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Complaint Handling Procedure - ISO 13485

Complaint Handling Procedure - ISO 13485

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ISO 13485:2016 +A11 2021

QMS.8.2.2 - QP - Complaint Handling Procedure 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. For updates on Regulatory and Quality Assurance news visit Patient Guards blogs.

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

  • The ISO 13485 standard requires that your organisation document procedures for complaint handling.
  • If handled unsatisfactorily, haphazardly or inconsistently, customers could escalate complaints 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 a procedure that allows your organisation to handle complaints productively.

How will the Complaints Procedure help my organisation?

  • The purpose of this template is to help your organisation to author a procedure that will define how customer complaints relating to your medical device product are handled.
  • This procedure will cover customer complaints relating to your medical device product and product related activities, it will not cover customer complaints relating to other organisational activities such as non-medical device products and customer services, etc.

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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