Does ISO 9001 *require* that Internal Audits be Process Audits? I know it says it "promotes" a process approach, but is there a specific requirement in the standard that I am missing?
It is not a requirement for:
1. The IA is to determine the conformance to the planned arrangements to the requirements of the standard, and to the QMS requirement established by the organization. Here all the established process can be standalone audited.
However ...
2. The IA is also to determine if the QMS is effectively implemented and maintained.
Some key lines here...
* Status and importance of the processes and areas to be audited
* Plan and develop the processes needed for the product realization
* Consistent with the requirements of the other processes of the QMS
* Determine the processes needed for the quality management system and their application throughout the organization
* Determine the sequence and interaction of these processes,
* The Quality manual requires a description of the interaction between the processes of the quality management system.
So I deduce that for the conformance it can be plain process audit, however for effectiveness it must be processes based audit.