Volume 8 · Issue 4 · June 2002
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 products 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
doesnt do, but he provides additional observations that
are appropriate to consider during ISO 9001:2000 implementation.