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Does an RMA = a Customer Complaint


Quite Involved in Discussions
Viewing this from a medical device / ISO 13485 perspective but it could be viewed broader than that......

Does an RMA / return for repair automatically require that a customer complaint be initiated?

Yes there are cases when I could see an customer complaint be initiated. Cases like "I took the product out of the box and it didn't work". However there are other times when the customer drops the unit and it now needs repair. Or this has been in use for a number of years and now the product is not working like it used to. Or even an RMA for annual calibration of the unit.

Is there any guidance or criteria as to when a customer complaint is REQUIRED for an RMA return?

Ed Panek

VP QA RA Small Med Dev Company FDA and ISO13485:16
I would say the customer contact that generated the RMA is the complaint. The nature of the repair to bring the item into specification is seperate.

Bev D

Heretical Statistician
Staff member
Super Moderator
We do ‘screen’ our Customer contacts into complaint and a couple of other categories. (Very few). We have never had a problem with this with our auditors. Not all contacts are complaints so there is no value in calling all contacts complaints.


Involved In Discussions
Especially if you are separately logging and analyzing your RMAs for problems/trends/hazards/etc., then it would be redundant to record them as complaints as well; except where an actual complaint is also raised by the customer.

Ronen E

Problem Solver
Staff member
Super Moderator
A Complaint is an expression of dissatisfaction. If the return is not accompanied by such an expression, it's not a complaint. Most people tend to be at least a little vocal when they're dissatisfied, so I think that the risk of missing such expressions is quite low... especially if people on the receiving side are trained and instructed to look for it. Some (rare, I guess) cases would be in the grey, but in this situation I think a conservative approach will be quite healthy, so not really a problem.
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