there is much todo about that question andy....but let me add my 2 cents here before the group gets fired up.
Perform the audit to the procedures, then that done, answer the canned questions from what you observed/noted while auditing. Your audit trail, over time and experience, will have the details you need to determine whether the System is functioning properly. The audit trail is key. You should be able to recreate..many months later...the situations noted, both conforming and not. That and a cross reference of elements to areas will provide you all the information you need, of course that assumes (arrrrhhh I hate that word)the documentation has covered the shalls in the first place and has been properly cross referenced.
Add to the schedule... the 20 elements, then the scope of taht audit is to review the findings from all the audits in that element..for instance. Training....review all area audits for findings on training issues. I do this best with a report cover sheet (electronic) that has classifiations of findings, those include things like training, traceability, inspection status, stats, doc control, equipment, records, repeat occurrances, previous CAs issued/closed....what ever works, serves a quick reference for Management Review as well. This came from a retention report for the DoD I used to have to do, and adapted it to ISO.
[This message has been edited by barb butrym (edited 12 July 1999).]