ISO 9001, or ISO 9002?
ISO 9001, or ISO 9002?
That's where ISO 9000 fits in. The term refers to a series of universal standards that define a
"Quality Assurance" system developed by the International Organization for Standardization
(ISO) and adopted by 90 countries around the world. National standards representatives from
more than 100 countries comprise the ISO. Its goal is to promote the international exchange of
goods and services around the world, and to encourage worldwide cooperation in intellectual,
scientific, technological and economic arenas.
To gain ISO 9000 registration, a company must meet certain standards for quality assurance in
its operations, as certified by a third-party registration agency. The quality assurance system, not
the product or service itself, achieves the registration. An ISO 9000 registration says to
customers: This company has a system in place to insure that any product or service it sells will
consistently meet international standards of quality.
Companies that gain ISO 9000 registration often benefit from reduced customer complaints,
reduced operating costs and increased demand for their product or services. Although
manufacturing industries first led the charge toward quality assurance, the ISO 9001 standard
does not exclude any specific industries or economic sector. Your decision on whether to seek
compliance will depend more on what your customers expect or the market requires. Some
companies, for instance, do not buy parts and products from manufacturers who are not ISO
9000 registered.
These two standards are nearly identical; however, ISO 9001 applies to companies involved in
the design of products or services, as well as their production and installation or implementation.
ISO 9002 simply excludes the design element from a similar model for quality assurance.
Other designations of quality assurance standards include the QS 9000 series for companies
manufacturing parts for the automotive industry, and the ISO 14000 standards for companies
involved in environmental management systems specification.
DO I NEED TO REGISTER?
Many companies have found that simply working toward compliance with ISO 9000 standards
has brought its own rewards, even before achieving registration, simply by improving their
quality processes.
WHERE DO I START?
The effort required to comply with ISO 9000 standards will depend on the existence and
maturity of your quality system. Fortunately, training resources abound to help companies seek
achieve ISO 9000 registration. Check with your local community college, university, regional
manufacturing assistance center, small business development center, business incubation center,
or industry association to inquire about classes, recommend consultants, and arrange for pre-
registration assessments.
Several free publications on ISO 9000 registration are available from the International
Organization for Standardization (ISO). The ISO brochure, "Compatible technology worldwide,"
answers common questions about ISO 9000, while the ISO 9000 Forum Library lists
publications on quality management, quality assurance standards, and related issues.
Computer software packages have been created by several companies to help walk registrants
through the creation, documentation and registration of your quality system. Several offer free or
demonstration copies. Too many products exist to list here. We suggest you search the Internet
for "ISO 9000 software" as a starting point.
WHAT NEXT?
You're probably wondering what ISO 9000 registration involves. In broad terms, it requires your
company to design and implement a quality system that complies with the appropriate ISO
standard (ISO 9001, ISO 9002, QS 9000, ISO 14000). You will be asked to:
The certificate saying that your company complies with the ISO 9000 standard can only be
issued by an accredited, third-party registration agency. You should select your registrar at the
beginning of the process, and find out in detail what they require before they will grant a
registration. Typically, the registrar will conduct a "preassessment audit" to identify areas of
noncompliance so that you can correct those areas before the "registration audit."
An ISO 9000 registration certificate is valid for three years, and the registration agency may
conduct audits at six-month intervals to insure that the company continues to comply with the
standard.
Small business development centers may offer group classes in ISO 9000 certification on a
sliding scale, based on the size of your company (number of employees) and the number of class
participants. Regional manufacturing assistance centers are partially subsidized by federal funds
and may offer pre-assessment audits and individual ISO 9000 consulting services on a sliding
scale.
The charge to conduct the final registration audi is set by the registration agency, and usually
varies according to company size. For accurate information, contact your training source or
registrar directly.