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类别: QUALITY SYSTEMS
纠正和预防措施(CAPA)
系统性调查、识别根本原因和解决质量问题的过程。CAPA是ISO 13485、FDA 21 CFR 820和EU MDR要求的关键QMS要素。
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
CAPA investigates systemic quality issues, implements corrections/preventive actions, and verifies effectiveness—required in device QMS frameworks worldwide.
PROCESS / STEPS
- Identify issue and contain product risk.
- Investigate root cause with evidence.
- Implement corrective and preventive actions.
- Verify effectiveness and close with management review visibility.
EXAMPLES
- Recurring complaint codes trigger CAPA beyond one-off rework.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to 纠正和预防措施(CAPA) across 27 authorities in real time.
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