The CD-ROM includes two versions of the ISO 9001 internal audit checklist:

In addition to general topics this checklist also includes specific, practical questions and tips with auditing techniques. This is especially helpful for inexperienced auditors and for auditor training.

To download demo (MS Word file), click on appropriate picture or link. Your browser will do the rest.

Using the process approach, you audit your company's processes instead of individual elements of the quality system. The criteria and scope of the audit are basically the same, but the sequence, approach and focus changes from the ISO 9001 standard to the actual organization and processes of your company.

In process approach the flow and focus of the audit is on the organization rather than the ISO 9001 standard. It considers the effectiveness and efficiency of processes, such as purchasing, for example, and how the process interfaces with other processes. Process auditing is more natural and logical, and adds more value to the organization than the element (compliance) approach.

Difficult and time consuming to implement than element based auditing. The additional steps in implementing process approach auditing are developing a process map and associating all major processes with relevant ISO 9001 requirements.

Compliance is verified by associating all ISO 9001 requirements to relevant processes and verifying whether the process and its implementation meet these requirements. For example, The purchasing process in your organization, in addition to being effective and efficient, and meeting your other internal requirements (procedures), must also meet all requirements of ISO 9001 Clause 7.4, Purchasing, and other relevant clauses.

Process approach internal auditing is not explicitly required in the ISO 9001 standard, and you should not have any problems (at least not yet) with your registrar if you choose the element approach. However, a broader process approach to quality management is explicitly required in the standard and a growing number of registrars and auditors would like to see it extend also to internal auditing. It is likely that within a couple of years process approach auditing will be required by all registrars. (It is already unconditionally required by the automotive industry in ISO/TS 16949.)

First you must define your processes and establish your process map (which you should have anyway in order to comply with ISO 9001 Clause 4.1). Then associate each process with all relevant ISO 9001 requirements (sections, clauses and sub clauses). And finally organize the checklist into sections representing your processes, and for each process list the corresponding requirements and audit questions. The scope of the checklist remains the same as for the element approach (all ISO 9001 requirements) but the basic unit of the audit is now a real process instead of an arbitrary clause in the standard.