[Federal Register Volume 65, Number 216 (Tuesday, November 7, 2000)]
[Proposed Rules]
[Pages 66659-66663]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-28577]


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DEPARTMENT OF COMMERCE

National Institute of Standards and Technology

14 CFR Part 285

[Docket No. 000831249-0249-01]
RIN 0693-ZA39


National Voluntary Laboratory Accreditation Program; Operating 
Procedures

AGENCY: National Institute of Standards and Technology, Commerce.

ACTION: Notice of proposed rulemaking: request for comments.

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SUMMARY: The Director of the National Institute of Standards and 
Technology (NIST), United States Department of Commerce, requests 
comments on proposed amendments to regulations pertaining to the 
operation of the National Voluntary Laboratory Accreditation Program 
(NVLAP). NIST proposes to revise the NVLAP procedures to ensure 
continued consistency with international standards and guidelines 
currently set forth in the International Organization for 
Standardization (ISO)/International Electrotechnical Commission (IEC) 
17025:1999, General requirements for the competence of testing and 
calibration laboratories, and ISO/IEC Guide 58:1993, Calibration and 
testing laboratory accreditation systems--General requirements for 
operation and recognition, thereby facilitating and promoting 
acceptance of test and calibration results between countries to avoid 
barriers to trade. Provisions in this regard will facilitate 
cooperation between laboratories and other bodies, assist in the 
exchange of information

[[Page 66660]]

and experience and in the harmonization of standards and procedures, 
and establish the basis for national and international mutual 
recognition arrangements.
    In addition, NIST proposes to reorganize and simplify part 285 for 
ease of use and understanding. While the existing regulations 
accurately set forth the NVLAP procedures, the regulations themselves 
are complex and difficult to understand. In an effort to simplify the 
format and make the regulations more user friendly, NIST proposes to 
rewrite in plain English and consolidate sections previously contained 
in subparts A through C of part 285.

DATES: Submit comments on or before January 8, 2001.

ADDRESSES: Address all comments concerning this proposed rule to David 
F. Alderman, Chief, National Voluntary Laboratory Accreditation 
Program, National Institute of Standards and Technology, 100 Bureau 
Drive, Stop 2140, Gaitehrsburg, MD 20899-2140.

FOR FURTHER INFORMATION CONTACT: David F. Alderman, Chief, National 
Voluntary Laboratory Accreditation Program, 301-975-4016.

SUPPLEMENTARY INFORMATION:

Background

    Part 285 of title 15 of the Code of Federal Regulations sets out 
procedures and general requirements under which the National Voluntary 
Laboratory Accreditation Program (NVLAP) operates as an unbiased third 
party to accredit both testing and calibration laboratories.
    The NVLAP procedures were first published in the Federal Register 
as part 7 of title 15 of the Code of Federal Regulations (CFR) (41 FR 
8163, February 25, 1976). On June 2, 1994, the procedures were 
redesignated as part 285 of title 15 of the CFR, expanded to include 
accreditation of calibration laboratories, and updated to be compatible 
with conformity assurance and assessment concepts, including the 
provisions contained in ISO/IEC Guide 25:1990, General requirements for 
the competence of calibration and testing laboratories (59 FR 22742, 
May 3, 1994).

Description and Explanation of Proposed Changes

    The National Institute of Standards and Technology proposes to 
revise 15 CFR Part 285 to ensure continued consistency with 
international standards and guidelines. At this time, the management 
and technical requirements of the new standard, ISO/IEC 17025:1999, 
General requirements for the competence of testing and calibration 
laboratories, and the internationally accepted requirements for 
accrediting bodies, including those found in ISO/IEC Guide 58:1993, 
Calibration and testing laboratory accreditation systems--General 
requirements for operation and recognition, are applicable; however, 
the proposed revisions include provisions allowing for updated versions 
and replacements of these documents. ISO/IEC 17025:1999 supersedes and 
replaces ISO/IEC Guide 25:1990, upon which the current NVLAP 
accreditation criteria are based.
    In addition, NIST proposes to reorganize the simplify part 285 for 
ease of use and understanding. While the existing regulations 
accurately set forth the NVLAP procedures, the regulations themselves 
are complex and difficult to understand. In an effort to simplify the 
format and make the regulations more user friendly, NIST proposes to 
rewrite in plain English and consolidate sections previously contained 
in subparts A through C of part 285. Since the consolidated format does 
not require subparts, NIST proposes to remove subparts A through C. The 
removal of these subparts will not alter the operations of NVLAP, but 
will promote ease of use and facilitate understanding of the program's 
operations.
    To ensure continued consistency with applicable international 
standards and guidelines, NIST proposes to remove subpart D, Conditions 
and Criteria for Accreditation, and to apply the conditions and 
criteria contained in the applicable internationally accepted documents 
as they are revised from time to time, as set forth in new section 
285.14, Criteria for Accreditation.

Request for Comments

    The Director of the National Institute of Standards and Technology, 
United States Department of Commerce, requests comments on proposed 
changes to regulations found at 15 CFR Part 285 pertaining to the 
National Voluntary Laboratory Accreditation Program.
    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 6022, 14th and Constitution Ave. NW, Washington, DC 
20230.

Classification Section

Paperwork Reduction Act

    This proposed rule contains information collection requirements 
subject to the Paperwork Reduction Act. The collection has been 
forwarded to the Office of Management and Budget (OMB) for approval 
under the Act. Notwithstanding any other provision of the law, no 
person is required to respond to, nor shall any person be subject to a 
penalty for failure to comply with, no collection of information 
subject to the requirements of the Act, Unless that collection of 
information displays a currently valid OMB control number. The 
information collected will be used by NVLAP to help assess laboratory 
compliance with the applicable criteria. Responses to the collection of 
information are required for a laboratory to be considered for NVLAP 
accreditation. Confidentiality of the information submitted will be 
handled in accordance with Sec. 285.2 of this proposed rule. It is 
estimated that the annual public burden for the collection will average 
2.75 hours per response, including the time for reviewing instructions, 
searching existing data sources, gathering and maintaining the data 
needed, and completing and reviewing the collection of information. 
Send comments regarding this burden estimate or any other aspect of 
this collection of information, including suggestions for reducing this 
burden, to the Office of Information and Regulatory Affairs, Office of 
Management and Budget, Washington, DC, 20503 (Attention: NIST Desk 
Officer).

Executive Order 12866

    This notice has been determined to be not significant for purposes 
of Executive Order 12866.

Regulatory Flexibility Act

    The Chief Counsel for Regulation of the Department of Commerce has 
certified to the Chief Counsel for Advocacy of the Small Business 
Administration that this rule will not have a significant economic 
impact on a substantial number of small entities for the following 
reasons: (1) the regulation is procedural and has no impact on any 
entity unless that entity chooses to participate, in which case, the 
cost to any participant is the same, small cost ($500/application; 
other associated costs cannot be projected because they are dependent 
upon in which LAP an entity is participating, and in some cases LAPs 
have not yet been established) for any size participant; (2) access to 
NVLAP's

[[Page 66661]]

accreditation system is not conditional upon the size of a laboratory 
or membership of any association or group, nor are there undue 
financial conditions to restrict participation; and (3) the technical 
components of NVLAP, that is, the specific technical criteria that 
individual laboratories are accredited against, are not significantly 
changed by this proposal.

List of Subjects in 15 CFR Part 285

    Laboratories, Measurement standards, Reporting and recordkeeping 
requirements, Voluntary standards

    Dated: October 30, 2000.
Karen H. Brown,
Deputy Director.
    For reasons set forth in the preamble, it is proposed that 15 CFR. 
chapter II, be amended by revising part 285 to read as follows:

PART 285--NATIONAL VOLUNTARY LABORATORY ACCREDITATION PROGRAM

Sec.
285.1  Purpose.
285.2  Confidentiality.
285.3  Referencing NVLAP accreditation.
285.4  Establishment of laboratory accreditation programs (LAPs) 
within NVLAP.
285.5  Termination of a LAP.
285.6  Application for accreditation.
285.7  Assessment.
285.8  Proficiency testing.
285.9   Granting accreditation.
285.10   Renewal of accreditation.
285.11   Changes to scope of accreditation.
285.12   Monitoring visits.
285.13   Denial, suspension, revocation or termination of 
accreditation.
285.14   Criteria for accreditation.
285.15   Obtaining documents.

    Authority: 15 U.S.C. 272 et seq.


Sec. 285.1  Purpose.

    The purpose of Part 285 is to set out procedures and general 
requirements under which the National Voluntary Laboratory 
Accreditation Program (NVLAP) operates as an unbiased third party to 
accredit both testing and calibration laboratories. Supplementary 
technical and administrative requirements are provided in supporting 
handbooks and documents as needed, depending on the criteria 
established for specific Laboratory Accreditation Programs (LAPs).


Sec. 285.2  Confidentiality.

    To the extent permitted by applicable laws, NVLAP will protect the 
confidentiality of all information obtained relating to the 
application, on-site assessment, proficiency testing, evaluation, and 
accreditation of laboratories.


Sec. 285.3  Referencing NVLAP accreditation.

    The term NVLAP (represented by the NVLAP logo) is a federally 
registered certification mark of the National Institute of Standards 
and Technology and the federal government, who retain exclusive rights 
to control the use thereof. Permission to use the term and/or logo is 
granted to NVLAP-accredited laboratories for the limited purposes of 
announcing their accredited status, and for use on reports that 
describe only testing and calibration within the scope of 
accreditation. NIST reserves the right to control the quality of the 
use of the term NVLAP and of the logo itself.


Sec. 285.4  Establishment of laboratory accreditation programs (LAPs) 
within NVLAP.

    NVLAP establishes LAPs in response to legislative actions or to 
requests from private sector entities and government agencies. For 
legislatively mandated LAPs, NVLAP shall establish the LAP. For 
requests from private sector entities and government agencies, the 
Chief of NVLAP shall analyze each request, and after consultation with 
interested parties through public workshops and other means shall 
establish the requested LAP if the Chief of NVLAP determines there is 
need for the requested LAP.


Sec. 285.5  Termination of a LAP.

    (a) The Chief of NVLAP may terminate a LAP when he/she determines 
that a need no longer exists to accredit laboratories for the services 
covered under the scope of the LAP. In the event that the Chief of 
NVLAP proposes to terminate a LAP, a notice will be published in the 
Federal Register setting forth the basis for that determination.
    (b) When a LAP is terminated, NVLAP will no longer grant or renew 
accreditations following the effective date of termination. 
Accreditations previously granted shall remain effective until their 
expiration date unless terminated voluntarily by the laboratory or 
revoked by NVLAP. Technical expertise will be maintained by NVLAP while 
any accreditation remains effective.


Sec. 285.6  Application for accreditation.

    A laboratory may apply for accreditation in any of the established 
LAPs. The applicant laboratory shall provide a completed application to 
NVLAP, pay all required fees and agree to certain conditions as set 
forth in the NVLAP Application for Accreditation, and provide a quality 
manual to NVLAP (or a designated NVLAP assessor) prior to the 
assessment process.


Sec. 285.7  Assessment.

    (a) Frequency and scheduling. Before initial accreditation, during 
the first renewal year, and every two years thereafter, an on-site 
assessment of each laboratory is conducted to determine compliance with 
the NVLAP criteria.
    (b) Assessors. NVLAP shall select qualified assessors to evaluate 
all information collected from an applicant laboratory pursuant to 
Sec. 285.6 of this part and to conduct the assessment on its behalf at 
the laboratory and any other sites where activities to be covered by 
the accreditation are performed.
    (c) Conduct of assessment. (1) Assessors use checklists provided by 
NVLAP so that each laboratory receives an assessment comparable to that 
received by others.
    (2) During the assessment, the assessor meets with management and 
laboratory personnel, examines the quality system, reviews staff 
information, examines equipment and facilities, observes demonstrations 
of testing or calibrations, and examines tests or calibration reports.
    (3) The assessor reviews laboratory records including resumes, job 
descriptions of key personnel, training, and competency evaluations for 
all staff members who routinely perform, or affect the quality of the 
testing or calibration for which accreditation is sought. The assessor 
need not be given information which violates individual privacy, such 
as salary, medical information, or performance reviews outside the 
scope of the accreditation program. The staff information may be kept 
in the laboratory's official personnel folders or separate folders that 
contain only the information that the NVLAP assessor needs to review.
    (4) At the conclusion of the assessment, the assessor conducts an 
exit briefing to discuss observations and any deficiencies with the 
authorized representative who signed the NVLAP application and other 
responsible laboratory staff.
    (d) Assessment report. At the exit briefing, the assessor submits a 
written report on the compliance of the laboratory with the 
accreditation requirements, together with the completed checklists, 
where appropriate.
    (e) Deficiency notification and resolution. (1) Laboratories are 
informed of deficiencies during the on-site assessment, and 
deficiencies are documented in the assessment report (see paragraph (d) 
of this section).

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    (2) A laboratory shall, within thirty days of the date of the 
assessment report, provide documentation that the specified 
deficiencies have either been corrected and/or a plan of corrective 
actions as described in the NVLAP handbooks.
    (3) If substantial deficiencies have been cited, NVLAP may require 
an additional on-site assessment, at additional cost to the laboratory, 
prior to granting accreditation. All deficiencies and resolutions will 
be subject to thorough review and evaluation prior to an accreditation 
decision.
    (4) After the assessor submits their final report, NVLAP reviews 
the report and the laboratory's response to determine if the laboratory 
has met all of the on-site assessment requirements.


Sec. 285.8  Proficiency testing.

    (a) NVLAP proficiency testing is consistent with the provisions 
contained in ISO/IEC Guide 43 (Parts 1 and 2), Proficiency testing by 
interlaboratory comparisons, where applicable, including revisions from 
time to time. Proficiency testing may be organized by NVLAP itself or a 
NVLAP-approved provider of services. Laboratories must participate in 
proficiency testing as specified for each LAP in the NVLAP program 
handbooks.
    (b) Analysis and reporting. Proficiency testing data are analyzed 
by NVLAP and reports of the results are made known to the participants. 
Summary results are available upon request to other interested parties; 
e.g., professional societies and standards writing bodies. The identity 
and performance of individual laboratories are kept confidential.
    (c) Proficiency testing deficiencies. (1) Unsatisfactory 
participation in any NVLAP proficiency testing program is a technical 
deficiency which must be resolved in order to obtain initial 
accreditation or maintain accreditation.
    (2) Proficiency testing deficiencies are defined as, but not 
limited to, one or more of the following:
    (i) Failure to meet specified proficiency testing performance 
requirements prescribed by NVLAP;
    (ii) Failure to participate in a regularly scheduled ``round'' of 
proficiency testing for which the laboratory has received instructions 
and/or materials;
    (iii) Failure to submit laboratory control data as required; and
    (iv) Failure to produce acceptable test or calibration results when 
using NIST Standard Reference Materials or special artifacts whose 
properties are well-characterized and known to NIST/NVLAP.
    (3) NVLAP will notify the laboratory of proficiency testing 
deficiencies and actions to be taken to resolve the deficiencies. 
Denial or suspension of accreditation will result from failure to 
resolve deficiencies.


Sec. 285.9  Granting accreditation.

    (a) The Chief of NVLAP is responsible for all NVLAP accreditation 
actions, including granting, denying, renewing, suspending, and 
revoking any NVLAP accreditation.
    (b) Initial accreditation is granted when a laboratory has met all 
NVLAP requirements. One of four accreditation renewal dates (January 1, 
April 1, July 1, or October 1) is assigned to the laboratory and is 
usually retained as long as the laboratory remains in the program. 
Initial accreditation is granted for a period of one year; 
accreditation expires and is renewable on the assigned date.
    (c) Renewal dates may be reassigned to provide benefits to the 
laboratory and/or NVLAP. If a renewal date is changed, the laboratory 
will be notified in writing of the change and any related adjustment in 
fees.
    (d) when accredition is granted, NVLAP shall provide to the 
laboratory a Certificate of Accredition and a Scope of Accreditation.


Sec. 285.10  Renewal of accredition.

    (a) An accredited laboratory must submit both its application for 
renewal and fees to NVLAP prior to expiration of the laboratory's 
current accreditation to avoid a lapse in accreditation.
    (b) On-site assessments of currently accredited laboratories are 
performed in accordance with the procedures in Sec. 285.7. If 
deficiencies are found during the assessment of an accredited 
laboratory, the laboratory must follow the procedures set forth in 
Sec. 285.7(e)(2) of this part or face possible suspension or revocation 
of accreditation.


Sec. 285.11  Changes to scope of accreditation.

    A laboratory may request in writing changes to its Scope of 
Accreditation. If the laboratory requests additions to its Scope, it 
must meet all NVLAP criteria for the additional tests or calibrations, 
types of tests or calibrations, or standards. The need for an 
additional on-site assessment and/or proficiency testing will be 
determined on a case-by-case basis.


Sec. 285.12  Monitoring visits.

    (a) In addition to regularly scheduled assessments, monitoring 
visits may be conducted by NVLAP at any time during the accreditation 
period. They may occur for cause or on a random selection basis. While 
most monitoring visits will be scheduled in advance with the 
laboratory, NVLAP may conduct unannounced monitoring visits.
    (b) The scope of a monitoring visit may range from checking a few 
designated items to a complete review. The assessors may review 
deficiency resolutions, verify reported changes in the laboratory's 
personnel, facilities, or operations, or administer proficiency 
testing, when appropriate.


Sec. 285.13  Denial, suspension, revocation or termination of 
accreditation.

    (a) A laboratory may at any time voluntarily terminate its 
participation and responsibilities as an accredited laboratory by 
advising NVLAP in writing of its desire to do so.
    (b) If NVLAP finds that an accredited laboratory does not meet all 
NVLAP requirements, has violated the terms of its accreditation, or 
does not continue to comply with the provisions of these procedures, 
NVLAP may suspend the laboratory's accreditation, or advise of NVLAP's 
intent to revoke accreditation.
    (1) If a laboratory's accreditation is suspended, NVLAP shall 
notify the laboratory of that action stating the reasons for and 
conditions of the suspension and specifying the action(s) the 
laboratory must take to have its accreditation reinstated. Conditions 
of suspension will include prohibiting the laboratory from using the 
NVLAP logo on its test or calibration reports, correspondence, or 
advertising during the suspension period in the area(s) affected by the 
suspension.
    (2) NVLAP will not require a suspended laboratory to return its 
Certificate and Scope of Accreditation, but the laboratory must refrain 
from using the NVLAP logo in the area(s) affected until such time as 
the problem(s) leading to the suspension has been resolved. When 
accreditation is reinstated, NVLAP will authorize the laboratory to 
resume testing or calibration activities in the previously suspended 
area(s) as an accredited laboratory.
    (c) If NVLAP proposes to deny or revoke accreditation of a 
laboratory, NVLAP shall inform the laboratory of the reasons for the 
proposed denial or revocation and the procedure for appealing such a 
decision.
    (1) The laboratory will have thirty days from the date of receipt 
of the proposed denial or revocation letter to appeal the decision to 
the Director of NIST. If the laboratory appeals the decision to the 
Director of NIST, the proposed denial or revocation will be stayed 
pending the outcome of the appeal. The proposed denial or

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revocation will become final through the issuance of a written decision 
to the laboratory in the event that the laboratory does not appeal the 
proposed denial or revocation within the thirty-day period.
    (2) If accreditation is revoked, the laboratory may be given the 
option of voluntarily terminating the accreditation.
    (3) A laboratory whose accreditation has been revoked must cease 
use of the NVLAP logo on any of its reports, correspondence, or 
advertising related to the area(s) affected by the revocation. If the 
revocation is total, NVLAP will instruct the laboratory to return its 
Certificate and Scope of Accreditation and to remove the NVLAP logo 
from all test or calibration reports, correspondence, or advertising. 
If the revocation affects only some, but not all of the items listed on 
a laboratory's Scope of Accreditation, NVLAP will issue a revised Scope 
that excludes the revoked area(s) in order that the laboratory might 
continue operations in accredited areas.
    (d) A laboratory whose accreditation has been voluntarily 
terminated, denied or revoked, may reapply and be accredited if the 
laboratory:
    (1) Completes the assessment and evaluation process; and
    (2) Meets the NVLAP conditions and criteria for accreditation.


Sec. 285.14  Criteria for accreditation.

    The requirements for laboratories to be recognized by the National 
Voluntary Laboratory Accreditation Program as competent to carry out 
tests and/or calibrations are contained in clauses 4 and 5 of ISO/IEC 
17025, General requirements for the competence of testing and 
calibration laboratories, including revisions from time to time.


Sec. 285.15  Obtaining documents.

    (1) Application forms, NVLAP handbooks, and other NVLAP documents 
and information may be obtained by contacting the NVLAP, National 
Institute of Standards and Technology, 100 Bureau Drive, Mail Stop 
2140, Gaithersburg, Maryland 20899-2140; phone: 301-975-4016; fax: 301-
926-2884; e-mail: [email protected].
    (b) Copies of all ISO/IEC documents are available from the American 
National Standards Institute, 11 West 42nd Street, 13th Floor, New 
York, New York, 10036; phone: 212-642-4900; fax: 212-398-0023; web 
site: www.ansi.org>. You may inspect copies of all applicable ISO/IEC 
documents at the National Voluntary Laboratory Accreditation Program, 
National Institute of Standards and Technology, 820 West Diamond 
Avenue, Room 297, Gaithersburg, MD.

[FR Doc. 00-28577 Filed 11-6-00; 8:45 am]
BILLING CODE 3510-13-M