My company was recently going through a ISO 13485 surveillance audit. During the audit, the lead auditor would not allow/accept corrections to documents where errors were discovered. We were told that all corrections would need to go through the third party process with an Action Plan, Root Cause and Corrective Action written and approved by the audit team. This is the first time in +20 years in the medical device industry that I have not been allowed to make corrections. My question is, has anyone one else experienced this?