Iso 13485 fdis12/5/2023 ![]() ![]() ![]() In 2008, there was an update to the ISO 9001 standard, but the changes were minor, only clarified a few points, and the periodic review of ISO 13485 in 2008 determined there was not a need to update 13485 at that time. That standard was written following the same format and structure of the overall quality system standard at the time (i.e., ISO 9001:2000). The previous version of ISO 13485 was released in 2003. This blog explains how to reconcile the conflict between ISO 13485 and ISO 9001, and discusses whether you should maintain dual certification. Posted by Rob Packard on December 9, 2014 How to reconcile the conflict between ISO 13485 and ISO 9001
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