SAA/SNZ HB18.

61:1996 ISO/IEC Guide 61:1996

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Guidelines for third-party certification and accreditation

Guide 61 General requirements for assessment and accreditation of certification/ registration bodies

SAA/SNZ HB18.61:1996 This Joint Australian/New Zealand Handbook was prepared by Joint Technical Committee QR/10, Conformity Assessment. It was published on 5 November 1996.

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The following interests are represented on Committee QR/10: Australian Chamber of Manufactures Australian Quarantine and Inspection Service Department of Industry, Science and Tourism (Commonwealth of Australia) Joint Accreditation System of Australia and New Zealand Ministry of Commerce, New Zealand Ministry of Defence, New Zealand Queensland Government Quality Assessment Unit Telstra Corporation Third-party certification bodies (Australia and New Zealand)

Review of Standards. To keep abreast of progress in industry, Joint Australian/ New Zealand Standards are subject to periodic review and are kept up to date by the issue of amendments or new editions as necessary. It is important therefore that Standards users ensure that they are in possession of the latest edition, and any amendments thereto. Full details of all Joint Standards and related publications will be found in the Standards Australia and Standards New Zealand Catalogue of Publications; this information is supplemented each month by the magazines The Australian Standard and Standards New Zealand, which subscribing members receive, and which give details of new publications, new editions and amendments, and of withdrawn Standards. Suggestions for improvements to Joint Standards, addressed to the head office of either Standards Australia or Standards New Zealand, are welcomed. Notification of any inaccuracy or ambiguity found in a Joint Australian/New Zealand Standard should be made without delay in order that the matter may be investigated and appropriate action taken.

SAA/SNZ HB18.61:1996 ISO/IEC Guide 61:1996

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Guidelines for third-party certification and accreditation

Guide 61 General requirements for assessment and accreditation of certification/ registration bodies
PUBLISHED JOINTLY BY: STANDARDS AUSTRALIA 1 The Crescent, Homebush NSW 2140 Australia STANDARDS NEW ZEALAND Level 10, Standards House, 155 The Terrace, Wellington 6001 New Zealand
ISBN 0 7337 0745 9

ii

PREFACE
This Joint Handbook, prepared by the Joint Standards Australia/Standards New Zealand Committee QR/10 on Conformity Assessment, is presented as a series of separate publications, each of which is identical with the corresponding guide published either jointly by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) or solely by ISO. The information contained in the various guides making up this Handbook is intended to assist organizations in understanding the basis of product certification and third-party certification systems and how the various bodies operating such schemes should function. Coverage is given to guidance on the establishment and operation of laboratory accreditation bodies as well as the type of information that such bodies will require of testing laboratories, including those carrying out calibration, when making application for accreditation. This guide is relevant to the Joint Accreditation SystemAustralia and New Zealand (JAS-ANZ) and to other organizations concerned with the recognition of competence. Reference should also be made to the quality management and quality assurance Standards which are published jointly in Australia and New Zealand as the AS/NZS ISO 9000 series. The other guides covered in this Handbook are as follows: Guide 2: Guide 7: Guide 16: Guide 22: Guide 23: Guide 25: Guide 27:

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Guide Guide Guide Guide Guide Guide

28: 39: 40: 42: 43: 44:

Guide 53: Guide 55: Guide 56: Guide 57: Guide 58: Guide 60: Guide 62:

General terms and their definitions concerning standardization and related activities Guidelines for drafting of Standards suitable for use for conformity assessment Code of principles on third-party certification systems and related Standards Information on manufacturers declaration of conformity with Standards or other technical specifications Methods of indicating conformity with Standards for third-party certification systems General requirements for the competence of calibration and testing laboratories Guidelines for corrective action to be taken by a certification body in the event of either misapplication of its mark of conformity to a product, or products which bear the mark of the certification body being found to subject persons or property to risk General rules for a model third-party certification system for products General requirements for the acceptance of inspection bodies General requirements for the acceptance of certification bodies Guidelines for a step-by-step approach to an international certification system Development and operation of laboratory proficiency testing General rules for ISO or IEC international third-party certification schemes for products An approach to the utilization of a supplier s quality system in third-party product certification Testing laboratory accreditation systemsGeneral recommendations for operation An approach to the review by a certification body of its own internal quality system Guidelines for the presentation of inspection results Calibration and testing laboratory accreditation systems General requirements for operation and recognition Code of good practice for conformity assessment General requirements for bodies operating assessment and certification/ registration of quality systems

iii

CONTENTS
Page

Section 1: General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.1 1.2 1.3 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1 1 1 2 3 3 3 3 4 4 5 5 5 6 6 6 6 6 6 7 7 7 7 8 8 8 8

Section 2: Requirements for accreditation bodies . . . . . . . . . . . . . . . . . . . . . .

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2.1

Accreditation body . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.1.1 2.1.2 2.1.3 2.1.4 2.1.5 2.1.6 2.1.7 2.1.8 2.1.9 General provisions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Organization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Subcontracting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Quality system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Conditions for granting, maintaining, extending, reducing, suspending and withdrawing accreditation . . . . . . . . . . . . . . . . . . . . . Internal audits and management reviews . . . . . . . . . . . . . . . . . . . . . . Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Confidentiality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2.2

Accreditation body personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.2.1 2.2.2 2.2.3 2.2.4 2.2.5 2.2.6 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Qualification criteria for auditors and technical experts . . . . . . . . . . . Selection procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Contracting of assessment personnel . . . . . . . . . . . . . . . . . . . . . . . . . Assessment personnel records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Procedures for assessment teams . . . . . . . . . . . . . . . . . . . . . . . . . . .

2.3 2.4 2.5 2.6 2.7

Decision on accreditation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . References to accredited status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Change in the accreditation requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . Appeals, complaints and disputes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Access to records of appeals, complaints and disputes . . . . . . . . . . . . . . . . .

iv

Section 3: Requirements for assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.1 Application for accreditation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.1.1 3.1.2 3.2 3.3 3.4 3.5 Information on the procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

9 9 9 9 9

Preparation for assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Assessment report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Surveillance and reassessment procedures . . . . . . . . . . . . . . . . . . . . . . . . . . 10

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First publi shed as SAA/SNZ HB18.61:1996.

Copyright STANDARDS AUSTRALIA/ STANDARDS NEW ZEALAND Users of Standards are reminded that copyright subsists in all Standards Australia and Standards New Zealand publications and software. Except where the Copyright Act allows and except where provided for below no publications or software produced by Standards Australia or Standards New Zealand may be reproduced, stored in a retrieval system in any form or transmitted by any means without prior permission in writing from Standards Australia or Standards New Zealand. Permission may be conditional on an appropriate royalty payment. Australian requests for permission and information on commercial software royalties should be directed to the head office of Standards Australia. New Zealand requests should be directed to Standards New Zealand. Up to 10 percent of the technical content pages of a Standard may be copied for use exclusively in-house by purchasers of the Standard without payment of a royalty or advice to Standards Australia or Standards New Zealand. Inclusion of copyright material in computer software programs is also permitted without royalty payment provided such programs are used exclusively in-house by the creators of the programs. Care should be taken to ensure that material used is from the current edition of the Standard and that it is updated whenever the Standard is amended or revised. The number and date of the Standard should therefore be clearly identified. The use of material in print form or in computer software programs to be used commercially, with or without payment, or in commercial contracts is subject to the payment of a royalty. This policy may be varied by Standards Australia or Standards New Zealand at any time.

Introduction
The requirements contained in this Guide are written, above all, to be considered as general requirements for bodies operating accreditation systems. This Guide, however, is in three sections 50 that If used by organizations other than accreditation bodies concerned with recognition of competence, Sections 1 and 3 apply, and users need simply replace accreditation by recognition.

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Foreword
ISO (the International Organization for Standardization) and IEC (the International Electrotechnical Commission) form the specialized system for worldwide standardization. National bodies that are members of ISO or IEC participate in the development 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. Draft Guides adopted by the responsible Committee or Group are circulated to national bodies for voting. Publication as a Guide requires approval by at least 75 % of the national bodies casting a vote. ISO/IEC Guide 61 was prepared by the Committee on Conformity Assessment (CA SC O).
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Guidelines for third-party certification and accreditation Guide 61 General requirements for assessment and accreditation of certification/registration bodies
Section 1: General

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1.1 Scope
This 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 promote equivalence 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 accredited bodies. However, organizations other than accreditation bodies, concerned with recognition of competence, may also use it by replacing accreditation by recognition. In some countries, bodies which verify conformity of products, processes, services or systems to specified standards are called certification bodies, in other countries registration bodies, and in still others assessment bodies. For ease of understanding, this Guide always refers to such bodies as bodies. This should not be understood to be limiting, as this Guide may also be applicable to the assessment and accreditation of conformity assessment bodies other than certification or registration bodies, such as inspection bodies.
NOTE 1 It is recognized that agreements on mutual recognition of accreditat ions aiming at the removal of barriers to cross-border trade may have to cover other aspects not explicitly specified in these general requirements, such as

the exchange of staff or tr aining programmes. In particular, with a view to create confidence and harmonize the interpretati on and implementation of standards, each accredit ation body should encourage technical cooperation and exchange of experi ence among bodies accredit ed by it, and it should be prepared to exchange information on accredit ation procedures and practices with other accreditation bodies. Certification and certificati on/ registrati on body standards oft en contain non-specific requir ements such as staff shall be competent . Mutual recognit ion of accreditati on requires harmonization of interpretati on of such clauses.

1.2 References
ISO/IEC Guide 2:1996, General terms and their definitions concerning standardization and related activities. ISO/IEC Guide 25:1990, General requirements for the competence of calibration and testing laboratories. ISO/IEC 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 28:1982, General rules for a model third-party certification system for products. ISO/IEC Guide 40: 1) , General requirements bodies operating product certification systems.

for

1) To be published. (Revision of ISO/I EC Guide 40:1983)

COPYRIGHT

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HB 18.61:1996, Guidelines for third-party certification and accreditation Guide 61 - General requirements for assessment and accreditation of certification/registration bodies

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