Clarification regarding customer communication

Answer:

It is a mandatory requirement to inform the customers of the complaint if it is pertaining to a medical device recall or a field safety corrective action as the customers might need to quarantine any stocks that have been sold out or are currently in their warehouse. You should be looking at clause 8.2.2 Complaint handling which provides you with more information on the procedure of complaint handling. With regards to clause 7.2.3, it means that the company should have a way to get feedback from a custom er with regards to the purchased product or services (quality or not quality related), including complaints.

For more information, please read articles:

How to comply with the latest changes in ISO 13485 clause 7.2.3 Communication
https://advisera.com/13485academy/blog/2018/05/16/how-to-comply-with-the-latest-changes-in-iso-13485-clause-7-2-3-communication/

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/

Customer Feedback Report
https://advisera.com/13485academy/documentation/customer-feedback-report-iso-13485-2016/