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.”
So what’s the problem? Why is there an issue at all? Other departments of organizations have implemented controls with little or no adverse effect and have often found the resulting quality management system to significantly improve both operations and financial position. Is the apparent fear of formal design and development controls just a red herring, or is there some real underlying issue? I think there’s a bit of both.
Design and development departments often think of themselves as special. After all, they hold the keys to the organization’s product innovations. If they’re not innovative and clever in developing new designs that customers will like, the organization will fail. They’re under tremendous pressure to innovate, yet are expected to follow a set of rules laid down in an international standard. From their point of view, such a demand may appear absurd. The perception is that placing controls on design and development will limit innovation and creativity, inject nonvalue-adding activities in the design and development process, or impose additional cost or time conditions. It’s discouraging to hear that these controls are being rejected before they’ve been understood. The controls are actually simple and, without dealing with the details, they can be summarized as follows:
• Plan the design and development stages, and the design review, verification, and validation activities.
• Manage the design and development interfaces.
• Control the determination of design and development inputs, and make certain that outputs meet input requirements, and are suitable for subsequent review, verification, and validation activities.
• Conduct the design and development review, verification, and validation activities needed to make certain that the product will meet specifications and fulfill the customer’s application needs.
Because design and development processes often involve costly, time- sensitive activities, top managers should see opportunities to get their new products developed on time and within budget. That’s the major benefit of these controls: They promote orderly completion of innovative work. More specifically, see figure 1 for benefits attained by applying these controls.