Re: PROCESS APPROACH AUDIT
In earlier days of the ISO 9001 program, audits were performed using a checklist that walked through all of the requirements of ISO 9001. This is referred to as an element based audit as it walks through the elements of the standard.
This approach lead to lots of problems. For one thing, some of the requirements are repeated, at least in part, so you audited some topics more than once.
One of the biggest issues, in my opinion, is that it forced companies and auditors to focus on the minutia, becoming overly detailed, and loosing the bigger picture. The analogy I like is that it forced you to look so hard at the leaves that you forgot that the leaves belonged to a tree and that tree was part of a forest.
Process based audits focus on the basic business processes of the company. Exactly what comprises a process varies from one company to another, but a typical set could be Sales, Planning, Design, Purchasing, Production, Quality, and Management Related.
The company identifies what their processes are and describe them in the description of the interaction of processes that is required to be a part of their quality manual.
An auditor determines what the processes are by finding that description (auditors are not permitted to make up their own). An auditor also determines which elements of ISO 9001 apply to each process. The auditor then creates an audit plan that entails auditing those processes. Instead of using a checklist, he uses an audit working document to record what he finds, good and bad.
I hope this explanation helps.