I've been auditing to ISO 9001 since 1992. A part of my auditing philosophy has been to add value to the audited organizations by suggesting opportunities for improvement. Following, I will describe the most effective “value adds.”

Continual improvement

Look at ISO 9001:2000 subclause 8.5.1--"Continual Improvement." The statement of this requirement is “The organization shall continually improve the effectiveness of the quality management system (QMS) through use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive action, and management review. ...well-run quality organizations have innovative methods of communicating with their customers.”

There are three major ways subclause 8.5.1 can be improved. Who is responsible for compliance to this requirement? Top management should have the responsibility. Also, there is no requirement for a process to accomplish continual improvement. Finally, how does one measure the effectiveness of the quality management system? Without a defined measurement of effectiveness it will be difficult to show improvement.

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