Transfer of an ISO 13485 Certificate to another Company

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58431Check

#1
Does anyone know if it is possible to transfer a company's 13485 cert to another company? The reason I ask is my family's company, which I work for, has recently endured the death of its President (my mother), who happens to be the sole shareholder also. The company is in awful financial condition but recently had its 13485 cert re-issued. I was planning on forming a new company and didn't want to incur anymore unnecessary cost. Any advice is appreciated.
 
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MIREGMGR

#2
Re: Transfer of 13485 Cert

Any such process would be determined by the certificate issuer.

I'd guess that as your new company will be new, with no history of utilizing the exact same quality and operational systems that were in place for the existing company, they'll want to cancel the existing certificate and start a new relationship with the new company.

As to costs...the NB's costs are related to the audit and review processes that I assume preceded the renewal, and those processes went forward since there was no way of knowing what events subsequently would occur. So, I'd guess that unfortunately the costs to the existing company are just lost.
 
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Golfman25

Trusted Information Resource
#3
Does anyone know if it is possible to transfer a company's 13485 cert to another company? The reason I ask is my family's company, which I work for, has recently endured the death of its President (my mother), who happens to be the sole shareholder also. The company is in awful financial condition but recently had its 13485 cert re-issued. I was planning on forming a new company and didn't want to incur anymore unnecessary cost. Any advice is appreciated.
When you say you are planning on forming a new company, will you be acquiring the old company? In other words, will it be a simple transfer of assets, process, people, etc. for estate planning purposes? Or will you be starting a new company from scratch? When I asked my auditors, the basic premise was the more continuity you have, the better chance you have for a simple "transfer."
 
5

58431Check

#4
When you say you are planning on forming a new company, will you be acquiring the old company? In other words, will it be a simple transfer of assets, process, people, etc. for estate planning purposes? Or will you be starting a new company from scratch? When I asked my auditors, the basic premise was the more continuity you have, the better chance you have for a simple "transfer."
Because the company is in such financial trouble, I was planning on using the existing quality system, customer list, vendors etc. to form the new company without absorbing the debt of the old. Where could I find out more info about a "simple transfer"?
 
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