- 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.
ADVANCED QUALITY SYSTEM SOLUTIONS
Everything should be made as simple as possible, but not one bit simpler.