ISO 9001 is the
internationally recognised standard for the
quality management of businesses. It applies
to the processes that create and control the
products and services an organisation
supplies. It prescribes systematic control of
activities to ensure that the needs and
expectations of customers are met. It is
designed and intended to apply to virtually
any product or service, made by any process
anywhere in the world.
Some of the
requirements in ISO 9001 include:
· A set of
procedures that cover all key processes in the
business
· Monitoring
processes to ensure they are effective
· Keeping
adequate records
· Checking
output for defects, with appropriate and
corrective action where necessary
· Regularly
reviewing individual processes and the quality
system itself for effectiveness
· Facilitating
continual improvement
The term ISO 9000
refers to a set of quality management
standards. ISO 9000 currently includes three
quality standards: ISO 9000:2000, ISO
9001:2000, and ISO 9004:2000. ISO 9001:2000
presents requirements while ISO 9000:2000 and
ISO 9004:2000 present guidelines.
ISO 9000:2000
(Fundamentals and vocabulary): Covers the
basics of what quality management systems are
and also contains the core language of the ISO
9000 series of standards. A guidance document,
not used for certification purposes, but
important reference document to understand
terms and vocabulary related to quality
management systems. In the year 2005, revised
ISO 9000:2005 standard has been published, so
it is now advised to refer to ISO 9000:2005.
ISO 9001:2000
(Requirements): Is intended for use in any
organization which designs, develops,
manufactures, installs and/or services any
product or provides any form of service. It
provides a number of requirements which an
organization needs to fulfill if it is to
achieve customer satisfaction through
consistent products and services which meet
customer expectations. It includes a
requirement for the continual improvement of
the Quality Management System, for which ISO
9004:2000 provides many hints. This is the
only implementation for which third-party
auditors may grant certification. It should be
noted that certification is not described as
any of the 'needs' of an organization as a
driver for using ISO 9001 but does recognize
that it may be used for such a purpose.
ISO 9004:2000:
(Guidelines for performance improvements):
This gives advice on what could be done to
enhance a mature system. This standard very
specifically states that it is not intended as
a guide to implementation.
ISO 9001:2000 is
the most accepted management system standard
in the world because it controls quality as
well as it saves money. Regardless of the
organisation size, effective management
systems are critical for maintaining and
improving business performance. This standard
has proven itself to be a measurable success
in many organisations. It is not specific to a
particular product or service, but applies to
the processes that create them. As a generic
set of standards, manufacturing and service
industries around the world are using it.
The Quality
Management System requirements defines the
system creating a comprehensive and user
friendly application. The process-based
structure of the standard provides real value,
which recognizes that every organisation and
process is different. Therefore, it is
flexible enough to allow differences by
offering the option of omitting inapplicable
requirements.