Part 285 of Title 15 of the U.S. Code of Federal Regulations (CFR)

NIST, Dept. of Commerce

§ 285.1

pertinent portions of the document assigning rights in the alphanumeric designation. Such application must be
filed within six months of the date of
assignment.
(f) An alphanumeric designation that
is reactivated after it has been transferred or assigned shall remain in active status until the expiration of the
five year period that began upon the
issuance of the alphanumeric designation to its original owner.

manufacturers and their recorded insignia.

[61 FR 50558, Sept. 26, 1996. Redesignated and
amended at 65 FR 39803, 39804, June 28, 2000;
72 FR 30704, June 4, 2007]

[61 FR 50558, Sept. 26, 1996. Redesignated and
amended at 65 FR 39803, 39804, June 28, 2000]

§ 280.324 Change in status of trademark registration or amendment of
the trademark.

PART 285—NATIONAL VOLUNTARY
LABORATORY
ACCREDITATION
PROGRAM

(a) The Director, USPTO, shall designate the certificate of recordal as inactive, upon:
(1) Issuance of a final decision on appeal which refuses registration of the
application which formed the basis for
the certificate of recordal;
(2) Abandonment of the application
which formed the basis for the certificate of recordal;
(3) Cancellation or expiration of the
trademark registration which formed
the basis of the certificate of recordal;
or
(4) An amendment of the mark in a
trademark application or registration
that forms the basis for a certificate of
recordal. The certificate of recordal
shall become inactive as of the date
the amendment is filed. A new application for recordal of the amended trademark application or registration may
be submitted to the Commissioner at
any time.
(b) Certificates of recordal designated
inactive due to cancellation, expiration, or amendment of the trademark
registration,
or
abandonment
or
amendment of the trademark application, cannot be reactivated.
[61 FR 50558, Sept. 26, 1996. Redesignated and
amended at 65 FR 39803, 39804, June 28, 2000]

§ 280.325 Cumulative
listing
recordal information.

of

The Director, USPTO, shall maintain
a record of the names, current addresses, and legal entities of all recorded

[65 FR 39804, June 28, 2000]

§ 280.326 Records and files of the
United States Patent and Trademark Office.
The records relating to fastener insignia shall be open to public inspection. Copies of any such records may be
obtained upon request and payment of
the fee set by the Director, USPTO.

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.
285.16 Incorporation by reference.
AUTHORITY: 15 U.S.C. 272 et seq.
SOURCE: 66 FR 29221, May 30, 2001, unless
otherwise noted.

§ 285.1

Purpose.

The purpose of this part 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).
[85 FR 60060, Sept. 24, 2020]

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§ 285.2
§ 285.2

15 CFR Subtitle B, Ch. II (1–1–21 Edition)
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.
§ 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.

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.
§ 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 management system documentation to NVLAP (or a designated
NVLAP assessor) prior to the assessment process.
[85 FR 60060, Sept. 24, 2020]

§ 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 or other
means to ensure open participation,
shall establish the requested LAP, if
the Chief of NVLAP determines there
is need for the requested LAP.
[66 FR 29221, May 30, 2001, as amended at 76
FR 78815, Dec. 20, 2011]

§ 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

§ 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 § 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.

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NIST, Dept. of Commerce

§ 285.8

(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 nonconformities 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
nonconformities during the on-site assessment, and nonconformities 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 nonconformities have either
been corrected and/or a plan of corrective actions as described in the NVLAP
handbooks.
(3) If substantial nonconformities
have been cited, NVLAP may require
an additional on-site assessment, at additional cost to the laboratory, prior to
granting
accreditation.
All
nonconformities 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.

§ 285.8

Proficiency testing.

(a) Proficiency testing requirements.
Proficiency testing undertaken to meet
the criteria for NVLAP accreditation
shall be consistent with the provisions
contained in NIST Handbook 150,
NVLAP Procedures and General Requirements (incorporated by reference, see
§ 285.16), where applicable, including revisions from time to time. Laboratories must participate in proficiency
testing as specified for each LAP in the
NVLAP program handbooks.
(b) Analysis and reporting. Proficiency
testing results are analyzed by NVLAP
and results of the analysis are made
known to the participants. Any result
not meeting the criteria specified in
the NVLAP LAP program handbook is
identified as a nonconformity.
(c) Proficiency testing nonconformities.
(1) Unsatisfactory participation in any
proficiency testing program is a technical nonconformity which must be resolved in order to obtain initial accreditation or maintain accreditation.
(2)
Proficiency
testing
nonconformities 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; or
(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 nonconformities
and actions to be taken to resolve the
nonconformities. Denial or suspension
of accreditation will result from failure
to resolve nonconformities.
[85 FR 60060, Sept. 24, 2020]

[66 FR 29221, May 30, 2001, as amended at 85
FR 60060, Sept. 24, 2020]

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§ 285.9
§ 285.9

15 CFR Subtitle B, Ch. II (1–1–21 Edition)
Granting accreditation.

§ 285.12

(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,
§ 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
§ 285.7. If nonconformities are found
during the assessment of an accredited
laboratory, the laboratory must follow
the procedures set forth in § 285.7(e)(2)
or face possible suspension or revocation of accreditation.
[66 FR 29221, May 30, 2001, as amended at 85
FR 60060, Sept. 24, 2020]

§ 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 caseby-case basis.

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 nonconformity resolutions, verify reported
changes in the laboratory’s personnel,
facilities or operations, or evaluate
proficiency testing activities, when appropriate.
[85 FR 60060, Sept. 24, 2020]

§ 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

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NIST, Dept. of Commerce

§ 285.16

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.

§ 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
NIST Handbook 150, NVLAP Procedures
and General Requirements (incorporated
by reference, see § 285.16).
[85 FR 60061, Sept. 24, 2020]

§ 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:
[email protected].
(b) Copies of all ISO/IEC documents
are available for purchase from the
American National Standards Institute’s eStandards Store at http://
webstore.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, 100
Bureau Drive, Room B119, Gaithersburg, MD. For access to the NIST campus, please contact NVLAP by phone at
301–975–4016
or
by
email
at
[email protected] to obtain instructions
for visitor registration.
[66 FR 29221, May 30, 2001, as amended at 72
FR 36347, July 3, 2007; 85 FR 60061, Sept. 24,
2020]

§ 285.16

Incorporation by reference.

Certain material is incorporated by
reference into this part with the approval of the Director of the Federal
Register under 5 U.S.C. 552(a) and 1
CFR part 51. All approved material is
available for inspection at National Institute of Standards and Technology,
National Voluntary Laboratory Accreditation Program (NVLAP), National Institute of Standards and Technology, 100 Bureau Drive, Room B119,
Gaithersburg, MD and is available from
the source(s) listed in the following
paragraph(s). It is also available for inspection at the National Archives and
Records Administration (NARA). For

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Pt. 286

15 CFR Subtitle B, Ch. II (1–1–21 Edition)

access to the NIST campus, please contact NVLAP by phone at 301–975–4016 or
by email at [email protected] to obtain
instructions for visitor registration.
For information on the availability of
this
material
at
NARA,
email
[email protected]
or
go
to
www.archives.gov/federal-register/cfr/ibrlocations.html.
(a) National Institute of Standards
and Technology (NIST), U.S. Department of Commerce, 100 Bureau Drive,
Room B119, Gaithersburg, MD, 301–975–
4016 [email protected], www.nist.gov/publications/.
(1) NIST Handbook 150, National Voluntary Laboratory Accreditation Program
Procedures (NVLAP) and General Requirements, authored by Dana S.
Leaman and Bethany Hackett, 2020
Edition, August 2020, 2020 (NVLAP Procedures
and
General
Requirements)
https://nvlpubs.nist.gov/nistpubs/hb/2020/
NIST.HB.150-2020.pdf; into §§ 285.8(a) and
§ 285.14.
(2) [Reserved]
(b) [Reserved]
[85 FR 60061, Sept. 24, 2020]

PART 286—NATIONAL VOLUNTARY
CONFORMITY ASSESSMENT SYSTEM
EVALUATION
(NVCASE)
PROGRAM
Sec.
286.1
286.2
286.3
286.4
286.5
286.6
286.7
286.8
286.9
286.10
286.11
286.12

Purpose.
Scope.
Objective.
Implementation.
Program requirements.
Public consultation.
Evaluation process.
Confidentiality of information.
Maintaining recognized status.
Appeal.
Listings.
Terminations.

AUTHORITY: 15 U.S.C. 272 et seq.
SOURCE: 59 FR 19131, Apr. 22, 1994, unless
otherwise noted.

§ 286.1 Purpose.
The purpose of this program is to enable U.S. industry to satisfy mandated
foreign technical requirements using
the results of U.S.-based conformity assessment programs that perform technical evaluations comparable in their
rigor to practices in the receiving

country. Under this program, the Department of Commerce, acting through
the National Institute of Standards
and Technology, evaluates U.S.-based
conformity assessment bodies in order
to be able to give assurances to a foreign government that qualifying bodies
meet that government’s requirements
and can provide results that are acceptable to that government. The program is intended to provide a technically-based U.S. approval process for
U.S. industry to gain foreign market
access; the acceptability of conformity
assessment results to the relevant foreign government will be a matter for
agreement between the two governments.
§ 286.2 Scope.
(a) For purposes of this program, conformity assessment consists of product
sample testing, product certification,
and quality system registration. Associated activities can be classified by
level:
(1) Conformity level: This level encompasses comparing a product, process,
service, or system with a standard or
specification. As appropriate, the evaluating body can be a testing laboratory, product certifier or certification
body, or quality system registrar.
(2) Accreditation level: This level encompasses the evaluation of a testing
laboratory, a certification body, or a
quality system registrar by an independent body—an accreditation body—
based on requirements for the acceptance of these bodies, and the granting
of accreditation to those which meet
the established requirements.
(3) Recognition level: This level encompasses the evaluation of an accreditation body based on requirements for
its acceptance, and the recognition by
the evaluating body of the accreditation body which satisfies the established requirements.
(b) NIST operates the NVCASE program as follows:
(1) Conformity level: Under this program NIST accepts requests for evaluations of U.S. bodies involved in activities related to conformity assessment.
NIST does not perform conformity assessments as part of the program and
therefore does not accept requests for
such evaluations.

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