The Missing Key

摘要

Past perceptions about conformity to ISO 9001 suggest an organization may have a good quality management system (QMS) that conforms to ISO 9001, but it can still produce junk. In fact, ISO 9001 contains many requirements that, taken together, should provide reasonable assurance that the output of the system-the organization's products and services-will indeed meet customer requirements. There is also the myth that the design and development clauses of ISO 9001 cannot be applied to highly innovative product developments because they are too restrictive. Yet, we continue to see product and service disasters in the marketplace that could readily have been prevented by judicious application of these same design and development requirements.