Ten Tips for Selecting and Using a Consultant – 4. Adjust your audit approach

The intent of ISO 9001:2000 is to encourage the adoption of the process approach to manage an organization. As a result, internal audits of your quality management system need to adopt a similar approach.

An activity that uses resources to transform inputs to outputs can be considered a process. The output from one process may become the input to the next process. To function well, organizations have to identify and manage numerous interacting processes.

The Process Approach involves the systematic identification and management of these process interactions within an organization. For effective audits, you have to understand the process nature of the system and follow the appropriate audit trails.

For example, auditing to the requirements for “quality objectives” requires considering clause 5.4.1, quality objectives, as well as, related clauses that refer to quality objectives (4.2.1.a, 5.1.c, 5.3.c, 5.4.2.a, 5.6.1, 6.2.2.d, 7.1.a, and 8.5.1).

So, an audit to see if “quality objectives” have been planned, implemented, monitored, and improved will consider requirements from multiple clauses. Use of an electronic version of the standard can help these identify important cross-references.

ISO 9001:2000 requires your processes to be identified (4.1.a) and their sequence and interaction to be determined (4.1.b). Clause 4.2.2.c states these process interactions must be described in your quality manual.

Audit planning should identify process linkages and ensure these audit trails are followed for more effective evaluations of your quality management system.