ISO13485认证 新版ISO13485:2016认证标准进展
Progress of ISO13485:2016 certification standards for ISO13485 certification
据ISO官网消息显示，ISO13485:2016标准于3月1日正式生效！ISO13485即《Medical device - Quality management system -requirements for regulatory purpose》是由ISO/TC210医疗器械质量管理和通用要求技术委员会制定，应用于医疗器械行业，在法规目的要求下运行的独立标准。现就新版ISO13485的换版情况进行介绍。
According to the official website of ISO news shows, ISO13485:2016 standard in March 1st, the official entry into force! ISO13485 is the medical device quality management system -requirements for regulatory purpose "is by ISO / TC210 medical device quality management and general request the technical committee to develop, the application in the medical device industry in regulations to run independent standard. Now on the new version of the ISO13485 version of the introduction of the case.
ISO13485:2016认证标准新版本进展
Development of new version of ISO13485:2016 certification standards
2014.2，ISO 13485:201X（DIS.1）发布
2014.2, 13485:201X ISO (DIS.1) release
2015.2，ISO 13485:201X（DIS.2）发布
2015.2, 13485:201X ISO (DIS.2) release
2015.5，ISO 13485:201X（DIS.2）评审期结束
2015.5, 13485:201X ISO (DIS.2) the end of the assessment period
2015.6，ISO/TC 210在美国会谈，对DIS.2的评论意见进行讨论并形成决议
2015.6, ISO/TC 210 talks in the United States, comments on the DIS.2 comments to discuss and form a resolution
2015.10.29，ISO 13485:201X（FDIS）发布， 12月29日投票通过
ISO, 13485:201X 2015.10.29 (FDIS) released in December 29th voted through
2016.3.1，ISO 13485:2016 新版标准正式发布。
ISO, 13485:2016 2016.3.1 version of the official release of the standard.
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
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