DRAFT

ÖVE/ÖNORM

EN ISO/IEC 17011 Edition: 2016-10-01

Conformity assessment ― Requirements for accreditation bodies accrediting conformity assessment bodies (ISO/IEC/DIS 17011:2016)

Konformitätsbewertung ― Anforderungen an Akkreditierungsstellen, die Konformitätsbewertungsstellen akkreditieren (ISO/IEC/DIS 17011:2016) Évaluation de la conformité ― Exigences pour les organismes d'accréditation procédant à l'accréditation d'organismes d'évaluation de la conformité (ISO/IEC/DIS 17011:2016)

Note: Because of possible comments, the final version of this ÖNORM can differ from the present Draft. Please send your comments (in writing) by 2016-11-15 to Austrian Standards Institute. Publisher and printing OVE Austrian Electrotechnical Association Austrian Standards Institute

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Copyright © OVE/Austrian Standards Institute 2016 All rights reserved. No part of this publication may be reproduced or utilized in any form or by any means – electronic, mechanical, photocopying or any other data carrier – without prior permission! Sale and distribution: Austrian Standards Institute Heinestraße 38, 1020 Vienna E-Mail: [email protected] Internet: www.austrian-standards.at Webshop: www.austrian-standards.at/webshop Tel.: +43 1 213 00-300 Fax: +43 1 213 00-818 OVE Austrian Electrotechnical Association Eschenbachgasse 9, 1010 Vienna E-Mai: [email protected] Internet: www.ove.at Webshop: www.ove.at/webshop Tel.: +43 1 587 63 73 Fax: +43 1 587 63 73 - 99

ICS Identical (IDT) with Identical (IDT) with

03.120.20 ISO/IEC/DIS 17011:2016-08 prEN ISO/IEC 17011:2016-08

Supersedes

ÖVE/ÖNORM EN ISO/IEC 17011:2004-12

responsible

Committee 253 Conformity assessment

DRAFT ÖVE/ÖNORM EN ISO/IEC 17011:2016-10

Explanations concerning Draft The present Draft European Standard EN ISO/IEC 17011 has been submitted to CEN members for voting. In case of a positive result of the voting as required by CEN/CENELEC regulations, this Draft will be published as EN. Like all member organizations of CEN/CENELEC, Austrian Standards Institute is basically obliged to implement European Standards in Austria and to withdraw conflicting standards. Austrian Standards Institute herewith submits this Draft of a European Standard as Draft ÖVE/ÖNORM to public enquiry and information.

Comments on this Draft Please find below some practical instructions intended to offer you and the responsible committee assistance for the processing of comments and proposals for modification: Form

Structure

Please use a new line for each comment. This facilitates the attribution of the comments received to the different clauses and chapters of the respective Draft.

Language

Please formulate technical comments on European Standards if possible in English, since English is the common working language of the most European standardizing bodies. Editorial and/or linguistic proposals for change/improvement of German versions of European Standards shall (certainly) be submitted in German.

Script/Format Dispatch

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Aspects concerning patent law

2

For your comments/proposals for change, please use the relevant form available from Internet. Download under http://www.austrian-standards.at/comments/ or use the Draft Standard Portal http://www.austrian-standards.at/standards-draft-portal/

Please use the script „Arial“ with 9 pt font size. Please do not change the formats. Please send your comments by E-Mail to the responsible Committee Manager ([email protected]) The recipients of this Draft ÖNORM are requested to add information on any patent rights known to their comments and to provide supporting documentation, if available.

DRAFT INTERNATIONAL STANDARD ISO/IEC DIS 17011 ISO/CASCO Secretariat: ISO Voting begins on: 2016-08-25

Voting terminates on: 2016-11-16

Conformity assessment — Requirements for accreditation bodies accrediting conformity assessment bodies Évaluation de la conformité — Exigences pour les organismes d’accréditation procédant à l’accréditation d’organismes d’évaluation de la conformité

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ICS: 03.120.20

THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH. IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME STANDARDS TO WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.

RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT, WITH THEIR COMMENTS, NOTIFICATION OF ANY RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE AND TO PROVIDE SUPPORTING DOCUMENTATION.

ISO/CEN PARALLEL PROCESSING Reference number ISO/IEC DIS 17011:2016(E) © ISO/IEC 2016

ISO/IEC DIS 17011:2016(E) 

ÖVE/ÖNORM DRAFT

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COPYRIGHT PROTECTED DOCUMENT © ISO/IEC 2016, Published in Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of the requester. ISO copyright office Ch. de Blandonnet 8 • CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 [email protected] www.iso.org

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© ISO/IEC 2016 – All rights reserved

ÖVE/ÖNORM DRAFT

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Contents

ISO/IEC DIS 17011:2016(E)

Page

1

Scope..................................................................................................................................4

2

Normative references ...........................................................................................................4

3

Terms and definitions...........................................................................................................4

4 4.1 4.2 4.3 4.4 4.5 4.6

General requirements...........................................................................................................8 Legal entity..........................................................................................................................8 Accreditation agreement ......................................................................................................8 Use of accreditation symbols and other claims of accreditation..............................................9 Impartiality requirements.................................................................................................... 10 Financing and liability ........................................................................................................ 11 Establishing accreditation schemes.................................................................................... 11

5

Structural requirements...................................................................................................... 12

6 6.1 6.2 6.3 6.4

Resource requirements ...................................................................................................... 13 Competence of personnel................................................................................................... 13 Personnel involved in the accreditation process .................................................................. 15 Personnel records.............................................................................................................. 15 Outsourcing....................................................................................................................... 15

7 7.1 7.2 7.3 7.4 7.5 7.6 7.7 7.8 7.9 7.10 7.11 7.12 7.13 7.14

Process requirements ........................................................................................................ 16 Accreditation requirements ................................................................................................ 16 Application for accreditation............................................................................................... 16 Resource review ................................................................................................................ 17 Preparation for assessment ................................................................................................ 17 Review of documented information ..................................................................................... 18 Assessment....................................................................................................................... 18 Accreditation decision-making............................................................................................ 19 Accreditation information ................................................................................................... 20 Accreditation cycle ............................................................................................................ 22 Extending accreditation...................................................................................................... 22 Suspending, withdrawing or reducing accreditation............................................................. 23 Complaints ........................................................................................................................ 23 Appeals............................................................................................................................. 24 Records on Conformity Assessment Bodies........................................................................ 24

8 8.1 8.2

Information requirements ................................................................................................... 25 Confidential information ..................................................................................................... 25 Publicly available information ............................................................................................. 25

9 9.1 9.2 9.3 9.4 9.5 9.6 9.7 9.8

Management system requirements...................................................................................... 26 General ............................................................................................................................. 26 Management system .......................................................................................................... 26 Document control .............................................................................................................. 27 Records control ................................................................................................................. 27 Nonconformities and corrective actions .............................................................................. 27 Improvement...................................................................................................................... 27 Internal audits.................................................................................................................... 28 Management reviews.......................................................................................................... 28

Annex A (Informative) Required knowledge and skills for functions in the accreditation process ..... 30 Table A1 – Table of knowledge and skills........................................................................................ 30

1 © ISO/IEC 2016 – All rights reserved

ÖVE/ÖNORM DRAFT

ISO/IEC DIS 17011:2016(E)

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. In the field of conformity assessment, ISO and IEC develop joint ISO/IEC documents under the management of the ISO Committee on Conformity assessment (ISO/CASCO). The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of document should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives). Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO and IEC shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents). Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement. For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO's adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information

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ISO/IEC 17011 was prepared by the ISO Committee on Conformity Assessment (CASCO).

2 © ISO/IEC 2016 – All rights reserved

ÖVE/ÖNORM DRAFT

ISO/IEC DIS 17011:2016(E)

Introduction This International Standard specifies the requirements for accreditation bodies accrediting conformity assessment bodies. In the context of this International Standard, activities covered by accreditation include but are not limited to testing, calibration, inspection, certification of management systems, persons, products, processes and services, provision of proficiency testing, production of reference materials and validation and verification. It is important for interested parties to know that conformity assessment bodies are competent to perform their tasks. For that reason there is an increasing demand for impartial attestation of their competence. Such attestation is done by accreditation bodies that are impartial and independent in relation to the conformity assessment bodies and the conformity assessment bodies' clients. Accreditation bodies normally operate in a non-profit distributing manner and conduct regular assessments of conformity assessment bodies to ensure that conformity assessment bodies conform with relevant international standards, specifications and other normative documents. A system to accredit conformity assessment bodies should provide for a consistent application of conformity assessment to international consensus based standards and conformity assessment schemes in order to benefit public health, safety, environment and welfare and support regulators and end users. It should facilitate national and cross-border trade, as pursued by trade authorities and organizations. This International Standard can be used to support peer evaluation mechanisms which have been created at regional and international levels, through which confidence is provided that accreditation bodies are operating in accordance with this International Standard. In this International Standard, the following verbal forms are used: - “shall” indicates a requirement; - “should” indicates a recommendation; - “may” indicates a permission; - “can” indicates a possibility or a capability.

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Further details can be found in the ISO/IEC Directives, Part 2.

3 © ISO/IEC 2016 – All rights reserved

ÖVE/ÖNORM DRAFT

ISO/IEC DIS 17011:2016(E)

2

Conformity assessment —Requirements for accreditation bodies accrediting conformity assessment bodies

3

1

4 5

This International Standard specifies requirements for the competence, consistent operation and impartiality of accreditation bodies assessing and accrediting conformity assessment bodies.

6 7 8

NOTE In the context of this International Standard, activities covered by accreditation include but are not limited to testing, calibration, inspection, certification of management systems, persons, products, processes and services, provision of proficiency testing, production of reference materials and validation & verification.

9

2

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1

Scope

Normative references

10 11 12

The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

13

ISO 9000, Quality management systems — Fundamentals and vocabulary

14

ISO/IEC 17000, Conformity assessment — Vocabulary and general principles

15 16

ISO/IEC Guide 99, International vocabulary of metrology -- Basic and general concepts and associated terms (VIM)

17

3

18 19

For the purposes of this document, the terms and definitions given in ISO/IEC 17000 and the following apply.

20 21 22 23

3.1 accreditation third-party attestation related to a conformity assessment body conveying formal demonstration of its competence to carry out specific conformity assessment tasks

24

SOURCE: ISO/IEC 17000:2004, 5.6

25 26 27

3.2 accreditation body authoritative body that performs accreditation

28 29 30 31 32 33 34

NOTE to entry The authority of an accreditation body is generally derived from government.

3.3 accreditation body logo logo used by an accreditation body to identify itself

35 36 37 38

3.4 accreditation symbol symbol issued by an accreditation body to be used by accredited conformity assessment bodies to indicate their accredited status

Terms and definitions

SOURCE ISO/IEC 17000:2004, 2.6

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