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Volume 8 · Issue 4 · June 2002


Page 14…

Potential Risks Associated With Product Realization

James W. Kolka writes that it is important to recognize that there are limitations to what an organization can do when its role in a product’s development is limited or nonexistent. He examines what one industry group perceives as a potential liability exposure if organizations in its sector were to conform with a requirement in ISO 9001:2000. The group proposes that those members that do not engage in design and development should exclude Subclause 7.2.1(b from their quality manuals. Kolka notes no organization should comply with something it doesn’t do, but he provides additional observations that are appropriate to consider during ISO 9001:2000 implementation.