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CATEGORY: QUALITY SYSTEMS
Quality Management System (QMS)
A formalized system documenting processes, procedures, and responsibilities for achieving quality objectives. For medical devices, QMS must comply with ISO 13485 and applicable regulatory requirements such as FDA 21 CFR 820 or EU MDR Annex IX.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · 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
Track regulatory signals related to Quality Management System (QMS) across 27 authorities in real time.
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