Certification Scope

[H.Richardson]

Hello, Our current scope on our cert is design and development as we are contract manufacturers. We have a recertification audit at the end of the year. If we want to chnage the scope of our cert to be advisory/consultation instead, what are the implications of that? Does anybody what that process would look like? And if we changed the scope, what consultation related docs would we need in our QMS prior to the audit to demonstrate the functionality of our QMS?

 

[indubioush]

Can you clarify what you mean by advisory/consultation?

 

[Ed Panek]

I’m not familiar with the advisory consultation portion of iso 13485. I don’t see it on the standard.

 

[Chrisx]

I would advise checking with your notified body or registrar to see if this is even permissible. There are guidances they have to follow on certificate scope. They may not allow this terminology.

 

[ChrisM]

I'd also check with your customers, they may require you to maintain ISO13485 certification to include specific topics/areas