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Two Quality Management Systems - ISO 13485 in one company possible?

J

JuergenW

#1
our buisiness unit is bought from a medical company and we are now a subsidiary (no legal entity), but still want to keep our quality system (13485). Is it possible, that the company gets a second 13485 certificate for this settlement? It would cause a lot of trouble to implement the QM system of the company to our organisation. The notified body could not give an answer and DIMDI neither. Any body there who has similar experiance?
 
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R

Rickser

#2
Re: two quality management systems 13485 in one company possible?

Are the two business units co-located or separate. That may have an impact. I'm not sure about the medical field, but an aerospace company with two separate locations can be certified at one and not the other.
 
I

isoalchemist

#3
Re: two quality management systems 13485 in one company possible?

My apologies in advance if I misunderstand the relationships and go down a long path. If your NB can’t answer the question it leads me to believe I’m missing something already but…

Your organization can certainly have their own registration to whatever standard makes sense as a stand-alone organization. That registration would not apply to the other entity.

If you combine QS for the entities with both using the same processes (which you said would be difficult) both could have the same registration as long as both meet the requirements. It eliminates the need to duplicate efforts i.e. duplicate Quality Manual, Management reviews, but if the business processes are not similar it will not work.

If you are asking if you can maintain your listing with your old business partner the answer would be no.

IMHO there are a lot of outstanding issues to help decide how best to proceed. Most revolve around the business relationship of the two organizations, the integration o or lack of integration f the systems, and the terms of the sale.

With a bit more information I’m sure the Cove can offer direction.
 
J

JuergenW

#4
Re: two quality management systems 13485 in one company possible?

the two business units are completely seperated. even more, we don't report to them because this company is also a daughter of a large company located in the US, we report directly to the mother in the US. The other organisation is just a legal entity.
 
J

JuergenW

#5
Re: two quality management systems 13485 in one company possible?

ok, i would like to give a bit more information. A few weeks ago we were a company with two business units, the company is ISO 13485 certified. Now our business unit is bought by a medical device company in germany that is also daughter of a large company in the US. Our establishment is just a facility, no legal entity like a GmbH. the old company keeps the 13485 certification. As we will not being integrated into the company's processes we will keep our processes as before and will therefore have our own quality manual. however there are some things in the quality manual that regards the legal entity, e.g. the safety officer. what about chapter 4 of the standard, may they being applyed for our location, like company strategy, policy, etc?
 
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