Corrective and Preventive Action Procedure | ISO 13485 | FDA QMSR

Investigate and resolve medical device quality-system issues with this editable ISO 13485 Corrective and Preventive Action (CAPA) Procedure and forms. It covers initiation, root-cause investigation, CAPA plans, action implementation, effectiveness checks and closure.

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Supplied as one editable Microsoft Word document, with its forms included as attachments, in a digital download.

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.

From signal to investigation

A CAPA may originate from complaints, audits, supplier findings, acceptance activities, nonconforming material or post-market information. The procedure describes formal initiation, assignment, investigation and root-cause analysis so the action addresses the underlying problem rather than only its immediate symptom.

Action and effectiveness

The CAPA plan documents corrections and corrective or preventive actions, responsible owners, due dates and implementation evidence. Quality review and an effectiveness check determine whether the action worked before closure and reporting to management.

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.

Related inputs include the Internal Audit Procedure and the Nonconforming Material Procedure.

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Practical guide

Read Nonconforming Material, Failure Investigation and CAPA for workflow guidance, a checklist and common mistakes.