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What
is ISO 9000?
In
1987, the Geneva-based International
Organization for Standardization (ISO) published
the ISO 9000 series international standards to
serve as the basis for a quality management
system. It
is the descendant of British standard BS-5750.
The American equivalent is Q9000.
Since the original release, the standards
have been revised in 1994 and in 2000.
Registration
is granted by accredited organizations called
registrars, who review the company’s quality
manual and procedures to ensure that they meet
the requirements of the applicable standard, and
audit the processes to ensure that the
documented system is implemented and effective.
Once registration is granted, the
registrar conducts surveillance audits once to
twice per year to ensure that the system
continues to be implemented and meets the
requirements of the applicable standard.
ISO
9000, which couples a total quality management
approach with documentation methodology to
create an internal auditing system, is also the
first-ever attempt to create an international
quality assurance standard to cover all
industries and the service sector.
The
so-called ISO 9000 standard is actually
comprised of a series of standards.
The
three new standards that were released on
December 15, 2000 are:
ISO
9000:2000 Quality Management Systems —
Fundamentals and Vocabulary
ISO
9001:2000 Quality Management Systems —
Requirements
ISO
9004:2000 Quality Management Systems —
Guidance for Performance Improvement
ISO 9000:2000 describes underlying
concepts and approaches for the new ISO
9000:2000 family, and provides definitions for
the vocabulary.
ISO 9000 is not a specification, however,
it is named in ISO 9001 as a normative reference
and thus can be used by auditors to support
their interpretation of ISO 9001 requirements
— in particular in reference to the
vocabulary.
ISO 9001:2000 is the actual requirements
for the quality management system.
Its requirements define the criteria for
the quality system.
The role of this standard in the series
has not changed, but its content and
organization are completely revised.
ISO 9004:2000 describes a quality system
that goes beyond the basic requirements
specified in ISO 9001.
It is intended as a guide for
organizations that want to further expand and
improve the quality system after implementing
ISO 9001 (i.e., in the post-certification
phases). ISO
9004 is not a requirement and should not b
e used by third-party auditors for registration
audits.
What
is an ISO 9001 Compliant Quality System?
An
ISO 9001 compliant quality system satisfies the
requirements of the ISO 9001 standard but has
not been formally assessed and registered by a
third party registrar. This means that you could
enjoy the benefits of an ISO 9001 Compliant
Quality System without going through the expense
normally associated with registration. You would
be in a position to register at anytime should
the need arise.
ISO
9000 for Small Businesses
ISO
9000 certification is a growing trend as
customers require it. Companies also are
beginning to realize that the process it
represents is an excellent way to assure their
products will be of high quality and that their
customers will be satisfied. Limited
resources prevent many small businesses from
establishing a quality system. Part of the
problem is not knowing what is really required.
Quality Systems Innovations, Inc. can help.
We
have developed a quality system which is easily
customized for small businesses in a broad range
of industries. We have eliminated the
bureaucratic approach commonly found in many
large companies. Our
pre-written ISO
9001
compliant
quality manual satisfies ISO 9001:2000
requirements and includes
all required procedures and forms, which you
customize specifically for your needs. This
manual will save you months of documentation time,
significantly reducing your costs.
Quality
Manual Sample
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