Without a doubt, the most significant issues about implementing the control requirements in section 7 of ISO 9001 have been related to subclause 7.3 on design and development.

During the early days of ISO 9001:2000 implementation, many organizations had been certified to ISO 9002:1994, a standard that, unlike ISO 9001:1994 and ISO 9001:2000, didn’t include the design control requirements. Many organizations had opted to use ISO 9002:1994 because their design and development departments didn’t want to implement the required design controls. Yet most would admit that the majority of product-related problems had root causes either in the design process itself or in the design-to-manufacturing or service-delivery process. ISO 9001:2000 offered such organizations the opportunity to “exclude” design and development only if the requirement “… cannot be applied due to the nature of an organization and its product…,” as might be the case for a machine shop that only machines parts to other companies’ drawings. Many organizations found themselves having to meet design and development control requirements that they’d never really considered before, as specified in ISO 9001 subclause 7.3.1--”Design and development planning--The organization shall plan and control the design and development of the product.”

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