ISO 13485 - The use of virtual offices (everything is sub-contracted)

[Wheeljem]

Hi Everyone,

A client wants to move his office (he manufactures a medical device but sub-contracts the whole of the purchasing, build and test process). His 13485 is held at this current office address but wants to keep that address as his registered office as a virtual office and move the actual office plus staff to a new office.

What are your thoughts on whether the new office should be added as an additional facility or whether he can just move and not make any changes?

I look forward to your thoughts.

Cheers!

 

[somashekar]

Re: 13485 - The use of virtual offices

Hi Everyone,

A client wants to move his office (he manufactures a medical device but sub-contracts the whole of the purchasing, build and test process). His 13485 is held at this current office address but wants to keep that address as his registered office as a virtual office and move the actual office plus staff to a new office.

What are your thoughts on whether the new office should be added as an additional facility or whether he can just move and not make any changes?

I look forward to your thoughts.

Cheers!

Where there are no processes happening, no controls from there are being executed on other processes that are outsourced, where no people are performing tasks and interacting...how can a QMS be established there and further, what can a CB auditor witness there to recommend a certification .....

 

[Ronen E]

Re: 13485 - The use of virtual offices

Hi,

I agree with Somashekar. The fact that purchasing, production and testing are outsourced is irrelevant - if they move address then this has to be reflected in the certification. If they sell the device(s) under their name then they are specification developers and in general, legal manufacturers. As such, the new address needs to be on the labelling - I assume that the office is where they handle complaints.

Cheers,
Ronen.

 

[Wes Bucey]

Occam's razor postulates something to the effect:
"simpler explanations are, other things being equal, generally better than more complex ones"

In this case, the simplest explanation (solution) to the holder of a 13485 registration would be to pose the question to the registrar which issued the certificate. "Hiding" this plan from the current registrar bespeaks "intent to defraud, at a minimum to mislead, regulatory authorities about the true nature of the business."

 

[Wheeljem]

Thanks Guys,

I have been highly uncomfortable with the idea but was having problems on how to actually put it across in order to kill it off.

Your comments have been most helpful.

Have a great day.