Chapter 14: The Biggest Change in ISO 9001:2000 From ISO 9001:1994


To learn something about the Standard, it is necessary to examine the Standard in detail. For example, the Standard mandates that the organization continually improve the QMS effectiveness. Activities that illustrate continual improvement can be obtained by means of such requirements as the quality policy, quality objectives, audit results, analysis of data, corrective and preventive action, and management review (Par. 8.5.1: Continual Improvement of the Standard).

This highly prescriptive language is not only remarkable for a generic Standard but it is backed up by even more prescriptive language in Par. 8.4: Analysis of Data. This mandates that we are to use quantitative methods in the analysis of data, which demonstrates not only how suitable and effective our QMS is but where its effectiveness can be continually improved.

This is powerful stuff! You are required to continually improve the effectiveness of your QMS, and you are required to do it by quantitative means!

Obviously, this is an idealist view of how enterprises actually work. Given the ebb and flow of real-world pressures, an enterprise could not be expected to always show QMS effectiveness. There will often be times when just survival is the primary aim of the enterprise, let alone demonstrating that product return rates have declined. In fact, you may be in the midst of a total recall of your last year's shipments. That anomalous spike in your product return rates would certainly indicate ineffectiveness of your QMS but would not be a predictor of your long-term health.

The Standard should probably have added the caveat, "and quantitatively indicate how ineffectiveness is being corrected." That is really what is important. If you are doing well, how do you intend to do better? If you are in trouble, how do you intend to dig your way out? In both cases, one should ask how quantitative analysis is used as an improvement tool? This is the answer that I attempt to seek out as a third-party assessor, and I believe this is the intent of the Standard.

The issue of quantitative analysis, by means of effective quality objectives, is discussed in the next chapter.




ISO 9001(c) 2000 Quality Management System Design
ISO 9001: 2000 Quality Management System Design
ISBN: 1580535267
EAN: 2147483647
Year: 2003
Pages: 155

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