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Process Improvement Essentials by James R. Persse PhD

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The Structure and Design of ISO 9001:2000

ISO 9001:2000 is designed as a generic quality management standard. It can be used by just about any manufacturing organization to control the production of its components in such a way as to ensure control, visibility, and adjustability in meeting preset quality objectives. There are distinct advantages to implementing a 9001 program, but the degree to which you are bound by the design and structure of the program depends upon one factor: whether you wish your organization to become ISO-registered.

ISO registration is the process of having your 9001 Quality System audited and then having compliance rated against the Standard. If you pass the audit, your organization can register this result (active for a period of three years) with the ISO. You are then recognized as operating in a way that satisfies the performance criteria in the Standard. ISO registration is seen as a mark of distinction, as a competitive advantage, and as a required entry into certain market segments. But registration is not a required activity for all those who adopt ISO 9001. 9001 can deliver its benefits to an organization without that organization needing to move through the registration process.

With this objective removed, an organization is free to use any or all parts of 9001, in full or partial implementation, in such a way as to improve the areas it wishes to improve. This approach—implementation without third-party recognition—probably represents the best approach ...

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