1.3 Selection of a QMS Baseline

A number of quality management baselines exist that can result in an effective QMS. They consist primarily of custom designed total quality management (TQM) programs, and programs built upon a nationally or internationally recognized standard. Figure 1.4 illustrates three specific types of systems for evaluation: a typical TQM example, a system based on ISO 9001:2000, and a system based on the Baldrige standard ^[3].

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Figure 1.4: Potential effective QMS baselines.

We note that all three systems can be designed to encompass all of the organization's core competencies. In addition, all three can employ action teams to measure cost of quality and to provide top management with a corrective and preventive action protocol. The key difference between the three lies in the ability of the ISO 9001:2000 approach to attain certification, either nationally, internationally, or both.

Although the Baldrige award is a nationally recognized certification, of the three concepts, only the ISO 9001:2000 QMS provides for both accredited international and national recognition. In addition, the 1994 version is used as the foundation for a number of sector-specific applications that include the automotive, medical, aerospace, and telecommunications industries ^[4]. The adoption of the 2000 version as the foundation for the sector-specific standards is already underway.

^[3]ISO 9001:2000, American National Standard, Quality management systems - Requirements, American Society for Quality, Milwaukee, Wisconsin, December 13, 2000; and Baldrige National Quality Program 2001, Criteria for Performance Excellence, NIST, Gaithersburg, MD. The Spring/Summer, 2001, ASQ Quality Press Publication Catalog lists 17 selections for TQM, at (http://qualitypress.asq.org).

^[4]At this writing, this policy to use the latest ISO 9000 Standard as the basis for sector-specific standards will be followed for the medical device industry (i.e., ISO 13485) and will most likely be followed for all other sector-specific standards.