BS EN ISO 13485:2016 Incorporating corrigenda March 2016 and December 2016 BSI Standards Publication UniversityofExeterVersioncorre Medical devices Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) bsi. BS EN ISO 13485:2016 BRITISH STANDARD National foreword This British Standard is the UK implementation of EN ISO 13485:2016) incorporating corrigendum December 2016. It supersedes BS EN ISO 13485:2012 which is withdrawn. The start and finish of text introduced or altered by corrigendum is indicated in the text by tags. Text altered by CEN/CENELEC corrigendum December 2016 is indicated in the text by [Ac) (Ac]. , University of Exeter, Version correct as of25/05/2018 The UK participation in its preparation was entrusted by Technical Committee CH/210, Quality management and corresponding general aspects for medical devices, to Subcommittee CH/210/1, Quality systems for medical devices. A list of organizations represented on this subcommittee 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 2017. Published by BSI Standards Limited 2017 ISBN 978 0 580 96770 2 ICS 03.120.10; 11.040.01 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 31 March 2016. Amendments/corrigenda issued since publication Date Text affected 31 March 2016 CEN Foreword updated Licensed copy:University of Exeter 31 March 2016 CEN Foreword and Annexes ZA, ZB and ZC updated 31 January 2017 Implementation of CEN/CENELEC corrigendum December 2016 EN ISO 13485 EUROPEAN STANDARD NORME EUROPEENNE EUROPAISCHE NORM March 2016 ICS 03.120.10; 11.040.01 Versioncorrectasof25/05/2018 English version Medical devices - Quality management systems Requirements for regulatory purposes (Is0 13485:2016) Dispositifs medicaux - Systemes de management de la Medizinprodukte - Qualitatsmanagementsysteme - qualité - Exigences a des fins réglementaires (ISO Anforderungen fur regulatorische Zwecke (ISO 13485:2016) 13485:2016) This European Standard was approved by CEN on 30 January 2016. CEN and CENELEC 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 Exeter any CEN and CENELEC member. This European Standard exists in three official versions (English, French, German). A version in any other language made by Universityof Management Centre has the same status as the official versions. CENandCENELECmembersarethenationalstandardsbodiesandnationalelectrotechnicalcommittees ofAustria,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. Licensedcopy:UniversityofExeter cen CENELEC CEN-CENELECManagementCentre: Avenue Marnix 17,B-1000Brussels 2016CEN/CENELEC All rights of exploitation in any form and by any means Ref.No.ENISO 13485:2016E reserved worldwide for CEN national Members and for CENELECMembers. BS EN ISO 13485:2016 EN ISO 13485:2016 (E) European foreword This document (EN IS0 13485:2016) has been prepared by Technical Committee IS0/TC 210 "Quality Committee CEN/CLC/TC 3 “Quality management and corresponding general aspects for medical devices" the secretariat of which is held by NEN. This European Standard shall be given the status of a national standard, either by publication of a