GHTF · International guidance
GHTF/SG3/N18:2010
Guidance on Corrective Action and Preventive Action (CAPA) and Related QMS Processes
International Medical Device Regulators ForumGHTF/IMDRFTechnical guidance
International guidance
This document provides international technical guidance. Publication here does not establish its adoption or binding effect in any national market. Check the applicable national requirements and the issuing authority’s latest publication.
Source identity
- Issuing body
- GHTF/IMDRF
- Reference
- GHTF/SG3/N18:2010
- Published (source metadata)
- November 4, 2010
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About this guidance
Guidance on Corrective Action and Preventive Action (CAPA) and Related QMS Processes
Comprehensive guidance on CAPA processes within medical device quality management systems. Covers root cause analysis, corrective actions, and preventive measures.