CAPA Procedure - ISO 13485

CAPA Procedure - ISO 13485

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ISO 13485:2016 QMS Template - Corrective & Preventive Action Procedure (QMS.8.5.2 - QP)

Enhance your Quality Management System with our ISO 13485:2016 compliant Corrective & Preventive Action Procedure 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 corrective and preventive action 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 Corrective & Preventive Action Procedure Help My Organisation?

This template will assist your organisation in defining a process for your corrective and preventive action activities, including:

  • Root Cause Analysis: Outlining steps for analyzing and investigating the root cause of non-conformities.
  • Action Identification: Identifying necessary actions to correct and prevent deficiencies related to products, processes, or the quality management system.
  • Effectiveness Verification: Verifying and validating that the CAPA was effective and did not adversely affect the finished device.

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

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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