CAPA - Corrective Action and Preventative Action Procedure - ISO 9001

Implement a structured and effective CAPA system with our ISO 9001:2015 Clause 10.2 Corrective & Preventive Action (CAPA) Procedure Template. A well-defined CAPA process is critical for identifying, investigating, and addressing non-conformities, ensuring compliance with ISO 9001:2015, ISO 13485, and FDA 21 CFR Part 820. This ready-to-use procedure template provides a systematic approach for handling corrective and preventive actions, driving continuous improvement and regulatory readiness.

✔ Pre-Formatted CAPA Procedure Template – Covers key ISO 9001:2015 Clause 10.2 requirements.

✔ Non-Conformance Identification & Documentation – Define how issues are logged, categorized, and assessed.

✔ Root Cause Analysis & Risk-Based Evaluation – Ensure structured problem-solving and impact assessment.

✔ Corrective & Preventive Action Implementation – Outline steps for containment, resolution, and future prevention.

✔ Responsibility Assignment & Timeline Tracking – Assign CAPA owners and set completion deadlines.

✔ Effectiveness Review & Verification Process – Ensure CAPA actions prevent recurrence and improve quality.

✔ Audit-Ready Documentation & Compliance Tracking – Maintain structured records for internal audits and regulatory inspections.

✔ Editable Digital Format – Fully customizable for different business models and compliance needs.

This CAPA procedure template is ideal for quality managers, regulatory teams, and compliance professionals, ensuring a structured, compliant, and effective approach to non-conformance management.

Download the ISO 9001:2015 CAPA Procedure Template today and enhance your quality management and continuous improvement efforts!