2.3 The ISO 9000 QMS Process Model

The manner in which the Standard achieves continual improvement is by means of its process orientation. The roots of this process are inextricably wound into the QMS definition.

2.3.1 Quality Management System Defined

The characteristics of a QMS in regard to quality include the following ^[6]:

The establishment of policy and objectives by an organization to manage resources;
The assignment of responsibilities and authority to personnel;
The development of a an organizational structure among the personnel.

2.3.2 Operational Model for ISO 9001:2000

Based on this definition, we can graphically demonstrate the functional relationships between the various parts of a QMS. This concept is shown in Figure 2.1.

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Figure 2.1: Operational model for the ISO 9001—2000 QMS.

The difference between Figure 2.1 and Figure 1.1 is that Figure 2.1 explicitly lists the appropriate section number for each activity. This means that Section 4.0 of the Standard is indicated where it is not included in the Standard's model. Figure 2.1 also indicates the benefits to the enterprise in terms of increased profitability, productivity, and product performance ^[7].

Figure 2.1 also integrates the three pillars of ISO 9000 (i.e., the documented system, its implementation, and its demonstration of effectiveness). This is not meant to imply that one model is better than the other. We do mean to clearly illustrate how our operational approach adheres in detail with the Standard's model. In fact, those who have either created the ISO 9001:2000 QMS already or are in the process will often format their process discussions in terms of 5.0 Management Responsibility; 6.0 Resource Management; 7.0 Product Realization; and 8.0 Measurement, Analysis, and Improvement rather than in terms of core competencies. Unfortunately, the 5.0, 6.0, 7.0, 8.0 approach can bypass the key process requirements of Section 4.0, Quality Management System.

Although I have found little difficulty with the use of the Standard's sections (instead of core competencies), the approach seems to need a more extensive, careful set of reference links to send the reader from one process to another as compared to core competencies that tend to automatically link functions. But this is really more style than substance.

Regardless of which model you choose, you will always have to integrate into the flow support functions such as management review, control of documents, control of records, control of monitoring and measuring devices, internal audit, and corrective and preventive action. Core competencies tend to highlight these support functions more—witness the missed Section 4.0 in the Standard's model.

We see in Figure 2.1 that the Standard has essentially defined a classic engineering feedback system complete with inputs, outputs, and feedback loops. The inputs of end-user requirements, quality objectives, and quality management protocols are framed by the documentation system and trans-formed by the implementation system to produce continuously improved processes and products. These lead to outputs that include enhanced products, productivity, profitability, performance, and customer satisfaction.

In summary, between the Standard's process model and our operational model—in concert with our plan-do-check/study-act models—it is possible to graphically display the most important aspects of the ISO 9001:2000 requirements designed to create continual improvement.

^[6]Re: ISO 9000:2000, Clause 3.2.3.

^[7]Guidance on the Process Approach to Quality Management Systems at http://www.bsi.org.uk/iso-tc176-sc2.