Standards Australia
1 The Crescent,
Homebush NSW 2140 Australia
PREFACE
This Standard was prepared by the Joint Standards Australia / Standards New Zealand Committee
QR/10, Conformity Assessment. It is identical with, and has been reproduced from, ISO/IEC
Guide 65:1996, which was prepared by the ISO Committee on Conformity Assessment (CASCO).
ISO/IEC Guide 65:1996 was first published and is currently available as a Handbook, SAA/SNZ
HB18.65, i.e. part of the Series HB18, Guidelines for third-party certification and accreditation.
However, Committee QR/10 considers that it should also be available as a Standard, i.e. as a
normative document providing a suitable basis for certification and accreditation procedures.
As this Standard is reproduced from an international Standard, the following applies:
(a) Its number does not appear on each page of text and its identity is shown only on the cover
and title page.
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(b) In the source text ‘this Guide’ should read ‘this Australian/New Zealand Standard’.
(c) A full point substitutes for a comma when referring to a decimal marker.
Reference to International Standards should be replaced by Australian or Joint Australian/
New Zealand Standards as follows:
Reference to International Standard or other Australian or Joint Australian/New Zealand
publication Standard
ISO AS/NZS
8402 Quality management and quality ISO 8402 Quality management and quality
assurance — Vocabulary assurance — Vocabulary
AS
10011 Guidelines for auditing quality 3911 Guidelines for auditing quality
systems systems
10011-1 Part 1: Auditing 3911.1 Part 1: Auditing
ISO/IEC SAA
Guide 2 Standardization and related HB18 Guidelines for third-party
activities — General vocabulary certification and accreditation
HB18.2 Guide 2 — General terms and their
definitions concerning
standardization and related activities
(SANZ HB18.2)
SAA/SNZ
Guide 7 Guidelines for drafting of standards HB18.7 Guide 7 — Guidelines for drafting of
suitable for use for conformity standards suitable for use for
assessment conformity assessment
SAA
Guide 23 Methods of indicating conformity HB18.23 Methods of indicating conformity
with standards for third-party with standards for third-party
certification systems certification systems
(SANZ HB18.23)
Guide 25 General requirements for the HB18.25 Guide 25 — General requirements for
competence of calibration and testing the competence of calibration and
laboratories testing laboratories (SANZ HB18.25)
iii
ISO/IEC SAA
Guide 27 Guidelines for corrective action to be HB18.27 Guide 27 — Guidelines for corrective
taken by a certification body in the action to be taken by a certification
event of misuse of its mark on body in the event of misuse of its
conformity mark of conformity
(SANZ HB18.27)
Guide 28 General rules for a model third-party HB18.28 Guide 28 — General rules for a
certification system for products model third-party certification
system for products (SANZ
HB18.28)
Guide 39 General requirements for the HB18.39 Guide 39 — General requirements for
acceptance of inspection bodies the acceptance of inspection bodies
(SANZ HB18.39)
Guide 53 An approach to the utilization of a HB18.53 Guide 53 — An approach to the
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CONTENTS
Page
1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
2 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
3 Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
4 Certification body . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
4.1 General provisions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
4.2 Organization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
4.3 Operations, . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
4.4 Subcontracting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
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10 Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
11 Evaluation report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
12 Decision on certification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
13 Surveillance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
15 Complaints to suppliers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
v
INTRODUCTION
vi
NOTES
1
1.1 This Guide specifies general requirements ISO/IEC Guide 7:1994, Guidelines for drafting of
This is a free 9 page sample. Access the full version at http://infostore.saiglobal.com.
that a third-party operating a product certification standards suitable for use for conformity
system shall meet if it is to be recognized as assessment.
competent and reliable.
ISO/IEC Guide 23:1982, Methods of indicating
In this Guide the term “certification body” is used conformity with standards for third-party
to cover any body operating a product certification certification systems.
system. The word “product” is used in its widest
sense and includes processes and services; the ISO/IEC Guide 25:1990, General requirements for
word “standard” is used to include other normative the competence of calibration and testing
documents such as specifications or technical laboratories.
regulations.
ISO/IEC Guide 27:1983, Guidelines for corrective
1.2 The certification system used by the action to be taken by a certification body in the
certification body may include one or more of the event of misuse of its mark of conformity.
following, which could be coupled with production
surveillance or assessment and surveillance of the ISO/EC Guide 28:1982, General rules for a model
supplier’s quality system or both, as described in third-party certification system for products.
ISO/IEC Guide 53:
ISO/IEC Guide 39:1988, General requirements for
a) type testing or examination; the acceptance of inspection bodies.
b) testing or inspection of samples taken from ISO/IEC Guide 53:1988, An approach to the
the market or from supplier’s stock or from utilization of a supplier’s quality system in
a combination of both;
third-party product certification.
c) testing or inspection of every product or of a
particular product, whether new or already ISO/IEC Guide 62:1996, General requirements for
in use; bodies operating assessment and certification/
registration of quality systems.
d) batch testing or inspection;
COPYRIGHT
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