ASTM E994-95
(Guide)Standard Guide for Calibration and Testing Laboratory Accreditation Systems General Requirements for Operation and Recognition (Withdrawn 2004)
Standard Guide for Calibration and Testing Laboratory Accreditation Systems General Requirements for Operation and Recognition (Withdrawn 2004)
SCOPE
1.1 This guide covers the general requirements for the operation of a system for accreditation of calibration and testing laboratories so that the accreditation granted and the services covered by the accreditations may be recognized at a national or an international level and the body operating the accreditation system may be recognized at a national or international level as competent and reliable.
1.2 Users of the services of an accreditation body, other than the laboratories accredited by that accreditation body, may require compliance with additional requirements to those specified in this guide.
1.3 The object of this guide is to provide guidance for the set-up and operation of an accreditation body and to facilitate agreement on mutual recognition of accreditation of laboratories between such bodies. Note 1-It is recognized that agreements on mutual recognition of accreditation aiming at the removal of barriers to across-border trade may have to cover other aspects not explicitly specified in these general requirements, such as proficiency testing or other interlaboratory comparisons, exchange of staff or training programs. In particular, with a view to create confidence and harmonize the interpretation and implementation of standards, each accreditation body should encourage technical cooperation and exchange of experience among laboratories accredited by it, and it should be prepared to exchange information on accreditation procedures and practices with other accreditation bodies.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsiblity of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
WITHDRAWN RATIONALE
This guide covers the general requirements for the operation of a system for accreditation of calibration and testing laboratories so that the accreditation granted and the services covered by the accreditations may be recognized at a national or an international level and the body operating the accreditation system may be recognized at a national or international levels as competent and reliable.
Formerly under this jurisdiction of Committee E36 on Conformity Assessment, this guide was withdrawn in December 2003.
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn
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Designation:E994–95
AMERICAN SOCIETY FOR TESTINGAND MATERIALS
100 Barr Harbor Dr., West Conshohocken, PA19428
Reprinted from theAnnual Book ofASTM Standards. CopyrightASTM
Standard Guide for
Calibration and Testing Laboratory Accreditation Systems
General Requirements for Operation and Recognition
This standard is issued under the fixed designation E994; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope ciency Testing Programs
2.2 ISO Standards:
1.1 This guide covers the general requirements for the
ISO/IEC Guide 2, General Terms and Their Definitions
operation of a system for accreditation of calibration and
Concerning Standardization and Related Activities
testing laboratories so that the accreditation granted and the
ISO/IEC Guide25, General Requirements for the Compe-
services covered by the accreditations may be recognized at a
tence of Calibration and Testing Laboratories
national or an international level and the body operating the
ISO/IEC Guide43, Development and Operation of Labora-
accreditation system may be recognized at a national or
tory Proficiency Testing
international level as competent and reliable.
ISO Standard 10011-1 Guidelines for Auditing Quality
1.2 Usersoftheservicesofanaccreditationbody,otherthan
Systems—Part 1: Auditing
the laboratories accredited by that accreditation body, may
ISO Standard 10011-2 Guidelines for Auditing Quality
require compliance with additional requirements to those
Systems—Part 2: Qualification Criteria for Quality Sys-
specified in this guide.
tems Auditors
1.3 The object of this guide is to provide guidance for the
ISO Standard 10011-3 Guidelines for Auditing Quality
set-up and operation of an accreditation body and to facilitate
Systems—Part 3: Management of Audit Programmes
agreement on mutual recognition of accreditation of laborato-
ries between such bodies.
3. Terminology
NOTE 1—It is recognized that agreements on mutual recognition of
3.1 Definitions:
accreditation aiming at the removal of barriers to across-border trade may
3.1.1 TherelevantdefinitionscontainedinISO/IECGuide2
have to cover other aspects not explicitly specified in these general
and Terminology E1187 are applicable. In addition, the
requirements,suchasproficiencytestingorotherinterlaboratorycompari-
following descriptions of terms apply for the purpose of this
sons, exchange of staff or training programs. In particular, with a view to
guide:
create confidence and harmonize the interpretation and implementation of
standards, each accreditation body should encourage technical coopera- 3.2 Definitions of Terms Specific to This Standard:
tion and exchange of experience among laboratories accredited by it, and
3.2.1 accreditation—procedure by which an authoritative
itshouldbepreparedtoexchangeinformationonaccreditationprocedures
body gives formal recognition that a body or person is
and practices with other accreditation bodies.
competent to carry out specific tasks.
1.4 This standard does not purport to address all of the
3.2.2 client—an organization or person that engages the
safety concerns, if any, associated with its use. It is the
services of a calibration or testing laboratory.
responsiblity of the user of this standard to establish appropri-
3.2.3 laboratory—body that calibrates or tests, or both.
ate safety and health practices and determine the applicability
4. Significance and Use
of regulatory limitations prior to use.
4.1 The object of this guide is to provide guidance for the
2. Referenced Documents
set-up and operation of an accreditation body and to facilitate
2.1 ASTM Standards:
agreements on mutual recognition of accreditation of labora-
E548 Guide for Generic Criteria Used for Evaluating
tories between such bodies.
Laboratory Competence
5. Accreditation Body
E1187 Terminology Related to Laboratory Accreditation
E1301 Guide for Development and Operation of Profi-
5.1 General Provisions:
5.1.1 The procedures under which the accreditation body
operatesshallbeadministeredinanon-discriminatorymanner.
This guide is under the jurisdiction of ASTM Committee E-36 on Laboratory
Access to an accreditation system operated by an accreditation
and InspectionAgency Evaluation andAccreditation and is the direct responsibility
of Subcommittee E36.10 on Generic Criteria.
Current edition approved Jan. 15, 1995. Published March 1995. Originally
published as E994–84. Last previous edition E994–84 (1990). Available from American National Standards Institute, 11 W. 42nd St., 13th
Annual Book of ASTM Standards, Vol 14.02. Floor, New York, NY 10036.
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E994
body shall not be conditional upon membership of any asso-
5.2.1.10 Establish one or more technical committees, each
ciation or group, nor shall there be undue financial conditions responsible, within its scope, for advising the accreditation
to restrict participation. body on the technical matters relating to the operation of its
5.1.2 The competence of an applicant laboratory shall be accreditation system. Criteria for these committees should be
defined to ensure that adequate expertise and diversity of
assessed by the accreditation body against all of the require-
ments outlined in Guide E548. experience is considered. Public hearings may be necessary to
ensure fair representation.
5.1.3 The requirements of Guide E548 may have to be
5.2.1.11 Not offer consultancies or other services that may
interpreted for a specific calibration, test or type of calibration
or test by the accreditation body.These interpretations shall be compromise the objectivity of its accreditation process and
decisions; and
formulated by relevant and impartial committees or persons
possessing the necessary technical competence. They shall be 5.2.1.12 Have arrangements that are consistent with appli-
published by the accreditation body. cable laws to safeguard, at all levels of its organization
(including committees), confidentiality of the information ob-
5.1.4 The accreditation body shall require accredited labo-
ratories to maintain impartiality, independence, and integrity. tainedrelatingtoapplications,assessment,andaccreditationof
laboratories.
5.1.5 The accreditation body shall confine its requirements,
5.2.2 The accreditation body shall have arrangements for
assessment, and decision on accreditation to those matters
specifically related to the scope of the accreditation being either controlling the ownership, use, and display of the
accreditation documents or controlling the manner in which an
considered.
accreditedlaboratorymayrefertoitsaccreditedstatus,orboth.
5.1.6 Accreditationdoesnot,ofitself,qualifythelaboratory
to approve any particular product. However, accreditation may 5.3 Quality System:
be relevant to approval and certification authorities when they 5.3.1 The accreditation body shall operate a quality system
decide whether or not to accept data produced by a given appropriate to the type, range, and volume of work performed.
laboratory in connection with their own activities. Thisprogramshallbedocumentedandthedocumentationshall
be available for use by the accreditation body staff. The
5.2 Organization of the Accreditation Body:
accreditation body shall designate a person having direct
5.2.1 The accreditation body shall:
access to its highest executive level to take responsibility for
5.2.1.1 Be a legally identifiable, public or private entity;
the quality system and the maintenance of the quality docu-
5.2.1.2 Have rights and responsibilities relevant to its ac-
mentation.
creditation activities;
5.3.2 The quality system shall be documented in a quality
5.2.1.3 Have adequate arrangements to cover liabilities
manual and associated quality procedures, and the quality
arising from its operations or activities, or both;
manual shall contain or refer to at least the following:
5.2.1.4 Have the financial stability and resources required
5.3.2.1 A quality policy statement;
for the operation of an accreditation system;
5.3.2.2 The organizational structure of the accreditation
5.2.1.5 Employ a sufficient number of personnel having the
body;
necessary education, training, technical knowledge, and expe-
5.3.2.3 The operational and functional duties and services
rience for the type, range, and volume of work performed
pertaining to quality, so that each person concerned will know
underaseniorexecutivewhoisresponsibletotheorganization,
the extent and the limits of their responsibility;
body, or board to which it reports;
5.3.2.4 Administrative procedures, including documenta-
5.2.1.6 Have a quality system including an organizational
tion control;
structure that enables it to give confidence in its ability to
5.3.2.5 Policies and procedures to implement the accredita-
operate a laboratory accreditation system satisfactorily;
tion process;
5.2.1.7 Have documented policies and procedures for the
5.3.2.6 Arrangements for feedback and corrective actions
operation of the quality system that include policies and
whenever discrepancies are detected;
decision-making procedures that distinguish between labora-
5.3.2.7 The policy and procedure for dealing with appeals,
tory accreditation and other activities in which the body is
complaints, and disputes;
engaged; and policies and procedures for the resolution of
complaints and appeals received from laboratories about the 5.3.2.8 The policy and procedures for conducting internal
audits;
handling of accreditation matters, or from users of services
about accredited laboratories or any other matters; 5.3.2.9 The policy and procedures for conducting quality
5.2.1.8 Together with its senior executive and staff, be free system reviews; and
from any commercial, financial, or other pressures that might 5.3.2.10 The policy and procedures for recruitment and
influence the results of the accreditation process; training of assessors and monitoring their performance.
5.2.1.9 Haveformalrulesandstructuresfortheappointment
5.3.3 The activities of the accreditation body be audited to
and operation of committees involved in the accreditation verify that they comply with the requirements of the quality
process; such committees shall be free from any commercial, system.The quality system shall also be reviewed to ensure its
financial, or other pressures that might influence decisions or continuedeffectiveness.Auditsandreviewsshallbecarriedout
shall have a structure where members are chosen to provide systematically and periodically and recorded together with
impartiality through a balance of interest where no single details of any corrective action taken. Criteria for the auditing
interest predominates; program and the selection of the auditor(s) should be defined.
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E994
NOTE 2—Guidanceonauditingprogramsandauditorsmaybeobtained
6.1.2 Have a thorough knowledge of the relevant assess-
from ISO10011-1, 10011-2, and 10011-3.
ment method and assessment documents;
6.1.3 Have appropriate technical knowledge of the specific
5.3.4 The accreditation body shall maintain records to
calibrations, tests or types of calibrations or tests for which
demonstrate that accreditation procedures have been effec-
accreditationissoughtand,whererelevant,withtheassociated
tively fulfilled, particularly with respect to application forms,
sampling procedures;
assessment reports, and reports relating to granting, maintain-
6.1.4 Be able to communicate effectively, both in writing
ing, extending, suspending or withdrawing accreditation.
and orally;
These accreditation documents should form part of the record.
6.1.5 Be free of any commercial, financial, or other pres-
5.3.5 The accreditation body shall have a policy and proce-
sures or conflicts of interest that might cause an assessor(s) to
dures for retaining records for a period consistent with its
act in other than an impartial or non-discriminatory manner.
contractual and legal obligations. The accreditation body shall
6.1.6 Not have offered consultancies to laboratories that
have a policy and procedures concerning access to these
might compromise their impartiality in the accreditation pro-
records consistent with 5.2.1 of this guide.
cess and decisions.
5.4 Granting,maintaining,extending,suspending,andwith-
drawing accreditation.
NOTE 3—Guidance on personal attributes of assessors may be obtained
5.4.1 Theaccreditationbodyshallspecifytheconditionsfor
from ISO10011-2, Clause 7.
granting, maintaining, and extending accreditation and the
6.2 Qualification Procedures—The accreditation body shall
conditions under which accreditation may be suspended or
have an adequate procedure for:
withdrawn,partiallyorintotalforallorpartofthelaboratory’s
6.2.1 Qualifying assessors, comprising an assessment of
scope of accreditation.
theircompetenceandtraining,attendanceatoneormoreactual
5.4.2 The accreditation body shall have arrangements to
assessments with a qualified assessor, and
grant,maintain,suspend,orwithdrawaccreditation,increaseor
6.2.2 Monitoring the performance of assessors.
reduce the scope of accreditation or require reassessment, in
6.3 Contracting of Assessors—The accreditation body shall
the event of changes affecting the laboratory’s activity and
require the assessors to sign a contract or other document by
operation, such as changes in personnel or equipment, or if
which they commit themselves to comply with the rules
analysis of a complaint or any other information indicates that
defined by the accreditation body, including those relating to
the laboratory no longer complies with the requirements of the
confidentiality and those relating to independence from com-
accreditation body.
mercial and other interests, and any prior association with
5.4.3 The accreditation body shall have arrangements relat-
laboratories to be assessed.
ing to the transfer of accreditation when the legal status (for
6.4 AssessorRecords—Theaccreditationbodyshallpossess
example, ownership) of the accredited laboratory changes.
and maintain up-to-date records on assessors consisting of:
5.5 Documentation:
6.4.1 Name and address;
5.5.1 The accreditation body shall provide (through publi-
6.4.2 Organization affiliation and position held;
cations, electronic media, or other means), update at adequate
6.4.3 Educational qualification and professional status;
intervals, and make available on request:
6.4.4 Work experience;
5.5.1.1 Information about the authority under which ac-
6.4.5 Traininginqualityassurance,assessment,andcalibra-
creditation s
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