New changes to ISO 13485, published this spring as EN ISO 13485:2016, mean U.S. medical device companies that sell in Europe will need to integrate risk-based approaches throughout their quality management systems. The emphasis on risk management is the biggest of several changes in the third version of ISO 13485.
RISK IS GIVEN A FRONT-AND-CENTER PRESENCE IN SECTION 6 OF THE STANDARD.
October 2, 2015
Years in the making, the ISO 9001:2015 revision has been published. Prior to the release date, auditors, inspectors, quality managers, and many others studied the initial drafts in an attempt to understand the changes.