Introduction of ISO 9001

What is ISO 9001 Certification?

Since its introduction in 1987, ISO 9001 has been the target of criticism and considerable debate. Much of this is due to a misunderstanding and misapplication of the requirements. Some practitioners of quality disciplines view the requirements as too generic to be of any significant value. Some organizations view certification as simply the “ticket” for doing business. Purists state that it is physically impossible to manufacture products or deliver services defect free on a continuous basis. And some organizations view certification to be just one more mandated cost, a cost for which there is no return on investment.

In 1979, Phil Crosby created quite a stir in business when his book Quality is Free1 was published. What Mr. Crosby was saying is that “quality,” that is, a product or service that conforms to requirements, is the natural outcome of a well-planned and implemented manufacturing or service business. It is “non-quality” that results in the extra, profit limiting, cost to business. Simply said, if you plan correctly, make product or deliver service correctly, provide on-time delivery, you will make money – assuming your pricing is correct and affordable.

With the introduction of ISO 9001, the business world now has a generic model for a quality management system that, when designed, developed and implemented, will provide the framework for assuring that customer requirements are defined, quality product or service is made or delivered on time, and that product/service and the management system are improved on a continuing basis. However, with the emphasis on the terms “system” and “process,” many readers of ISO 9001 miss the linkage or tie-in between the specific requirements and product or service quality. This paper will provide this linkage, sometimes as an overview, sometimes with specific links. The reader will also be provided with a view of the dynamics and interactions of various processes, and hints at what to audit for when assessing the quality management system.

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