ISO 9000: A Universal Standard Of Quality
Those managers familiar with the lexicon of quality know what ISO 9000 is and realize the impact it will have on their companies. For those who don't know, now is the time to find out, because ISO 9000, a series of five international standards that establish requirements for the quality systems of organizations, is starting to have international business repercussions.
The standards have been adopted by the European Community and by the individual nations of that community. They are being used to provide a universal framework for quality assurance. As trade barriers are torn down and Europe becomes economically unified in anticipation of EC 1992, ISO 9000 is becoming a tool to ensure cross-border quality.
On this side of the Atlantic, the standards also are being adopted by NATO, the U.S. Department of Defense, the American Society for Quality Control (ASQC) and the American National Standards Institute (ANSI). In addition, at least 35 countries around the world have adopted ISO 9000. The ISO 9000 series are the best selling standards in the history of the International Organization for Standardization under whose auspices they were developed. ISO 9000 even has outsold the international weights and measurement standards.
What does this mean from a competitive point of view? Right now, the EC requires that companies that produce regulated products, such as medical devices, must be registered to the ISO 9000 standards. The EC is encouraging other producers to register their products, and so far, about 20,000 European companies have been registered. By the end of 1992 when EC economic unification has been achieved, nearly all European companies will have met ISO 9000 requirements. As it now stands, registered companies can and do display the EC mark as a seal of approval; unregistered companies cannot.
ISO 9000 is becoming a de facto market requirement for companies that wish to do business with the EC. If two suppliers are trying to land the same contract in Europe, the supplier who has achieved registration of its quality system to ISO 9000 standards has a clear competitive edge.
At Du Pont, our plants and businesses regularly receive inquiries from European customers about ISO 9000 status, which has spurred Du Pont's registration efforts. At our European facilities, where the pressure is greatest, we have registered more than 35 plant sites and are working toward certification of others. And we are catching up in the United States. So far, 14 plants or businesses have been registered domestically, and many others are involved in the registration process.
Because the EC's support of the ISO 9000 standards has increased their international importance, it's reasonable to believe that the adoption of the standards by the Department of Defense and major U.S. companies like Du Pont will result in ISO 9000 becoming increasingly important here. And ISO 9000 is catching on elsewhere in the world. The Japanese, for example, not only have adopted the standards, but also have mounted a major national effort to get their companies registered. Some experts believe that within five years ISO 9000 registration will be necessary for businesses to stay competitive.
ISO 9000 need not be complicated, however. It's not an awards program like the Baldrige and it doesn't require the use of any state-of-the-art systems. As a matter of fact, you don't even have to use any prescribed method of process control such as Shewhart, CUSUM, or engineering process control. As long as you document what you do, do what you document, and produce the quality of product you have promised to your customers, you can be certified and registered.
In many ways, you call the shots because ISO 9000 doesn't set up "quality cops" looking over your shoulder, telling you what to do. You, however, must determine …