Irish Standard I.S. EN ISO 9001:2015 Quality management systems - Requirements (ISO 9001:2015) © CEN 2015 No copying without NSAI permission except as permitted by copyright law. This is a free 19 page sample. Access the full version online. I.S. xxx: Irish Standard – national specification based on the consensus of an expert panel and subject to public consultation. S.R. xxx: Standard Recommendation - recommendation based on the consensus of an expert panel and subject to public consultation. SWiFT xxx: A rapidly developed recommendatory document based on the consensus of the participants of an NSAI workshop. EN ISO 9001:2015 23 September, 2015 EN ISO 9001:2008 15 November, 2008 ICS number: This document was published 03.120.10 under the authority of the NSAI This is a free 19 page sample. Access the full version online. and comes into effect on: 23 September, 2015 1 Swift Square, T +353 1 807 3800 T +353 1 857 6730 Northwood, Santry F +353 1 807 3838 F +353 1 857 6729 Dublin 9 E [email protected] W standards.ie W Údarás um Chaighdeáin Náisiúnta na hÉireann I.S. EN ISO 9001:2015 EUROPEAN STANDARD EN ISO 9001 NORME EUROPÉENNE EUROPÄISCHE NORM September 2015 ICS 03.120.10 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 2015. 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, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. This is a free 19 page sample. Access the full version online. EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR 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. I.S. EN ISO 9001:2015 EN ISO 9001:2015 (E) Contents Page European foreword ....................................................................................................................................................... 3 This is a free 19 page sample. Access the full version online. 2 I.S. EN ISO 9001:2015 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 2016. 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. This is a free 19 page sample. Access the full version online. 3 I.S. EN ISO 9001:2015 This page is intentionally left BLANK. This is a free 19 page sample. Access the full version online. I.S. EN ISO 9001:2015 INTERNATIONAL ISO STANDARD 9001 Fifth edition 2015-09-15 Quality management systems — Requirements Systèmes de management de la qualité — Exigences This is a free 19 page sample. Access the full version online. Reference number ISO 9001:2015(E) © ISO 2015 I.S. EN ISO 9001:2015 ISO 9001:2015(E) This is a free 19 page sample. Access the full version online. 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 orthe by requester. any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. 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EN ISO 9001:2015 ISO 9001:2015(E) Contents Page Foreword ..........................................................................................................................................................................................................................................v Introduction ................................................................................................................................................................................................................................vi 1 Scope ................................................................................................................................................................................................................................. 1 2 Normative references ...................................................................................................................................................................................... 1 3 Terms and definitions ..................................................................................................................................................................................... 1 4 Context of the organization ....................................................................................................................................................................... 1 4.1 Understanding the organization and its context ....................................................................................................... 1 4.2 Understanding the needs and expectations of interested parties .............................................................. 2 ............................................................................. 2 .......................................................................................................... 2 4.3 Determining the scope of the quality management system 5 Leadership .................................................................................................................................................................................................................. 3 4.4 Quality management system and its processes 5.1 Leadership and commitment ..................................................................................................................................................... 3 5.1.1 General...................................................................................................................................................................................... 3 5.1.2 Customer focus .................................................................................................................................................................. 3 ............................................................................................................................................................................................................... 4 ............................................................................................................................. 4 5.2 Policy .................................................................................................................... 4 5.3 Or5.2.1ganizational Establishing roles, responsibilitiesthe quality policy and authorities.......................................................................................... 4 5.2.2 Communicating the quality policy 6 Planning ........................................................................................................................................................................................................................