The primary purpose was to assure customers that the certified company produces products at a consistent level of quality. ISO is quite different from the original standard. The new standard is based on a process model that any enterprise can use, whether they are a manufacturer, a chemical processor or a service provider.
Instead of 20 elements as in the old standard, the process model of the new standard has four major sections Sections 0 through 4 provide background and logistical information :.
Sections 5 through 8 contain all the requirements for the new ISO standard. Using more generic, and less prescriptive terms, than ISO , ISO makes it easier for all types of enterprises to adapt their operations to the new ISO standard.
The requirements are a quantum leap forward and in line with progressive thinking in the quality field. Edwards Deming. The quantum leaps featured in ISO focus on customer input, continual improvement, resource management and management responsibility. Figure 1 is a graphic depiction of the process model, showing the power of the customer under the new standard.
Customer requirements drive the input, while customer satisfaction drives the output. In regard to continual improvements, it will not be enough for an organization to measure customer satisfaction. It will be necessary to improve the level of satisfaction, which requires a way to measure and improve internal processes. Continually improving defect rates, with consequent increased customer satisfaction, is a core value of Deming and total quality management TQM.
Although many, including the authors of this article, believe that continual improvement was always implied in ISO , continual improvement is now a clearly defined requirement. In regards to resource management, the standard contained a paragraph that required management to provide all necessary resources. These provisions are expanded in the revision. The resource management section of the new standard spells out a wide range of resources that should be utilized.
These include human resources, the availability of adequate numbers of competent people, training necessary to assure competence, infrastructure, work environment, safety, ergonomics, hygiene, suppliers, partners and financial resources. However, for the most part, under ISO , the quality management system was largely the responsibility of quality professionals, not upper management. Executive management plays a far more central role with the new standard.
In ISO , management responsibility is expanded so that management presides over a multi-step version of the process:. Management review requirements have been expanded in the new standard. Management must specifically check the policies and objectives of the QMS to find ways where improvements can be made. Every element of its predecessor can be mapped onto the new ISO Moreover, since the new version requires written procedures, the familiar four-tier pyramid structure for documentation need not change, although it can be simplified under the new standard.
On the other hand, much of the existing documentation may need to be remapped and expanded to meet the requirements of ISO In many cases, these revisions are substantial.
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