Thank you Sreenu and Rob for your comments. I do agree that these requirements should be covered under the scope of our NB audit, but I just don't see the direct link to the requirement that they be covered by our internal audit schedule. We also have never been written up for this in the past. Rob, while we do look at labels under D&D, we don't really have a formal method of approving them per the MDD like the table you provided. All of our devices are pretty basic and similar, so the first labels were created by following the MDD and CMDR. This format was verified by the review and approval of our NB and Health Canada. From there, I just swap out part numbers and descriptions for the new products, but the format and content is the same. They are then transposed onto blueprints and controlled that way.
In looking at 13485, is it 8.2.2 a) ...to the requirements of this International Standard and to the quality management system requirements established by the organization ... that require it to be covered? One of our quality objectives is: To demonstrate that the quality system is being achieved, maintained and continually improved in accordance with ISO 13485, FDA QSR, European MDD, Canadian CMDR and [FONT="]Brazilian RDC #59. [/FONT]If so, then all requirements should be audited not just labeling. Right?
In the end, I probably need to just take it up with the auditor, but I appreciate your help so I can go into the conversation with a little more knowledge on my end.
Thanks, Paul