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Volume 7 · Issue 10 · October 2002

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Page 27…

The ISO 9001:2000 PSI IDEAS Q&A—Effectiveness

The PSI IDEAS program has launched a Q&A process aimed at providing a variety of perspectives on requirements of ISO 9001:2000 and the challenges they present to users. The fifth question is: Continually improving the effectiveness of the QMS is the focus of Subclause 8.5.1, as discussed in Question 4. But what is meant by "effectiveness"? Specifically, what are some examples of how an organization will determine if its QMS is effective? What types of changes may need to be made to ensure that the QMS’s effectiveness is continually improved over time? What types of process performance measures might an organization need to establish to help it determine effectiveness? Further, how will registrar auditors determine that an organization has continually improved the QMS’s effectiveness over time? What types of objective evidence will they look for? If many continual improvement activities are taking place, what evidence would prove that the effectiveness of the QMS is actually improving?