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Risk Management Procedure - ISO 13485

Risk Management Procedure - ISO 13485

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ISO 13485: 2016 +A11 2021 

QMS.7.1.0 - QP - Risk Management Procedure

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 Risk Management?

  • Risk management is the identification, evaluation, and prioritisation of risk factors affecting the business.
  • Risk management can also involve the application of resources to minimise, monitor, and control the probability or impact of identified risks.
  • The purpose of this template is to define the process for addressing the risks associated with the activities of the business.
  • You will use this template to ensure that all significant risks are identified, assessed, and treated, enabling maximum capability for the achievement of the organisation’s objectives.

How will this template help my organisation meet the requirements for ISO 13485?

  • The standard requires that your organisation shall document one or more processes for risk management in the Quality Management System.
  • When completed with information from your organisation, this template in combination with QMS. - QR - Strategic Risk Register Template 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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