CAPA - Corrective and Preventative Action Report Form - ISO 13485

Effectively track, manage, and document Corrective and Preventive Actions (CAPA) with our ISO 13485:2016 Clause 8.5 CAPA Report Form Template. A structured CAPA system is essential for identifying, addressing, and preventing non-conformities, ensuring regulatory compliance, product quality, and risk mitigation in medical device manufacturing. This ready-to-use form simplifies CAPA documentation, ensuring compliance with ISO 13485:2016, FDA 21 CFR Part 820, MDR, and IVDR.

✔ Pre-Formatted CAPA Report Form – Covers key ISO 13485:2016 Clause 8.5 requirements.

✔ Root Cause Analysis & Problem Description – Clearly define issues and contributing factors.

✔ Corrective Action Tracking – Document actions taken to resolve non-conformities.

✔ Preventive Action Plan – Ensure long-term risk mitigation and continuous improvement.

✔ Verification of Effectiveness (VOE) Section – Validate CAPA success before closure.

✔ Approval & Sign-Off Workflow – Assign accountability and maintain compliance.

✔ Audit-Ready Documentation – Keep thorough records for regulatory audits and inspections.

✔ Editable Digital Format – Fully customizable for various medical device QMS applications.

This user-friendly CAPA report form is ideal for quality managers, compliance teams, and regulatory professionals, ensuring a structured, traceable, and effective approach to non-conformance management.

Download the ISO 13485:2016 CAPA Report Form Template today and enhance quality control and compliance!