hb 18.61-1996 guidelines for third-party certification and accreditation guide 61 - general...

7/31/2019 HB 18.61-1996 Guidelines for Third-party Certification and Accreditation Guide 61 - General Requirements For

1/10

SAA/SNZ HB18.61:1996

ISO/IEC Guide 61:1996

Guidelines for third-party

certification and accreditation

Guide 61General

requirements forassessment andaccreditation ofcertification/

registration bodies


2/10


This Joint Australian/New Zealand Handbook was prepared by Joint TechnicalCommittee QR/10, Conformity Assessment. It was published on 5 November 1996.

The following interests are represented on Committee QR/10:

Australian Chamber of ManufacturesAustralian Quarantine and Inspection ServiceDepartment of Industry, Science a nd Tourism (Commonwealth of Australia)Joint Accreditation System of Australia and New ZealandMinistry of Commerce, New ZealandMinistry of Defence, New ZealandQueensland Government Quality Assessment UnitTelstra CorporationThird-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 theissue of amendments or new editions as necessary. It is important therefore thatStandards users ensure that they are in possession of the latest edition, and anyamendments thereto.

Full details of all Joint Standards and related publications will be found in the StandardsAustralia and Standards New Zealand Catalogue of Publications; this information issupplemented each month by the magazines The Australian Standard and StandardsNew 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publications, new editions and amendments, and of withdrawn Standards.Suggestions for improvements to Joint Standards, addressed to the head office of eitherStandards Australia or Standards New Zealand, are welcomed. Notification of anyinaccuracy or ambiguity found in a Joint Australian/New Zealand Standard should bemade without delay in order that the matter may be investigated and appropriate actiontaken.


3/10


ISO/IEC Guide 61:1996

Guidelines for third-party

certification and accreditation

Guide 61Generalrequirements forassessment andaccreditation ofcertification/

registration bodies

PUBLISHED JOINTLY BY:

STANDARDS AUSTRALIA1 The Crescent,Homebush NSW 2140 Australia

STANDARDS NEW ZEALANDLevel 10, Standards House,155 The T errace,Wellington 6001 New Zealand

ISBN 0 7337 0745 9


4/10

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 separatepublications, each of which is identical with the corresponding guide published either jointlyby the International Organization for Standardization (ISO) and the InternationalElectrotechnical Commission (IEC) or solely by ISO.

The information contained in the various guides making up this Handbook is intended toassist organizations in understanding the basis of product certification and third-partycertification systems and how the various b odies operating such schemes should function.Coverage is given to guidance on the establishment and operation of laboratory accreditationbodies 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 guideis relevant to the Joint Accreditation SystemAustralia and New Zealand (JAS-ANZ) and toother organizations concerned with the recognition of competence. Reference should also bemade to the quality management and quality assurance Standards which are published jointlyin Australia and New Zealand as the AS/NZS ISO 9000 series.

The other guides covered in this Handbook are as follows:

Guide 2 : General terms and their definitions concerning standardization and relatedactivities

Guide 7 : Guidelines for drafting of Standards suitable for use for conformity assessmentGuide 16: Code of principles on third-party certification systems and related StandardsGuide 22: Information on manufacturers declaration of conformity with Standards or other

technical specificationsGuide 23: Methods of indicating conformity with Standards for third-party certification

systemsGuide 25: General requirements for the competence of calibration and testing la boratoriesGuide 27: 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 whichbear the mark of the certification body being found to subject persons or propertyto risk

Guide 28: General rules for a model third-party certification system for pr oductsGuide 39: General requirements for the acceptance of inspection bodiesGuide 40: General requireme nts for the acceptance of certification bodiesGuide 42: Guidelines for a step-by-step approach to an international certification systemGuide 43: Development and operation of laboratory proficiency testing

Guide 44: General rules for ISO or IEC international third-party certification schemes forproducts

Guide 53: An approach to the utilization of a suppliers quality system in third-party productcertification

Guide 55: Testing laboratory accreditation systemsGeneral recommendations foroperation

Guide 56: An approach to the review by a certification body of its own internal qualitysystem

Guide 57: Guidelines for the presentation of inspection resultsGuide 58: Calibration and testing laboratory accreditation systems General requirements

for operation and recognitionGuide 60: Code of good practice for conformity assessmentGuide 62: General requirements for bodies operating assessment and certification/

registration of quality systems


5/10

iii

CONTENTS

Page

Section 1: General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

1.1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

1.2 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

1.3 Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Section 2: Requirements for accreditation bodies . . . . . . . . . . . . . . . . . . . . . . 3

2.1 Accreditation body . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

2.1.1 General provisions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

2.1.2 Organization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

2.1.3 Subcontracting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

2.1.4 Quality system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

2.1.5 Conditions for granting, maintaining, extending, reducing,

suspending and withdrawing accreditation . . . . . . . . . . . . . . . . . . . . . 5

2.1.6 Internal audits and management reviews . . . . . . . . . . . . . . . . . . . . . . 5

2.1.7 Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

2.1.8 Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

2.1.9 Confidentiality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

2.2 Accreditation body personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

2.2.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

2.2.2 Qualification criteria for auditors and technical experts . . . . . . . . . . . 6

2.2.3 Selection procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

2.2.4 Contracting of assessment personnel . . . . . . . . . . . . . . . . . . . . . . . . . 7

2.2.5 Assessment personnel records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

2.2.6 Procedures for assessment teams . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

2.3 Decision on accreditation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

2.4 References to accredited status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

2.5 Change in the accreditation requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

2.6 Appeals, complaints and disputes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

2.7 Access to records of appeals, complaints and disputes . . . . . . . . . . . . . . . . . 8


6/10

iv

Section 3: Requirements for assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

3.1 Application for accreditation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

3.1.1 Information on the procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

3.1.2 The application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

3.2 Preparation for assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

3.3 Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

3.4 Assessment report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

3.5 Surveillance and reassessment procedures . . . . . . . . . . . . . . . . . . . . . . . . . . 10

First published 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 byStandards Australia or Standards New Zealand may be reproduced, stored in a retrieval system in any form or transmitted by any meanswithout prior permission in writing from Standards Australia or Standards New Zealand. Permission may be conditional on anappropriate royalty payment. Australian requests for permission and information on commercial software royalties should be directed tothe 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 theStandard 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 programsare 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 Standardis 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 commercialcontracts is subject to the payment of a royalty. This policy may be varied by Standards Australia or Standards New Zealand at any time.


7/10

Introduction

The requirements contained in this G uide are written, above all, to beconsidered as general requirements for bodies operating accreditationsystems. This Guide, however, is in three sections 50 that If used byorganizations other than accreditation bodies concerned with recognitionof competence, Sections 1 and 3 apply, and users need simply replaceaccreditation by recognition.


8/10

Foreword

ISO (the International Organization for Standardization) and IEC (theInternational Electrotechnical Commission) form the specialized system

for worldwide standardization. National bodies that are members of ISOor IE C participate in the development of International Standards throughtechnical committees established by the respective organization to dealwith particular fields of technical activity. ISO and IEC technicalcommittees collaborate in fields of mutual interest. Other internationalorganizations, governmental and non-governmental, in liaison with ISOand IEC, also take part in the work.

Draft Guides adopted by the responsible Committee or Group arecirculated to national bodies for voting. Publication as a Guide requiresapproval by at least 75 % of t he national bodies casting a vote.

ISO/IEC Guide 61 was prepared by the Committee on ConformityAssessment (CASCO).


9/10

1

Guidelines for third-party certification and accreditation

Guide 61General requirements for assessment and accreditationof certification/registration bodies

Section 1: General

1.1 Scope

This Guide specifies g eneral requirements for a bodyto follow if it is to be recognized at a national orinternational level as competent and reliable inassessing and subsequently accrediting certificationbodies or registration bodies. Conformity to therequirements of this Guide will promote equivalenceof national systems and facilitate agreements onmutual recognition of accreditations between suchbodies.

The primary objective of this Guide is to describeaccreditation as providing, by m eans of assessmentand subsequent surveillance, an assurance that the

market can rely on certi ficates issued by theaccredited bodies. However, organizations other thanaccreditation bodies, concerned with recognition ofcomp etence, ma y also use it by r eplacingaccreditation by recognition.

In some countries, bodies which verify conformity ofproducts, processes, services or systems to specifiedstandards are called certification bodies, in othercountries registration bodies, and in still othersassessment bodies. For ease of understanding, thisGuide always refers to such bodies as bodies. Thisshould not be understood to be limiting, as this Guidemay also be applicable to the assessment and

accreditation of conformity assessment bodies otherthan certification or registration bodies, such asinspection bodies.

NOTE 1 It is recognized that agreements on mutualrecognition of accreditations aiming at the removal of barriersto cross-border trade may have to cover other aspects notexplicitly specified in these general requirements, such as

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

the exchange of staff or tr aining programmes. In particular,

with a view to create confidence and harmonize theinterpretation and implementation of standards, each

accreditation body should encourage technical cooperation

and exchange of experience among bodies accredited by it,and it should be prepared to exchange information on

acc re d it at i on pro ce du res an d pra ct i ce s wi t h o t he r

accreditation bodies. Certi fication and certification/

registration body standards often contain non-specificrequirements such as staff shall be competent. Mutual

recognition of accreditation requires harmonization of

interpretation of such clauses.

1.2 References

ISO/IEC Guide 2:1996, General terms and theirdefinitions 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 eventof misuse of its mark of conformity.

ISO/IEC G uide 28:1982, General rules for a model

third-party c ertification system for products.

ISO/IEC Guide 40:1)

, General requirements for

bodies operating product certification systems.

COPYRIGHT


10/10

This is a free preview. Purchase the entire publication at the link below:

Looking for additional Standards? Visit SAI Global Infostore

Subscribe to ourFree Newsletters about Australian Standards in Legislation; ISO, IEC, BSI and more

Do you need to Manage Standards Collections Online?

Learn about LexConnect, All Jurisdictions, Standards referenced in Australian legislation

Do you want to know when a Standard has changed?

Want to become an SAI Global Standards Sales Affiliate?

Learn about other SAI Global Services:

LOGICOM Military Parts and Supplier DatabaseMetals Infobase Database of Metal Grades, Standards and Manufacturers

Materials Infobase Database of Materials, Standards and Suppliers

Database of European Law, CELEX and Court Decisions

Need to speak with a Customer Service Representative - Contact Us

HB 18.61:1996, Guidelines for third-partycertification and accreditation Guide 61 - Generalrequirements for assessment and accreditation ofcertification/registration bodies
http://infostore.saiglobal.com/store?utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSiteshttp://www.saiglobal.com/Information/Standards/Newsletters/?utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSiteshttp://www.saiglobal.com/Information/Standards/Collections/?utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSiteshttp://www.saiglobal.com/Information/Standards/Law/?utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSiteshttp://www.saiglobal.com/Information/Standards/StandardsWatch/?utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSiteshttp://www.saiglobal.com/Information/Standards/Affiliate/?utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSiteshttp://www.saiglobal.com/Information/Standards/Databases/LOGICOM/?utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSiteshttp://www.saiglobal.com/Information/Standards/Databases/LOGICOM/?utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSiteshttp://www.saiglobal.com/Information/Standards/Databases/Metals/?utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSiteshttp://www.saiglobal.com/Information/Standards/Databases/Materials/?utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSiteshttp://www.saiglobal.com/Information/Standards/Databases/European-Law/?utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSiteshttp://infostore.saiglobal.com/store/getpage.aspx?path=/InformationServices/shop/pages/ContactingUs.htm&utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSiteshttp://infostore.saiglobal.com/store/Details.aspx?ProductId=568773&utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSiteshttp://infostore.saiglobal.com/store/getpage.aspx?path=/InformationServices/shop/pages/ContactingUs.htm&utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSiteshttp://www.saiglobal.com/Information/Standards/Databases/European-Law/?utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSiteshttp://www.saiglobal.com/Information/Standards/Databases/Materials/?utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSiteshttp://www.saiglobal.com/Information/Standards/Databases/Metals/?utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSiteshttp://www.saiglobal.com/Information/Standards/Databases/LOGICOM/?utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSiteshttp://www.saiglobal.com/Information/Standards/Affiliate/?utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSiteshttp://www.saiglobal.com/Information/Standards/StandardsWatch/?utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSiteshttp://www.saiglobal.com/Information/Standards/Law/?utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSiteshttp://www.saiglobal.com/Information/Standards/Collections/?utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSiteshttp://www.saiglobal.com/Information/Standards/Newsletters/?utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSiteshttp://infostore.saiglobal.com/store?utm_source=PDF&utm_medium=Website_Infostore&utm_campaign=DocSharingSites

hb 18.61-1996 guidelines for third-party certification and accreditation guide 61 - general...

Documents