ISO Standard
Medical Devices QMS
ISO 13485:2016
Focus
QMS for medical devices
Based on
ISO 9001 + regulatory requirements
Relevant for
Gloves, masks, gowns
ISO 13485 is the specialized QMS standard for the medical device industry. It is based on ISO 9001 but contains additional requirements for risk management, sterilization, traceability and regulatory compliance.
Frequently Asked Questions
What is the difference between ISO 9001 and ISO 13485?
ISO 13485 builds on ISO 9001 but adds medical device-specific requirements: risk management, clinical evaluation, vigilance reporting and stricter documentation.