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Is there a way to customize intake forms when filling out a customer complaint?

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Guest user Created:   Jun 20, 2019 Last commented:   Jun 20, 2019

Is there a way to customize intake forms when filling out a customer complaint?

Is there a way to customize the intake forms when filling out a customer complaint?
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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.

Expert
Kristina Zvonar Brkić Jun 20, 2019

Answer:
According to the requirement 8.2.2 Complaint handling, following data are necessary for each customer complaint:
-Date of receiving the complaint
-Complaint description
-Who received a complaint
-Who reviewed it – investigated it – is it reasonable or unreasonable
-Suggestion for complaint treatment
-Who approved suggestion
-Execution deadline
-Responsible for execution
-Is there any corrective or preventive action initiated

It can be done in table form. When taking the customer description, be sure to take the Lot number and to how many pieces of the medical device this compliant referred to. When you create a form that will cover all of these elements, you must ensure that such a form is available to anyone who needs it whenever they need it.

For more about handling customer complaints, please read 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/

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Jun 20, 2019

Jun 20, 2019