Glossary
CAPA
Full name: Corrective and Preventive Action
Category
Quality Management System (QMS)
Industry
Manufacturing, Medical Device, Aerospace
Required By
ISO 9001:2015 · FDA 21 CFR Part 820 · ISO 13485
Related Terms
Nonconformance · Root Cause Analysis · Change Control
CAPA (Corrective and Preventive Action) is a structured quality management process used to identify, investigate, and eliminate the root causes of defects and nonconformances.
What is CAPA in quality management?
CAPA is one of the foundational processes in any quality management system.Corrective action vs preventive action
Corrective action addresses existing failures while preventive action addresses potential failures.Frequently Asked Questions
What triggers a CAPA?
A CAPA is triggered by significant or recurring nonconformances, complaints, audit findings, or process failures.
Does ISO 9001 require CAPA?
Yes. ISO 9001:2015 clause 10.2 requires corrective action processes.
Related quality management terms
Last reviewed: May 19, 2026