Folks, there are several reasons for this to happen, but, by and large, the primary culprit is the misunderstanding of how ISO 9001 should be implemented. Going straight to the point, most quality programs fail because organizations don?t understand the difference between management of quality and managing FOR Quality.
Managing for quality is the concept that the organization business processes are designed, maintained and improved to incorporate proper quality principles and practices. So, quality and customer satisfaction become the natural result of running the organization?s business processes. Managing for quality requires that each process owner will ensure their processes have the appropriate requirements for effective and efficient quality, environmental, occupational health & safety (to name a few disciplines) embedded in the process. For example, a New Product Introduction Process (which is a key process for many organizations) goes across several departments and functions and transcends the requirements of ISO 9001 section 7.3. But, instead of developing, maturing and improving the NPI process, what do many organizations do? They have a procedure to comply with 7.3 of ISO 9001. Instead of someone at the Engineering function being appointed as the NPI process owner, someone in the quality function will be responsible to baby-sit the organization for compliance against 7.3. There are tremendous implications in the different approaches. While the first approach promotes process ownership by the appropriate individuals, the second approach promotes the unsustainable path of someone from quality ?policing? other departments (such as Engineering) to ensure they go through their necessary steps of planning, input, review, output, verification and validation. Such path is ineffective and can not be sustained over time.
Any organization has business process to operate. The key for effective and sustainable ISO 9001 implementation and certification is to make ISO 9001 INVISIBLE to most people working there. Comply with the standard(s) by embedding the applicable requirements into the business processes. That is the way to do it. Conformance with voluntary standards should be similar with compliance with legal requirements: it should happen as a natural deployment of a process that was designed to comply with the law. The operator on the shop floor should not be required to know the law(s) (such as FDA, EPA, OSHA, etc.). S/he should simply be required to follow the established process.
So, why don?t more organizations experience this epiphany? Unfortunately, in many cases ISO 9001 implementation and certification is misperceived by top management, as something that the quality folks can do in isolation and ?in absentia? of the rest of the organization. And, in many cases, the quality professionals ?tasked? with ISO 9001 implementation and certification are not proficient either in ?business-process-language?.