RESTRICTEDWORLD TRADE
ORGANIZATIONG/TBT/W/72
24 June 1998
(98-2549)
Committee on Technical Barriers to Trade Original:  English
A LIST OF RELEVANT INTERNATIONAL GUIDES AND RECOMMENDATIONS
RELATED TO CONFORMITY ASSESSMENT PROCEDURES
Note by the Secretariat
At the First Triennial Review of the Agreement on Technical Barriers to Trade, the
Committee agreed that for transparency purposes and to support the work of the Committee, a list of
relevant international guides and recommendations related to conformity assessment procedures will
be consolidated, circulated and updated regularly by the Secretariat for the information of Members(G/TBT/5, para. 29 (b)).
This paper contains information provided by the ISO/CASCO on a list of ISO/IEC Guides
related to conformity assessment procedures by field of application, and a short description of the
Guides.G/TBT/W/72
Page 2
LIST OF CASCO GUIDES BY FIELD OF APPLICATION
GENERAL ISO/IEC Guide 60:1994 Code of good practice for conformity assessment
ISO/IEC Guide 7:1994 Guidelines for drafting of standards suitable for use
for conformity assessment
ISO/IEC Guide 2:1996
Sections 12 - 17 *Standardization and related activities - General
vocabulary   (NOT A CASCO GUIDE)
SUPPLIER'SDECLARATIONISO/IEC Guide 22:1996 Information on manufacturer's declaration of
conformity with standards or other technical
specifications
ACCREDITATION ISO/IEC Guide 58:1993 Calibration and testing laboratory accreditation
systems – General requirements for operation and
recognition
ISO/IEC Guide 61:1996 General requirements for assessment and
accreditation of certification/registration bodies
CALIBRATION/
TESTINGISO/IEC Guide 25:1990 **General requirements for the competence of
calibration and testing laboratories
ISO/IEC Guide 43-1:1997
ISO/IEC Guide 43-2:1997Proficiency testing by interlaboratory comparisons –
Part 1: Development and operation of proficiencytesting schemes
Proficiency testing by interlaboratory comparisons –
Part 2: Selection and use of proficiency testing
schemes by laboratory accreditation bodies
INSPECTION ISO/IEC Guide 39:1988 ***General requirements for the acceptance of
inspection bodies
ISO/IEC Guide 57:1991 ***Guidelines for the presentation of inspection results
PRODUCTCERTIFICATIONISO/IEC Guide 65:1996 General requirements for bodies operating product
certification systems
ISO/IEC Guide 23:1982 Methods of indicating conformity with standards for
third-party certification systems
(cont'd)
                                                     
*  Conformity assessment part of ISO/IEC Guide 2:1996 is under revision as ISO/IEC Standard  17000.
** ISO/IEC Guide 25:1990 is under revision as ISO/IEC Standard 17025.
*** ISO/IEC Guide 39:1988 and Guide 57:1991 are under revision as ISO/IEC Standard 17020.G/TBT/W/72
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ISO/IEC Guide 28:1982 General rules for a model third-party certification
system for products
ISO/IEC Guide 53:1988 An approach to the utilization of a supplier's quality
system in third party product certification
ISO Guide 27:1983 Guidelines for corrective action to be taken by a
certification body in the event of misuse of its mark
of conformity
ISO/IEC Guide 56:1989 An approach to the review by a certification body of
its own internal quality system
(QUALITYSYSTEM
CERTIFICATIONISO/IEC Guide 62:1996 General requirements for bodies operating
assessment and certification/registration of quality
systems
INTERNATIONALCERTIFICATIONISO/IEC Guide 42:1984 Guidelines for a step-by-step approach to an
international certification system
ISO/IEC Guide 44:1985 General rules for ISO or IEC international third-
party certification schemes for productsG/TBT/W/72
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SHORT DESCRIPTION OF CASCO GUIDES
ISO/IEC Guide 7:1994
Guidelines for drafting of standards
suitable for use for conformity assessmentThis Guide sets out guidelines to assist technical
committees in drafting standards suitable for use for
conformity assessment of products.
The guidelines contained herein may also be used as
appropriate for the drafting of standards intended for
conformity assessment of processes and services.
ISO/IEC Guide 22:1996
General criteria for supplier's
declaration of conformityThis Guide specifies general criteria for a supplier's
declaration of conformity in cases where it is desirable,or necessary, that conformity of a product, process or
service to normative documents be indicated,
irrespective of the sector involved. The supplier may
then declare under his/her responsibility the conformity
to normative documents.
ISO/IEC Guide 23:1982
Methods of indicating conformity with standards
for third-party certification systemsThis Guide lays down methods of indicating conformity
with standards and reference thereto in standards.
Whilst it is directed specifically to conformity withstandards, it is recognized that it may be equally
applicable to conformity with other technical
specifications. It applies to indications of conformity
made under the authority of a certification body. This
Guide is primarily intended for International Standardsbut may be used for national standards or other
purposes.
ISO/IEC Guide 25:1990
General requirements for the competence
of calibration and testing laboratoriesThis Guide 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
Additional requirements and information which have to
be disclosed for assessing competence or for
determining compliance with other criteria may be
specified by the organization or authority granting therecognition (or approval), depending upon the specific
character of the task of the laboratory.
This Guide is for use by calibration and testing
laboratories in the development and implementation of
their quality systems. It may also be used byaccreditation bodies, certification bodies and others
concerned with the competence of laboratories.G/TBT/W/72
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ISO Guide 27:1983
Guidelines for corrective action to be
taken by a certification body in the event of
misuse of its mark of conformityThe purpose of this paper is to identify a series of
procedures which a national certification body (non-
governmental) should consider in deciding how to
respond to:
(a) a reported misuse of its registered mark of 
conformity, or
(b) a situation in which a certified product
is subsequently found to be hazardous.
ISO/IEC Guide 28:1982
General rules for a model third-party
certification system for productsThese model general rules are valid for the following
type of certification system:
A third party certification system of determining
conformity with product standards through initial
testing and assessment of a factory quality management
system and its acceptance followed by surveillance thattakes into account the factory quality management
system and the testing of samples form the factory and
the open market. (System No. 5).
The identification of conformity may be in the form of a
certificate of conformity or a mark of conformity. (SeeISO/IEC Guide 23).
A certification body operating the system at national
level shall as a minimum have a suitable organizational
structure and utilize personnel, equipment, and
operating procedures that comply with the criteria givenin ISO Guide 24 and ISO/IEC Guide 25.
Any certification scheme under the system requires as a
prerequisite a standard that is suitable for certification
purposes.  (See ISO/IEC Guide 7).
ISO/IEC Guide 39:1988
General requirements for the
acceptance of inspection bodiesThis Guide sets out general criteria, the observance of
which is intended to provide that the services of
inspection bodies are conducted with technical
competence, impartiality, confidentiality and
thoroughness, careful observation and accurate
reporting by competent qualified staff, and to serve theneeds of individual users, national government, local
government, certification, accreditation and other
bodies, as they relate to certification and related
activities.
ISO/IEC Guide 42:1984
Guidelines for a step-by-step approach
to an international certification systemThis paper is prepared as a guide to those parties who
wish to gain some experience in the operation of
acceptance arrangements in the international area, but
who may not be prepared currently to participate fully
in an international certification system.G/TBT/W/72
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ISO/IEC Guide 43-1:1997
Proficiency testing by interlaboratory comparisons –
Part 1: Development and operation of
proficiency testing schemesWhile there are a number of uses of inter-laboratory
comparisons, and variations in their design and
implementation, it is still possible to specify the
essential principles that need to be considered whenorganizing such comparisons. This Part of ISO/IEC
Guide 43 defines those principles and describes the
factors which should be taken into account in the
organization and conduct of  proficiency testing
schemes.
This part of ISO/IEC Guide 43 is intended for use by
proficiency testing operators and users such asparticipant laboratories, accreditation bodies, regulatory
authorities and clients of laboratory services who have a
need to assess the technical competence of laboratories.
It is particularly useful for laboratories in self-
evaluation, but recognizes that proficiency testing isonly one mechanism which can contribute to the
establishment of mutual confidence between users of
different testing laboratories.
ISO/IEC Guide 43-2:1997
Proficiency testing by interlaboratory comparisons –
Part 2: Selection and use of proficiency testing
schemes by laboratory accreditation bodiesThe objectives of this part of ISO/IEC Guide 43 are:
(a) to establish principles for the selection of 
proficiency testing schemes for use in 
laboratory accreditation programmes; and
(b) to assist in harmonizing the use of results
of proficiency testing schemes by laboratory 
accreditation bodies.
ISO/IEC Guide 44:1985
General rules for ISO and IEC international
third-party certification schemes for productsThis Guide applies to international certification schemes
for determining conformity with product standards
through initial testing and assessment of a
manufacturer's quality system and its acceptance
followed by surveillance that takes into account the
manufacturer's quality system and the testing of samples
from the factory and the open market. They are operatedin accordance with ISO/IEC Guide 28 and place under
the authority of ISO or IEC. This Guide outlines general
rules which parties interested in establishing an ISO or
IEC certification scheme should use in developing such
schemes.
ISO/IEC Guide 53:1988
An approach to the utilization of a supplier's
quality system in third-party product certificationThis Guide outlines a general approach by which
certification bodies wishing to do so can develop and
apply product certification programmes utilizingelements of suppliers' quality systems.G/TBT/W/72
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ISO/IEC Guide 56:1989
An approach to the review by a certification body
of its own internal quality systemThis Guide provides a framework for use by
a certification body in assessing itself, its procedures,
and its operations. The framework incorporates
requirements and recommendations to be found in allrelevant ISO/IEC reference documents. Using this
framework, a certification body should be able to
compile a documentary record of its internal quality
system review procedure. It will also be possible to
use this documentary record for subsequent
distribution to all parties concerned.
Certification bodies may include other specific
elements and criteria depending on specific needs.
ISO/IEC Guide 57:1991
Guidelines for the presentation of inspection results This Guide sets for the requirements for the
presentation of inspection results and otherinformation of relevance to the understanding of the
procedures followed and the results obtained in
performing inspection functions.
Inspection functions may be identified to cover such
work as assessing, recommending for acceptance andsubsequent audit of suppliers' production and testing
facilities, personnel and quality assurance operations,
and selection and evaluation of products, processes or
services on site or in factories, laboratories or
elsewhere as directed.
This Guide is intended to be used by inspection bodies
or other parties reporting on inspection activities. Its
intent is not to replace other ISO/IEC guidelines such
as those on the accreditation of testing laboratories,
the presentation of test results or the assessment ofquality systems.
ISO/IEC Guide 58:1993
Calibration and testing laboratory accreditation
systems –
General requirements for operation
and recognitionThis document sets out the general requirements for
the operation of a system for accreditation of
calibration and/or testing laboratories so that the
accreditations granted and the services covered by theaccreditations may be recognized at a national or an
international level and the body operating the
accreditation system may be recognized at national or
international level as competent and reliable.
Users of the services of an accreditation body, other
than the laboratories accredited by that accreditation
body, may require compliance with requirements
additional to those specified in this document.G/TBT/W/72
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The object of this document is to provide guidance for
the setting up and operation of an accreditation body
and to facilitate agreements on mutual recognition of
accreditation of laboratories between such bodies.
ISO/IEC Guide 60:1994
ISO/IEC Code of good
practice for conformity assessmentThis Code, which is intended to promote equal rights
of access to conformity assessment services
worldwide, is presented in a form suitable for use by
conformity assessment bodies, whether governmental
or non-governmental, at international, regional,
national or sub-national level.
This Code, which is intended to promote equal rights
of access to conformity assessment services
worldwide, is presented in a form suitable for use by
conformity assessment bodies, whether governmental
or non-governmental, at international, regional,
national or sub-national level.
This Code is intended to be used in conjunction with,
or when preparing, ISO/IEC standards
or guides relating to conformity assessment activities.
Although this Code has been prepared primarily with
third-party conformity assessment in mind, itsprovisions may be used as appropriate for first-party
or second-party activities.
ISO/IEC Guide 61:1996
General requirements for assessment
and accreditation of certification/registration
bodiesThis Guide specifies general requirements for
a body to follow if it is to be recognized at a national
or international level as competent
and reliable in assessing and subsequently accrediting
certification bodies or registration bodies. Conformity
to the requirements of this Guide will promoteequivalence of national systems and facilitate
agreements on mutual recognition of accreditations
between such bodies.
The primary objective of this Guide is to describe
accreditation as providing, by means of assessment
and subsequent surveillance, an assurance that the
market can rely on certificates issued by the accreditedbodies. However, organizations other than accredit-
ation bodies, concerned with recognition of
competence, may also use it by replacing
"accreditation" by "recognition".G/TBT/W/72
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ISO/IEC Guide 62:1996
General requirements for bodies
operating assessment and certification/
registration of quality systemsThis Guide specifies general requirements for a third-
party body operating quality system
certification/registration to meet if it is to be
recognized as competent and reliable in the operation
of quality system certification/registration.
The requirements contained in this Guide
are written, above all, to be considered as general
requirements for any body operating
certification/registration of quality systems.
ISO/IEC Guide 65:1996
General requirements for bodies operating
product certification systemsThis Guide specifies general requirements that a third-
party operating a product certification system shall
meet if it is to be recognized as competent and
reliable.
The certification system used by the certification body
may include one or more of the following, whichcould be coupled with production surveillance or
assessment and surveillance of the supplier's quality
system or both, as described in ISO/IEC Guide 53:
(a) type testing or examination;
(b) testing or inspection of samples taken
from the market or from supplier's stock or
from a combination of both;
(c) testing or inspection of every product or
of a particular product, whether new or 
already in use;
(d) batch testing or inspection;
(e) design appraisal.
ISO/IEC Guide 2:1996
Standardization and related activities –
General vocabulary
(Not CASCO Guide)This Guide provides general terms and definitions
concerning standardization and related activities. It is
intended to contribute fundamentally towards mutual
understanding amongst the members of ISO and IEC
and the various governmental and non-governmental
agencies involved in standardization at inter-national,
regional and national levels. It is intended also to
provide a suitable source for teaching and forreference, briefly covering basic theoretical and
practical principles of standardization, certification
and laboratory accreditation.
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