I am putting an ISO 13485 QMS system. I have previously had 2 QMS systems in other companies accredited by notified bodies and thought that this is the only way to gain certification.
My present line Manager states other companies other than notified bodies can issue ISO 13485 instead of going down the notified body route, I am not sure that this is right. I cannot find a company that does this.
Am I right in thinking it has to be a notified body