ISO 13485:2016: Medical devices — Quality management systems —Requirements for regulatory purposes

  • ISO 13485 is a voluntary quality system standard
  • Generic in nature
  • 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.