ISO 13485 and new warehousing


Hi all,

I am in need of a little help here.
We are ISO 13485 certified and the scope of application is testing and consulting services for medical devices. We are considering sub-locating part of our facility to another company for warehousing materials which are insensitive to environmental factors. We will not be involved in anything regarding handling, receiving and shipping for the materials stored in this part of our facility, and we do not handle materials which are sensitive to environmental factor neither. Activities will be completely separated.

My main question would be: does that type of service (new but not related to our products / lab or quality system) need to be explicitly defined in our QMS even though it will have virtually zero impact?
My guess is since it is not an applicable scope, no, but I am a bit torn here.

Thanks for your help.


Super Moderator
At most, it might drive some infrastructure requirements (access controls? storage area not on the physical floor?). It's probably a service that should be covered under purchasing (with possibly a Quality Agreement ... to segregate from anything else stored there, limit access, etc.
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