Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes
Specifies requirements for a quality management system for organisations involved in the design, development, production, installation, and servicing of medical devices. Emphasises safety and effectiveness requirements distinct from general ISO 9001.
Medical device manufacturers, distributors, importers, and suppliers to the medical device industry. Required for CE marking under EU MDR/IVDR and expected by FDA under 21 CFR Part 820.
- 01Design and development controls with documented DHF
- 02Risk management throughout the product lifecycle (references ISO 14971)
- 03Post-market surveillance and complaint handling system
- 04Customer communication and feedback processes
- 05Traceability — unique device identification (UDI) linkage
Third edition March 2016. Significant restructuring from 2003 version. Greater emphasis on risk management and risk-based decisions throughout.
ISO 13485:2016: frequently asked questions
Quick answers to common questions about ISO 13485:2016.
What is ISO 13485:2016?
ISO 13485:2016 — Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes — is a standard issued by the International Organization for Standardization. Specifies requirements for a quality management system for organisations involved in the design, development, production, installation, and servicing of medical devices. Emphasises safety and effectiveness requirements distinct from general ISO 9001.
Who does ISO 13485:2016 apply to?
Medical device manufacturers, distributors, importers, and suppliers to the medical device industry. Required for CE marking under EU MDR/IVDR and expected by FDA under 21 CFR Part 820.
What are the key requirements of ISO 13485:2016?
ISO 13485:2016 requires, among other things: Design and development controls with documented DHF; Risk management throughout the product lifecycle (references ISO 14971); Post-market surveillance and complaint handling system; Customer communication and feedback processes.
When was ISO 13485:2016 last updated?
The current version of ISO 13485:2016 dates from March 2016. Third edition March 2016. Significant restructuring from 2003 version. Greater emphasis on risk management and risk-based decisions throughout.
Live openFDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.
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