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Corrective and Preventative Action (CAPA) Report Form - ISO 13485

Corrective and Preventative Action (CAPA) Report Form - ISO 13485

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ISO 13485:2016 QMS Template - Corrective and Preventive (CAPA) Report Form (QMS.8.5.2.2 - QR)

Elevate your Quality Management System with our ISO 13485:2016 compliant Corrective and Preventive (CAPA) Report Form template, expertly crafted by the professionals at Patient Guard. Our Medical Device Quality Assurance and Regulatory Affairs document templates are developed by experienced experts, ensuring they meet the specific requirements of each clause and section of the relevant standards or regulations.

Why Choose Our Template?

  • Expertly Designed: Created by seasoned Quality Assurance and Regulatory Affairs specialists, our templates ensure full compliance with ISO 13485:2016 standards.
  • Easy Customization: Fully editable in Microsoft Word, our templates allow you complete control to modify and tailor them to your specific business needs and branding.
  • Compliance Assurance: Utilizing our template helps you maintain effective CAPA procedures, demonstrating robust quality management as required by ISO 13485:2016.

What is Corrective Action?

Corrective Action involves steps taken to reduce or eliminate the cause of a reported non-conformity or source of inefficiency within your Quality Management System. It aims to prevent recurrence by establishing or updating procedures.

What is Preventive Action?

Preventive Action involves steps taken to reduce or eliminate the chance of a non-conformity or inefficiency before it occurs. It is usually based on risk analysis, GAP assessment, or similar processes that highlight potential inadequacies within your Quality Management System.

How Will the CAPA Report Form Template Help My Organisation?

The ISO 13485 standard mandates that organizations identify and implement necessary changes to ensure the effectiveness of their Quality Management System. The CAPA Report Form template will:

  • Effective CAPA Implementation: Allow your organisation to perform and record effective CAPAs in line with your Corrective & Preventive Action Procedure (see the QMS.8.5.2 template).
  • Compliance Demonstration: Help demonstrate compliance with ISO 13485 through thorough documentation and record-keeping.
  • Process Improvement: Ensure that all CAPAs are documented systematically, providing a clear history of actions taken to address non-conformities and prevent their recurrence.

Why Patient Guard?

Stay ahead with Patient Guard’s consultancy services, offering a cost-effective solution for all your Quality Management System needs. For more templates and services in Medical Device Quality Assurance and Regulatory Affairs, or to provide feedback, contact us at qmsregs@patientguard.com.

Visit our blog for updates on regulatory and quality assurance news, and take the next step in enhancing your Quality Management System with Patient Guard.

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