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KATEGORIE: QUALITY SYSTEMS
Qualitätsmanagementsystem (QMS)
Ein formalisiertes System zur Dokumentation von Prozessen, Verfahren und Verantwortlichkeiten zur Erreichung von Qualitätszielen. Für Medizinprodukte muss das QMS ISO 13485 und anwendbare Regulierungsanforderungen erfüllen.
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
Track regulatory signals related to Qualitätsmanagementsystem (QMS) across 27 authorities in real time.
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