CAPA - Corrective and Presentative Action Report Log - ISO 13485

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

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

Why Choose Our Template?

• Expertly Designed: Our Quality Assurance and Regulatory Affairs specialists created this template to ensure full compliance with ISO 13485:2016 standards.
• Easy Customization: The template is fully editable in Microsoft Word, allowing you to modify it to suit your business needs and branding.
• Compliance Assurance: Using our template helps you maintain effective CAPA procedures, supporting robust quality management as required by ISO 13485:2016.

What is Corrective Action?

Corrective Action involves taking steps to reduce or eliminate the cause of a reported non-conformity or inefficiency in your Quality Management System. The goal is to prevent recurrence by establishing or 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. This action is based on risk analysis, GAP assessment, or other processes that identify potential issues in your Quality Management System.

How Will the CAPA Log Help My Organization?

The CAPA Log helps your organization in several ways:

• Record CAPA Events: Keep a detailed record of CAPA events and their causes.
• Set Actions and Reviews: Document the actions taken and the reviews conducted to ensure effectiveness.
• Demonstrate Compliance: Show compliance with ISO 13485 requirements through clear and comprehensive record-keeping.

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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Explore More Templates

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