The following application article is part of a larger set of articles
published under the title ISO 9000 in Scientific
Computing as a special supplement to Scientific Computing & Automation
magazine.
A common misconception is that ISO 9000 is a manufacturing standard or a
product specification. It is neither. ISO 9000 is a set of management standards
governing quality assurance. It provides a framework for a systematic approach
to process management that requires an organization to keep a detailed accounting
of its procedures and work. This includes documenting the processes for
how a company designs, produces, inspects, packages, and installs products.
The structure focuses on management of processes; the result is quality.
It was developed by the International Organization for Standardization (ISO)
of Geneva, Switzerland, who assigned the task to Technical Committee (TC)
176. The first ISO committee on quality, TC 176 chose the British Standard
BS 5750 as their model, renaming it ISO 9000. Some 100 countries have since
endorsed the standard, but generally given it a different alphanumeric designation.
In the U.S., it is known as ANSI/ASQC Q90.
While ISO 9000 was conceived as an international standard, it was quickly
adopted by the European Community (EC) as a means of standardizing quality
processes across national boundaries in Europe. This caused consternation
that Europe was establishing a "fortress" mentality towards trade.
However, ISO 9000 has not locked foreign competition out of Europe and is
steadily gaining acceptance worldwide. In fact, according to BSI, ISO 9000
registrations in the Pacific Rim are really taking off.
The standard is composed of five parts. ISO 9000 is essentially a statement
of purpose. ISO 9001, 9002, and 9003 are three specific quality system models
based on the company's function and organization. ISO 9004 is a set of guidelines
for the implementation and auditing of the actual process.
ISO 9001 is a quality system model for organizations involved in all aspects
of product production, from design and development to manufacturing and
installation. ISO 9002 applies to companies performing production and assembly,
but not R&D or servicing. ISO 9003 offers a model for final inspection
and testing only.
ISO 9001, the most comprehensive model, is composed of 20 elements. 9002
and 9003 are subsets of 9001, requiring only those elements applicable to
the specific model. "The selection of 9001 versus 9002 is done not
by what you do, but by what you don't do," states Rob Ireland, Beckman
Instruments' U.K. Quality and Regulatory Manager. "If you don't do
design, you're not 9001."
One of the biggest areas of confusion surrounding the standard is the mistaken
belief that 9001 is better than 9002 or 9003. It's not, nor are companies
registered to 9001 "better" companies. Currently, companies that
do not perform design or post-sale product servicing apply for 9002 which
excludes those two elements; hence ISO 9002 is composed of 18 criteria.
9003 was written for companies that don't perform manufacture or assembly,
just final inspection and test. As a result, there are only 12 criteria.
It is only "easier" to achieve 9002 than 9001 because there are
fewer departments involved. 9003, however, does not take into account certain
quality system elements that are required by 9002 and 9001. The grey area
of what is and what isn't included within the scope of the three models
will be clarified with the upcoming 1994 revisions to the standard.
However, companies that perform design and servicing can apply for 9002
or 9003. Because the process of implementing ISO 9000 is difficult, some
companies choose to incorporate it in stages and step up through the standard.
If the company can separate their processes, this is an acceptable choice.
The steps toward registration include selecting the appropriate model, assembling
a steering committee, choosing a registrar and (possibly) consultants, documenting
processes, and undergoing a third-party audit by the registrar. Once certification
is achieved, the company continues to be audited by the registrar at regular
intervals.
After achieving ISO registration, the benefits of process management by
quality kick in. "Registration is just the first step on the path to
quality improvement," emphasizes James Davies, Senior Business Development
Officer for BSI's Quality Assurance division. Organizations find they can
significantly reduce the potential for production errors or rework. They
are able to drive defect statistics down to impressive lows. Their streamlined
processes enable reduced in-process testing and inspection, saving time
and lowering costs. ISO 9000 makes continuous improvement a pragmatic process
that delivers results to the bottom line. Companies that have been registered
for several years will testify to the power and positive impact of ISO 9000
on their operations.