Internal audits are often scheduled, and therefore conducted, according to the ISO 9001:2000 clause structure. These audits are more focused on judging conformity than evaluating effectiveness. Looking clause by clause, the quality management system may appear conforming, yet be fragmented and ineffective.
- Inputs: What, when, and from whom?
- Resources: With what people, materials, equipment?
- Methods: How done (procedures and instructions)?
- Controls: How monitored and controlled?
- Measures: What are performance indicators?
- Outputs: What is delivered, when, and to whom?
The traditional “process” audit has been a short, detailed evaluation of a single process within a department. The audit scope may not have included the process interactions outside the functional area. ISO 9001:2000 requires an audit of the entire system, either at one time or spread over multiple subset audits. This broader view must address the process linkages to evaluate the overall system. To be less disruptive, and maintain quality awareness, audits of individual processes may be scheduled each month until the full system is covered.
Auditors should view the quality management system as a set of integrated processes (by understanding the interfaces and interactions). Adopt the process approach for your audits. Add value by looking at more than just conformity. Evaluate the linked processes for their “effectiveness”. Verify their controls and identify any process risks. Also, determine opportunities for improvement.