ISO 13485 Multiple Site Registration - Corporate HQ is listed as a subsidiary

M

Masey B

#1
The corporate HQ of the company I work for is listed as a subsidiary on our ISO 13485 certifcates with a subsidiary of the company listed as the main address. This strikes me as a little unusual & I wanted to see if this is normal practice or not.

Initially the company had a single site registration with the corporate HQ address as the main one but Quality & Regulatory functions within the group moved twice to different sites and with it the registration. We obtained multiple site registration in 2010 but only found out today that the main address for the certification is our subsidiary & not HQ

My background is in R&D not Quality & Regulatory, I've just been landed with a caretaker role in QA while the company is restructured.

Thank you in advance for your help!
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Re: ISO 13485 Multiple Site Registration

The corporate HQ of the company I work for is listed as a subsidiary on our ISO 13485 certifcates with a subsidiary of the company listed as the main address. This strikes me as a little unusual & I wanted to see if this is normal practice or not.

Initially the company had a single site registration with the corporate HQ address as the main one but Quality & Regulatory functions within the group moved twice to different sites and with it the registration. We obtained multiple site registration in 2010 but only found out today that the main address for the certification is our subsidiary & not HQ

My background is in R&D not Quality & Regulatory, I've just been landed with a caretaker role in QA while the company is restructured.

Thank you in advance for your help!
Hello & welcome to the cove :bigwave:

I wouldn't be too concerned with that; I believe there are no substantial consequences either way. I guess the last certification audit was based in the subsidiary and focused on its operations, hence its certification as the primary site.

Maybe some gentlemen around here would have different perspectives.

Cheers,
Ronen.
 
A

arios

#3
Re: ISO 13485 Multiple Site Registration

The corporate HQ of the company I work for is listed as a subsidiary on our ISO 13485 certifcates with a subsidiary of the company listed as the main address. This strikes me as a little unusual & I wanted to see if this is normal practice or not.
This does not seem like usual IMHO. Talk to your registrar or check your contract with them to see it they are aligned
 
B

beyedoers

#4
Based on the info supplied, I agree that this is a cosmetic "address change" issue as long as no significant changes, i.e., company management, acquisition, product registration (CE marking), or any other critical QMS changes have occurred since your last surveillance audit.

As mentioned by the previous contributor, you should get your hands on your company's registration agreement and familiarize yourself with the contractual agreements the company signed up to upon QMS registration and certificates issuance.

Again, it sounds like you should contact your registrar and ask them to provide you with the form you need to complete to notify the registrar of such changes as address, etc. Note that there may be a cost associated with this in case the registrar has to issue corrected certs.

Hope this helps and best wishes,

Jerome Council, ISO 13485:2003 Lead Auditor
 
M

Masey B

#5
Re: ISO 13485 Multiple Site Registration

Thank you all for your help & advice, it's much appreciated.

Ronen - You are correct in your assumption that the last certification audit took place in the subsidiary. We have out renewal audit this summer with the 3 sites on the certification being audited so maybe that would be the right time for us to speak to our NB about which facility should be the main address.

Thanks again everyone for your help :)
 
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