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QW Academy - What is ISO 9001?
The history of standards for contemporary quality management 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 1980ís, 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
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 9001:2008 - Requirements
ISO 9004:2000 - Guide for performance improvement
The processes required by ISO 9001:2000, which are applicable to
the company's QMS, but which are not performed by the
organization, are the responsibility of the organization and are
accounted for in the organization's quality management system.
For example, if a company sub-contracts manufacturing or other
activities, the company is still responsible for these
processes. To ensure that these outsourced processes are in
compliance with applicable requirements, a company may use
supplier audits. Check our
Product page to see how our
products can help you developing your management system.
today if you have questions about ISO 9001, ISO 13485 or ISO
14001 management systems!