ISO 13485:2015 – Moving to ISO 13485:2016

Standard writers for ISO 13485 released this medical device standard earlier this year using ISO 9001:2008 with its base of 8 sections, but it now appears it has been sent back for alignment with the new structure of ISO 9001:2015.

ISO 13485:2015 was rewritten using ISO 13485:2003 as they had started revision work prior to the introduction of the high level (10 sections) structure.  Revisions were made using the 2008 version of ISO 9001 plus added medical device language.  The plan was to adjust ISO 13485:2015 to the high level structure at some future date.   This rewritten 2015 standard was released in March 2016.  

Revision writers have returned to the drawing board with the possibility that a rewritten ISO 13485:2016 document could be released sometime this year.  Third party registrars may be able to start the ANAB accreditation process in late 2016.  Registration and upgrades to the 2016 version of ISO 13485 may begin in 2017.

ASR will continue to provide clients with updates regarding ISO 13485:2016.

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