This paper I have written contains a lot of information about ISO 9000 and Quality Management Systems. I will first talk about some of the history and origins of the ISO phenomenon. I will also mention some of the changes and elements of the Quality Management Systems, financial issues, pros and cons of being certified, and the relationship ISO 9000 has with ISO 14000.
The International Organization for Standardization was founded shortly after the end of World War II to bring commonality and uniformity to products as well as to a number of critical quality areas. Development of the ISO 9000 series was a natural step for the International Organization for Standardization. According to Donald Sanders (1997, p.6), "As its other standards brought uniformity to products throughout Europe and the world, so the ISO 9000 series was designed to bring uniformity to the area of quality systems" Quality standards grew as quality became more important to consumers and as each country often instituted its own quality standards. This large number of standards posed a hardship for many companies as they tried to keep track of the wide range of requirements and regulations. Multinational firms found it particularly difficult because they often had to juggle a number of often-conflicting regulations or face the fact that they might not be able to sell products designed for one country in another nation because they did not meet that country's unique standards. It was also becoming obvious that quality products and services demanded company wide commitment instead of just the efforts of the quality department.
The ISO 9000 series standards that we know today were developed by committees of quality experts selected from member bodies around the world. These members began meeting in 1979 as Technical Committee 176. The ISO member body in the US is the American National Standards Institute (ANSI), which has worked through the American Society for Quality Control to contribute to the development and ongoing improvement of the standards. The letters ISO in ISO 9000 is taken from the Greek isos, meaning "equal". "ISO" was chosen in an intentional effort to inform users that the standards apply to all users equally, regardless of a company's size, products, services, or the country in which it is located. The term ISO 9000 refers to a dynamic and comprehensive set of standards for a companywide quality system that is "built in," not "inspected in." These ISO standards are revised and reissued roughly about every six years (Sanders 1997). The first set of standards was published in 1987, and the first revision appeared in 1994. And now the latest updated version in 2000. These new standards are referred to as the "ISO 9000 2000 Standards". ISO 9000 currently includes three quality standards: ISO 9000:2000 (fundamentals and vocabulary), ISO 9001:2000 (requirements), and ISO 9004:2000 (guidelines).
When you compare ISO 9001:1994 and ISO 9001:2000 you'll notice a lot of different changes that have been undergone. ISO has abandoned the 20-clause structure of the old standard. Instead of 20 sections, the new standard now has 5 sections. ISO reorganized the ISO 9001 standard in order to create a more logical structure, and in order to make it more compatible with the ISO 14001 environmental management standard. ISO 9001:2000 is more customer-oriented than the old standard. While the old standard was also oriented towards meeting customer requirements and achieving customer satisfaction, the new standard addresses this in much greater detail. In addition, it expects you to communicate with customers and to measure and monitor customer satisfaction. In the past, organizations that wished to be certified were referred to as "suppliers" because they supplied products and services to customers. Since many people were confused by this usage, ISO standards focus on the "organization," not the "supplier." The term "supplier" now refers to the organization's supplier. The new redefined term "supplier" replaces the old term "subcontractor". Also, under the new standards, you may ignore or exclude some requirements. Requirements that may be ignored under special circumstances are known as exclusions. According to ISO, you may ignore or exclude any of the requirements found in Section 7 Product realization as long as you meet certain conditions.
The main clauses that make up the