[Federal Register Volume 59, Number 84 (Tuesday, May 3, 1994)]
[Unknown Section]
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From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-10449]
[[Page Unknown]]
[Federal Register: May 3, 1994]
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DEPARTMENT OF COMMERCE
Office of the Secretary
15 CFR Part 7
National Institute of Standards and Technology
15 CFR Part 285
[Docket No. 930103-4017]
RIN 0693-AB15
National Voluntary Laboratory Accreditation Program
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, United States Department of Commerce, is today issuing a
final rule making changes to regulations previously found at 15 CFR
part 7 pertaining to the operation of the National Voluntary Laboratory
Accreditation Program (NVLAP). The NVLAP procedures are redesignated as
part 285 of title 15 of the Code of Federal Regulations, and are
revised to expand the procedures to include accreditation of
calibration laboratories; update the procedures for compatibility with
conformity assurance and assessment concepts; assure consistency with
relevant International Organization for Standardization (ISO) documents
(e.g., ISO Guides 25, 38, 43, 58, and 9000); and facilitate and promote
acceptance of calibration and test results between countries to avoid
barriers to trade. Provisions in this regard will facilitate
cooperation between laboratories and other bodies to assist in the
exchange of information and experience, harmonize standards and
procedures, and establish the basis for bi-lateral and multi-lateral
agreements.
EFFECTIVE DATE: This rule is effective June 2, 1994.
ADDRESSES: Albert D. Tholen, Chief, National Voluntary Laboratory
Accreditation Program, National Institute of Standards and Technology,
Building 411, room A162, Gaithersburg, MD 20899, telephone number (301)
975-4016.
FOR FURTHER INFORMATION CONTACT:
Albert D. Tholen, Chief, National Voluntary Laboratory Accreditation
Program, (301) 975-4016.
SUPPLEMENTARY INFORMATION: The Director of the National Institute of
Standards and Technology, (NIST) is today issuing a final rule making
changes to regulations previously found at 15 CFR Part 7 pertaining to
the operation of the National Voluntary Laboratory Accreditation
Program (NVLAP). NVLAP provides an unbiased third party evaluation and
recognition of laboratory performance, as well as expert technical
assistance to upgrade that performance, by accrediting calibration
laboratories and testing laboratories found competent to perform
specific tests or calibrations.
Competence is defined as the ability of a laboratory to meet the
NVLAP conditions set out in the NVLAP regulations and to conform to the
criteria in NVLAP publications for particular calibration and test
methods. Specifically, NVLAP accreditation indicates that a
laboratory's quality system, staff, facilities and equipment,
calibration protocols, methods and procedures, records and reports have
been evaluated and found to meet NVLAP criteria.
Accreditation is granted following successful completion of a
process which includes submission of an application and payment of fees
by the laboratory, an on-site assessment, resolution of any
deficiencies identified during the on-site assessment, participation in
proficiency testing, technical evaluation, and administrative review.
The accreditation is formalized through issuance of a Certificate of
Accreditation and Scope of Accreditation and is publicized by
announcement in various government and private media. NVLAP
accreditation does not imply any guarantee or certification of
laboratory performance or test/calibration data; it is solely a finding
of laboratory competence.
NVLAP accreditation is available to commercial laboratories,
manufacturers' in-house laboratories, university laboratories, and
federal, state and local government laboratories. Foreign-based
laboratories may also be accredited if they meet the same requirements
as domestic laboratories and pay any additional fees required for
travel expenses.
NVLAP is comprised of a series of laboratory accreditation programs
(LAPs) which are established on the basis of requests and demonstrated
need. Each LAP includes specific calibration and/or test standards and
related methods and protocols assembled to satisfy the unique needs for
accreditation in a field of testing, field of calibration, product or
service.
Description of the Changes
The NVLAP procedures are redesignated as part 285 of title 15 of
the Code of Federal Regulations; expanded to include accreditation of
calibration laboratories; updated for compatibility with conformity
assurance and assessment concepts; made consistent with relevant
International Organization for Standardization (ISO) documents (e.g.,
ISO Guides 25, 38, 43, 58, and 9000); revised to facilitate and promote
acceptance of calibration and test results between countries to avoid
barriers to trade; and to eliminate references to the NVLAP advisory
committee. Section D has been replaced with language essentially
identical to ISO Guide 25. Provisions in this regard will facilitate
cooperation between laboratories and other bodies to assist in the
exchange of information and experience, harmonize standards and
procedures, and establish the basis for bi-lateral and multi-lateral
agreements.
Summary of Comments
On July 27, 1993, the National Institute of Standards and
Technology published a notice of proposed rulemaking in the Federal
Register (58 FR 40087). A total of 11 letters were received: Four trade
associations, three manufacturers, one government agency, one
laboratory accrediting organization, one testing laboratory, and one
consultant commented. All eleven supported the proposal, especially the
changes in procedures that will result in achieving compatibility with
international standards and guides and broadening the scope of NVLAP to
include accreditation of calibration laboratories.
Other than recommendations to strengthen the national and
international recognition of NVLAP accredited laboratory data, the
comments covered a wide range of suggestions made by only one or two of
the respondents. Recommendations are addressed below with a summary
``Recommendation'' and a ``Response'' for each.
Comment. One accreditation organization and one consultant
suggested that NVLAP clarify Sec. 285.24 Denying, Suspending, and
revoking accreditation, to specify the conditions for making a
suspension decision vis-a-vis a revocation decision.
Response. Section 285.24 (e) clearly states that invoking
suspension or revocation ``will depend on the nature of the
violation(s)''. It is very difficult to be prescriptive because of the
vast possible combinations of laboratory operations and deficiencies.
Selecting suspension action implies the expectation that deficiencies
can be resolved before actual suspension is invoked; additionally, if
suspension is invoked, the expectation is that it will be rather short
lived. Revocation, in contrast, is clearly used in cases of more
serious deficiencies that are not likely to be resolved. The return of
the Certificate and Scope of Accreditation are required under
revocation; it is expected that suspension will be short lived,
therefore return of the Certificate and Scope are not required.
Comment. One manufacturer and one laboratory suggested that NVLAP
procedures should provide for an ``office of government liaison'' to
work toward reduction of redundant accreditation programs in the United
States to save laboratories the expense of paying for multiple
programs.
Response. Although redundant programs and multiple audits cause
confusion and added expense to accredited laboratories, NVLAP has no
authority to add a provision regarding redundant programs and/or
multiple audits. The NVLAP process is designed so that NVLAP itself
does not offer a LAP that duplicates one that exists or could be
offered by a public sector accreditor.
Comment. One consultant suggested that although a definition is
provided for the term ``Certificate of Accreditation'', a definition is
needed for the term ``Certificate'' as used in the definition of
``Reference material''.
Response. See NIST Special Publication 260, ``Standard Reference
Materials Catalog'', for definition and discussion of the term
``certificate'' as it applies to Standard Reference Materials. Defining
the term in the NVLAP procedures would be confusing and out of context
with its use.
Comment. One manufacturer suggested that part 285 should be
referenced in Sec. 285.6 NVLAP documentation.
Response. Section 285.6 (a) will be changed to include such a
reference.
Comment. One trade association suggested that NVLAP modify the
definition for Authorized Representative in Sec. 285.5 Definitions to
provide an organization with more flexibility in naming an Authorized
Representative.
Response. This section will be reworded to provide additional
flexibility by stating that the Authorized Representative of an
accredited laboratory may be an individual who is authorized by the
laboratory or the parent organization.
Comment. One manufacturer suggested adding a definition for
Competent to Sec. 285.5 Definitions.
Response. The definition of Competence will be added as ``the
ability of a laboratory to meet the NVLAP conditions and to conform to
the criteria in NVLAP publications for specific calibration and test
methods''.
Comment. One manufacturer suggested modifying the definition of
NVLAP in Sec. 285.5 Definitions to include its relationship to NIST.
Response. Agree. The definition for NVLAP will be changed to state
that NVLAP ``is an Office within the National Institute of Standards
and Technology''.
Comment. One trade association suggested changing the definition of
Traceability of the accuracy--in Sec. 285.5 Definitions by changing
``primary'' standard to ``reference'' standard.
Response. The definition is correct as written. Traceability
follows a path which may include the ``reference standard'' in the
laboratory but, as the definition states, must be traceable
``ultimately to a primary standard''.
Comment. One trade association suggested that Sec. 285.33 (k)
Certificates and reports identify the type of laboratory issuing the
certificate and report (e.g., independent, manufacturer's, etc.). It is
the belief of the writer of this comment that ``in-house'' laboratories
can not necessary produce ``unbiased'' results.
Response. No change is needed. Information describing the type of
laboratory accredited is provided by the laboratory in its application
and included in the NVLAP data base. However, the type of laboratory
has no bearing on the accreditation decision; rather, the accreditation
decision is based on the judgment (using results from on-site
assessments, proficiency testing, and monitoring visits) that the
laboratory meets all of the criteria established for a particular
Laboratory Accreditation Program (LAP), independent of the
``organizational'' association of the laboratory.
Comment: One consultant suggested revision of Sec. 285.23(a)
Granting and renewing accreditation to remove decisions based on
variations of compliance.
Response: Full compliance results in accreditation action. Less
than full compliance can result in accreditation or other actions
depending on variation from full compliance in terms of deficiencies
and the expectations of corrective action.
Comment: One consultant suggested that Sec. 285.23(b)(3) Granting
and renewing accreditation should contain a stronger statement than
``reminding'' laboratories of their legal obligations.
Response: NVLAP has no responsibility or authority to do more than
remind laboratories of this fact.
Comment: One trade association and one laboratory suggested that
Secs. 285.32(a)(10) and 285.33(b)(2)(ii) and (iii) be either deleted or
limited to ensure that the requirement for laboratories to avoid undue
or coercive commercial or financial pressures on staff are not applied
to the normal course of employer-employee and independent contractor
relationships of a manufacturer's in-house laboratory.
Response: These Sections clearly avoid undue interference by
limiting the requirement to ``pressures which might adversely affect
the quality of the work.'' Accreditation of a laboratory depends on
NVLAP's confidence that the laboratory will provide accurate test and
calibration services. These services must no be degraded by pressures
of any kind. NVLAP cannot deal with degrees or types of pressure, only
with the accuracy of data provided to customers.
Comment: One trade association suggested that NVLAP needs to
clarify its policy for addressing the recognition of foreign-based
laboratories based on accreditation by a foreign government or
accrediting organization.
Response: The policy will be clarified by adding to Sec. 285.11
Requesting a LAP a new paragraph (f) which states that ``consistent
with applicable laws and regulations, the Director may negotiate and
conclude agreements with the governments of other countries for NVLAP
recognition of foreign laboratories. At a minimum, any agreement must
provide that accredited foreign laboratories meet conditions for
accreditation comparable to and consistent with those set out in these
requirements''.
Comment: One manufacturer suggested deleting the requirement in
Sec. 285.26 Change in status of laboratory for laboratories to advise
NVLAP of any change in location and/or configuration of its facilities.
Response: NVLAP must get this information prior to the laboratory
making any changes. The fact of moving or reconfiguration of a
laboratory could significantly affect the quality of its testing or
calibration activities.
Comment: One trade association suggested revising Sec. 285.32(a)(6)
Conditions for accreditation, to limit the services that a laboratory
offers to customers to NVLAP accredited areas.
Response: NVLAP accreditation does not limit the freedom of
laboratories to offer services outside the scope of accreditation.
NVLAP only limits laboratories from claiming accreditation for services
not included on their Scopes of Accreditation issued to the
laboratories.
Comment: One trade association asked that the regulation be made
more specific in defining the meaning of ``staffing'' in Sec. 285.26.,
stating that it is too broad.
Response: NVLAP believes that there are so many possibilities
regarding staffing changes that the reference needs to be general so
that an objective opinion can be made on the specific change proposed
or made. NVLAP focuses on staffing changes that could affect the
quality of the testing or calibration work.
Comment: One trade association suggested changing Sec. 285.33 (1)
Subcontracting of calibration or testing to limit subcontracting to
accredited laboratories only.
Response: This section is in full conformity with international
requirements which do not impose such a restriction. This is partly
based on the fact that no other accredited laboratory may be
geographically available or willing to provide the services needed.
NVLAP believes that its procedures for subcontracting will ensure that
the data provided by the subcontractor will meet the established
quality standards.
Comment. Two trade associations and one Government agency stated
that NVLAP procedures need to be more explicit regarding coordination
with the private and public sectors in defining the contents of a LAP,
especially when the LAP will be addressing regulatory responsibilities
of other agencies.
Response. NVLAP invites the participation of all interested parties
in the determination of need and in the design of a new accreditation
program (Secs. 285.15 and 285.16). The Federal Register, public
workshops, news releases, direct mailings to organizations and
associations, and participation in industry and professional meetings
are all mechanisms used in order to encourage such participation.
Comment. A trade association, a Government agency and an
accreditation organization commented that Sec. 285.12(b)(3) LAP
development decision does not adequately prevent a conflict of interest
for NIST in making LAP development decisions that could be in
competition with private sector accreditation programs.
Response. The conditions under which NVLAP establishes and operates
accreditation programs is explicit and addresses the conflict of
interest question. NVLAP believes that the requirements followed in
making a development decision are adequate and that NVLAP has guarded
against establishment of programs already existing or that could be
offered by private sector accreditors.
Comment. A trade association, a Government agency and an
accreditation organization commented that Sec. 285.18 Adding to or
modifying an established LAP should be strengthened to require NVLAP to
follow the same requirements for modifying a LAP as for establishing a
new LAP. NVLAP should not add test methods without going through a full
``need'' analysis.
Response. Every LAP is established after an exhaustive process that
includes the determination of need. Changes needed by a LAP sponsor,
caused by standards updated by standards bodies, or due to revisions in
regulatory requirements, must be made expeditiously so that the
accreditation program continues to meet the needs of its sponsor.
Comment. One manufacturer and one government agency suggested that
Sec. 285.13 Request from a government agency be revised to contain all
of the information required from a private sector organization
requesting a LAP (Sec. 285.14).
Response. The procedures to be followed by private sector
organizations and government agencies are, of necessity, different.
Regulatory and public service program authorities are specified in laws
and administrative procedures. Accreditation requirements established
by government agencies may contain the conditions noted in Sec. 285.14
and are automatically referenced in the specific authority establishing
a laboratory accreditation program.
NVLAP, however, agrees that the procedures do need to explicitly
address establishing or modifying NVLAP LAPs to meet the requirements
mandated by the Federal Government including legislative action and/or
intergovernmental understandings or agreements. Accordingly, section
285.1 is revised to state that NVLAP will operate to accredit both
calibration laboratories and testing laboratories ``in response to (a)
Mandates by the Federal government through legislative or
administrative action; (b) Requests from a government agency
(Sec. 285.13); and (c) Requests from a private section organization
(Sec. 285.14)''.
In addition, Sec. 285.11, Requesting a LAP, is revised to provide
that following receipt of the identification of a mandate for a LAP
based on legislative or administrative action, the Director must
publish a Federal Register notice (1) stating the purpose of the LAP
including the national or international need; (2) describing the
general scope of the LAP; (3) identifying government agencies having
oversight; and (4) providing information to any interested party
wishing to be on the NVLAP mailing list to receive routine information
on the development of the LAP. In addition, Sec. 285.12 is revised to
provide that the Director of NIST shall establish all LAPs on the basis
of need; and that a mandate to develop a LAP by NVLAP will be
interpreted as a defacto decision to develop the specified LAP, and a
LAP will be developed (or existing LAPs modified, if practical)
following these procedures.
Comment. In the context of the establishment of LAPs at the request
of Government agencies, one manufacturer stated that the proposed
change to the NVLAP procedures does not cover: (1) Requirements for
factory inspections as a part of certification; (2) certification
organizations; and (3) the need for a public review of the findings.
Further, the changes would allow the use of subcontractors who are not
independent of manufacturers, employers, and distributors.
Response. No changes are made. The comments reflect some of the
conditions of accreditation required by a government agency. These
kinds of conditions are normally addressed in gathering information
leading to a decision whether or not to develop a new LAP. The NVLAP
procedures can not be complete in anticipation of any and all possible
conditions required by a sponsor.
Comment. Three trade associations, two manufacturers, a Government
agency, an accreditation organization and a consultant each commented
on the need for more specifics regarding international trade,
international recognition of testing and calibration data, and
memoranda of understanding (MOUs) and mutual recognition agreements.
Most letters contained some reference to these issues, either pointing
out the need for explicit language recognizing international trade
interests such as ``reduction of non-tariff barriers''; working to
``make the program more acceptable nationally and internationally'';
stating that ``it is of great interest to U.S. manufacturers to have
U.S./EC recognized accreditation for testing to European
specifications''; and identifying the need to ``promote the acceptance
of calibration and testing results between countries to encourage
international trade''.
The comment was also made that the NVLAP revision should state that
inquiries from other countries regarding memoranda of understandings
(MOUs) and mutual recognition agreements (MRAs) will be referred to the
appropriate U.S. agency to participate in any detailed negotiations.
Response. Other than a general statement, the proposed regulation
did not specifically deal with these concerns.
Comment. One consultant suggested changing Sec. 285.22 Assessing
and evaluating a laboratory to eliminate the suggestion that NVLAP
provides consulting or legal services.
Response. Regarding consulting services, communications with
laboratories are in the context of these procedures, none of which
provide for consulting services. NVLAP identifies the deficiencies
noted; it is the responsibility of the laboratory, not NVLAP, to
determine how deficiencies will be rectified. Regarding legal services,
NVLAP provides guidance to the accredited laboratories on the
conditions for referencing accredited status; this is procedural, not
legal advice.
Comment. One consultant suggested that NVLAP expand and elaborate
Sec. 285.3 Description and goal of NVLAP to include additional
information explaining methods for achieving the various objectives and
goals in the section.
Response. The language in this section clearly defines the goals
and objectives of NVLAP. Methods for achieving these goals and
objectives are already contained in many other publications, including
NIST administrative procedures and various NVLAP programmatic
documents.
Comments. One trade association and one consultant suggested that
NVLAP reword Sec. 285.8 Referencing NVLAP accreditation, to remove the
implication that laboratories must advertise accredited status, etc.
Response. Section 285.8(a) has been revised to make clear that
advertising is voluntary.
Comment. One accreditation organization suggested that NVLAP should
not make any changes to Sec. 285.33 Criteria for accreditation in
response to comments received as a result of the Federal Register
notice because it is important that the NVLAP regulation remain
compatible with the ISO Guide 25. It was recommended that such changes
should be compiled for use in discussions at upcoming ISO meetings
related to changing ISO Guide 25.
Response. NVLAP agrees, and is doing this.
Comment. One accreditation organization suggested that ASTM
Standard E 1301 should be referenced instead of ISO Guide 38, which is
``no longer a viable standard''; ISO Guide 43 should not be referenced
because it is very general and being revised.
Response. Guides 38 and 43 served as reference to ensure that the
NVLAP procedures meet all current international requirements. In fact,
the NVLAP procedures are more robust than the procedures contained in
either Guide 38 or Guide 43. NVLAP is committed to meeting
international requirements for laboratory accreditation, therefore we
reference the ISO guides and standards. We also know that ISO
``equivalents'' are published by other standards bodies. However, we do
not plan to invest time in evaluating the equivalence of these
standards in order to reference them in our procedures.
Comment. One accreditation organization suggested that the
reference to ISO Series 9000 documents in Sec. 285.4 References might
imply that NVLAP accreditation also conveys ISO 9000 registration.
Response. Reference to the ISO Series 9000 does not imply that
NVLAP is an ISO 9000 registrar. However, NVLAP accepts the statement in
ISO Guide 25 that ``laboratories meeting the requirements of the Guide
comply with the relevant requirements of the ISO 9000 series of
standards including those of the model described in ISO 9002''.
Comment. One consultant suggested deleting reference to ISO 9004
because it is intended only as a guideline document for use by
operators of quality management systems and not for regulatory adoption
or referencing as being compatible.
Response. The entire ISO Series is referenced because of the strong
relationship of this series with the quality systems criteria of ISO
Guide 25.
Additional Information
Executive Order 12866
This final rule has been determined to be not significant for
purposes of Executive Order 12866.
Executive Order 12612
This rule does not contain policies with Federalism implications
sufficient to warrant preparation of a Federalism assessment under
Executive Order 12612.
Regulatory Flexibility Act
The General Counsel 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 because (1) participation in NVLAP
is entirely voluntary, and (2) the changes are primarily
administrative, affecting the management of the program rather than
laboratories seeking or holding accreditation. Further, the technical
components of NVLAP, that is, the specific technical criteria that
individual laboratories are accredited against, are not changed in any
significant way by this proposal.
Paperwork Reduction Act
The information collection requirements contained in this proposed
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.
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
Environment Policy Act of 1969.
List of Subjects in 15 CFR Part 285
Business and industry, Commerce, Laboratories, Measurement
standards.
Dated: April 25, 1994.
Mary Good,
Under Secretary for Technology, Department of Commerce.
Dated: April 19, 1994.
Samuel Kramer,
Associate Director, NIST.
For reasons set forth in the preamble, Title 15 of the Code of
Federal Regulations is amended as follows:
PART 7--[REDESIGNATED AS PART 285]
1. Part 7 is redesignated as part 285.
1a. The authority citation for part 285 is revised to read as
follows:
Authority: 15 U.S.C. 272 et seq.
PART 285--[AMENDED]
2. The Table of Contents for Part 285 is revised to read as
follows:
Subpart A--General Information
Sec.
285.1 Purpose.
285.2 Organization of procedures.
285.3 Description and goal of NVLAP.
285.4 References.
285.5 Definitions.
285.6 NVLAP Documentation.
285.7 Confidentiality.
285.8 Referencing NVLAP Accreditation.
Subpart B--Establishing a LAP
285.11 Requesting a LAP.
285.12 LAP development decision.
285.13 Request from a government agency.
285.14 Request from a private sector organization.
285.15 Development of technical requirements.
285.16 Coordination with federal agencies.
285.17 Announcing the establishment of a LAP.
285.18 Adding to or modifying an established LAP.
285.19 Termination of a LAP.
Subpart C--Accrediting a Laboratory
285.21 Applying for accreditation.
285.22 Assessing and evaluating a laboratory.
285.23 Granting and renewing accreditation.
285.24 Denying, suspending, and revoking accreditation.
285.25 Voluntary termination of accreditation.
285.26 Change in Status of Laboratory.
Subpart D--Conditions and Criteria For Accreditation
285.31 Application of accreditation conditions and criteria.
285.32 Conditions for accreditation.
285.33 Criteria for accreditation.
3. Section 285.1 is revised to read as follows:
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 to accredit both calibration
laboratories and testing laboratories in response to:
(a) Mandates by the Federal government through legislative or
administrative action;
(b) Requests from a government agency (Sec. 285.13); and
(c) Requests from a private sector organization (Sec. 285.14).
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).
4. Section 285.2 is revised to read as follows:
Sec. 285.2 Organization of procedures.
Subpart A describes considerations which relate in general to all
aspects of NVLAP. Subpart B describes how new LAPs are requested,
developed, and announced, and how LAPs are terminated. Subpart C
describes procedures for accrediting laboratories. Subpart D sets out
the conditions and criteria for NVLAP accreditation.
5. Section 285.3 is revised to read as follows:
Sec. 285.3 Description and goal of NVLAP.
(a) NVLAP is a system for accrediting calibration laboratories and
testing laboratories found competent to perform specific tests or
calibrations. Competence is defined as the ability of a laboratory to
meet the NVLAP conditions (Sec. 285.32) and to conform to the criteria
(Sec. 285.33) in NVLAP publications for specific calibration and test
methods.
(b) NVLAP is a process which:
(1) Provides the technical and administrative mechanisms for
national and international recognition for competent laboratories based
on a comprehensive procedure for promoting confidence in calibration
and testing laboratories that show that they operate in accordance with
NVLAPs requirements;
(2) Provides laboratory management with documentation for use in
the development and implementation of their quality systems;
(3) Identifies competent laboratories for use by regulatory
agencies, purchasing authorities, and product certification systems;
(4) Provides laboratories with guidance from technical experts to
aid them in reaching a higher level of performance resulting in the
generation of improved engineering and product information; and
(5) Promotes the acceptance of calibration and test results between
countries, and facilitates cooperation between laboratories and other
bodies to assist in the exchange of information and experience,
facilitating removal of non-tariff barriers to trade and promoting the
harmonization of standards and procedures.
(c) NVLAP is comprised of a series of laboratory accreditation
programs (LAPs) which are established on the basis of requests and
demonstrated need. The specific calibration and test methods, types of
calibration and test methods, products, services, or standards to be
included in a LAP are determined by an open process during the
establishment of the LAP (see Sec. 285.11). The Director of the
National Institute of Standards and Technology (NIST) does not
unilaterally propose or decide the scope of a LAP. Communication with
other laboratory accreditation systems is fostered to encourage
development of common criteria and approaches to accreditation and to
promote the domestic, foreign, and international acceptance of test
data produced by the accredited laboratories.
6. Section 285.4 is revised to read as follows:
Sec. 285.4 References.
NVLAP is designed to be compatible with domestic and foreign
laboratory accreditation programs to ensure the universal acceptance of
test data produced by NVLAP-accredited laboratories. In this regard,
these Procedures are compatible with:
(a) The most recent official publications of ISO Guides 2, 25, 30,
38, 43, 45, 49, 58, and Standards 8402, 9001, 9002, 9003, and 9004.
(b) International vocabulary of basic and general terms in
metrology (VIM) and Guide to the expression of uncertainty in
measurement, issued by International Bureau of Weights and Measures
(BIPM), International Electrotechnical Commission (IEC), International
Federation of Clinical Chemistry (IFCC), International Organization for
Standardization (ISO), International Union of Pure and Applied
Chemistry (IUPAC), International Union of Pure and Applied Physics
(IUPAP), and International Organization of Legal Metrology (OIML).
7. Section 285.5 is revised to read as follows:
Sec. 285.5 Definitions.
Accreditation (of a laboratory): A formal recognition that a
laboratory is competent to carry out specific tests or calibrations or
types of test or calibrations.
Accreditation criteria: A set of requirements used by an
accrediting body which a laboratory must meet in order to be
accredited.
Approved Signatory (of an accredited laboratory): An individual who
is recognized by NVLAP as competent to sign accredited laboratory
calibration or test reports.
Assessment (of a laboratory): The on-site examination of a testing
or calibration laboratory to evaluate its compliance with the
conditions and criteria for accreditation.
Authorized Representative (of an accredited laboratory): An
individual who is authorized by the laboratory or the parent
organization to sign the NVLAP application form and commit the
laboratory to fulfill the NVLAP requirements (The Authorized
Representative may also be recommended by the laboratory as an Approved
Signatory).
Calibration: A set of operations which establish, under specified
conditions, the relationship between values indicated by a measuring
instrument or system, or values represented by a material measure, and
the corresponding known values of a measurand.
Calibration method: A defined technical procedure for performing a
calibration.
Certificate of Accreditation: A document issued by NVLAP to a
laboratory that has met the criteria and conditions for accreditation.
The Certificate of Accreditation may be used as proof of accredited
status. A Certificate of Accreditation is always accompanied with a
Scope of Accreditation.
Competence: The ability of a laboratory to meet the NVLAP
conditions and to conform to the criteria in NVLAP publications for
specific calibration and test methods.
Deficiency: The non-fulfillment of NVLAP conditions and/or criteria
for accreditation.
Director of NIST: The Director of the National Institute of
Standards and Technology or designate.
Laboratory: An organization that performs calibrations and/or
tests. When a laboratory is part of an organization that carries out
activities additional to calibration and testing, the term
``laboratory'' refers only to those parts of that organization that are
involved in the calibration and testing process. The laboratory
activities may be carried out at or from a permanent location, at or
from a temporary facility, or in or from a mobile facility.
LAP: A laboratory accreditation program established and
administered under NVLAP, consisting of test methods or calibrations
relating to specific products or fields of testing or calibration.
NIST: The National Institute of Standards and Technology.
NVLAP: The National Voluntary Laboratory Accreditation Program.
NVLAP is an Office within the National Institute of Standards and
Technology.
Person: Associations, companies, corporations, educational
institutions, firms, government agencies at the federal, state and
local level, partnerships, and societies--as well as divisions
thereof--and individuals.
Product: A type or a category of manufactured goods, constructions,
installations, and natural and processed materials, or those associated
services whose characterization, classification, or functional
performance is specified by standards or test methods.
Proficiency testing: The determination of laboratory performance by
means of comparing and evaluating calibrations or tests on the same or
similar items or materials by two or more laboratories in accordance
with predetermined conditions.
Quality manual: A document stating the quality policy, quality
system, and quality practices of an organization. The quality manual
may reference other laboratory documentation.
Quality system: The organizational structure, responsibilities,
procedures, processes, and resources for implementing quality
management.
Reference material: A material or substance one or more properties
of which are sufficiently well established to be used for the
calibration of an apparatus, the assessment of a measurement method, or
for assigning values to materials. A ``certified reference material''
means that one or more of the property values of the reference material
are certified by a technically valid procedure, accompanied by or
traceable to a certificate or other documentation which is issued by a
certifying body.
Reference standard: A standard, generally of the highest
metrological quality available at a given location, from which
measurements made at that location are derived.
Scope of accreditation: A document issued by NVLAP which lists the
test methods or services, or calibration services for which the
laboratory is accredited.
Sub-facility: A laboratory operating under the technical direction
and quality system of a main facility that is accredited.
Test: A technical operation that consists of the determination of
one or more characteristics or performance of a given product,
material, equipment, organism, physical phenomenon, process or service
according to a specified procedure.
Test method: A defined technical procedure for performing a test.
Testing laboratory: A laboratory which measures, examines, tests,
calibrates or otherwise determines the characteristics or performance
of products or materials.
Traceability of the accuracy of measuring instruments: A documented
chain of comparison connecting the accuracy of a measuring instrument
to other measuring instruments of higher accuracy and ultimately to a
primary standard.
8. Section 285.6 is revised to read as follows:
Sec. 285.6 NVLAP documentation.
NVLAP publications are available for information and use by staff
of accredited laboratories, those seeking accreditation, other
laboratory accreditation systems, and others needing information on the
requirements for accreditation under the NVLAP program. Accredited
laboratories will be sent revised publications routinely. Publications
include:
(a) The Procedures and General Requirements, (15 CFR part 285);
(b) Handbooks containing the administrative and operational
procedures and technical requirements of specific LAPs;
(c) A directory of accredited laboratories published annually and
updated periodically; and
(d) Policy Guides that provide changes to the Procedures and
General Requirements and Handbooks between formal revisions of those
publications.
9. Section 285.7 is revised to read as follows:
Sec. 285.7 Confidentiality.
To the extent permitted by applicable laws, NVLAP will seek to
ensure confidentiality of all information obtained relating to the
application, on-site assessment, proficiency testing, evaluation, and
accreditation of laboratories.
10. Section 285.8 is added to read as follows:
Sec. 285.8 Referencing NVLAP accreditation.
To become accredited and maintain accreditation, a laboratory shall
agree in writing to:
(a) Follow NVLAP guidance when advertising its accredited status
(including the use of the NVLAP logo) on letterheads, brochures, test
reports, and professional, technical, trade, or other laboratory
services publications.
(b) Inform its clients that the laboratory's accreditation or any
of its calibration or test reports in no way constitutes or implies
product certification, approval, or endorsement by NIST.
11. Section 285.11 is amended by revising paragraphs (a), (b)(1),
(b)(3)(ii) and (c) and adding paragraphs (e) and (f) to read as
follows:
Sec. 285.11 Requesting a LAP.
(a) A request to establish a LAP must be made to the Director of
NIST.
(b) * * *
(1) The scope of the LAP in terms of products, calibration
services, or testing services proposed for inclusion;
* * * * *
(3) * * *
(ii) Evidence of a national need to accredit calibration or testing
laboratories for the specific scope beyond that served by an existing
laboratory accreditation program in the public or private sector;
* * * * *
(c) NVLAP may request clarification of the information submitted
according to paragraph (b) of this section.
* * * * *
(e) Following receipt of the identification of a mandate for a LAP
based on legislative or administrative action, the Director shall
publish a Federal Register notice:
(1) Stating the purpose of the LAP including the national or
international need;
(2) Describing the general scope of the LAP;
(3) Identifying government agencies having oversight; and
(4) Providing information to any interested party wishing to be on
the NVLAP mailing list to receive routine information on the
development of the LAP.
(f) Consistent with applicable laws and regulations, the Director
may negotiate and conclude agreements with the governments of other
countries for NVLAP recognition of foreign laboratories. At a minimum,
any agreement must provide that accredited foreign laboratories meet
conditions for accreditation comparable to and consistent with those
set out in these requirements.
12. Section 285.12 is amended by revising paragraphs (a) and (b)(6)
to read as follows:
Sec. 285.12 LAP development decision.
(a) The Director of NIST shall establish all LAPs on the basis of
need.
(1) A mandate to develop a LAP by NVLAP will be interpreted as a de
facto decision to develop the specified LAP, and a LAP will be
developed (or existing LAPs modified, if practical) following these
procedures.
(2) Government agencies may document the need by using Sec. 285.13,
and private sector organizations by using Sec. 285.14.
(b) * * *
(6) The economic and technical feasibility of accrediting
laboratories for the calibration or test methods, types of calibration
or test methods, products, services, or standards requested; and
* * * * *
13. Section 285.13 is amended by revising paragraphs (a) and (c) to
read as follows:
Sec. 285.13 Request from a government agency.
(a) Any Federal, state or local agency responsible for regulatory
or public service programs established under statute or code, which has
determined a need to accredit laboratories within the context of its
programs, may request the Director of NIST to establish a LAP.
* * * * *
(c) NVLAP may request clarification of the information required by
Sec. 285.11(b).
* * * * *
14. Section 285.14 is amended by revising paragraphs (a)
introductory text and (c) to read as follows:
Sec. 285.14 Request from a private sector organization.
(a) Any private sector organization which has determined a need to
accredit laboratories for specific products, calibrations, or testing
services, may request the Director of NIST to establish a LAP if it
uses procedures meeting the following conditions:
* * * * *
(c) NVLAP may request clarification of the information required by
Sec. 285.11(b).
* * * * *
15. Section 285.15 is amended by revising paragraphs (a) and (c) to
read as follows:
Sec. 285.15 Development of technical requirements.
(a) Technical requirements for accreditation are specific for each
LAP. The requirements tailor the criteria referenced in Sec. 285.33 to
the calibration or test methods, types of calibration or test methods,
products, services, or standards covered by the LAP.
* * * * *
(c) NVLAP shall make every reasonable effort to ensure that the
affected calibration or testing community within the scope of the LAP
is informed of any planned workshop. Summary minutes of each workshop
will be prepared. A copy of the minutes will be made available for
inspection and copying at the NIST Records Inspection Facility.
16. Section 285.17(c) is revised to read as follows:
Sec. 285.17 Announcing the establishment of a LAP.
* * * * *
(c) NVLAP shall establish fees in amounts that will enable it to
recover its full costs, and shall, from time to time as necessary,
revise the fees for this purpose.
17. Section 285.18 is revised to read as follows:
Sec. 285.18 Adding to or modifying an established LAP.
(a) Established or developing LAPs may be added to, modified, or
realigned based on either a written request from any person wishing to
add or delete specific standards, calibration or test methods, or types
of calibration or test methods or a need identified by NIST.
(b) NVLAP may choose to make the additions or modifications
available for accreditation under a LAP when:
(1) The additional standards, calibration or test methods, or types
of calibration or test methods requested are directly relevant to the
LAP;
(2) It is feasible and practical to accredit calibration or testing
laboratories for the additional standards, calibration or test methods,
or types of calibration or test methods; and
(3) It is likely that laboratories will seek accreditation for the
additional standards, calibration or test methods, or types of
calibration or test methods.
18. Section 285.19(a) is revised to read as follows:
Sec. 285.19 Termination of a LAP.
(a) The Director of NIST may terminate a LAP when the Director of
NIST 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 Director of NIST proposes to terminate a LAP, a notice will be
published in the Federal Register setting forth the basis for that
determination.
* * * * *
19. Section 285.21 is amended by revising paragraphs (a) and (c) to
read as follows:
Sec. 285.21 Applying for accreditation.
(a) A laboratory may complete and remit an application for
accreditation in any of the established LAPs.
* * * * *
(c) Accreditation of laboratories outside of the United States may
require:
(1) Translation of laboratory documentation into English; and
(2) Payment of additional traveling expenses for on-site
assessments and proficiency testing.
20. Section 285.22 is revised to read as follows:
Sec. 285.22 Assessing and evaluating a laboratory.
(a) Information use to evaluate a laboratory's compliance with the
conditions for accreditation set out in Sec. 285.32, the criteria for
accreditation set out in Sec. 285.33, and the technical requirements
established for each LAP will include (not necessarily in this order):
(1) Application and other material submitted by the laboratory
(Sec. 285.32(b));
(2) On-site assessment reports;
(3) Laboratory performance on proficiency tests;
(4) Laboratory responses to identified deficiencies; and
(5) Technical evaluation.
(b) NVLAP shall arrange the assessment and evaluation of applicant
laboratories in such a way as to minimize potential conflicts of
interest.
(c) NVLAP shall inform each applicant laboratory of any additional
action(s) that the laboratory must take to qualify for accreditation.
21. Section 285.23 is amended by removing paragraph (d), and by
revising paragraphs (a) and (b) to read as follows:
Sec. 285.23 Granting and renewing accreditation.
(a) NVLAP will take action to: (1) Grant initial accreditation, or
(2) renew, suspend, or propose to deny or revoke accreditation of an
applicant laboratory, based on the degree to which the laboratory
complies with the specific NVLAP requirements.
(b) If accreditation is granted or renewed, NVLAP shall:
(1) Provide a Certificate of Accreditation and a Scope of
Accreditation to the laboratory;
(2) Provide guidance on referencing the laboratory's accredited
status, and the use of the NVLAP logo by the laboratory and its
clients, as needed; and
(3) Remind the laboratory that accreditation does not relieve it
from complying with applicable federal, state, and local laws and
regulations.
* * * * *
22. Section 285.24 is revised to read as follows:
Sec. 285.24 Denying, suspending, and revoking accreditation.
(a) 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.
(b) The laboratory will have 30 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 that 30-day period.
(c) If NVLAP finds that an accredited laboratory has violated the
terms of its accreditation or the provisions of these procedures, NVLAP
may, after consultation with the laboratory, suspend the laboratory's
accreditation, or advise of NVLAP's intent to revoke accreditation. If
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.
(d) A laboratory whose accreditation has been denied, revoked,
terminated, or expired, or which has withdrawn its application before
being accredited, may reapply and be accredited if the laboratory:
(1) Completes the assessment and evaluation process; and
(2) Meets the conditions and criteria for accreditation that are
set out in Secs. 285.32 and 285.33.
(e) Conditions of suspension will include prohibiting the
laboratory from using the NVLAP logo on its test or calibration reports
during the suspension period. The determination of NVLAP whether to
suspend or to propose revocation of a laboratory's accreditation will
depend on the nature of the violation(s) of the terms of its
accreditation.
23. Section 285.26 is added to read as follows:
Sec. 285.26 Change in status of laboratory.
Accreditation of a laboratory is based on specific conditions and
criteria including the laboratory ownership, location, staffing,
facilities, and configuration. Changes in any of these conditions or
criteria could result in loss of accreditation. NVLAP must be informed
if any of the conditions or criteria for accreditation are changed so
that a determination can be made concerning the status of the
accreditation.
24. Section 285.31 is revised to read as follows:
Sec. 285.32 Application of accreditation conditions and criteria.
To become accredited and maintain accreditation, a laboratory must
meet the conditions for accreditation set out in Sec. 285.32, the
criteria set out in Sec. 285.33, and the guidance provided in the
Handbooks for specific LAPs.
25. Section 285.32 is revised to read as follows:
Sec. 285.32 Conditions for accreditation
(a) To become accredited and maintain accreditation, a laboratory
shall agree in writing to:
(1) Be assessed and evaluated initially and on a periodic basis;
(2) Demonstrate, on request, that it is able to perform the
calibrations or tests representative of those for which it is seeking
accreditation;
(3) Pay all fees;
(4) Participate in proficiency testing as required;
(5) Be capable of performing the calibrations or tests for which it
is accredited according to the latest version of the calibration or
test method within one year after its publication or within another
time limit specified by NVLAP;
(6) Limit the representation of the scope of its accreditation to
only those calibrations, tests or services for which accreditation is
granted;
(7) Resolve all deficiencies;
(8) Limit all its work or services of clients to those areas where
competence and capacity are available;
(9) Maintain records of all actions taken in response to complaints
for a minimum of one year;
(10) Maintain an independent decisional relationship between itself
and its clients, affiliates, or other organizations so that the
laboratory's capacity to render calibration or test reports objectively
and without bias is not adversely affected;
(11) Report to NVLAP within 30 days any major changes involving the
location, ownership, management structure, authorized representative,
approved signatories, or facilities of the laboratory; and
(12) Return to NVLAP the Certificate of Accreditation and the Scope
of Accreditation for revision or other action should it:
(i) Be requested to do so by NVLAP;
(ii) Voluntarily terminate its accredited status; or
(iii) Become unable to conform to any of these conditions, the
applicable criteria of Sec. 285.33, and related technical requirements.
(b) To become accredited and maintain accreditation, a laboratory
shall supply, upon request, the following information:
(1) Legal name and full address;
(2) Ownership of the laboratory;
(3) Organization chart defining relationships that are relevant to
performing testing and calibrations covered in the accreditation
request;
(4) General description of the laboratory, including its facilities
and scope of operation;
(5) Name, address, and telephone and FAX number of the authorized
representative of the laboratory;
(6) Names or titles and qualifications of laboratory staff
nominated to serve as approved signatories of calibration or test
reports that reference NVLAP accreditation;
(7) The laboratory Quality Manual; and
(8) Other information as may be needed for the specific LAP(s) in
which accreditation is sought.
26. Section 285.33 is revised to read as follows:
Sec. 285.33 Criteria for accreditation.
(a) Scope. (1) This section sets out the general requirements in
accordance with which a laboratory has to demonstrate that it operates,
if it is to be recognized as competent to carry out specific
calibrations or tests.
(2) Additional requirements and information which have to be
disclosed for assessing competence or for determining compliance with
other criteria may be specified by NVLAP, depending upon the specific
character of the task of the laboratory.
(3) This section is for use by calibration and testing laboratories
in the development and implementation of their quality systems. It may
also be used by accreditation bodies, certification bodies and others
concerned with the competence of laboratories.
(b) Organization and management. (1) The laboratory shall be
legally identifiable. It shall be organized and shall operate in such a
way that its permanent, temporary and mobile facilities meet these
requirements.
(2) The laboratory shall:
(i) Have managerial staff with the authority and resources needed
to discharge their duties;
(ii) Have policies to ensure that its personnel are free from any
commercial, financial and other pressures which might adversely affect
the quality of their work;
(iii) Be organized in such a way that confidence in its
independence of judgement and integrity is maintained at all times;
(iv) Specify and document the responsibility, authority and
interrelation of all personnel who manage, perform or verify work
affecting the quality of calibrations and tests;
(v) Provide supervision by persons familiar with the calibration or
test methods and procedures, the objective of the calibration or test
and the assessment of the results. The ratio of supervisory to non-
supervisory personnel shall be such as to ensure adequate supervision;
(vi) Have a technical manager (however named) who has overall
responsibility for the technical operations;
(vii) Have a quality manager (however named) who has responsibility
for the quality system and its implementation. The quality manager
shall have direct access to the highest level of management at which
decisions are taken on laboratory policy or resources, and to the
technical manager. In some laboratories, the quality manager may also
be the technical manager or deputy technical manager;
(viii) Nominate deputies in case of absence of the technical or
quality manager;
(ix) Have documented policy and procedures to ensure the protection
of clients' confidential information and proprietary rights;
(x) Where appropriate, participate in interlaboratory comparisons
and proficiency testing programs.
(c) Quality system, audit and review. (1) The laboratory shall
establish and maintain a quality system appropriate to the type, range
and volume of calibration and testing activities it undertakes. The
elements of this system shall be documented. The quality documentation
shall be available for use by the laboratory personnel. The laboratory
shall define and document its policies and objectives for, and its
commitment to, good laboratory practice and quality of calibration or
testing services. The laboratory management shall ensure that these
policies and objectives are documented in a quality manual and
communicated to, understood, and implemented by all laboratory
personnel concerned. The quality manual shall be maintained current
under the responsibility of the quality manager.
(2) The quality manual, and related quality documentation, shall
state the laboratory's policies and operational procedures established
in order to meet the requirements of procedures. The quality manual and
related quality documentation shall also contain:
(i) A quality policy statement, including objectives and
commitments, by top management;
(ii) The organization and management structure of the laboratory,
its place in any parent organization and relevant organizational
charts;
(iii) The relations between management, technical operations,
support services and the quality system;
(iv) Procedures for control and maintenance of documentation;
(v) Job descriptions of key staff and reference to the job
descriptions of other staff;
(vi) Identification of the laboratory's approved signatories;
(vii) The laboratory's procedures for achieving traceability of
measurements;
(viii) The laboratory's scope of calibrations and/or tests;
(ix) Arrangements for ensuring that the laboratory reviews all new
work to ensure that it has the appropriate facilities and resources
before commencing such work;
(x) Reference to the calibration, verification and/or test
procedures used;
(xi) Procedures for handling calibration and test items;
(xii) Reference to the major equipment and reference measurement
standards used;
(xiii) Reference to procedures for calibration, verification and
maintenance of equipment;
(xiv) Reference to verification practices including interlaboratory
comparisons, proficiency testing programs, use of reference materials
and internal quality control schemes;
(xv) Procedures to be followed for feedback and corrective action
whenever discrepancies are detected, or departures from documented
policies and procedures occur;
(xvi) The laboratory management policies for departures from
documented policies and procedures or from standard specifications;
(xvii) Procedures for dealing with complaints;
(xviii) Procedures for protecting confidentiality and proprietary
rights;
(xix) Procedures for audit and review.
(3) The laboratory shall arrange for audits of its activities at
appropriate intervals to verify that its operations continue to comply
with the requirements of the quality system. Such audits shall be
carried out by trained and qualified staff who are, wherever possible,
independent of the activity to be audited. Where the audit findings
cast doubt on the correctness or validity of the laboratory's
calibration or test results, the laboratory shall take immediate
corrective action and shall immediately notify, in writing, any client
whose work may have been affected.
(4) The quality system adopted to satisfy the requirements of this
section shall be reviewed at least once each year by the management to
ensure its continuing suitability and effectiveness and to introduce
any necessary changes or improvements.
(5) All audit and review findings and any corrective actions that
arise from them shall be documented. The person responsible for quality
shall ensure that these actions are discharged within the agreed
timescale.
(6) In addition to periodic audits the laboratory shall ensure the
quality of results provided to clients by implementing checks. These
checks shall be reviewed and shall include, as appropriate but not be
limited to:
(i) Internal quality control schemes using whenever possible
statistical techniques;
(ii) Participation in proficiency testing or other interlaboratory
comparisons;
(iii) Regular use of certified reference materials and/or in--house
quality control using secondary reference materials;
(iv) Replicate testings using the same or different methods;
(v) Re-testing of retained items;
(vi) Correlation of results for different characteristics of an
item.
(d) Personnel. (1) The testing laboratory shall have sufficient
personnel, having the necessary education, training, technical
knowledge and experience for their assigned functions.
(2) The testing laboratory shall ensure that the training of its
personnel is kept up-to-date.
(3) Records on the relevant qualifications, training, skills and
experience of the technical personnel shall be maintained by the
laboratory.
(e) Accommodation and environment. (1) Laboratory accommodation,
calibration and test areas, energy sources, lighting, heating and
ventilation shall be such as to facilitate proper performance of
calibrations or tests.
(2) The environment in which these activities are undertaken shall
not invalidate the results or adversely affect the required accuracy of
measurement. Particular care shall be taken when such activities are
undertaken at sites other than the permanent laboratory premises.
(3) The laboratory shall provide facilities for the effective
monitoring, control and recording of environmental conditions as
appropriate. Due attention shall be paid, for example, to biological
sterility, dust, electromagnetic interference, humidity, voltage,
temperature, and sound and vibration levels, as appropriate to the
calibrations or tests concerned.
(4) There shall be effective separation between neighboring areas
when the activities therein are incompatible.
(5) Access to and use of all areas affecting the quality of these
activities shall be defined and controlled.
(6) Adequate measures shall be taken to ensure good housekeeping in
the laboratory.
(f) Equipment and reference materials. (1) The laboratory shall be
furnished with all items of equipment (including reference materials)
required for the correct performance of calibrations and tests. In
those cases where the laboratory needs to use equipment outside its
permanent control it shall ensure that the relevant requirements of
this section are met.
(2) All equipment shall be properly maintained. Maintenance
procedures shall be documented. Any item of equipment which has been
subjected to overloading or mishandling, or which gives suspect
results, or has been shown by verification or otherwise to be
defective, shall be taken out of service, clearly identified and
wherever possible stored at a specified place until it has been
repaired and shown by calibration, verification or test to perform
satisfactorily. The laboratory shall examine the effect of this defect
on previous calibrations or tests.
(3) Each item of equipment including reference materials shall,
when appropriate, be labelled, marked or otherwise identified to
indicate its calibration status.
(4) Records shall be maintained of each item of equipment and all
reference materials significant to the calibrations or tests performed.
The records shall include:
(i) The name of the item of equipment;
(ii) The manufacturer's name, type identification, and serial
number or other unique identification;
(iii) Date received and date placed in service;
(iv) Current location, where appropriate;
(v) Condition when received (e.g. new, used, reconditioned);
(vi) Copy of the manufacturer's instructions, where available;
(vii) Dates and results of calibrations and/or verifications and
date of next calibration and/or verification;
(viii) Details of maintenance carried out to date and planned for
the future;
(ix) History of any damage, malfunction, modification or repair.
(g) Measurement traceability and calibration. (1) All measuring and
testing equipment having an effect on the accuracy or validity of
calibrations or tests shall be calibrated and/or verified before being
put into service. The laboratory shall have an established program for
the calibration and verification of its measuring and test equipment.
(2) The overall program of calibration and/or verification and
validation of equipment shall be designed and operated so as to ensure
that, wherever applicable, measurements made by the laboratory are
traceable to national standards of measurement where available.
Calibration certificates shall wherever applicable indicate the
traceability to national standards of measurement and shall provide the
measurement results and associated uncertainty of measurement and/or a
statement of compliance with an identified metrological specification.
(3) Where traceability to national standards of measurement is not
applicable, the laboratory shall provide satisfactory evidence of
correlation of results, for example by participation in a suitable
program of interlaboratory comparisons or proficiency testing.
(4) Reference standards of measurement held by the laboratory shall
be used for calibration only and for no other purpose, unless it can be
demonstrated that their performance as reference standards has not been
invalidated.
(5) Reference standards of measurement shall be calibrated by a
body that can provide traceability to a national standard of
measurement. There shall be a program of calibration and verification
for reference standards.
(6) Where relevant, reference standards and measuring and testing
equipment shall be subjected to in-service checks between calibrations
and verifications.
(7) Reference materials shall, where possible, be traceable to
national or international standards of measurement, or to national or
international standard reference materials.
(h) Calibration and test methods. (1) The laboratory shall have
documented instructions on the use and operation of all relevant
equipment, on the handling and preparation of items and for calibration
and/or testing, where the absence of such instructions could jeopardize
the calibrations or tests. All instructions, standards, manuals and
reference data relevant to the work of the laboratory shall be
maintained up-to-date and be readily available to the staff.
(2) The laboratory shall use appropriate methods and procedures for
all calibrations and tests and related activities within its
responsibility (including sampling, handling, transport and storage,
preparation of items, estimation of uncertainty of measurement and
analysis of calibration and/or test data). They shall be consistent
with the accuracy required, and with any standard specifications
relevant to the calibrations or tests concerned.
(3) Where methods are not specified, the laboratory shall, wherever
possible, select methods that have been published in international or
national standards, those published by reputable technical
organizations or in relevant scientific texts or journals.
(4) Where it is necessary to employ methods that have not been
established as standard, these shall be subject to agreement with the
client, be fully documented and validated, and be available to the
client and other recipients of the relevant reports.
(5) Where sampling is carried out as part of the test method, the
laboratory shall used documented procedures and appropriate statistical
techniques to select samples.
(6) Calculations and data transfers shall be subject to appropriate
checks.
(7) Where computers or automated equipment are used for the
capture, processing, manipulation, recording, reporting, storage or
retrieval of calibration or test data, the laboratory shall ensure
that:
(i) The requirements of these procedures are complied with;
(ii) Computer software is documented and adequate for use;
(iii) Procedures are established and implemented for protecting the
integrity of data; such procedures shall include, but not be limited
to, integrity of data entry or capture, data storage, data transmission
and data processing;
(iv) Computer and automated equipment is maintained to ensure
proper functioning and provided with the environmental and operating
conditions necessary to maintain the integrity of calibration and test
data;
(v) It establishes and implements appropriate procedures for the
maintenance of security of data including the prevention of
unauthorized access to, and the unauthorized amendment of, computer
records.
(8) Documented procedure shall exist for the purchase, reception
and storage of consumable materials used for the technical operations
of the laboratory.
(i) Handling of calibration and test items. (1) The laboratory
shall have a documented system for uniquely identifying the items to be
calibrated or tested, to ensure that there can be no confusion
regarding the identity of such items at any time.
(2) Upon receipt, the condition of the calibration or test item,
including any abnormalities or departures from standard condition as
prescribed in the relevant calibration or test method, shall be
recorded. Were there is any doubt as to the item's suitability for
calibration or test, where the item does not conform to the description
provided, or where the calibration or test required is not fully
specified, the laboratory shall consult the client for further
instruction before proceeding. The laboratory shall establish whether
the item has received all necessary preparation, or whether the client
requires preparation to be undertaken or arranged by the laboratory.
(3) The laboratory shall have documented procedures and appropriate
facilities to avoid deterioration or damage to the calibration or test
item, during storage, handling, preparation, and calibration or test;
any relevant instructions provided with the item shall be followed.
Where items have to be stored or conditioned under specific
environmental conditions, these conditions shall be maintained,
monitored and recorded where necessary. Where a calibration or test
item or portion of an item is to be held secure (for example, for
reasons of record, safety or value, or to enable check calibrations or
tests to be performed later), the laboratory shall have storage and
security arrangements that protect the condition and integrity of the
secured items or portions concerned.
(4) The laboratory shall have documented procedures for the
receipt, retention or safe disposal of calibration or test items,
including all provisions necessary to protect the integrity of the
laboratory.
(j) Records. (1) The laboratory shall maintain a record system to
suit its particular circumstances and comply with any applicable
regulations. It shall retain on record all original observations,
calculations and derived data, calibration records and a copy of the
calibration certificate, test certificate or test report for an
appropriate period. The records for each calibration and test shall
contain sufficient information to permit their repetition. The records
shall include the identity of personnel involved in sampling,
preparation, calibration or testing.
(2) All records (including those listed in Sec. 285.33(f)(4)
pertaining to calibration and test equipment), certificates and reports
shall be safely stored, held secure and in confidence to the client.
(k) Certificates and reports. (1) The results of each calibration,
test, or series of calibrations or tests carried out by the laboratory
shall be reported accurately, clearly, unambiguously and objectively,
in accordance with any instructions in the calibration or test methods.
The results should normally be reported in a calibration certificate,
test report or test certificate and should include all the information
necessary for the interpretation of the calibration or test results and
all information required by the method used.
(2) Each certificate or report shall include at least the following
information:
(i) A title, e.g., ``Calibration Certificate'', ``Test Report'' or
``Test Certificate'';
(ii) Name and address of laboratory, and location where the
calibration or test was carried out if different from the address of
the laboratory;
(iii) Unique identification of the certificate or report (such as
serial number) and of each page, and the total number of pages;
(iv) Name and address of client, where appropriate;
(v) Description and unambiguous identification of the item
calibrated or tested;
(vi) Characterization and condition of the calibration or test
item;
(vii) Date of receipt of calibration or test item and date(s) of
performance of calibration or test, where appropriate;
(viii) Identification of the calibration or test method used, or
unambiguous description of any non-standard method used;
(ix) Reference to sampling procedure, where relevant;
(x) Any deviations from, additions to or exclusions from the
calibration or test method, and any other information relevant to a
specific calibration or test, such as environmental conditions;
(xi) Measurements, examinations and derived results, supported by
tables, graphs, sketches and photographs as appropriate, and any
failures identified;
(xii) A statement of the estimated uncertainty of the calibration
or test result (where relevant);
(xiii) A signature and title, or an equivalent identification of
the person(s) accepting responsibility for the content of the
certificate or report (however produced), and date of issue;
(xiv) Where relevant, a statement to the effect that the results
relate only to the items calibrated or tested;
(xv) A statement that the certificate or report shall not be
reproduced except in full, without the written approval of the
laboratory.
(3) Where the certificate or report contains results of
calibrations or tests performed by sub-contractors, these results shall
be clearly identified.
(4) Particular care and attention shall be paid to the arrangement
of the certificate or report, especially with regard to presentation of
the calibration or test data and ease of assimilation by the reader.
The format shall be carefully and specifically designed for each type
of calibration or test carried out, but the headings shall be
standardized as far as possible.
(5) Material amendments to a calibration certificate, test report
or test certificate after issue shall be made only in the form of a
further document, or data transfer including the statement ``Supplement
to Calibration Certificate for Test Report or Test Certificate), serial
number * * * for as otherwise identified]'', or equivalent form of
wording. Such amendments shall meet all the relevant requirements of
Sec. 285.33(j).
(6) The laboratory shall notify clients promptly, in writing, of
any event such as the identification of defective measuring or test
equipment that casts doubt on the validity of results given in any
calibration certificate, test report or test certificate of amendment
to a report or certificate.
(7) The laboratory shall ensure that, where clients require
transmission of calibration or test results by telephone, telex,
facsimile or other electronic or electromagnetic means, staff will
follow documented procedures that ensure that the requirements of these
procedures are met and that confidentiality is preserved.
(l) Subcontracting of calibration or testing. (1) Where a
laboratory subcontracts any part of the calibration or testing, this
work shall be placed with a laboratory complying with these
requirements. The laboratory shall ensure and be able to demonstrate
that its subcontractor is competent to perform the activities in
question and complies with the same criteria of competence as the
laboratory in respect of the work being subcontracted. The laboratory
shall advise the client in writing of its intention to subcontract any
portion of the calibration or testing to another party.
(2) The laboratory shall record and retain details of its
investigation of the competence and compliance of its subcontractors
and maintain a register of all subcontracting.
(m) Outside support services and supplies. (1) Where the laboratory
procures outside services and supplies, other than those referred to in
these procedures, in support of calibrations or tests, the laboratory
shall use only those outside support services and supplies that are of
adequate quality to sustain confidence in the laboratory's calibrations
or tests.
(2) Where no independent assurance of the quality of outside
support services or supplies is available, the laboratory shall have
procedures to ensure that purchased equipment, materials and services
comply with specified requirements. The laboratory should, wherever
possible, ensure that purchased equipment and consumable materials are
not used until they have been inspected, calibrated or otherwise
verified as complying with any standard specifications relevant to the
calibrations or tests concerned.
(3) The laboratory shall maintain records of all suppliers from
whom it obtains support services or supplies required for calibrations
or tests.
(n) Complaints. (1) The laboratory shall have documented policy and
procedures for the resolution of complaints received from clients or
other parties about the laboratory's activities. A record shall be
maintained of all complaints and of the actions taken by the
laboratory.
(2) Where a complaint, or any other circumstances, raises doubt
concerning the laboratory's compliance with the laboratory's policies
or procedures, or with the requirements of this section or otherwise
concerning the quality of the laboratory's calibrations or tests, the
laboratory shall ensure that those areas of activity and responsibility
involved are promptly audited in accordance with this section.
[FR Doc. 94-10449 Filed 5-2-94; 8:45 am]
BILLING CODE 3510-13-M