has been 
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 proposed rule revises an existing collection of information 
subject to the requirements of the Paperwork Reduction Act that was 
previously approved by the Office of Management and Budget under the 
control number 0693-0015. The revision is applicable to persons 
requiring approval of the Accreditation Body Evaluation Program (ABEP) 
at NIST to register quality system registrars who would in turn 
register fastener manufacturing facilities.
    The collection of information requirement is applicable to persons 
requiring approval of the Accreditation Body Evaluation Program (ABEP) 
at NIST to accredit quality system registrars who would register 
fastener manufacturing facilities. The public reporting burden per 
respondent for the collection of information contained in this rule is 
estimated to average 4 hours annually. This estimate includes the time 
for reviewing instructions, searching existing information, gathering 
and maintaining the information needed, and completing and reviewing 
the collection of information.
    Comments are requested concerning: (a) Whether the proposed 
collection of information is necessary for the proper performance of 
the functions of the agency, including whether the information will 
have practical utility; (b) the accuracy of NIST's burden estimate; (c) 
ways to enhance the quality, utility, and clarity of the information 
collected; and (d) ways to minimize the burden of the collection of 
information on the respondents, including the use of automated 
collection techniques or other forms of information technology. 
Comments should be addressed to the Office of Information and 
Regulatory Affairs, Office of Management and Budget, Washington, D.C. 
20503; and to NIST (Attn.: ABEP 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: August 13, 1997.
Robert E. Hebner,
Acting Director, National Institute of Standards and Technology.

    Dated: August 21, 1997.
William A. Reinsch,
Under Secretary for Export Adminstration.

    For reasons set forth in the preamble, it is proposed that Title 15 
of the Code of Federal Regulations be amended as follows:

PART 280--FASTENER QUALITY

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

    Authority: Section 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 had also delegated concurrent 
authority to amend the regulations issued under section 8 of the Act, 
regarding recordal of insignias, to the Assistant Secretary and

[[Page 47246]]

Commissioner of Patents and Trademarks.
    3. Section 280.2 is amended by revising the definitions for 
accreditation, lot number, original laboratory testing report, and 
significantly alter 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).
* * * * *
    Accreditor means a registrar accreditation body that meets the 
requirements of subpart K of this part, is recognized by NIST, and 
appears on the Accreditors List described in Sec. 280.810(a).
* * * * *
    Facility means a fastener manufacturing facility implementing a 
quality assurance system as defined in this part, that has been 
registered by a Registrar and appears on the Facilities List described 
in Sec. 280.810(c).
* * * * *
    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, ARD-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, and performed by 
a Facility on the Facilities List described in Sec. 280.810 or tested 
by a Laboratory on the Laboratories List described in Sec. 280.101, to 
avoid product lot contamination, and that finished lots of fasteners 
shall be traceable to subcontracted processes;
    (iv) A QAS plan, requiring 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 or 
specifications (consensus or major end-user standards as defined by the 
Act and this part), or those characteristics appropriate for evaluating 
product functionality.
* * * * *
    Lot number means a number assigned by a manufacturer, importer, 
distributor, or significant alterer to the lot. A lot number assigned 
by an importer, distributor, or significant alterer shall be traceable 
to a manufacturer's single, unique lot number.
* * * * *
    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.
* * * * *
    Registrar means a quality systems registrar that meets the 
requirements of subpart L of this part, is accredited by an Accreditor 
as defined in this part, and appears on the Registrars List described 
in Sec. 280.810(b).
* * * * *
    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 amended by redesignating paragraphs (b) and (c) 
as paragraphs (c) and (d) respectively, adding new paragraphs (b) and 
(e), and revising redesignated paragraph (c)(5)(ii) to read as follows:


Sec. 280.6  Laboratory Test Reports.

* * * * *
    (b) When performing tests for which they are registered under this 
part, each facility registered under Subpart I or J of these 
regulations and currently listed in the Facilities List shall issue 
test reports of its work which accurately, clearly, and unambiguously 
present a synopsis of 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

[[Page 47247]]

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 facility;
    (2) Unique identification of the test report including date of 
issue and serial number, or other appropriate means;
    (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, if any, 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) Production lot size and the number sampled;
    (iii) Name(s) and affiliation of person performing the lot 
sampling;
    (6) Test Results:
    (i) Actual tests required by the standard and specification;
    (ii) Test results;
    (iii) All deviations from the test method;
    (iv) All other items required on test reports according to the test 
method;
    (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/facility and accreditation/registration 
information listed in paragraph (b)(10) of this section.
    (vi) A statement that the samples tested either conform or do not 
conform to the fastener standards and specifications or standards and 
identification of any nonconformance;
    (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 registrar which registered the facility, and 
code number assigned to the facility by the registrar, and the 
expiration of registration.
    (c) * * *
    (5) * * *
    (ii) Test results for such coil or heat number chemical 
characteristics;
* * * * *
    (e) For tests carried out by a Facility registered pursuant to 
subpart I or J, 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, 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 involved in sample preparation and 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.

    In the event that the standard or specification to which a 
manufacturer represents the fasteners in a particular sample to have 
been manufactured does not provide for the size, selection or integrity 
of the sample to be inspected and tested, inspections and tests under 
section 5 of the Act shall be carried out using 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, or a sampling plan provided by a Fastener Quality Assurance 
System or by standards and specifications intended for use with a 
Fastener Quality Assurance System, as appropriate.
    7. Section 280.11 is amended by redesignating paragraphs (c) and 
(d) as paragraphs (d) and (e) respectively, adding new paragraph (c), 
and revising paragraph (b) and redesignated paragraph (d) 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.
    (c) If the significant alteration is only the removal of 
manufacturer or grade identification markings for decorative purposes 
at the customer's request, the requirements set forth in paragraph 
(a)(2) 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 either test the fasteners or provide a written statement 
disclosing the alteration as set forth in paragraph (a)(3) of this 
section. Along with such an order the fastener manufacturer must 
require a written certification from the customer stating that 
fasteners from the altered lot will not be held or sold as meeting the 
requirements of a consensus standard which requires manufacturer or 
grade identification markings.
    (d) Any person who knowingly sells a significantly altered fastener 
as described in paragraph (a) of this section, and who did not alter 
such fastener, shall provide to the purchaser a copy of the statement 
required by paragraph (a)(3) of this section; unless the significant 
alteration is only electroplating of the fastener, as described in 
paragraph (b) of this section or removal of manufacturer or grade 
identification markings, as described in paragraph (c) of this section.
* * * * *
    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 May 26, 
1998.
    (b) Metal manufactured prior to May 26, 1998 may not be used to

[[Page 47248]]

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 May 26, 1998 or representing that such 
fasteners meet standards and specifications of a consensus standards 
organization or a government agency.
    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 
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 and 280.7.
    (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 testing 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), and (n) to read as 
follows:


Sec. 280.602  Violations.

* * * * *
    (e) Misrepresentation and concealment of facts * * *
    (2) In connection with the preparation, submission, use, 
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 May 26, 1998 as being in 
conformance with the Act or 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.
    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  Recordkeeping.
280.810  Listing of recognized accreditors, accredited registrars, 
and registered facilities.
280.811  Removal from a list.
280.812  Appeal.


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. 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

[[Page 47249]]

Facilities: NIST recognizes Accreditors that meet the requirements of 
subpart K, which is based upon ISO Guide 61; the NIST-recognized 
Accreditors may, in turn, accredit Registrars that meet the 
requirements of Subpart L, 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. Section 280.810 establishes three lists that NIST 
will maintain: Sec. 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

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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.


Sec. 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 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.
    (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 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.
    (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.


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, 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. 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 and accredit Registrars of Facilities to conditions 
set out in subpart L.

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

Sec.

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.

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

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 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 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 Sec. 280.1010(d), 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 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 
Sec. 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

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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 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 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;
    (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,

[[Page 47253]]

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 Fastener Quality Act and its implementing 
regulations, 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 fulfil 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;
    (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 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 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) Product categories.
    (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

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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) The Accreditor shall maintain up-to-date as specified in 
Sec. 280.1010(g)(1), detailed description 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
    (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.

[[Page 47255]]

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--Requirements for Registrars

Sec.

General

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.

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'' 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

[[Page 47256]]

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 Sec. 280.1110(d), 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 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 section 
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 paragrphs (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, im plemented, and maintained in accordance with 
this part, and report on 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

[[Page 47257]]

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 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 dis closed to a third party without the written consent of 
the fastener manufacturer.

[[Page 47258]]

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 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 Fastener Quality Act and its implementing 
regulations, 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 corrective and preventive action; and 
document the actions taken and assess their effectiveness.

Requirements for Registration


Sec. 280.1120  Application for registration.

    (a)(1) The Registrar shall maintain up-to-date as specified in 
Sec. 280.1110(g)(1), 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),

[[Page 47259]]

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 section 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 assess 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 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;

[[Page 47260]]

    (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. 97-23613 Filed 9-5-97; 8:45 am]
BILLING CODE 3510-13-P