Why has ISO 9000 been controversial? How has the 2000 revision addressed some of the controversial issues?
The original standards and the 1994 revision met with considerable controversy. The standards only required that the organization have a documented, verifiable process in place to ensure that it consistently produces what it says it will produce. A company could comply with the standards and still produce a poor-quality product-as long as it did so consistently. Many never used the standards to drive improvement. Dissatisfaction with ISO 9000 resulted in the European Union calling for deem phasizing ISO 9000 registration, citing the fact that companies were more concerned with “passing a test” than on focusing their energies on quality processes. ISO 9000:2000 is a response to the widespread dissatisfaction that resulted from the old standards. The new standards have a completely new structure, based on eight principles-“comprehensive and fundamental rules or beliefs for leading and operating an organization” that reflect the basic principles of total quality and many of the core values and concepts of the Baldrige and European Quality Award criteria. With this underlying philosophy, the 2000 revision aligns much closer to the performance excellence concept of Baldrige. Organizations now need a process to determine customer needs and expectations, translate them into internal requirements, and measure customer satisfaction and dissatisfaction. Managers must communicate the importance of meeting customer and regulatory requirements, integrate ISO 9000 into business plans, set measurable objectives, and conduct management reviews. No longer can top management delegate the program to people lower in the organization. Organizations must now view work as a process and manage a system of interrelated processes. This approach is significantly different from the “document what you do” requirements of earlier versions. Analysis now needs to be done to provide information about customer satisfaction and dissatisfaction, products, and processes with the focus on improvement. Evaluation of training effectiveness and making personnel aware of the importance of their activities in meeting quality objectives are stressed. In the previous standards, organizations were required to perform corrective and preventive action but now must have a planned process for improvement.