Management Responsibilities Procedure - ISO 13485

Management Responsibilities Procedure - ISO 13485

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ISO 13485:2016 QMS Template - Management Responsibilities Procedure (QMS.5.0.0 – QP)

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

What is a Management Responsibilities Procedure?

A Management Responsibilities Procedure is a critical part of the Quality Management System (QMS) that outlines the commitments and responsibilities of your organization’s top management. This template helps your organization:

  • Establish Quality Policy: Define and communicate the Quality Policy (QMS.5.3.0).
  • Meet Requirements: Ensure compliance with customer, statutory, and regulatory requirements.
  • Maintain QMS Effectiveness: Outline the responsibilities of the Management Team (MT) in supporting and maintaining the effectiveness of the QMS.

How Does This Template Show Compliance with ISO 13485?

The ISO 13485 standard requires top management to demonstrate its commitment to developing and maintaining the QMS. This template helps you satisfy clause 5.1 of ISO 13485, which states: “Top management shall provide evidence of its commitment to the development of the quality management system and maintenance of its effectiveness.” By using this template, you will:

  • Ensure Compliance: Satisfy the requirements of ISO 13485 by putting in place an effective Management Responsibilities Procedure.
  • Document Commitments: Clearly document the responsibilities and commitments of top management in supporting the QMS.

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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