Does Risk Management apply to re-labeler (MDR)

[Daliane]

Hi everyone
my client is a re-labeler of resins. They buy resins from an EU manufacturer and relabel the bottle. No changes to the content is made. The only change is the label and design of the bottle.

I am supporting the client to setup an ISO13485 QMS for their business. Among the purchasing process, what other core processes apply?
Do we have to apply Risk Management acc. to ISO 14971?

Appreciate any feedback and recommendation.

Have a great one!

Daliane

 

[koulidis]

You always have to apply risk management when having a QMS based on ISO 13485. ISO 14971 is not mandatory. You can use any other standard (e.g. ISO 31000) or have your own system. The core process is the re-labelling. You should identify risks related to this process (e.g. use of infrastructure, personnel training, applying the label etc)