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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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