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Complaint Investigation Form - ISO 9001

Complaint Investigation Form - ISO 9001

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ISO 9001:2015 - 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.

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

  • The ISO 9001 standard requires that your organisation documents a record of the complaint investigation process and results. For example, any correction or corrective action.
  • If not addressed customers could escalate complaints further and resulting in reputational damage via negative reviews or customer returns /loss of revenue.
  • Customer complaints can be a helpful catalyst in improving your product(s) 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

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