ISO 9000

This essay has a total of 1743 words and 8 pages.

ISO 9000

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 QMS are continual improvement; management
responsibility; resource management; product/service realization; and measurement,
analysis, and improvement.

General requirements for having a QMS is that the organization shall establish, document,
implement, and maintain a QMS and continually improve its effectiveness. The organization
shall (a) identify needed processes such as management activities, provision of resources,
product or service realization, and measurement, (b) determine their sequence and
interaction, (c) determine criteria and methods for effective operation and control of
these processes, (d) ensure the availability of resources and information necessary to
support and monitor these processes, (e) monitor, measure, and analyze these processes,
and (f) implement actions to achieve planned results and continual improvement of these

Top management shall provide evidence of its commitment to the development,
implementation, and continual improvement of the QMS by (a) communicating the need to meet
customer, legal, and regulatory expectations, (b) establishing a quality policy, (c)
ensuring that quality objectives are established, (d) conducting management reviews, and
(e) ensuring the availability of resources.

The organization shall determine and provide the resources needed (a) to enhance customer
satisfaction. Resources may be people, infrastructure, work environment, information,
suppliers, natural resources, and financial resources. Resources can be aligned with
quality objectives.

The organization should also plan and develop the processes needed for product or service
realization. Planning of product or service realization shall be consistent with the
requirements of the other processes of QMS. In planning product or service realization,
the organization shall determine the following, as appropriate: (a) quality objectives and
requirements for the product or service; (b) the need to establish processes, documents,
and provide resources specific to product or service; (c) required verification,
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