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What is ISO

International organization for Standardtization

ISO is a non-governmental organization established in 1947 in Geneva, Switzerland. Today, ISO has more than one hundred member countries. The mission of ISO is to promote the development of standardization and related activities in the global marketplace, to simplify the international exchange of goods and services, and to develop cooperation in the spheres of intellectual, scientific, technological and economic activities.

The term “ISO” refers to the International Organization for Standardization. You may be curious about the difference between the names of the organization: International Organization for Standardization (http://www.iso.ch/infoe/intro.htm), and the initials, ISO. If it were an acronym, you’d think it would be IOS. But the truth is, it’s not an acronym.

ISO is derived from the Greek word "isos", which means “equal”. The prefix -iso occurs in many words, such as isometric, meaning equal measure or dimensions and isonomy, meaning equality of laws or people before the law. From equal to "standard," the choice of ISO as the name of the organization is easy to follow. The name also has the advantage of being the same in each of the organization's three official languages - English, French and Russian. Therefore, the confusion that would arise through the use of an acronym is avoided, (e.g., IOS would not correspond to the official title of the organization in French - Organization Internationale de Normalisation).

What does this worldwide standardization mean to you and me? Well, thanks to ISO, we can get cash from an automated teller machine (ATM) in New York City, Hong Kong, Buenos Aires or Moscow. The format of the credit cards, phone cards and smart cards is based on a series of ISO standards. The use of these standards, which outlines features such as the size and thickness of the card as well as the location and data format on the magnetic strip, means that all ATMs, telephones and other card machines throughout the world can read the cards. Since its establishment, ISO has focused primarily on the development of product-specific standards. However, in the mid 1980s, ISO started its work on systems-related standards. This direction later resulted in the well-known ISO 9000 series of standards, ISO 13485, ISO 14001 and others.

The history of requirements for quality systems, or at least some elements of quality systems, goes back to pre-historic times. Almost 4,000 years ago, in the 18th century B.C., Hammurabi, the king of Babylonia, developed the first recorded code of law. The Hammurabi’s Code is a collection of laws and edicts, and is considered the earliest comprehensive legal standard. The code is engraved on a block of black diorite nearly 2.4 meters, or 8 feet high. A team of French archaeologists unearthed this block in Susa, Iraq, formerly ancient Elam during the winter of 1901-1902. The block, broken into three pieces, has been restored and now rests in the Louvre Museum in Paris. Hammurabi’s Code, translated by L. W. King [1], presents a few articles that may relate to a quality system:

Article 122. “If any one give another silver, gold or anything else to keep, he shall show everything to some witness, draw up a contract and then hand it over for safe keeping.”

Article 229. “If a builder builds a house for someone, and does not construct it properly, and the house which he built fall in and kill its owner, then that builder shall be put to death.”

While article 122 implies the need for a contract, required by element 7.4.2 of the ISO 9001 standard, article 229 appears to refer, quite extremely one might say, to a preventive action, required by element 8.5.3 of the standard. Centuries later, on January 11, 1723, Peter the Great issued a decree, as a preventive action I presume, to whip the owner of the Tulsk’s Armory plant for supplying defective ammunition to the Czar’s army.

The history of standards for contemporary quality systems traces back to 1959. Then, the U.S. Department of Defense released a quality management program under the designation MIL-Q-9858. For nearly three decades, this standard was primarily used in the U.S. defense and aerospace industries. In the mid 1960s, the former Soviet Union introduced a national standard (KC YKP) in an attempt to manage quality across the country.

In 1979, the British Standards Institution (BSI) developed the first commercial standard for quality systems that became known as BS 5750. That same year, BSI issued its first certificate to a small cement plant in England for compliance with BS 5750. It took almost another decade for the international community to recognize the benefits of standards for quality systems.

In 1987, ISO completed and released its 9000 series of standards, incorporating most of the elements of BS 5750 into its ISO 9001 standard. The ISO 9000 series of standards first gained popularity in Europe, when the European Union (EU), under the title EN 29000, adopted ISO 9000. By the late 1980’s, BS 5750 and ISO 9000 standards had reached the U.S. market.

The latest ISO 9001 registration data shows impressive growth. The number of ISO 9001 certifications issued worldwide for quality management systems reached 670,399 at the end of 2004, an increase of 35 percent over the previous year, according to ISO. This increase in new ISO 9001 certificates is the highest recorded since the organization launched its annual ISO survey in 1993.

ISO 9001 standard is not product specific and can be used by a wide range of manufacturing and service companies. Long time ago, I saw a flag-size poster on a theater in Singapore bragging about its registration to the ISO 9001 standard. One of my European colleagues recently mentioned that he received an application to register a church choir.

The ISO 9001 standard requires that a company develops and implements a basic quality management system, using the specific elements to ensure the company is capable of maintaining uniformity of its processes and, as a result, provides its customers with a consistent quality of products and services. ISO 9001:2000 comprises a series of standards outlining the requirements for quality management systems. There are three core standards in this group:

ISO 9000:2000 - Vocabulary
ISO 9001:2000 - Requirements
ISO 9004:2000 - Guide for performance improvement

Call us today if you have questions about ISO 9001, ISO 13485 or ISO 14001 management systems!

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