Corrective and Preventive Action Procedure | ISO 13485 | FDA QMSR

The ISO 13485:2016 Corrective and Preventive Action (CAPA) procedure governs the process to initiate, investigate, implement and track corrective and preventive actions.

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Corrective and Preventive Action Procedure

The Corrective and Preventive Action (CAPA) procedure governs the process to initiate, investigate, implement and track corrective and preventive actions.

Corrective and Preventive Action - Overview

The Corrective and Preventive Action (CAPA) procedure provides a means for coordinating action plans resulting from information obtained from several sources. The Corrective and Preventive Action (CAPA) Procedure includes instruction and all supporting forms, for CAPA initiation, CAPA Plan and CAPA Plan Closure.

Regulatory framework

For U.S. medical devices, the applicable quality-system framework is FDA's Quality Management System Regulation (QMSR), 21 CFR Part 820, effective February 2, 2026. It incorporates ISO 13485:2016 and includes additional FDA requirements. Adapt and implement this documentation for your device, activities and markets; purchasing a document does not establish regulatory compliance or certification.