CAPA - Corrective Action & Preventative Action form - ISO 9001

Streamline your corrective and preventive action (CAPA) process with our ISO 9001:2015 Clause 10.2 CAPA Form Template. A structured CAPA system is essential for identifying non-conformities, root causes, and improvement opportunities, ensuring continuous improvement and regulatory compliance with ISO 9001:2015, ISO 13485, and FDA 21 CFR Part 820. This ready-to-use form template provides a systematic approach for logging, investigating, and tracking CAPA activities, helping organizations maintain quality, efficiency, and audit readiness.

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

✔ Issue Identification & Non-Conformance Details – Document the problem, affected processes, and severity level.

✔ Root Cause Analysis & Risk Assessment – Use structured problem-solving methods to determine the cause.

✔ Corrective & Preventive Action Plan – Define steps for resolution and long-term prevention.

✔ Responsibility Assignment & Due Date Tracking – Assign tasks to team members with deadlines.

✔ Effectiveness Verification & Closure Section – Ensure corrective actions are properly implemented and verified.

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

✔ Editable Digital Format – Fully customizable for various business models and industries.

This CAPA form template is ideal for quality managers, compliance teams, and process auditors, ensuring a structured, compliant, and effective approach to issue resolution.

Download the ISO 9001:2015 Corrective & Preventive Action (CAPA) Form Template today and enhance your quality management system!