Management is held accountable for the quality management system
Appropriate for medical device manufacturers, contract manufacturers, component manufacturers, service providers to the medical device industry
Largely aligned with FDA’s Quality System Regulation (21 CFR Part 820) but NOT identical. Note that there are key differences and the QSR is more prescriptive but not contradictory.
ISO 13485 2016 version clarifies requirements in the 2003 version, added/removed definitions
New requirements in the areas of management review, design controls, purchasing controls, software validation, risk management (list is not all-inclusive)
Existing ISO 13485:2003 certificate holders must transition to ISO 13485:2016 by March 2019 but most registrars are requesting transitions be done much earlier.