Customer feedback
Our product is a class III single-use sterile device. We don't have any customer property and therefore Customer property, Installation, and Service have been excluded (not applicable). Does customer complaint/ feedback consider as Customer property?
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
No, customer complaint/feedback is not considered as customer property. You just need to explain in your Quality Manual that these clauses don't apply to your organization since you do not produce medical devices that need installation and service, and that you do not perform processes that include customer property.
For more information on customer complaint handling process regarding ISO 13485, please read this article:
How to comply with ISO 13485:2016 requirements for handling complaints https://advisera.com/13485academy/blog/2017/03/21/how-to-comply-with-iso-134852016-requirements-for-handling-complaints/
Thanks, it's my understanding also. Just to let you know that the statement regarding customer feedback related to customer property came from our NB. Mabey, the return of products (property) require investigation can be considered as customer property ?
Yes you are right. If you receive return product for investigation that is customer property, and you need to handle it in accordance with the requirement 7.5.10 of ISO 13485:2016.
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Nov 08, 2019