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类别: QUALITY SYSTEMS
质量管理体系(QMS)
记录实现质量目标的过程、程序和职责的正式体系。医疗器械QMS必须符合ISO 13485及适用的法规要求，如FDA 21 CFR 820或EU MDR附录IX。
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
A medical device QMS is the controlled system of processes ensuring consistent product quality and regulatory compliance (ISO 13485, FDA QSR/QMSR, MDR Annex IX routes).
PROCESS / STEPS
- Map core processes and regulatory obligations by market.
- Implement document control, training, design controls, production, CAPA, and complaint handling.
- Measure process effectiveness; escalate signals into risk management.
- Audit and improve continuously.
EXAMPLES
- A global manufacturer maintains one ISO 13485 QMS with country-specific work instructions.
RELATED GUIDES & TOOLS
SOURCES
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