Re: CMDCAS vs. ISO13485 - Additional requirements to normal ISO 13485 for CMDCAS audi
Your post was a little confusing.
As far as I could make out, your company already holds an SCC-accredited ISO13485 certified, issued under CMDCAS.
You will be changing locations in August.
I think the first thing to say is that your move in August shouldn't really impact your audit this week, except maybe to show control of the upcoming change via management review, risk management plans etc etc.
You are required to advise your registrar of significant changes, in advance, and it is sensible to give them at least three months notice, which you appear to have done. Note that a quick phonechat with your auditor is not necessarily the same thing as formal notification, best to follow that up with a fax or email directly to the registrar.
There will need to be a re-audit of the new facility at some point, you should discuss those logistics with your registrar. You will receive a new ISO13485 (SCC) certificate from the registrar, this will need to be copied to Health Canada within 30 days.
You will need amended device / establishment licenses from Health Canada, the F201/202 forms can be found on their website. I've forgotten the timing on that, I'm sure someone can remind me.