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类别: STANDARDS
ISO 13485
规定参与医疗器械设计、生产、安装和服务的组织的QMS要求的国际标准。ISO 13485:2016是当前版本，与EU MDR协调。
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
Expanded process notes below are currently maintained in English; the short definition above is localized. See our editorial policy.
WHEN IT APPLIES
ISO 13485 is the core QMS standard for medical device organizations across design, manufacture, and service. It underpins NB audits, MDSAP, and many market registrations.
PROCESS / STEPS
- Scope processes covering product realization and regulatory requirements.
- Document procedures for design controls, CAPA, purchasing, production, and PMS interfaces.
- Train personnel; run internal audits and management review.
- Certify with an accredited body if required by markets/customers.
EXAMPLES
- Contract manufacturers typically maintain ISO 13485 certification to supply OEMs.
RELATED GUIDES & TOOLS
SOURCES
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