Is it an onsite audit mandatory as part of ISO 13485 certification?

[Randy]

There will have to be a physical and real address on the certificate. I've got 3 or 4 virtual organization that I audit myself for a CB, so I'm not guessing like most of the others here. Virtual organizations are addressed in the compliance documents we have to meet, so if someone say that they have to do a physical visit for a virtual organization you might be using the wrong people.

 

[Hemoscd13#]

There will have to be a physical and real address on the certificate. I've got 3 or 4 virtual organization that I audit myself for a CB, so I'm not guessing like most of the others here. Virtual organizations are addressed in the compliance documents we have to meet, so if someone say that they have to do a physical visit for a virtual organization you might be using the wrong people.

Which compliance document are you referring to?

 

[Randy]

Which compliance document are you referring to?

The ones Certification Bodies have to follow set by the ISO & the appropriate Accreditation Bodies like ANAB or UKAS.

 

[Sidney Vianna]

Since we are a 100% virtual company we don't have a physical address to audit.

So how do you apply for a regulatory approval? Site identification is mandatory

 

[Hemoscd13#]

The ones Certification Bodies have to follow set by the ISO & the appropriate Accreditation Bodies like ANAB or UKAS.

I was looking for a document #.

 

[Randy]

ISO 17021 but it might not apply to medical and it's a mandatory document for CB's not certified organization as you are seeking to become. ............In the end it doesn't matter what you like, it matters what "is" and I'm pretty sure you will have to have a physical address of some kind on the certificate currently.

 

[Hemoscd13#]

I am truly baffled by this situation as we can't be the first virtual company to come across this issue. I'm hearing that some companies have rented office space but then the address of the audit won't match the corporate address even if it is a virtual mailbox.