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 companys 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.
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