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The Six-Step Plan to Implementing ISO 9001
The ultimate plan involves:
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Understanding how the ISO 9001 model should operate within
your organization
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Planning
the quality management system so as to achieve your quality
objectives
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Documenting
the quality management system
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Implementing the quality management
system
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Auditing
the performance of the quality management system
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Reviewing the performance of the quality
management system
For organizations that are in
the process of implementing or have yet to implement a QMS, ISO
9001:2008 emphasizes a process approach. This includes:
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Identifying the processes
necessary for the effective implementation of the quality
management system
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Understanding the
interactions between these processes.
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Documenting the processes
to the extent necessary to assure their effective operation and
control. (It may be appropriate to document the processes using
process maps. It is emphasized, however, that documented process
maps are not a requirement of ISO 9001:2008.)
These processes include the
management, resource, product realization and measurement processes
that are relevant to the effective operation of the QMS.
Analysis of the processes should be the driving force for defining
the amount of documentation needed for the quality management
system, taking into account the requirements of ISO 9001:2008. It
should not be the documentation that drives the processes.
For organizations that
currently have a QMS, the following comments are intended to assist
in understanding the changes to documentation that may be required
or facilitated by the transition to ISO 9001:2008
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An organization with an
existing QMS should not need to rewrite all of its documentation
in order to meet the requirements of ISO 9001:2008. This is
particularly true if an organization has structured its QMS
based on the way it effectively operates, using a process
approach. In this case, the existing documentation may be
adequate and can be simply referenced in the revised quality
manual.
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An organization that has
not used a process approach in the past will need to pay
particular attention to the definition of its processes, their
sequence and interaction.
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An organization may be
able to carry out some simplification and/or consolidation of
existing documents, in order to simplify its QMS.
For organizations wishing to
demonstrate conformity with the requirements of ISO 9001:2008, for
the purposes of certification/registration, contractual, or other
reasons, it is important to remember the need to provide evidence of
the effective implementation of the QMS.
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Organizations may be able
to demonstrate conformity without the need for extensive
documentation.
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To claim conformity with
ISO 9001:2008, the organization has to be able to provide
objective evidence of the effectiveness of its processes and its
quality management system. Clause 3.8.1 of ISO 9000:2005 defines
“objective evidence” as “data supporting the existence or
variety of something” and notes that “objective evidence may be
obtained through observation, measurement, test, or other
means.”
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Objective evidence does
not necessarily depend on the existence of documented
procedures, records or other documents, except where
specifically mentioned in ISO 9001:2008. In some cases, (for
example, in clause 7.1(d) Planning of product realization, and
clause 8.2.4 Monitoring and measurement of product), it is up to
the organization to determine what records are necessary in
order to provide this objective evidence.
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Where the organization
has no specific internal procedure for a particular activity,
and this is not required by the standard, (for example, clause
5.6 Management Review), it is acceptable for this activity to be
conducted using as a basis the relevant clause of ISO 9001:2008.
In these situations, both internal and external audits may use
the text of ISO 9001:2008 for conformity assessment purposes.
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