CAPA - Corrective and Preventative Action Report Form - ISO 13485

ISO 13485:2016 QMS Template - Corrective and Preventive (CAPA) Report Form

Improve your Quality Management System with our ISO 13485:2016 compliant Corrective and Preventive (CAPA) Report Form template. The professionals at Patient Guard designed this template to meet the specific needs of the ISO 13485:2016 standard.

Why Choose Our Template?

• Expertly Designed: Our specialists created this template to ensure it fully complies with ISO 13485:2016 standards.
• Easy Customization: The template is editable in Microsoft Word, allowing you to modify it to suit your business needs and branding.
• Compliance Assurance: Use our template to maintain effective CAPA procedures. It supports strong quality management as required by ISO 13485:2016.

What is Corrective Action?

Corrective Action involves steps to reduce or eliminate the cause of a reported non-conformity or inefficiency in your Quality Management System. The goal is to prevent the issue from happening again by updating procedures.

What is Preventive Action?

Preventive Action involves steps to reduce or eliminate the chance of a non-conformity or inefficiency before it happens. It is based on risk analysis, GAP assessment, or other processes that identify potential issues in your Quality Management System.

How Will the CAPA Report Form Template Help My Organization?

The ISO 13485 standard requires organizations to make changes that ensure their Quality Management System stays effective. The CAPA Report Form template will help your organization by:

• Effective CAPA Implementation: Enabling you to perform and record CAPAs in line with your Corrective & Preventive Action Procedure.
• Compliance Demonstration: Helping you show compliance with ISO 13485 through thorough documentation and record-keeping.
• Process Improvement: Ensuring all CAPAs are documented systematically. This provides a clear history of actions taken to address non-conformities and prevent them from happening again.

Why Choose Patient Guard?

Moreover, you can stay ahead with Patient Guard’s consultancy services, which offer affordable solutions for your Quality Management System needs. For more templates and services in Medical Device Quality Assurance and Regulatory Affairs, or to share feedback, you can easily email us at qmsregs@patientguard.com.

In addition, visit our blog for the latest updates on regulatory and quality assurance news. So, take the next step in improving your Quality Management System with Patient Guard.

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Finally, don’t forget to visit QMSREGS.com for more templates that might interest you.