iso-13485 2016版和2013版的区别

iso-13485 只有 2016版和2003版 具体可以查看一下原iso三体系认证，原iso三体系认证有提到，我有 摘录部分（Foreword The text of the International Standard ISO 13485:2003 has been prepared by Technical Committee ISO/TC 210 "Quality management and corresponding general aspects for medical devices, Working Group 1". The transposition  into  a  European  Standard  has  been  managed  by  the  CEN-CENELEC  Management  Centre (CCMC)  with  the  assistance  of  the  CEN-CENELEC  Technical  Committee  3  "Quality  Management  and corresponding general aspects for medical devices". 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of an identical text or by endorsement, at the latest by August 2012, and conflicting national standards shall be withdrawn at the latest by August 201
2. 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 has been prepared under a mandate given to CEN by the European Commission and the European  Free  Trade  Association,  and  supports  quality  system  requirements  of  EU  Medical  Devices Directives. Compliance with EN ISO 13485 does not provide a presumption of conformity with all the aspects of the quality systems of the Medical Devices Directives. It is important that the organization and the Notified Body  identify  the  regulatory  requirements  that  are  not  covered  by  the  standard.  The  Annexes Z  of  this standard shall be used for this purpose, describing the relationship between this European Standard and the conformity assessment requirements of the Medical Devices Directives.   This document supersedes EN ISO 13485:200
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