MDSAP Scope

#1
Hello everyone,

Thanks for all your help on this forum. A company plans to include both US and Canadian requirements in the MDSAP scope. If a company has a sister company in the US that is used as a warehouse/distribution center, should this US company be also included in the scope of the MDSAP and be audited during the MDSAP audit of the Canadian company? The QMS status of the US company is currently not clear. Any advice would be appreciated.

Thank you.
 
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#2
Morning Snoopy

I think the first port of call would be to define the status of the US company within the QMS. Is it within the scope of any other registrations you maintain (ISO 13485 or 9001)? If the company is within the scope of your other registrations then it should fall within MDSAP, if it is not then I would suggest it can be safely excluded.
 
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