@Jim Wynne, he cited section 8.2.4 a) of ISO 13485:2016...
"The organization shall conduct internal audits at planned intervals to determine whether the quality management system conforms to planned and documented arrangements, requirements of this International Standard, quality management system requirements established by the organization, and applicable regulatory requirements."
We feel we showed evidence of meeting this section and our organizational QMS requirements and we told our auditor this. Unfortunately, he was determined that this was a finding. Throughout the rest of the audit there were several additional instances in which we felt our responses to his findings and comments fell on deaf ears.
Some days the bear gets you...