Company purchased by holding company - What quality changes are needed?

B

Bridget

#1
Our company (manufacturer of Class I and IIa) has been quietly purchased but nothing is changing internally. In fact many of our employees are unaware of this. The only visible change will be on the org chart where we used to identify the company president as the owner and we changed the coorporate name but not the company name. In fact they have not even told me but googling visitors names told me what I need to know.
Can anyone think of changes that might affect the QS that I should address? Anywhere the corporate name appears on packaging has been changed with an ECO.
Thanks in advance,
Bridget
 
Elsmar Forum Sponsor
#2
Bridget,
My company's owner & parent changed from an overseas holding company to a domestic capital investment firm. Other than a couple of shuffles at the top, nothing changed, not even our name. We had a couple of job descriptions that needed a new name at the bottom (president & CEO changed).

In my case, the change was noted in Management Review under our "Changes that may effect the Quality Management System" section. Topic discussed. Management statement that this change does not effect the Quality Management System noted. Management requirement that Quality Management System continue operating in the current exemplary fashion noted. Done.

I would advise you to do the same. Unless you document your recognition that a change of this magnitude has taken place, a 3rd party might get the idea that the Quality department is pretty clueless.

P.S. - Advise your 3rd party auditor/registrar before they ask. Ask them if they need any documentation or other action from you. Don't let them be surprised by this change.
 
Last edited:

harry

Super Moderator
#3
Good advice from Icy. If you are still worried about the legalities, talk to your company secretary/corporate department. A one paragraph resolution will do the trick (at least for the time being). I would imagine that it had already been carried out.


Regards.
 
B

Bridget

#4
You both had some great points to consider and now I feel I can approach this with management before it comes out during an audit and we are not prepared.
I knew someone at the cove would have gone through this before.
Thanks to you both (and anyone else who would care to share their experience on this subject).
Bridget
 
#5
You are welcome, Bridget. I came back to look at the feedback and noticed that I was in the 13485 Forum. Be advised that our system is ISO9001 & TS16949 only. You may have additional requirements for reporting a change like this to your Registrar & your 13485 requiring customers. Under our registration agreement with DNV, we MUST report changes in ownership to them as a requirement of our continued certification. We are not required to report ownership changes to ALL of our customers; however, we have one TS subscriber that includes this as part of their customer specific requirements.
 
G

Gert Sorensen

#6
Our company (manufacturer of Class I and IIa) has been quietly purchased but nothing is changing internally. In fact many of our employees are unaware of this. The only visible change will be on the org chart where we used to identify the company president as the owner and we changed the coorporate name but not the company name. In fact they have not even told me but googling visitors names told me what I need to know.
Can anyone think of changes that might affect the QS that I should address? Anywhere the corporate name appears on packaging has been changed with an ECO.
Thanks in advance,
Bridget
Your notified body may have a requirement to be informed immediately of significant changes to management. This may be considered one :notme:

You may need to inform Health Canada if you have products registered on the canadian market. That is if my memory serves me, I have a faint recollection that they actually have a legal requirement to be informed of changes to the top management due to the fact that top management is judicially responsible.
 
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