I have a question for you.
I am experienced with ISO9001 and 13485. Conducted many audits as the company representative.
I am working with a small startup site, no employees or equipment yet and am tasked with putting in a 13485 system in an ISO8 cleanroom operation.
Using your toolkit and no employees, other than a few senior leadership individuals who will not help much, how long should I allocate to getting all the procedures in place to pass an audit?