CAPA Templates ISO 13485 Bundle

Ensure a systematic and compliant approach to managing Corrective and Preventive Actions (CAPA) with our ISO 13485:2016 Clause 8 CAPA Bundle of Templates. This comprehensive bundle provides all the essential tools to help your organization effectively identify, investigate, and resolve non-conformities, ensuring continuous improvement and regulatory compliance with ISO 13485:2016.

✔ Pre-Formatted CAPA Procedure Template – Establish a clear, compliant CAPA process aligned with ISO 13485:2016 requirements.
✔ CAPA Log Template – Track non-conformances, root causes, corrective actions, and preventive measures.
✔ CAPA Report Template – Document investigations, actions taken, and effectiveness evaluations for compliance.
✔ Corrective Action Plan Template – Define action steps, responsibilities, and timelines for resolving issues.
✔ Preventive Action Plan Template – Create strategies for preventing recurrence of identified issues.
✔ Root Cause Analysis Template – Use structured methods to identify underlying causes of non-conformities.
✔ Effectiveness Review Template – Ensure corrective and preventive actions have been effective and verify their impact.
✔ Editable Digital Format – Fully customizable for various industries and CAPA needs.

This CAPA bundle is ideal for quality managers, compliance officers, and regulatory professionals, ensuring a structured, compliant, and effective CAPA process.

Download the ISO 13485:2016 CAPA Bundle of Templates today and improve your quality management system and regulatory compliance efforts!