BS EN ISO 9001:2015 Quality Management Systems

BSI Standards PublicationBS EN ISO 9001:2015Quality management systemsRequirements.making excellence a habit.TM

BS EN ISO 9001:2015BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 9001:2015.It supersedes BS EN ISO 9001:2008 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee QS/1, Quality management and quality assuranceprocedures.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 91816 2ICS 03.120.10Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 September 2015.Amendments issued since publicationDateText affected

EN ISO 9001EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMSeptember 2015ICS 03.120.10Supersedes EN ISO 9001:2008English VersionQuality management systems - Requirements (ISO9001:2015)Systèmes de management de la qualité - Exigences (ISO9001:2015)Qualitätsmanagementsysteme - Anforderungen (ISO9001:2015)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 thisEuropean Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical referencesconcerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CENmember.This European Standard exists in three official versions (English, French, German). A version in any other language made bytranslation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC ManagementCentre 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 andUnited Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGCEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 9001:2015 E

BS EN ISO 9001:2015EN ISO 9001:2015 (E)European forewordThis document (EN ISO 9001:2015) has been prepared by Technical Committee ISO/TC 176 "Qualitymanagement and quality assurance".This European Standard shall be given the status of a national standard, either by publication of anidentical text or by endorsement, at the latest by March 2016, and conflicting national standards shallbe 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 ofpatent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patentrights.This document supersedes EN ISO 9001:2008.This document has been prepared under a mandate given to CEN by the European Commission and theEuropean Free Trade Association, and supports essential requirements of EU Directive(s).According to the CEN-CENELEC Internal Regulations, the national standards organizations of thefollowing 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 noticeThe text of ISO 9001:2015 has been approved by CEN as EN ISO 9001:2015 without any modification.3

BS EN ISO 9001:2015ISO 9001:2015(E)ContentsPageForeword .vIntroduction. viScope . 12Normative references . 13Terms and definitions . 14Context of the organization . 14.1Understanding the organization and its context . 14.2Understanding the needs and expectations of interested parties . 24.3Determining the scope of the quality management system. 24.4Quality management system and its processes . 25Leadership . 35.1Leadership and commitment . 35.1.1General. 35.1.2Customer focus . 35.2Policy . 45.2.1Establishing the quality policy. 45.2.2Communicating the quality policy. 45.3Organizational roles, responsibilities and authorities. 46Planning. 46.1Actions to address risks and opportunities . 46.2Quality objectives and planning to achieve them. 56.3Planning of changes . 57Support . 67.1Resources. 67.1.1General. 67.1.2People . 67.1.3Infrastructure . 67.1.4Environment for the operation of processes . 67.1.5Monitoring and measuring resources . 77.1.6Organizational knowledge. 77.2Competence . 87.3Awareness . 87.4Communication . 87.5Documented information. 87.5.1General. 87.5.2Creating and updating . 97.5.3Control of documented information . 98Operation . 98.1Operational planning and control . 98.2Requirements for products and services . 108.2.1Customer communication. 108.2.2Determining the requirements for products and services . 108.2.3Review of the requirements for products and services . 108.2.4Changes to requirements for products and services . 118.3Design and development of products and services . 118.3.1General. 118.3.2Design and development planning. 118.3.3Design and development inputs . 118.3.4Design and development controls . 128.3.5Design and development outputs . 128.3.6Design and development changes. 12www.kharazian.ir1 ISO 2015 – All rights reservediii

BS EN ISO 9001:2015ISO 9001:2015(E)8.48.58.68.7www.kharazian.ir910Control of externally provided processes, products and services . 138.4.1General. 138.4.2Type and extent of control. 138.4.3Information for external providers. 13Production and service provision. 148.5.1Control of production and service provision. 148.5.2Identification and traceability . 148.5.3Property belonging to customers or external providers. 158.5.4Preservation. 158.5.5Post-delivery activities . 158.5.6Control of changes . 15Release of products and services . 15Control of nonconforming outputs . 16Performance evaluation .169.1Monitoring, measurement, analysis and evaluation . 169.1.1General. 169.1.2Customer satisfaction . 179.1.3Analysis and evaluation . 179.2Internal audit . 179.3Management review . 189.3.1General. 189.3.2Management review inputs . 189.3.3Management review outputs . 18Improvement .1910.1 General . 1910.2 Nonconformity and corrective action . 1910.3 Continual improvement . 19Annex A (informative) Clarification of new structure, terminology and concepts.21Annex B (informative) Other International Standards on quality management and qualitymanagement systems developed by ISO/TC 176 .25Bibliography . 28iv ISO 2015 – All rights reserved

BS EN ISO 9001:2015ISO 9001:2015(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standardsbodies (ISO member bodies). The work of preparing International Standards is normally carried outthrough ISO technical committees. Each member body interested in a subject for which a technicalcommittee has been established has the right to be represented on that committee. Internationalorganizations, governmental and non-governmental, in liaison with ISO, also take part in the work.ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters ofelectrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance aredescribed in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for thedifferent types of ISO documents should be noted. This document was drafted in accordance with theeditorial 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 docu

BS EN ISO 9001:2015 ISO 9001:2015(E) Introduction 0.1 General The adoption of a quality management system is a strategic decision for an organization that can help to improve its overall performance and provide a sound basis for sustainable development initiatives.