Setting up a service center in the EU

J

Jkc3usc12

Involved In Discussions
I am setting up a service center in the EU. This service center is also not on a critical supplier list. This group will operate under our QMS and plan to have them brought under our iso cert later this year. I would like to do an internal audit and then go live with out them officially under our 13485 CERT.

I dont see this as an issue because there is no legal requirement to be iso certified.

Any thoughts or reasons why they couldn't go live and not have to wait for an audit.
 
Ed Panek

Ed Panek

QA RA Small Med Dev Company
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Super Moderator
Is this an EU service center for an EU company or for a company based outside the EU??

Will products be sent there from outside the EU and returned to customers?

I ran a service center for a US-based company with service/swap offices in Lisbon, Tokyo, and Shanghai. They were not audited by our NB but they were audited internally to our QMS>
 
J

Jkc3usc12

Involved In Discussions
Ed Panek said:
Is this an EU service center for an EU company or for a company based outside the EU??

Headquarters is in the USA

Will products be sent there from outside the EU and returned to customers?

Nope devices located in the EU would be serviced at this location.

I ran a service center for a US-based company with service/swap offices in Lisbon, Tokyo, and Shanghai. They were not audited by our NB but they were audited internally to our QMS>
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This is what i thought as well. Did you bring the service centers under your iso cert?
 
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