[Federal Register Volume 66, Number 104 (Wednesday, May 30, 2001)]
[Rules and Regulations]
[Pages 29219-29224]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-13448]


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DEPARTMENT OF COMMERCE

National Institute of Standards and Technology

15 CFR Part 285

[Docket No.: 000831249-1129-02]
RIN 0693-ZA39


National Voluntary Laboratory Accreditation Program; Operating 
Procedures

AGENCY: National Institute of Standards and Technology, Commerce.

ACTION: Final rule.

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SUMMARY: The Director of the National Institute of Standards and 
Technology (NIST), United States Department of Commerce, is today 
issuing a final rule revising regulations found at 15 CFR part 285 
pertaining to the operation of the National Voluntary Laboratory 
Accreditation Program (NVLAP). The NVLAP procedures are revised 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 and experience and in the harmonization of 
standards and procedures, and establish the basis for national and 
international mutual recognition arrangements.
    In addition, NIST is reorganizing and simplifying 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 is rewriting in plain English 
and consolidating sections previously contained in subparts A through C 
of part 285.

DATES: This rule is effective June 29, 2001.

ADDRESSES: David F. Alderman, Chief, National Voluntary Laboratory 
Accreditation Program, National Institute of Standards and Technology, 
100 Bureau Drive, Stop 2140, Gaithersburg, 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 
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

[[Page 29220]]

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 NVLAP procedures found at 15 CFR Part 285 are revised 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 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 is reorganizing and simplifying 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 is rewriting in plain English 
and consolidating sections previously contained in subparts A through C 
of part 285. Since the consolidated format does not require subparts, 
NIST is removing 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 is removing subpart D, Conditions and 
Criteria for Accreditation, and is applying 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.

Summary of Comments

    On November 7, 2000, the National Institute of Standards and 
Technology published a notice of proposed rulemaking in the Federal 
Register (65 FR 66659). In response, four letters were received from 
operators of NVLAP-accredited testing laboratories. The respondents 
applauded NIST's efforts to revise NVLAP procedures to ensure 
consistency with ISO/IEC standards and guides and make several specific 
recommendations, which are addressed below.
    Comment. The four respondents noted that the proposed rule 
references the term NVLAP as a federally registered certification mark, 
and stated that this is the first instance they had ever seen the mark 
of an accreditation body referred to as a certification mark and also 
one that is federally registered. The respondents recommended that an 
explanation be given on why this reference is made and what its impact 
will be on NVLAP-accredited laboratories.
    Response: The name ``National Voluntary Laboratory Accreditation 
Program'' and the acronym ``NVLAP'' have been in use since the 
announcement of the formal inception of the program on February 25, 
1976. The NVLAP logo was first used in interstate commerce on March 17, 
1980, and was first registered with the U.S. Patent and Trademark 
Office as a certification mark on March 22, 1983. Application for 
registration of the term NVLAP as a certification mark was filed with 
the U.S. Patent and Trademark Office on November 30, 2000. Registration 
of the term NVLAP is meant to strengthen NIST's rights in the mark. The 
registration will have no impact on NVLAP-accredited laboratories.
    The final rule, section 285.3, Referencing NVLAP accreditation, 
states: ``NIST reserves the right to control the quality of the use of 
term NVLAP and of the logo itself.'' Control of the term and the logo 
benefits NVLAP-accredited laboratories by promoting confidence that 
test and calibration reports endorsed with these certification marks 
will be accepted by economies throughout the world.
    Comment: Three respondents wrote that under the proposed new 
regulations, the termination of a LAP rests with the Chief of NVLAP, 
and that current regulations require the determination to be made by 
the Director. Concern was expressed that the proposed rule removes a 
layer of approval needed to terminate a LAP and leaves the decision 
solely in the hands of the Chief of NVLAP.
    Response. There is no change to current regulations, which already 
state that the Chief of NVLAP may terminate a LAP when the Chief of 
NVLAP determines that a need no longer exists to accredit laboratories 
for the services covered under the scope of the LAP. The final rule 
that amended the NVLAP procedures by replacing the Director of NIST 
with the Chief of NVLAP in Sec. 285.19(a) and (c), was published in the 
Federal Register (64 FR 59616) on November 3, 1999, and became 
effective on that date. The regulations were amended to conform with 
the delegation of authority at NIST. Subsequently, on November 18, 
1999, a NVLAP Policy Guide (PG-3-1999) was published to notify all 
NVLAP-enrolled laboratories of the change in the regulations, 
reflecting the delegation of certain designated authorities.
    Comment. The respondents stated that under the proposed regulation 
it appears that renewal responsibilities have been shifted entirely to 
the accredited laboratory. The respondents recommended that the 
proposed regulations be clarified to indicate who has the 
responsibility for initiating the renewal of a laboratory's 
accreditation.
    Response. NVLAP will continue to notify accredited laboratories 
when it is time to renew their accreditations; there will be no change 
in the renewal process. The regulations were simplified and reorganized 
for the purposes presented in the Summary of this notice and, 
therefore, no longer describe in detail the steps of the accreditation 
process. Renewing laboratories will continue to be sent a renewal 
application package before the expiration date of their accreditations 
to allow sufficient time to complete the renewal process. (See Section 
3.6.1 of NIST Handbook 150, 2001 Edition.)
    Comments. Three respondents expressed concern about the addition of 
Sec. 285.12, Monitoring visits, to the regulation, stating that the 
problem with unannounced monitoring visits by any accreditation body of 
an unlimited scope is the major disruption of the normal operations of 
the laboratory. These respondents requested that NVLAP reconsider the 
type of items that would be appropriate for unannounced monitoring 
visits and those that would be appropriate for announced monitoring 
visits and reduce them to a written list.
    Reponse. NIST added Sec. 285.12 to the revised rule to be 
consistent with NVLAP's actual practice and current procedures, which 
were previously set forth in the 1994 edition of NIST Handbook 150, 
Sec. 285.22(b)(6), Monitoring visits. This procedure has been added to 
the regulations to better notify the public of NVLAP's procedures.
    Use of the term ``monitoring visit'' dates back to 1982, when NIST 
published a notice in the Federal

[[Page 29221]]

Register to update its announcement of the availability of laboratory 
accreditation programs for certain fields of testing (44 FR 9492, March 
5, 1982). Under Supplementary Information, Unnannounced Visits, this 
notice stated:

    * * * ``In addition to regularly scheduled laboratory visits, 
unannounced visits * * * may be initiated * * *'' (45 FR 5572-5598). 
Experience has shown that in order to insure the availability of 
management and staff to demonstrate equipment and perform tests, a 
call to the laboratory from one day to one week before the visit may 
be necessary. Therefore, in the future these unannounced visits will 
be known as ``monitoring visits'' which may or may not be announced 
in advance of the visit. Monitoring visits may occur at any time. 
These visits may be initiated based on random selection or in 
response to a specific need because, in the opinion of DOC, the 
laboratory appears to have a testing problem. In general, a complete 
review of the laboratory is not contemplated for the monitoring 
visit. In the case of randomly selected visits, key aspects of the 
laboratory will be checked. In the case of visits due to an apparent 
problem, aspects relating to the problem, and possibly other 
selected key aspects as well, will be checked.

    Surveillance of laboratories is a requirement of ISO/IEC Guide 
58:1993, clause 6.7. NVLAP anticipates that this requirement will be 
expanded to include ``short notice visits'' when ISO/IEC Guide 58 is 
replaced byISO/IEC 17011, General requirements for bodies providing 
assessment and accreditation of conformity assessment bodies (now in 
draft status). NVLAP will continue to minimize disruptions to 
laboratories during on-site visits.
    Comments. The four respondents stated that the due process 
protections under Sec. 285.13, Denial, suspension, revocation or 
termination of accreditation, have been changed substantially from the 
current regulations, including the elimination of consultation with the 
laboratory prior to suspension. The respondents also said that it 
appears there is no recourse for a laboratory if it feels that it has 
been treated unfairly by the NVLAP auditor.
    Response. The phrase ``after consultation with the laboratory'' was 
removed because consultation is defined as a seeking of opinion or 
advice and is, therefore, an inappropriate choice of words for this 
requirement. There are many cases where consultation prior to 
suspension is inappropriate, such as the failure of an accredited 
laboratory to pass two rounds of proficiency testing within a set of 
three consecutive rounds in the Bulk Asbestos Fiber Analysis LAP. In 
this example, suspension is immediate and automatic because the 
laboratory failed to meet the program proficiency testing requirement. 
(See NIST Handbook 150-3 (1994): NVLAP Bulk Asbestos Analysis).
    Under section 285.13(b)(1) of the revised rule, NVLAP will continue 
to clearly state its requirements, to notify a laboratory of the 
reasons for and conditions of the suspension, and to specify the 
action(s) the laboratory must take to have its accreditation 
reinstated. Except for the deletion of the term ``consultation,'' the 
procedures contained in Sec. 285.13 of the revised rule remain the same 
as those contained in section 285.24(c) of the 1994 rule. Some minor 
changes were made to harmonize the wording of the proposed rule with 
NVLAP Policy Guide PG-2-1998, Accreditation Documents for Laboratories 
Whose Accreditation Has Been Suspended, Revoked, or Otherwise 
Terminated, issued to NVLAP-accredited laboratories on May 29, 1998.
    If a laboratory feels that it has been treated unfairly by a NVLAP 
assessor, the laboratory may state its grievance in its response to the 
assessment report or in a letter of complaint to NVLAP. Complaints from 
laboratories are addressed in accordance with NVLAP's quality system 
procedure for complaints, disputes and appeals, which applies to 
complaints concerning the handling of accreditation matters from 
laboratories or from users of NVLAP accredited laboratories. Copies of 
this procedure may be obtained pursuant to Sec. 285.15(a) of the 
revised regulation.

Paperwork Reduction Act

    The information collection requirements contained in this rule have 
been approved by the Office of Management and Budget under the 
Paperwork Reduction Act and have been assigned OMB control number 0693-
0003.

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 the LAP in which an entity is participating, and in some cases 
LAPs have not yet been established) for any size participant; (2) 
access to NVLAP's 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 rule.

List of Subjects in 15 CFR Part 285

    Accreditation, Business and industry, Calibration, Commerce, 
Conformity assessment, Laboratories, Measurement standards, Testing.

    Dated: May 22, 2001.
Karen H. Brown,
Deputy Director.

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

PART 285--NATIONAL VOLUNTARY LABORATORY ACCREDITATION PROGRAM

    1. The authority citation for Part 285 continues to read as 
follows:

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

    2. Part 285 is revised 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 scopes of accreditation.
285.12  Monitoring visits.
285.13  Denial, suspension, revocation or termination of 
accreditation.
285.14  Criteria for accreditation.
285.15  Obtaining documents.


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

[[Page 29222]]

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).
    (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

[[Page 29223]]

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 accreditation is granted, NVLAP shall provide to the 
laboratory a Certificate of Accreditation and a Scope of Accreditation,


Sec. 285.10  Renewal of accreditation.

    (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) 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 an 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 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.

    (a) 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: <a href="/cdn-cgi/l/email-protection#2d435b414c5d6d43445e59034a425b"><span class="__cf_email__" data-cfemail="2749514b465767494e545309404851">[email protected]</span></a>.

[[Page 29224]]

    (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. 01-13448 Filed 5-29-01; 8:45 am]
BILLING CODE 3510-13-M


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