ISO 9000 compliance is fast becoming de rigueur for doing business worldwide. It is not only a prudent business decision to become ISO 9000 certified in an effort to keep up with the market, but it is also a requirement for dealing with some industries in the E.U. and the U.S. For example, the European Union (E.U.) requires foreign companies in some industries to be ISO 9000 certified in order to do business within the E.U.’s borders. More recently, the United States’ automotive industry has also begun to demand a derivative of ISO 9000 certification for its national and foreign suppliers. Further, the U.S. Department of Defense is in the process of replacing its military quality specifications with the ISO 9000 quality series as a prerequisite for its suppliers.
The European Union requirements for ISO 9000 product or industry compliance are based on a system of classifying products as regulated or non-regulated. Regulated products are required to be manufactured under the ISO 9000 standards and are those products that have a health, safety, or an environmental impact. While these types of products account for only 15 percent of E.U. trade, it is still circumspect for businesses to become ISO 9000 certified. ISO 9000 certification is not technically mandatory to do business within the borders of the E.U. except in certain industries, but businesses with certification will have more opportunities to maintain and procure E.U. contracts than companies that do not. In addition, even if the law does not require ISO 9000 certification, purchasers may require ISO 9000 compliance from their suppliers. Purchasing companies favor ISO 9000 because the supplies bought from ISO 9000 certified vendors do not require a lengthy quarantine, testing or inspection after their receipt. Buying materials and products from ISO 9000 certified businesses, also limits the purchasers’ exposure to product liability.
Contents of the ISO 9000 Quality Series
Industry professionals describe the overriding principles of the ISO 9000 standards as “say what you do, do what you say, and prove it.” The ISO 9000 quality series consists of five sets of standards numbered 9000 to 9004 that are applicable to large and small companies alike, regardless of the industry. The standards are not product specific which gives them wide applicability, but also makes them very general.
When a company says that it is ISO 9000 certified, it generally means that it complies with all of the applicable ISO 9000 quality standards for its particular business. The terms “ISO 9000 certified” and “ISO 9000 registered” cause much confusion. First, companies must become ISO 9000 certified, and then they may become ISO 9000 registered. ISO 9000 certification is verification by an accredited third party auditing organization that a company’s quality system complies with all the requirements of its ISO 9000 series quality standard model. ISO 9000 registration, on the other hand, is the listing of the company and its scope of certification in a published directory. Registration also allows a company to use the registered firm symbol provided by the assessor on any advertising, correspondence, invoices, etc. as evidence of ISO 9000 compliance.
ISO 9000 – Conceptual Road Map
ISO 9000 is divided into three parts respectively referred to as: ISO 9001, ISO 9002 and ISO 9003. Primarily, ISO 9001 clarifies the quality-related concepts discussed throughout the ISO 9000 family of standards. It also provides guidance to companies in their selection and use of the individual ISO 9000 standards.
ISO 9001 – Design, Development, Production, Installation, and Servicing
ISO 9001 specifies the quality system requirements in the situation where a supplier’s capability to design and supply conforming products is at issue. The language of the ISO 9001 is that of what the supplier’s system “shall” do. The standard is aimed at achieving customer satisfaction through the elimination of nonconformity at all stages of manufacture and servicing.
ISO 9002 – Build-to-print, Installation, and Servicing Without Design
ISO 9002 focuses on a quality system in which the supplier’s capability to provide a product conforming to established design needs is of primary importance. Whereas customer satisfaction is present in the goals and other standards of the ISO 9000 series, it is the focal point of ISO 9002.
ISO 9003 – Assembly and Test
The quality system described in ISO 9003 focuses on a supplier’s ability to detect and control product nonconformity during final inspection and test. ISO 9003 is applicable to situations where the conformance of a product to specified requirements can be documented to ensure confidence in the supplier’s capability for inspection and tests on the finished product.
ISO 9004 – Implementation and Control
ISO 9004 describes “recommended practices” that “should” be followed by management regarding the implementation and control of a quality system.