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Organisational & Strategic Risk Register Template - ISO 13485

Organisational & Strategic Risk Register Template - ISO 13485

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ISO 13485:2016 QMS Template - Organisational/Strategic Risk Register (QMS. - QR)

Enhance your Quality Management System with our ISO 13485:2016 compliant Organisational/Strategic Risk Register 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 an effective risk management process, demonstrating robust quality management as required by ISO 13485:2016.

What is an Organisational/Strategic Risk Register?

The Strategic Risk Register (SRR) is an essential tool for identifying, defining, tabulating, and assessing risks that could impact your organization's operations and delivery of Quality Objectives. This template, used in conjunction with QMS.7.1.0 - QP - Risk Management, helps you establish actions to mitigate risks.

How Will the SRR Template Help My Organisation Show ISO 13485 Compliance?

The ISO 13485 standard requires organizations to document risk management processes within their Quality Management System (QMS) and maintain records of risk management activities. This template, when filled out with your organization's information, will help satisfy these requirements by:

  • Documenting Risks: Providing a comprehensive record of identified risks and their potential impacts.
  • Assessing Risks: Offering a structured approach to evaluating risks and determining appropriate mitigation actions.
  • Maintaining Records: Ensuring that records of risk management activities are kept up-to-date and accessible for audits and reviews.

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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