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Change Control Log Template - ISO 13485

Change Control Log Template - ISO 13485

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ISO 13485:2016 QMS Template - Change Control Log (QMS. - QR)

Enhance your Quality Management System with our ISO 13485:2016 compliant Change Control Log template, meticulously 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: Using our template helps you maintain a robust change control log, demonstrating effective document control as required by ISO 13485:2016.

What is a Change Control Log?

A Change Control Log is a Quality Record (QR) used to track changes or updates to documents within your Quality Management System (QMS). This log provides a comprehensive summary of all change control history recorded across individual procedures, forms, templates, and records.

Benefits of a Change Control Log

  • Immediate Overview: Quickly access a summary of changes made to controlled documents, including the reasons for those changes.
  • Document Tracking: Identify documents that frequently change or have not been updated for some time, aiding in the selection of items for review.
  • Audit Facilitation: Enable auditors to easily review the change history of documents, demonstrating compliance and good practice.
  • Data Analysis: Useful for summarizing data on activities such as archiving, supporting measurement and analysis efforts within your system.

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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