Quality management systems Requirements. Qualitätsmanagementsysteme Anforderungen(ISO 9001:2015)

Transcription

1 ÖNORM EN ISO 9001 Edition: Quality management systems Requirements (ISO 9001:2015) Qualitätsmanagementsysteme Anforderungen(ISO 9001:2015) Systèmes de management de la qualité Exigences (ISO 9001:2015,Version corrigée ) Publisher and printing Austrian Standards Institute/ Österreichisches Normungsinstitut Heinestraße 38, 1020 Wien Copyright Austrian Standards Institute 2015 All rights reserved. No part of this publication may be reproduced or utilized in any form or by any means electronic, mechanical and photocopying or any other data carrier without prior permission! Internet: Sale and distribution of national and foreign standards and technical regulations via Austrian Standards plus GmbH Heinestraße 38, 1020 Wien Internet: Webshop: Tel.: Fax: ICS Identical (IDT) with ISO 9001: Identical (IDT) with EN ISO 9001: Supersedes ÖNORM EN ISO 9001: responsible Committee 129 Quality management systems

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3 EUROPEAN STANDARD EN ISO 9001 NORME EUROPÉENNE EUROPÄISCHE NORM September 2015 ICS Supersedes EN ISO 9001:2008 English Version Quality management systems - Requirements (ISO 9001:2015) Systèmes de management de la qualité - Exigences (ISO Qualitätsmanagementsysteme - Anforderungen (ISO 9001:2015) 9001:2015) This European Standard was approved by CEN on 14 September CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Irelan d, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EURO PÉEN DE NORMA LISATION EUROP ÄISCHES KOMITEE F ÜR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 9001:2015 E worldwide for CEN national Members.

4 EN ISO 9001:2015 (E) Contents Page European foreword

5 EN ISO 9001:2015 (E) European foreword This document (EN ISO 9001:2015) has been prepared by Technical Committee ISO/TC 176 "Quality management and quality assurance". This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by March 2016, and conflicting national standards shall be withdrawn at the latest by March Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 9001:2008. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 9001:2015 has been approved by CEN as EN ISO 9001:2015 without any modification. 3

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7 INTERNATIONAL STANDARD ISO 9001 Fifth edition Quality management systems Requirements Systèmes de management de la qualité Exigences Reference number ISO 9001:2015(E) ISO 2015

8 ISO 9001:2015(E) COPYRIGHT PROTECTED DOCUMENT ISO 2015, 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 Fax copyright@iso.org ii ISO 2015 All rights reserved

9 ISO 9001:2015(E) Contents Page Foreword...v Introduction...vi 1 Scope Normative references Terms and definitions Context of the organization Understanding the organization and its context Understanding the needs and expectations of interested parties Determining the scope of the quality management system Quality management system and its processes Leadership Leadership and commitment General Customer focus Policy Establishing the quality policy Communicating the quality policy Organizational roles, responsibilities and authorities Planning Actions to address risks and opportunities Quality objectives and planning to achieve them Planning of changes Support Resources General People Infrastructure Environment for the operation of processes Monitoring and measuring resources Organizational knowledge Competence Awareness Communication Documented information General Creating and updating Control of documented information Operation Operational planning and control Requirements for products and services Customer communication Determining the requirements for products and services Review of the requirements for products and services Changes to requirements for products and services Design and development of products and services General Design and development planning Design and development inputs Design and development controls Design and development outputs Design and development changes ISO 2015 All rights reserved iii

10 ISO 9001:2015(E) 8.4 Control of externally provided processes, products and services General Type and extent of control Information for external providers Production and service provision Control of production and service provision Identification and traceability Property belonging to customers or external providers Preservation Post-delivery activities Control of changes Release of products and services Control of nonconforming outputs Performance evaluation Monitoring, measurement, analysis and evaluation General Customer satisfaction Analysis and evaluation Internal audit Management review General Management review inputs Management review outputs Improvement General Nonconformity and corrective action Continual improvement Annex A (informative) Clarification of new structure, terminology and concepts...21 Annex B (informative) Other International Standards on quality management and quality management systems developed by ISO/TC Bibliography...28 iv ISO 2015 All rights reserved