Management Review Procedure Template ISO 13485

Management Review Procedure Template ISO 13485

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ISO 13485:2016 QMS Template - Management Review Procedure (QMS.5.6.0)

Enhance your Quality Management System with our ISO 13485:2016 compliant Management Review 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 management review procedures, demonstrating robust quality management as required by ISO 13485:2016.

What is a Management Review Procedure?

A Management Review Procedure outlines the requirements for conducting formal Management Review Meetings (MRMs) within your organization. These meetings involve top leadership and are essential for maintaining and improving your Quality Management System (QMS). This template will help you set up your Management Review Procedure and plan your MRMs effectively.

Who is Responsible for Setting Up the Management Review?

  • Top Management: Appoints a Management Representative (MR), a member of the management team responsible for documenting and maintaining the Management Review Procedure.
  • Management Representative (MR): May appoint a delegate within the quality team to assist with responsibilities under the MR’s oversight.
  • Meeting Documentation: Each section or topic reviewed should include any recommendations for improvement identified by the MR, department manager, or other sources.

How Will This Template Help My Organisation?

  • Set Procedures: Define and document your Management Review Procedure in compliance with ISO 13485:2016.
  • Plan Meetings: Effectively plan and schedule Management Review Meetings.
  • Ensure Compliance: Demonstrate compliance with ISO 13485:2016 by maintaining thorough records of your 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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