ISO 13485 Certification for an Internal Warehouse?


Starting to get Involved
It's a somewhat confusing scenario, but if an internal warehouse that typically performs logistical activities for non-medical devices is now being tasked with performing logistical activities for a medical device, will it need to be ISO 13485 certified? Our assumption is yes, but hoping to confirm that with the group here.

And, if yes, will the warehouse itself need to establish its own QMS, or does the "parent entity" need to do so?

Thank you and please ask any clarifying questions as I'm sure there is additional nuance I have missed.

Jen Kirley

Quality and Auditing Expert

In my experience warehouses perform logistics processes as a follow up to manufacturing output from manufacturing sites versus having their own certifications. However, the stringent requirements of ISO 13485 are not well suited for warehouses, whose processes are limited. I more often find that ISO 9001:2015 applies. For that reason it is possible for the warehouse to hold its own certificate.
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