CAPA Procedure - ISO 13485

Implement a structured and effective CAPA system with our ISO 13485:2016 Clause 8.5 Corrective & Preventive Action (CAPA) Procedure Template. A well-defined CAPA process is essential for identifying, investigating, and addressing non-conformities, quality issues, and potential risks in medical device manufacturing. This ready-to-use CAPA procedure template ensures full compliance with ISO 13485:2016, FDA 21 CFR Part 820, MDR, and IVDR, supporting continuous improvement and regulatory readiness.

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

✔ Corrective Action Process – Define steps for identifying, investigating, and resolving non-conformities.

✔ Preventive Action Plan – Establish risk-based strategies to prevent recurrence.

✔ Root Cause Analysis & Risk Assessment – Ensure alignment with ISO 14971 risk management principles.

✔ Implementation & Effectiveness Verification – Track CAPA completion and success rate.

✔ Approval & Sign-Off Workflow – Assign responsibilities and ensure accountability.

✔ Audit-Ready Documentation – Maintain structured CAPA records for regulatory inspections.

✔ Editable Digital Format – Fully customizable for various medical device business models.

This CAPA procedure template is ideal for quality managers, compliance teams, and regulatory professionals, ensuring a structured, compliant, and effective approach to corrective and preventive actions.

Download the ISO 13485:2016 CAPA Procedure Template today and enhance your quality and compliance system!