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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. 
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.
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.

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.