ISO/IEC Guide 25:1990
(Main)General requirements for the competence of calibration and testing laboratories
General requirements for the competence of calibration and testing laboratories
Prescriptions générales concernant la compétence des laboratoires d'étalonnage et d'essais
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Standards Content (Sample)
GUIDE 25
General requirements for the
competence of calibration and
testing laboratories
Third edition 1990
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Page
Contents
iii
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Foreword
1
Introduction .
1
1 Scope .
.... 1
2 References.-.-.-.--.-
3 Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
4 Organization and management . . 3
Quality System, audit and review . . 3
5
6 Personne1 . . 4
7 Accommodation and environment 4
......................................
8 Equipment and reference materials. 4
.....................................
9 Measurement traceability and calibration . 5
10 Calibration and test methods. . . . 5
......................................
11 Handling of calibration and test items . . . 6
...............................
12 Records . . . . 6
13 Certificates and reports . . . 6
...........................................
14 Sub-contracting of calibration or testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
15 Outside support Services and supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
16 Complaints. 7
GI ISO 1990
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International Organization for Standardization
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Printed in Switzerland
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Foreword
ISO (the International Organization for Standardization) and IEC (the International
Electrotechnical Commission) together form a System for worldwide standardization as
a whole. National bodies that are members of ISO or IEC participate in the develop-
ment of International Standards through technical committees established by the
respective organization to deal with particular fields of technical activity. ISO and IEC
technical committees collaborate in fields of mutual interest. Other international
organizations, governmental and non-governmental, in liaison with ISO and IEC, also
take part in the work.
This third edition of ISO/IEC Guide 25 was drawn up by the ISO Council Committee on
conformity assessment (CASCO), in response to a request arising from ILAC ‘88, the
International Laboratory Accreditation Conference held in Auckland (New Zealand) on
17-21 October 1988.
lt was approved by the IEC Council in October 1990 and by the ISO Council in
December 1990.
The documents produced by CASCO are issued as Guides and follow the general rules
for development and promulgation of ISO and IEC Standards except that they are the
result of a consensus reached within a Council committee, endorsed by the ISO Coun-
cil and the IEC Council.
The work of ISOKASCO in preparing Guides, uses as a basis the principle that third
Party certification Systems should, to the extent possible, be based on internationally
agreed Standards and procedures. While recognizing the major role of manufacturers’
declaration of conformity through normal manufacturer/customer relationship, Coun-
cil resolutions have emphasized the preparation of guidance documents on third Party
conformity assessment procedures in Order that national Systems may be compatible
with one another so as to facilitate bilateral and multilateral agreements.
Whilst these documents are intended to provide guidance, it is hoped that any changes
from the documents made in introducing Systems nationally would be minimal. In
recognizing that some countries may choose to adopt the Guides directly, they are
written to enable this to be done by including words such as “shall” to indicate those
aspects which desirably would be mandatory. The overriding basis that the document
is intended to provide guidance holds good.
. . .
Ill
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ISO/IEC GUIDE 25 : 1990 (El
General requirements for the competence of calibration
and testing laboratories
1.2 Additional requirements and information which have to
Sntroduction
be disclosed for assessing competence or for determining com-
Since ISO/IEC Guide 25 was last revised in 1982 the use of
pliance with other criteria may be specified by the organization
quality Systems in laboratories has greatly increased. Many
or authority granting the recognition (or approval), depending
countries have adopted ISO/IEC Guide 25 as the basis both for
upon the specific Character of the task of the laboratory.
establishing quality Systems in laboratories and for recognizing
their competence, e.g. by accreditation. In recent years there
1.3 This Guide is for use by calibration and testing labora-
have been many developments in the field of quality assurance
tories in the development and implementation of their quality
which have led to new and improved guides and Standards; it
Systems. lt may also be used by accreditation bodies, certifi-
was recognized that there was a need to revise ISO/IEC
cation bodies and others concerned with the competence of
Guide 25 to reflect these changes.
laboratories.
In this revision of the Guide attention is paid to the activities of
both calibration and testing laboratories and account is taken of
other requirements for laboratory competence such as those
2 References
laid down in the OECD Code of Good Laboratory Practice
(GLP) and the ISO 9000 series of quality assurance Standards.
ISO 8402 : 1986, Quality - Vocabulary.
This Guide should provide a mechanism for promoting con-
ISO 9000 : 1987, Quality managemen t and quality assurance
fidence in calibration and testing laboratories that tan show
Standards - Guidelines for selection and use.
that they operate in accordance with its requirements.
ISO 9001 : 1987, Quality Systems - Model for quakt-y
Acceptance of calibration and test results between countries
assurance in design/developmen t, production, instala tion and
will facilitate the removal of non-tariff barriers to trade.
servicing.
The use of this Guide will facilitate cooperation between
ISO 9002 : 1987, Quality Systems - Model for quality
laboratories and other bodies to assist in the exchange of infor-
assurance in produc tion and ins talla tion.
mation and experience, and in the harmonization of Standards
and procedures.
ISO 9003 : 1987, Quality Systems - Model for quality
assurance in final inspection and test.
This Guide is specific to calibration laboratories and testing
laboratories.
ISO 9004 : 1987, Quality management and quality System
elemen ts - Guidelines.
Laboratories meeting the requirements of this Guide comply,
for calibration and testing activities, with the relevant
ISOIIEC Guide 2 : 1986, General terms and their definitions
requirements of the ISO 9000 series of Standards, including
concerning s tandardiza tion and rela ted ac tivities.
those of the model described in ISO 9002 when they are acting
as suppliers producing calibration and test results.
International vocabulary of basic and general terms in
For laboratories engaged in specific fields of testing such as the
metrology (VIM) : 1984, issued by BIPM, IEC, ISO and OIML.
Chemical field (see for example the OECD Code of Good
Laboratory Practice) or the information technology field, the
requirements of this Guide will need amplification and inter-
3 Definitions
pretation, as referred to in clause 4.2 of ISO/IEC Guide 55.
The relevant definitions from ISO/IEC Guide 2, ISO 8402 and
the International vocabulary of basic and general terms in
1 Scope
metrology (VIM) are applicable, the most relevant being quoted
below together with further definitions applicable for the pur-
1.1 This Guide sets out the general requirements in accord-
poses of this Guide.
ante 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. 3.1 laboratory: Body that calibrates and/or tests.
1
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ISO/IEC GUIDE 25 : 1990 (EI
NO-T-ES NOTE - In connection with the management of measuring equip-
ment, verification provides a means for checking that the deviations
1 In cases where a laboratory forms part of an organization that car- between values indicated by a measuring instrument and correspond-
ing known values of a measured quantity are consistently smaller than
ries out other activities besides calibration and testing, the term
the maximum allowable error defined in a Standard, regulation or
“laboratory” refers only to those Parts of that organization that are in-
specification peculiar to the management of the measuring equipment.
volved in the calibration and testing process.
2 As used herein, the term “laboratory” refers to a body that carries
The result of verification leads to a decision either to restore to Service,
out calibration or testing
or to perform adjustments, or to repair, or to downgrade, or to declare
obsolete. In all cases it is required that a written trace of the verification
-
at or from a permanent location,
performed be kept on the measuring instrument ’s individual record.
-
at or from a temporary facility, or
-
in or from a mobile facility.
3.9 quality System : The organizational structure, responsi-
bilities, procedures, processes and resources for implementing
quality management.
3.2 testing laboratory: Laboratory that performs tests.
[ISO 8402 - 3 8 without the notes]
- ,
[ISO/IEC Guide 2 - 12.41
3.10 quality manual: A document stating the quality policy,
3.3 calibration laboratory: Laboratory that performs
quality System and quality practices of an organization.
calibration.
NOTE - The quality manual may call up other documentation relating
to the laboratory ’s quality arrangements.
3.4 calibration : The set of operations which establish,
under specified conditions, the relationship between values in-
dicated by a measuring instrument or measuring System, or
3.11 reference Standard: A Standard, generally of the
values represented by a material measure, and the correspond-
highest metrological quality available at a given Iocation, from
ing known values of a measurand.
which measurements made at that location are derived.
NOTES
[VIM - 6.081
1 The result of a calibration permits the estimation of errors of indi-
cation of the measuring instrument, measuring System or material
3.12 reference material: A material or substance one or
measure, or the assignment of values to marks on arbitrary scales.
more properties of which are sufficiently well established to be
2 A calibration may also determine other metrological properties.
used for the calibration of an apparatus, the assessment of a
measurement method, or for assigning values to materials.
3 The result of a calibration may be recorded in a document,
sometimes called a calibration certificate or a calibration report.
[ISO Guide 30 - 2.11
4 The result of a calibration is sometimes expressed as a calibration
factor, or as a series of calibration factors in the form of a calibration
curve.
3.13 certified reference material (CRM): A reference
material one or more of whose property values are certified by a
[VIM - 6.131
technically valid procedure, accompanied by or traceable to a
certificate or other documentation which is issued by a certify-
ing body.
3.5 test: A technical Operation that consists of the deter-
mination of one or more characteristics or performante of a
[ISO Guide 30 - 2.21
given product, material, equipment, organism, physical
phenomenon, process or Service according to a specified pro-
cedure.
3.14 traceability: The property of a result of a measurement
whereby it tan be related to appropriate Standards, generally
NOTE - The result of a test is normally recorded in a document
international or national Standards, through an unbroken chain
sometimes called a test report or a test certificate.
of comparisons.
[ISO/IEC Guide 2 - 12.1, amended]
[VIM - 6.121
3.6 calibration method : Defined technical procedure for
[A note given in the VIM to this definition applies to the French
performing a calibration.
text only.]
test method: Defined technical procedure for perform-
3.7
3.15 proficiency testing : Determination of the Iaboratory
ing a test.
calibration or testing Performance by means of interlaboratory
comparisons.
verification : Confirmation by examination and Provision
3.8
of evidente that specified requirements have been met. IISO/IEC Guide 2 - 12.6, amendedl
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ISO/IEC GUIDE 25 : 1990 (El
3.16 requirement: A translation of the needs into a set of shall define and document its policies and objectives for, and its
individual quantified or descriptive specifications for the commitment to, good laboratory practice and quality of cali-
characteristics of an entity in Order to enable its realization and bration or testing Services. The laboratory management shall
ensure that these policies and objectives are documented in a
examination.
quality manual and communicated to, understood, and im-
plemented by all laboratory personnel concerned. The quality
manual shall be maintained current under the responsibility of
the quality manager.
4 Organkation and management
4.1 The laboratory shall be legally identifiable. It shall be
5.2 The quality manual, and related quality documentation,
organized and shall operate in such a way that its permanent,
shall state the laboratory ’s policies and operational procedures
temporary and mobile facilities meet the requirements of this
established in Order to meet the requirements of this Guide. the
Guide.
quality manual and related quality documentation shall also
contain
4.2 The laboratory shall
a) a quality policy Statement, including objectives and
a) have managerial staff with the authority and resources
commitments, by top management;
needed to discharge their duties;
b) the organization and management structure of the
b) have arrangements to ensure that its personnel are free
laboratory, its place in any parent organization and relevant
from any commercial, financial and other pressures which
organizational Charts;
might adversely affect the quality of their work;
c) the relations between management, technical oper-
c) be organized in such a way that confidence in its
ations, support Services and the quality System;
independence of judgement and integrity is maintained at all
times;
d) procedures for control and maintenance of documen-
d) specify and document the responsibility, authority and tation;
interrelation of all personnel who manage, perform or verify
e) job descriptions of key staff and reference to the job
work affecting the quality of calibrations and tests;
descriptions of other staff;
e) provide Supervision by persons familiar with the cali-
bration or test methods and procedures, the objective of the f) identification of the laboratory ’s approved signatories
calibration or test and the assessment of the results. The (where this concept is appropriate);
ratio of supervisory to non-supervisory personnel shall be
g) the laboratory ’s procedures for achieving traceability of
such as to ensure adequate Supervision;
measurements;
f) have a technical manager (however named) who has
Overall responsibility for the technical operations;
h) the laboratory ’s scope of calibrations and/or tests;
g) have a quality manager (however named) who has
i) arrangements for ensuring that the laboratory reviews all
responsibility for the quality System and its implementation.
new work to ensure that it has the appropriate facilities and
The quality manager shall have direct access to the highest
resources before commencing such work;
on
level of management at which decisions are taken
laboratory policy or resources, and to the technical j) reference to the calibration, verification and/or test pro-
manager. In some laboratories, the quality manager may cedures used;
also be the technical manager or deputy technical manager;
k) procedures for handling calibration and test items;
h) nominate deputies in case of absence of the technical
or quality manager; 1) reference to the major equipment and reference
measurement Standards used;
i) where relevant, have documented policy and pro-
cedures to ensure the protection of clients’ confidential m) reference to procedures for calibration, verification and
information and proprietary rights;
maintenance of equipment;
j) where appropriate, participate in interlaboratory com-
n) reference to verification practices including inter-
parisons and proficiency testing Programmes.
laboratory comparisons, proficiency testing Programmes,
use of reference materials and internal quality control
schemes;
o) procedures to be followed for feedback and corrective
5 Quality System, audit and review
action whenever testing discrepancies are detected, or
departures from documented policies and procedures
5.1 The laboratory shall establish and maintain a quality
occu r;
System appropriate to the type, range and volume of calibration
and testing activities it undertakes. The elements of this System p) the laboratory management arrangements for excep-
shall be documented. The quality documentation shall be
tionally permitting departures from documented policies
available for use by the laboratory personnel. The laboratory and procedures or from Standard specifications;
3
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ISO/IEC GUIDE 25 : 1990 (El
7 Accommodation and environment
q) procedures for dealing with complaints;
procedures for protecting confidentiality and proprietary
r)
Laboratory accommodation, calibration and test areas,
7.1
rights;
energy sources, lighting, heating and Ventilation shall be such
as to facilitate proper Performance of calibrations or tests.
s) procedures for audit and review.
7.2 The environment in which these activities are undertaken
shall not invalidate the results or adversely affect the required
5.3 The laboratory shall arrange for audits of its activities at
accuracy of measurement. Particular care shall be taken when
appropriate intervals to verify that its operations continue to
such activities are undertaken at sites other than the permanent
comply with the requirements of the quality System. Such
laboratory premises.
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 cas
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