ISO 9001 serves as the basis for benchmarking an organization’s quality management system. Quality management should not be confused with terms such as quality assurance” or quality control. Quality management measures the overall management function in determining the organization’s quality policy, its objectives, and its responsibilities, as well as the quality policy implementation through means such as quality assurance and quality control. Quality assurance measures all planned and systematic activities implemented within the organizations quality system. Quality control is the operational techniques and activities used to fulfil quality requirements (e.g., meeting a customer’s specifications or requirements for a given product or service).
Revision of the ISO 9000 standards has been under discussion for a number of years. Soon after the 1994 revisions, ISO Technical Committee 176 began the task of overcoming the standard’s manufacturing bias while, at the same time, overcoming other persistent criticisms that the standard did not adequately cover all aspects of the QMS.
The development of ISO 9001:2008 has been a particularly interesting process to behold. It is an object lesson in consensus building. ISO Technical Committee 176, with the participation of various national standards bodies, has actually managed to overcome criticisms from apparently opposite directions and written a document that appears to be acceptable to the great majority of ISO’s member bodies.
The manufacturing industry criticized the older versions of ISO 9001 for its failure to include a large range of quality management requirements in the standard. Some manufacturing industries considered ISO 9001 to be so inadequate that they developed their own expanded, industry-specific versions of the ISO 9001 standard. ISO was also criticized by non-manufacturing industries for catering to the manufacturing industries. Everything about the older versions of ISO 9001 seemed overwhelmingly rooted in a manufacturing environment.
The ISO technical committee found itself in a dilemma and then found a way out. ISO 9001:2008 appears to have actually reached a satisfactory compromise in which the language is generic enough to be applicable to industries other than manufacturing yet specific enough to satisfy the particular concerns of the manufacturing industry.
As far as actual implementation of the new standard was concerned, ISO Technical Committee 176 recommended that implementation of ISO 9001:2008 could begin as early as the fourth quarter of 1999 — one full year in advance of the standard’s scheduled publication. The ISO technical committee made this recommendation because ISO works through a lengthy consultative process to achieve a consensus. Once a consensus was obtained (in early 1999), further changes became improbable.
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