QMS - Medical Device - New company under a current one

[anonymous16]

Hello guys!

I'm trying to think here, but I need help!

If you have a possible new company under your current one (meaning new registration and all... "a company of...", DBA, possible PL) Do we need to create a new QMS with that new company's name and process even if it'll be part of the existing one? I think yes, but I could be wrong...

Help!!

 

[ScottK]

Hello guys!

I'm trying to think here, but I need help!

If you have a possible new company under your current one (meaning new registration and all... "a company of...", DBA, possible PL) Do we need to create a new QMS with that new company's name and process even if it'll be part of the existing one? I think yes, but I could be wrong...

Help!!

Contact your current registrar to find the best option for your organization.
I've operated in multi-site companies with separate registrations for each site, and in multi-site companies with a single umbrella registration listing all sites.

It comes down to a business decision on what's most efficient.

 

[anonymous16]

Thank you ScottK we are currently working on that...

My question is more geared towards needing a new process (SOPs, WI, etc) under this "new company" or keeping the current and add the process of the new company?

Thanks again

 

[ScottK]

Thank you ScottK we are currently working on that...

My question is more geared towards needing a new process (SOPs, WI, etc) under this "new company" or keeping the current and add the process of the new company?

Thanks again

It depends on how autonomous the new company will be.

If they are going to be very dependent on the current organization you may want to keep the big procedures like Doc Control, Record Control, CAPA, Nonconformance, Design& Development, etc. controlled in the current Org and make the new one comply with these. If they have different manufacturing processes they will need their specific work instructions and any procedures specific to that site. But it's perfectly acceptable to control all the common QMS processes from one place.

If they are going to be very autonomous they may need their own core QMS processes which will likely mean their own Registration.