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Customer Related Processes - ISO 9001

Customer Related Processes - ISO 9001

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ISO 9001:2015 - QMS.8.2.1 - QP - Customer Related Processes

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 are Customer Related Processes? Why do I need them in my Quality Management System (QMS)?

  • Customer Related Processes are any processes which relate to fulfilling or addressing customer requirements, such as:
    • conducting requirements review,
    • preparing quotations,
    • managing customer orders,
    • collecting customer feedback,
    • taking actions to improve customer satisfaction.
  • The purpose of this template is to provide your organisation with a framework to detail the processes used to determine, review and communicate customer requirements.
  • This is essential not only for a well-functioning QMS, but for maintaining a high level of customer service and satisfaction.
  • The ISO 9001 standard requires that organisations:
    • Determine the requirements relating to your product,
    • Review the requirements relating to your product,
    • Confirm customer requirements before acceptance.
  • These requirements could include:
    • User training,
    • Regulatory requirements,
    • Customer feedback.

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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