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Organisational/ Strategic Risk Register - ISO 13485

Organisational/ Strategic Risk Register - ISO 13485

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ISO 13485:2016 +A11 2021

QMS. - QR - Organisational/ Strategic Risk Register Template

Our Medical Device Quality Assurance and Regulatory Affairs document templates have been created by fully qualified and experienced professionals at Patient Guard, a Quality Assurance and Regulatory Affairs Service provider. The templates have been specially written to ensure that they meet the basic requirements needed for each clause/section of the standard or regulation the templates relate to. We have carefully curated the templates to ensure they are easy to follow and adapt to make them specifically modified to your business needs. All the templates are fully editable Microsoft word documents allowing you to have complete control over the templates which can then be modified to suit your company branding/marketing requirements.

What is a Organisational/ Strategic Risk Register?

  • The Strategic Risk Register, in conjunction with QMS.7.1.0 - QP - Risk Management, will help your organisation identify, define, tabulate and assess risks.
  • The risks included in the Strategic Risk Register are those which have been identified as likely to impact on the company’s operations and/or delivery of the Quality Objectives.
  • The Strategic Risk Register template will help your organisation identify and establish actions to reduce risk where possible.

How will the SRR Template help my organisation show ISO 13485 compliance?

  • The standard requires that your organisation shall document one or more processes for risk management in the Quality Management System, and that records of risk management activities be maintained.
  • When completed with information from your organisation, this template, in combination with QMS.7.1.0 - QP - Risk Management, will help to satisfy this section of the standard.

If you would like further information on our wide range of templates or have any suggestions for improvement that require support in addition to our templates in the form of other Medical Device Quality Assurance or Regulatory Affairs services, contact us at

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