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When is there a need to open and handle a complaint?

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Guest user Created:   Nov 20, 2020 Last commented:   Nov 23, 2020

When is there a need to open and handle a complaint?

Hello,

first of all thank you, that you offer this service and even free of charge!

I have more or less a simple question:
Does a complaint only begin when a company receives a complaint from a customer ( oral, written or electronic) OR also when a customer reports a case to a service hotline, e.g. if the medical device is not working properly and the service team can fix the problem - but there might be a problem with the device in general that needs to be investigated?
In the latter case, the company itself would initiate the complaint, but I wonder if this is even necessary because it was not officially reported by a customer?

I hope if it is clearly to understand what I mean.. :)

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Nov 23, 2020

No, you do not need to initiate the complaint in the case that you have described. However, this situation is an input to your design and development process and also for the risk analysis. Responsible persons from these two processes (D&D and risk management) must be informed about the cause and a change process probably need to be initiate. 

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Nov 20, 2020

Nov 23, 2020