ISO 13485:2016 - Complaints Handling

According to the ISO 13485:2016, section 3 Terms and definitions complaint is written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, usability, safety or performance of a medical device or related to a service that affects the performance of such medical devices. 

Please be careful here with understanding, because sometimes the medical device is service, like installation of service of a medical device in case of some malfunction or break.

So, information from the customers on late deliveries, wrong billing, and similar can be considered as feedback. 

For more information regarding customer complaints, please see the following articles:

• 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/
• Effective complaints management in a QMS https://advisera.com/9001academy/blog/2014/09/16/effective-complaints-management-qms/