The official handbook, ISO 13485:2016 – Medical devices – A practical guide
Part 6: Frequently Asked Questions (Practical Answers)
Q1: Do I need ISO 13485 if I sell to the USA?
Yes, but also comply with FDA 21 CFR Part 820 (QSR). Many companies use a harmonized QMS that meets both. Your practical guide should highlight the differences.
Target Audience: It is used by manufacturers, importers, distributors, and service providers across the medical device life cycle.
- Identify problem (data source: complaints, audit, yield)
- Investigate (5 Whys + fishbone)
- Implement action (who, what, due date)
- Verify action (check data improved)
- Validate no new risk introduced
Month 5: Internal audit
Supplier Control: Stricter requirements for monitoring suppliers based on the risk associated with the device. Core Structure of the Standard
Free resource in many PDF guides: Design History File (DHF) index template.