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Non-conformance Report Template - ISO 13485

Non-conformance Report Template - ISO 13485

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ISO 13485: 2016 +A11 2021

QMS. - QR - Non-Conformance Report 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 Non-Conformance?

  • A non-conformance is a failure to meet one or more of the requirements in the standard.
  • If your organisation finds or is issued with a non-conformance as part of a routine audit or otherwise, you are obligated to take immediate steps to rectify the issue.

How will keeping Non-conformance Reports help my organisation?

  • Filling in Non-conformance Reports will help your organisation document a record of non-conforming product as well as the associated investigation and action(s).
  • You will be able to ensure any non-conformances are corrected and demonstrate compliance with the standard.

What does the standard say about Non-conformances?

  • The standard requires that your organisation identifies any medical device which does not conform to the requirements specified both within the standard and your organisation’s procedures.
  • The standard also requires that a record of the nature of any non-conformity discovered and any ensuing action taken must be maintained.

If you would like further information on our wide range of templates or have any suggestions for improvements 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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