Risk Management for Distribution company?

N

NT Bregman

#1
Hello. This is my first time posting here at the forum. I have been reading through all the other threads regarding Risk Management but I couldn't find one that answered my question so I was hoping that somebody may give me some guidance.

One of my clients is setting up a distribution facility in Argentina. They would like to be ISO 9001 certified as a medical device distributor. During the initial audit, they were cited for not having a risk management procedure and report for their distribution process. :( They have asked me to help them put one together. Is anybody familiar with this? The only risk management procedures and reports that I have seen are for the design and manufacture of medical devices. Any help would be greatly appreciated. Thank you. :thanx:

Also, all the products that they would be distributing are manufactured by other companies so they are not involved in the design or manufacturing process at all.
 
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Marcelo

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#3
This is what is happening in Brazil also, the manufacturer OR distributor is required to have a risk management file according to ISO 14871 (which in practice makes ISO 14971 mandatory).

What happens is, from a regulatory standpoit, the distributor is regarded as the manufacturer in the country. So they have to have all the process and documentation required for a manufacturer, in this case, a risk management process and documents according to ISO 14971.

The distributor in this case should perform the activities which are designated to them by the original manufacturer. For example, ISO 14971 requires that post-production information be acquired as an input to the risk management process. A distributor in a country might be required to perform these actions for the original manufacturer and them feed the information to the original risk management process.

The only risk management procedures and reports that I have seen are for the design and manufacture of medical devices. Any help would be greatly appreciated. Thank you.
Well, then the risk management procedures you have seen are wrong, not according to ISO 14971; ISO 14971 is a liecycle standard which details a process wihch has to be active from conception of the device thru the removel form service/end of life phase. It´s not to be appliced only to design and manufacture.
 
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