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Customer Feedback Procedure - ISO 13485

Customer Feedback Procedure - ISO 13485

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ISO 13485:2016 +A11 2021

QMS.8.2.1 - QP - Customer Feedback 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.

What is a Feedback Procedure?

  • The purpose of a Feedback Procedure is to define how feedback is handled by the organisation.
  • This procedure covers all feedback received from customers, stakeholders and other sources relevant to the medical device product(s) and associated services provided by the organisation.
  • Feedback can be negative, neutral or positive. Negative feedback may also constitute a complaint (see template 8.2.2 - QP - Complaints Procedure).
  • This template will help you define your own Feedback Procedure and consider your organisations response when receiving feedback.

What does ISO 13485 say about customer feedback?

  • The standard requires that, as one of the measurements of the effectiveness of the quality management system, your organisation must gather and monitor information relating to whether it has met customer requirements.
  • you must document your methods for acquiring this information and what you do with it.
  • The standard also requires that your organisation document procedures for your feedback process.

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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