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.

“It was the best of times, it was the worst of times…” So begins A Tale of Two Cities , Charles Dickens’ epic novel. Dickens’ words are just as apropos to today’s uncertain times as they were during the French Revolution, when the novel is set.

There is much confusion about the constructs of quality and customer satisfaction (Q/CS). “Quality is doing the right things right,” say some experts, but how can we be assured that a service provider is doing the right things? Here’s an example: “I recognize that the opera singer has a tremendous vocal range [high quality], but I hate opera [dissatisfaction].” In other words, if service providers are interested in quality as a means of achieving customer satisfaction, the cognitive model of quality is inadequate.