Feedback & Complaints Database - ISO 13485

ISO 13485:2016 +A11 2021

QMS.8.2.2.1 - QR - Feedback & Complaints Database 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.

Why do I need to include a Feedback & Complaints Database in my Quality Management System?

• The ISO 13485 standard requires that your organisation document procedures for feedback and complaint handling and maintains records of feedback and complaint handling activities.
• If handled unsatisfactorily, haphazardly or inconsistently, customers could escalate complaints further and result in brand damage and loss of revenue.
• Customer feedback and complaints can be a helpful catalyst in improving your medical device and Quality Management System so it is important to maintain a database that allows your organisation to handle feedback and complaints effectively.

What information will I need in order to fill in the database?

• You will need to be able to easily identify individual complaints, i.e., assigning them unique complaint reference numbers.
• You will need to record complaint details including, but not limited to:
  • the date the complaint was made,
  • when any complaint investigations were opened and closed,
  • description of the complaint and the nature of any injury or harm that may have been caused.
• The template will help you record all the information required to show compliance with this section of the standard.

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 qmsregs@patientguard.com.