What is ISO 9001:2008?
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ISO
9001:2008 is the latest version of a
quality management standard which has
been in existence for many years and which
has been applied by more than 900,000
organizations world-wide in 155
countries. It specifies minimum
requirements for a quality management
system where an organization needs to: |
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Demonstrate its ability to provide
consistently a product that meets customer
and applicable regulatory requirements. |
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| b)
Address customer satisfaction through the
effective application of the system,
developing processes for continual
improvement and the prevention of errors
and mistakes. |
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Perceived benefits/advantages of ISO
9001:2008 certification
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Improvement in "bottom line" profit
through
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Better efficiency.
Continual improvement.
Less waste.
Consistent control of key processes.
Possible reduction in insurance premiums.
Promotion and standardization of good working
practices.
Greater marketing appeal and improved public
relations.
Meeting the requirements for inclusion on some
tender lists.
Provision of a vehicle for training new
employees.
The effective management of risk.
Provision of a vehicle for introducing a
culture for opportunity.
Increasing the potential for world-wide
recognition. |
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ISO 9000 Series of Standards
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The following comprises the family of ISO
9000 series of standards:
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ISO 9000:2005 – Quality
Management Systems: Concepts and Vocabulary.
ISO 9001:2008 – Quality Management Systems:
Requirements.
ISO 9004:2000 – Quality Management Systems:
Guidance for Performance Improvement.
Organizations will be assessed and awarded
certification against ISO 9001:2008, whether
or not they are involved in design.
ISO 9004:2000 offers guidance on implementing
a quality management system and although it is
consistent with ISO 9001:2000 it is not
intended for use for certification or
contractual purposes.
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| Organizations will be
assessed and awarded certification against ISO
9001:2000, whether or not they are involved in
design. |
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| ISO 9004:2000 offers
guidance on implementing a quality management
system and although it is consistent with ISO
9001:2000 it is not intended for use for
certification or contractual purposes. |
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Overview of the standards
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| ISO
9001:2008
contains five requirements sections, each
dealing with one of the fundamental
building blocks required by any process.
These are: |
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Quality management system:
This section details the general and
documentation requirements that are the
foundation of the management system. The
general requirements ask you to look at
the processes of the management system,
how they interact with each other, what
resources you need to run the processes;
and how you will measure and monitor the
processes. The second part of the section
then sets out the requirements for the
documentation needed to effectively
operate the system and how the
documentation should be controlled. |
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Management responsibility:
The management of the systems is the
responsibility of the “top management” at
a strategic level in the organization. The
“top management” must know customers’
requirements at a strategic level and make
a commitment to meeting these as well as
statutory and regulatory requirements.
“Top management” must also set policies;
and to achieve these policies set
objectives through planning how the
objectives will be met.
“Top management” should also ensure that
there are clear internal communications
and that the management system is
regularly reviewed. |
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Resource management:
This covers the people and physical
resources needed to carry out the
processes. People should be competent to
carry out their tasks and the physical
resources and work environment need to be
capable of ensuring that the customers'
requirements are met. |
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Product/Service realization:
These are the processes necessary to
produce the product or to provide the
service. This is the act of converting the
input of the process to the output. For a
manufacturing organization, this may be
the process of converting iron ore to
steel via a blast furnace for example. For
a service organization, this may be the
process of moving a product or person from
one place to another, for example, a taxi
journey.
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Measurement analysis and improvement:
These are the measurements to enable the
systems to be monitored to provide
information on how the systems are
performing with respect to the customer,
the management systems themselves through
internal audits, the processes and the
product. Analyzing these, including any
defect or shortfall in performance, will
provide valuable information for use in
improving the systems and products where
this is required. |
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Each of these five fundamental building
blocks is required for any process
because, if one is missing, a controlled
process does not occur. |
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