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Complaints Procedure - ISO 9001

Complaints Procedure - ISO 9001

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ISO 9001:2015 - QMS. - QP - Complaints 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.

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

  • The ISO 9001 standard requires that your organisation evaluate the degree of customer satisfaction with your product(s).
  • 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 a procedure that allows your organisation to handle complaints productively and identify any reoccurring trends.

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 product(s) are handled.
  • This procedure will cover customer complaints relating to your product(s) and product related activities, it will not cover customer complaints relating to other organisational activities such as customer services, advertising 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

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