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COPYRIGHT Danish Standards Foundation. NOT FOR COMMERCIAL USE OR REPRODUCTION. DS/ISO/IEC TS : PDF
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1 DS-information DS/ISO/IEC TS udgave Overensstemmelsesvurdering Krav til organer, der foretager audit og certificering af ledelsessystemer Del 3: Kompetencekrav til auditering og certificering af kvalitetsledelsessystemer Conformity assessment Requirements for bodies providing audit and certification of management systems Part 3: Competence requirements for auditing and certification of quality management systems
2 DS/ISO/IEC TS København DS projekt: M ICS: Første del af denne publikations betegnelse er: DS/ISO/IEC, hvilket betyder, at det er en international standard, der har status som dansk standard. TS Denne publikations overensstemmelse er: IDT med: ISO IEC TS :2013. DS-publikationen er på engelsk. DS-publikationstyper Dansk Standard udgiver forskellige publikationstyper. Typen på denne publikation fremgår af forsiden. Der kan være tale om: Dansk standard standard, der er udarbejdet på nationalt niveau, eller som er baseret på et andet lands nationale standard, eller standard, der er udarbejdet på internationalt og/eller europæisk niveau, og som har fået status som dansk standard DS-information publikation, der er udarbejdet på nationalt niveau, og som ikke har opnået status som standard, eller publikation, der er udarbejdet på internationalt og/eller europæisk niveau, og som ikke har fået status som standard, fx en teknisk rapport, eller europæisk præstandard DS-håndbog samling af standarder, eventuelt suppleret med informativt materiale DS-hæfte publikation med informativt materiale Til disse publikationstyper kan endvidere udgives tillæg og rettelsesblade DS-publikationsform Publikationstyperne udgives i forskellig form som henholdsvis fuldtekstpublikation (publikationen er trykt i sin helhed) godkendelsesblad (publikationen leveres i kopi med et trykt DS-omslag) elektronisk (publikationen leveres på et elektronisk medie) DS-betegnelse Alle DS-publikationers betegnelse begynder med DS efterfulgt af et eller flere præfikser og et nr., fx DS 383, DS/EN 5414 osv. Hvis der efter nr. er angivet et A eller Cor, betyder det, enten at det er et tillæg eller et rettelsesblad til hovedstandarden, eller at det er indført i hovedstandarden. DS-betegnelse angives på forsiden. Overensstemmelse med anden publikation: Overensstemmelse kan enten være IDT, EQV, NEQ eller MOD IDT: Når publikationen er identisk med en given publikation. EQV: Når publikationen teknisk er i overensstemmelse med en given publikation, men præsentationen er ændret. NEQ: Når publikationen teknisk eller præsentationsmæssigt ikke er i overensstemmelse med en given standard, men udarbejdet på baggrund af denne. MOD: Når publikationen er modificeret i forhold til en given publikation.
3 TECHNICAL SPECIFICATION ISO/IEC TS First edition Conformity assessment Requirements for bodies providing audit and certification of management systems Part 3: Competence requirements for auditing and certification of quality management systems Évaluation de la conformité Exigences pour les organismes procédant à l audit et à la certification des systèmes de management Partie 3: Exigences de compétence pour l audit et la certification des systèmes de management de la qualité Reference number ISO/IEC TS :2013(E) ISO 2013
4 ISO/IEC TS :2013(E) COPYRIGHT PROTECTED DOCUMENT ISO 2013 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 Case postale 56 CH-1211 Geneva 20 Tel Fax Web Published in Switzerland ii ISO 2013 All rights reserved
5 ISO/IEC TS :2013(E) Contents Page Foreword...iv Introduction...v 1 Scope Normative references Terms and definitions Generic competence requirements Competence requirements for QMS auditors General Quality management terminology, principles, practices and techniques Quality management system standards and normative documents Business management practices Client business sector Client products, processes and organization Competence requirements for other personnel General Competence of personnel conducting the application review to determine the audit team competence required, to select the audit team members and to determine the audit time Competence of personnel reviewing audit reports and making certification decisions... 4 Annex A (informative) Knowledge for QMS auditing and certification... 5 Bibliography... 6 ISO 2013 All rights reserved iii
6 ISO/IEC TS :2013(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, the ISO Committee on conformity assessment (CASCO) is responsible for the development of International Standards and Guides. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. In other circumstances, particularly when there is an urgent market requirement for such documents, a technical committee may decide to publish other types of document: an ISO/IEC Publicly Available Specification (ISO/IEC PAS) represents an agreement between technical experts in an ISO working group and is accepted for publication if it is approved by more than 50 % of the members of the parent committee casting a vote; an ISO/IEC Technical Specification (ISO/IEC TS) represents an agreement between the members of a technical committee and is accepted for publication if it is approved by 2/3 of the members of the committee casting a vote. An ISO/PAS or ISO/TS is reviewed after three years in order to decide whether it will be confirmed for a further three years, revised to become an International Standard, or withdrawn. If the ISO/PAS or ISO/TS is confirmed, it is reviewed again after a further three years, at which time it must either be transformed into an International Standard or be withdrawn. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO/IEC/TS was prepared by Technical Committee ISO/TC 176, Quality management and quality assurance, Subcommittee SC 3, Supporting technologies, and the ISO Committee on conformity assessment (CASCO). It was circulated for voting to the national bodies of both ISO and IEC, and was approved by both organizations. ISO/IEC consists of the following parts, under the general title Conformity assessment Requirements for bodies providing audit and certification of management systems: Part 2: Competence requirements for auditing and certification of environmental management systems [Technical Specification] Part 3: Competence requirements for auditing and certification of quality management systems [Technical Specification] The following parts are under preparation: Part 4: Competence requirements for auditing and certification of event sustainability management [Technical Specification] Part 5: Competence requirements for auditing and certification of asset management systems [Technical Specification] The next revision of ISO/IEC 17021:2011 will reflect the different parts and will become ISO/IEC iv ISO 2013 All rights reserved
7 ISO/IEC TS :2013(E) Introduction This Technical Specification complements ISO/IEC In particular, it clarifies the requirements for the competence of personnel involved in the certification process set out in ISO/IEC 17021:2011, Clause 7 and Annex A. Certification bodies have a responsibility to interested parties, including their clients and the customers of the organizations whose management systems are certified, to ensure that only those auditors who demonstrate the relevant competence are allowed to conduct quality management system (QMS) audits. It is intended that all QMS auditors and other personnel involved in certification functions possess the generic competence described in ISO/IEC 17021, as well as the specific QMS knowledge described in this Technical Specification. Certification bodies will need to identify the specific audit team competence needed for the scope of each QMS audit. The selection of a QMS audit team will depend upon various factors, including the client s technical area and specific processes. In this Technical Specification, 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. Further details can be found in the ISO/IEC Directives, Part 2. For the purposes of research, users are encouraged to share their views on this Technical Specification and their priorities for changes to future editions. Click on the link below to take part in the online survey: ISO 2013 All rights reserved v
9 TECHNICAL SPECIFICATION ISO/IEC TS :2013(E) Conformity assessment Requirements for bodies providing audit and certification of management systems Part 3: Competence requirements for auditing and certification of quality management systems 1 Scope This Technical Specification complements the existing requirements of ISO/IEC It includes specific competence requirements for personnel involved in the certification process for quality management systems (QMS). NOTE This Technical Specification is applicable for auditing and certification of a QMS based on ISO It can also be used for other QMS applications. 2 Normative references 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. ISO/IEC 17021:2011, Conformity assessment Requirements for bodies providing audit and certification of management systems 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO/IEC apply. 4 Generic competence requirements The certification body shall define the competence requirements for each certification function as referenced in ISO/IEC 17021:2011, Table A.1. When defining these competence requirements, the certification body shall take into account all the requirements specified in ISO/IEC 17021, as well as those specified in Clauses 5 and 6 of this Technical Specification that are relevant for the QMS technical areas (see ISO/IEC 17021:2011, 7.1.2), as defined by the certification body. NOTE 1 Annex A provides a summary of the competence requirements for personnel involved in specific certification functions. NOTE 2 Information on the principles of auditing is provided in ISO ISO 2013 All rights reserved 1