I'll give a plus 1 to Andy. You're auditor is out of his mind.
Also, if you can read you can audit. If you have formal training is ISO 9001 auditing, how hard is it to read and interpret the additions 13485 add? That's silly. As for training, see if there is a local auditor/consultant or association who can provide some 13485 specific training.
Good luck.
Also, if you can read you can audit. If you have formal training is ISO 9001 auditing, how hard is it to read and interpret the additions 13485 add? That's silly. As for training, see if there is a local auditor/consultant or association who can provide some 13485 specific training.
Good luck.