ISO13485认证 新版ISO13485:2016认证标准换版背景及过程
The new version of ISO13485 certification ISO13485:2016 certification standard version of the background and process
自1996年以来，ISO13485认证标准首次发布, 2003年7月15日第二次改版（ISO13485:2003）发布。
Since 1996, the first release of ISO13485 certification standards, July 15, 2003 second revision (ISO13485:2003) released.
鉴于医疗器械市场的运行模式变化和法规协调性的要求，2011年启动了201X版ISO13485的换版工作，至2014年共收集了868个评论并对第一版DIS进行投票，由于没有达到规定要求，第一版的DIS稿被否决，理由主要是标准结构问题和法规的协调性考虑。
In view of the requirements of the medical devices market operation mode changes and regulations coordination, 2011 started 201x version of ISO13485 for version of the work, to 2014 collected a total of 868 comment and vote on the first edition of DIS, because did not meet the requirements, the first edition of the dis draft was rejected, the main reason is considering the coordination of the standard structure and regulations.
2015年2月开始对DIS第二稿进行了投票，5月份正式宣布通过，8月份在伦敦进行FDIS的讨论，10月发布FDIS稿进行投票，只有2个负面的投票，最终于12月29日通过投票。鉴于标准的制定规范要求，ISO13485:2016通过了60.60阶段并于2016年3月1日正式发布。
To begin in February 2015 voted on the second draft dis. In may officially announced through discussions in August in London FDIS, October released FDIS draft vote, only 2 a negative vote, eventually on December 29, by voting. In view of the standard specification, ISO13485:2016 by the 60.60 stage and officially released in March 1, 2016.
ISO13485 ISO13485认证 ISO13485质量管理体系 ISO13485最新版本 ISO134852012 ISO13485/' target='_blank'>ISO13485标准下载
ISO13485 ISO13485 certification of ISO13485 quality management system ISO13485 the latest version of the ISO134852012 ISO13485 standard download