BSI Standards Publication BS EN ISO 9000:2015 Qu al ity management systems Fundamentals and vocabulary ...making excellence a habit.TM BS EN ISO 9000:2015 BRITISH STANDARD National foreword This British Standard is the UK implementation of EN ISO 9000:2015. It supersedes BS EN ISO 9000:2005 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee QS/1, Quality management and quality assurance procedures. A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. © The British Standards Institution 2015. Published by BSI Standards Limited 2015 ISBN 978 0 580 78878 9 ICS 01.040.03; 03.120.10 Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 September 2015. Amendments issued since publication Date Text affected EUROPEAN STANDARD EN ISO 9000 NORME EUROPÉENNE EUROPÄISCHE NORM September 2015 ICS 01.040.03; 03.120.10 Supersedes EN ISO 9000:2005 English Version Quality management systems - Fundamentals and vocabulary (ISO 9000:2015) Systèmes de management de la qualité - Principes Qualitätsmanagementsysteme - Grundlagen und essentiels et vocabulaire (ISO 9000:2015) Begriffe (ISO 9000:2015) 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. 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 9000:2015 E worldwide for CEN national Members. BS EN ISO 9000:2015 EN ISO 9000:2015 (E) European foreword This document (EN ISO 9000:2015) 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 9000:2005. 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 9000:2015 has been approved by CEN as EN ISO 9000:2015 without any modification. 3 BS EN ISO 9000:2015 ISO 9000:2015(E)  Contents Page Foreword.........................................................................................................................................................................................................................................iv Introduction...................................................................................................................................................................................................................................v 1 Scope.................................................................................................................................................................................................................................. 1 2 Fundamental concepts and quality management principles.................................................................................. 1 2.1 General............................................................................................................................................................................................................ 1 2.2 Fundamental concepts...................................................................................................................................................................... 2 ........................................................................................................................................................................................ 2 .................................................................................................................................. 2 2.2.12.2.3 QualityContext of an organization....................................................................................................................................... 2 2.2.22.2.4 QualityInterested management parties............................................................................................................................................................. system 2 2.2.5 Support...................................................................................................................................................................................... 2 ................................................................................................................................................ 3 2.3.1 Customer focus................................................................................................................................................................... 3 2.3 Quality2.3.2 managementLeadership.............................................................................................................................................................................. principles 4 2.3.3 Engagement of people.................................................................................................................................................. 5 2.3.4 Process approach............................................................................................................................................................. 6 2.3.5 Improvement....................................................................................................................................................................... 6 2.3.6 Evidence-based decision making....................................................................................................................... 7 2.3.7 Relationship management........................................................................................................................................ 8 2.4 Developing the QMS using fundamental concepts and principles.............................................................. 9 2.4.1 QMS model............................................................................................................................................................................. 9 2.4.2 Development of a QMS................................................................................................................................................. 9 ..............................10 3 Terms and definitions...................................................................................................................................................................................10 2.4.3 QMS standards, other management systems and excellence models 3.1 Terms related to person or people......................................................................................................................................10 3.2 Terms related to organization.................................................................................................................................................11 ...............................................................................................................................................................13 3.4 Terms related to process..............................................................................................................................................................15 3.3 Terms related to