![]() ![]() ![]() ![]() A gap analysis shall indicate the required modifications, which then shall be implemented. However, don’t underestimate the work to be done in order to fully adapt your current quality management system. This means that companies that have implemented an ISO 13485:2012 quality management system shall update their system to meet the requirements of an ISO 13485:2016 quality management system by the end of March 2019.Ĭompanies have over one (1) year to adapt their quality management system to the requirements of the ISO 13485:2016 standard. The 2012 version will be superseded from March 2019 after a transition period of three (3) years. The ISO 13485:2016 standard has been published in March 2016 to replace the ISO 13485:2012 version.
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