Product complaints
Is there a deadline for handling product complaints?
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There is no prescribed deadline for handling product complaints in ISO 13485:2016, in requirement 8.2.2. Complaint handling. It is the manufacturer who must define the time within which the complaint must be resolved in accordance with applicable regulatory requirements.
For more information on complying with ISO 13485:2016 requirements, please read the 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/
For more information managing recalls and advisory notices for medical devices according to ISO 13485, please read the following article:
How to manage recalls and advisory notices for medical devices according to ISO 13485 https://advisera.com/13485academy/blog/2017/08/31/how-to-manage-recalls-and-advisory-notices-for-medical-devices-according-to-iso-13485/
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Nov 26, 2019