Re: Process Audit Approach vs. Clause Audit Approach
This is one of my major frustrations in the ISO based standards. When they came out, there was much talk about "Process Approach" as if ISO invented it. At first it was not very clear, and the documents did not mandate it, it only inferred. However, it is evolving each year toward more clarity that a process approach is expected.
TS made it very clear (finally) in the Rules, 2nd ed. ISO has been a little slower, but both the ANAB in the US and the TGA in Germany are pressing more and more to expecting a process approach, not an element approach. Thus the CB's and auditors are pressing that as well.
I do not disagree with the process approach. I just made a note saying that ISO 9001:2000 does not include a shall for process audits. We must be very cautious mentioning requirements that do not exist or are misinterpretations from registrars and auditors. If CB's add requirements that are not in the Standard (even with the right intent), is that not defeating the purpose of having a Standard in the first place? Re: Many previous discussions abouts audits (internal/external) here at The Cove.
This is one of my major frustrations in the ISO based standards. When they came out, there was much talk about "Process Approach" as if ISO invented it. At first it was not very clear, and the documents did not mandate it, it only inferred. However, it is evolving each year toward more clarity that a process approach is expected.
TS made it very clear (finally) in the Rules, 2nd ed. ISO has been a little slower, but both the ANAB in the US and the TGA in Germany are pressing more and more to expecting a process approach, not an element approach. Thus the CB's and auditors are pressing that as well.
Some processes may be just within a Department, whereas some other processess may be cross-departments. As such the auditor may have to travel from one department to the others to complete his audit of particular process.... Can the auditor not doing so himself but to rely on his members (other auditor in the team) that perform audits at other departments to colloborate info or evidence require for that process? 
go figure, he has an MBA and I only have 2 yrs of college and you can guess what audits get cherry picked out of the schedule come the last two months before goals are reviewed! 
