Would this be a second site for the purposes of internal and third party audits?

[shelzkipp]

I work for a company that manufacturers in one site. We manufacture medical devices that use software developed by us, no stand alone software. My question is that we are considering hiring computer engineers for code writing and software development that will be working in another country. Would this be a second site for the purposes of internal and third party audits? They will have no hardware and will report to USA managers. They will be working from home and my management is asking for guidance in case we get them office space. Does anyone have any insight into this?

Thanks in advance!

 

[qualprod]

I work for a company that manufacturers in one site. We manufacture medical devices that use software developed by us, no stand alone software. My question is that we are considering hiring computer engineers for code writing and software development that will be working in another country. Would this be a second site for the purposes of internal and third party audits? They will have no hardware and will report to USA managers. They will be working from home and my management is asking for guidance in case we get them office space. Does anyone have any insight into this?

Thanks in advance!

I think it depend of the scope, if most of operations are in your office, probably no, but if they are in the remote place, the CB
could consider an additional site.
The most precise answer can come from your CB.
Cb´s have their own criteria, it may be different from one to another.
Hope this helps

 

[shelzkipp]

This does help, I have reached out to my CB but no answer as of yet.

 

[Randy]

Yep, most likely outsourced processes requiring everything else applicable to suppliers and supplier management. They are simply supplying product to you for incorporation into your product.

 

[qualprod]

Yep, most likely outsourced processes requiring everything else applicable to suppliers and supplier management. They are simply supplying product to you for incorporation into your product.

Well, in this case it may be convenient to hire them as an external supplier and be treated this way, contrary to hire people under your organization, in this schema, it may apply the additional site.