CAPA - Corrective and Presentative Action Report Log - ISO 13485
CAPA - Corrective and Presentative Action Report Log - ISO 13485
Template Overview
Template Overview
Ensure full traceability and compliance in your Corrective and Preventive Action (CAPA) system with our ISO 13485:2016 Clause 8.5 CAPA Report Log Template. A structured CAPA log is essential for monitoring and managing non-conformities, corrective actions, and preventive measures, ensuring continuous improvement in medical device manufacturing. This easy-to-use spreadsheet helps quality teams track CAPA progress, maintain regulatory compliance, and prepare for audits in accordance with ISO 13485:2016, FDA 21 CFR Part 820, MDR, and IVDR.
Key Features
Key Features
✔ Pre-Formatted CAPA Report Log – Covers key ISO 13485:2016 Clause 8.5 requirements.
✔ Issue Identification & Root Cause Analysis Section – Log details of non-conformities and risk assessments.
✔ Corrective & Preventive Action Tracking – Monitor implementation and effectiveness.
✔ Status & Closure Verification – Ensure CAPAs are successfully completed before sign-off.
✔ Compliance with Regulatory Requirements – Maintain audit-ready documentation for inspections.
✔ Automated Filtering & Sorting Features – Easily track open, pending, and closed CAPAs.
✔ Editable Digital Format – Fully customizable for various medical device QMS applications.
Why choose a QMS Template?
Why choose a QMS Template?
This ready-to-use CAPA log is ideal for quality managers, compliance teams, and regulatory professionals, ensuring structured, effective, and transparent CAPA management.
Download the ISO 13485:2016 CAPA Report Log Template today and streamline your quality and compliance tracking!
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QMSRegs was founded in 2020 by the Patient Guard group to help companies get their medical devices to market and achieve Medical Device compliance. Patient Guard’s consultancy services offers a cost-effective solution for all your Quality Management System needs.
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