ISO 13485 (Medical Device QMS)

ISO 13485 is the international standard for quality management systems specific to medical devices. The current edition, ISO 13485:2016, is harmonized with the EU MDR and IVDR and accepted by FDA as part of its Quality Management System Regulation (QMSR) modernization program. It is the QMS standard medical-device manufacturers certify against worldwide.

Scope

ISO 13485 takes ISO 9001’s structure and adds medical-device-specific requirements: design controls, risk-based decision-making, traceability of components and finished devices, sterilization and clean-room controls, post-market surveillance, and stricter document and record retention. Notified bodies and most regulators recognize it as the baseline QMS for placing devices on the market.

Relationships (see sidebar)

• Normative for the QMS capability, Design Controls, and the medical-device records DHF, DMR, and DHR.
• Succeeds (specializes) ISO 9001 for the medical-device sector.
• Companion to ISO 14971 (risk), 21 CFR Part 820 (US QSR), and EU MDR.

Steward

ISO/TC 210 (Quality management and corresponding general aspects for medical devices).