CAPA - Corrective and Preventative Action Report Form - ISO 13485
CAPA - Corrective and Preventative Action Report Form - ISO 13485
Template Overview
Template Overview
Effectively track, manage, and document Corrective and Preventive Actions (CAPA) with our ISO 13485:2016 Clause 8.5 CAPA Report Form Template. A structured CAPA system is essential for identifying, addressing, and preventing non-conformities, ensuring regulatory compliance, product quality, and risk mitigation in medical device manufacturing. This ready-to-use form simplifies CAPA documentation, ensuring compliance with ISO 13485:2016, FDA 21 CFR Part 820, MDR, and IVDR.
Key Features
Key Features
✔ Pre-Formatted CAPA Report Form – Covers key ISO 13485:2016 Clause 8.5 requirements.
✔ Root Cause Analysis & Problem Description – Clearly define issues and contributing factors.
✔ Corrective Action Tracking – Document actions taken to resolve non-conformities.
✔ Preventive Action Plan – Ensure long-term risk mitigation and continuous improvement.
✔ Verification of Effectiveness (VOE) Section – Validate CAPA success before closure.
✔ Approval & Sign-Off Workflow – Assign accountability and maintain compliance.
✔ Audit-Ready Documentation – Keep thorough records for regulatory audits and inspections.
✔ Editable Digital Format – Fully customizable for various medical device QMS applications.
Why choose a QMS Template?
Why choose a QMS Template?
This user-friendly CAPA report form is ideal for quality managers, compliance teams, and regulatory professionals, ensuring a structured, traceable, and effective approach to non-conformance management.
Download the ISO 13485:2016 CAPA Report Form Template today and enhance quality control and compliance!
Couldn't load pickup availability
Share

Additional information
-
About Patient Guard
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.
-
Secure Payment and Document Download
Our secure system keeps your transaction safe, and the email will be sent promptly to the address you provided. Just click the link to instantly access and download your documents.
-
Contact Us
For more templates and services in Medical Device Quality Assurance and Regulatory Affairs, or to provide feedback, contact us at qmsregs@patientguard.com.