Customer Related Process Procedure - ISO 13485

ISO 13485:2016 +A11 2021 

QMS.7.2.0 - QP - Customer Related Processes 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.

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 13485 standard requires that organisations:
  • Determine the requirements relating to your medical device,
  • Review the requirements relating to your medical device,
  • Communicate these requirements with your customers.
• 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 improvement that require support in addition to our templates in the form of other Medical Device Quality Assurance or Regulatory Affairs services, contact us at qmsregs@patientguard.com.