Change Control Log Template - ISO 13485

ISO 13485:2016 QMS Template - Change Control Log

Improve your Quality Management System with our ISO 13485:2016 compliant Change Control Log template. The experts at Patient Guard carefully designed this template to meet the specific needs of the ISO 13485:2016 standard.

Why Choose Our Template?

• Expertly Designed: Our experienced Quality Assurance and Regulatory Affairs specialists created this template. It ensures full compliance with ISO 13485:2016 standards.
• Easy Customization: The template is fully editable in Microsoft Word. You can easily modify it to suit your business needs and branding.
• Compliance Assurance: Using our template helps you keep a strong change control log. This ensures effective document control as required by ISO 13485:2016.

What is a Change Control Log?

A Change Control Log is a Quality Record (QR). It tracks changes or updates to documents in your Quality Management System (QMS). This log gives a summary of all changes across procedures, forms, templates, and records.

Benefits of a Change Control Log

• Immediate Overview: You can quickly see a summary of changes made to controlled documents. It also includes the reasons for those changes.
• Document Tracking: Identify documents that change often or have not been updated recently. This helps in selecting items for review.
• Audit Facilitation: Auditors can easily review the change history of documents. This shows compliance and good practices.
• Data Analysis: The log helps you summarize data on activities like archiving. This supports measurement and analysis efforts within your system.

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.