ISO 13485:2016 Starters’ Guide to Transition

This guide is intended as a starting point for medical device manufacturers currently certified to an existing version of ISO 13485 who are considering what steps to take towards a smooth transition to the new and revised standard, including manufacturers using EN ISO 13485 for presumption of conformity with the quality system requirements of the medical devices directives.

According to the International Accreditation Forum (IAF), a three-year transition period will apply to all existing ISO 13485:2003 and EN ISO 13485:2012 certifications.

Click on the image below to download the ISO 13485:2016 Starters’ Guide to Transition

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