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Complaint Investigation Form - ISO 13485

Complaint Investigation Form - ISO 13485

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ISO 13485: 2016+A11 2021 

QMS. - QR - Complaint Investigation Form

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. For updates on Regulatory and Quality Assurance news visit Patient Guards blogs.

Why do I need to include a Complaints Investigation Form in my Quality Management System?

  • The ISO 13485 standard requires that your organisation documents a record of the complaint investigation process and results. For example, any correction or corrective action.
  • If handled unsatisfactorily, haphazardly or inconsistently, customers complaints could escalate further and result in brand damage and loss of revenue.
  • Customer complaints can be a helpful catalyst in improving your medical device and Quality Management System so it is important to document your investigation in a way that allows your organisation to handle complaints productively.

What information will I need in order to fill in the form?

  • You will need to be able to easily identify individual complaints, i.e., assigning them unique complaint reference numbers.
  • You will need to record complaint details including, but not limited to:
    • the date the complaint was made,
    • when any complaint investigations were opened and closed,
    • description of the complaint and the root cause.
  • The template will help you record all the information required to show compliance with this section of the standard.

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

Quality Management Support:

If you are looking for support with your QMS then Patient Guards consultancy services could be a cost effective solution for your organisation.

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