Fitness-for-Use a Liability Exposure?

If your organization is not responsible for design, then it can exclude ISO 9001:2000 clause 7.3 from its system. Of course, this exclusion must be identified and justified in the quality manual.

If your customer is fully design-responsible, then your organization’s role in product development will be very limited, or even non-existent. So, if you’ve excluded clause 7.3, how will your organization ensure product fitness-for-use as required by clause 7.2.1.b?

Clause 7.2.1.b states an organization must determine any requirements not stated by the customer, but necessary for the specific or intended use, where known. If not excluded, this clause will place a burden on the manufacturer to ensure fitness-for-use, even if it had no involvement in the design and development process.

Determining fitness-for-use requirements should be part of the design and development process. If your organization is not involved in this customer process, does clause 7.2.1.b really apply to your system? Perhaps you should consider excluding clauses 7.3 and 7.2.1b as a related set of requirements.

Note: This entry was based on an article by James Kolka in the June issue of The Informed Outlook.