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Management Review Meeting Minutes Template - ISO 13485

Management Review Meeting Minutes Template - ISO 13485

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ISO 13485:2016 QMS Template - Management Review Meeting Minutes (QMS.5.6.0.2 – QR)

Enhance your Quality Management System with our ISO 13485:2016 compliant Management Review Meeting Minutes 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 documentation of management review meetings, demonstrating robust quality management as required by ISO 13485:2016.

Why Do I Need to Take Minutes of My Management Review Meetings?

Documenting each Management Review Meeting (MRM) with formal minutes is essential to show compliance with ISO 13485 clause 4.5 (Control of Records). This template provides a standard format to ensure your MRMs are documented correctly and in compliance with ISO 13485.

What Should Go Into My MRM Minutes?

Your MRM minutes should include detailed documentation of your meeting, including:

  • Attendance: Record attendance to ensure a representative from each responsible department is present.
  • Follow-Up Actions: Document follow-up actions from prior MRMs.
  • Agenda Items: Summarize discussions and decisions related to each agenda item.
  • Inputs and Outputs: Include information, reports, and products related to the meeting agenda items.
  • Action Summary: Summarize required actions and assign responsibilities.

Meeting minutes should be reviewed with absent Management Team members, and their signatures should be obtained to show that the review was performed.

Benefits of Using This Template

  • Structured Documentation: Ensure all necessary details are documented in a structured format.
  • Compliance: Demonstrate compliance with ISO 13485 requirements for record control.
  • Accountability: Keep track of actions and responsibilities assigned during MRMs.

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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