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ISO 9001 Documentation
The main objectives of an organization’s documentation, independent
of whether or not it has implemented a formal QMS are:
The following terms and
definitions are taken from ISO 9000:2005:
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A document is information
and its supporting medium
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Procedure is a specified
way to carry out an activity or a process (Note: Procedures can
be documented or not)
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Quality Manual is a
document specifying the quality management system of an
organization
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Quality Plan is a
document specifying which procedures and associated resources
shall be applied by whom and when to a specific project,
product, process or contract
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Record is a document
stating results achieved or providing evidence of activities
performed
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Specification is a
document stating requirements
The extent and magnitude of
an organization's documentation may depend on the size and type of
its activities; the complexity of its processes and their
interactions, and the competence of its personnel. And its
documentation could be in the of
ISO 9001:2008 clause 4.1
General requirements requires an organization to “establish,
document, implement, and maintain a quality management system and
continually improve its effectiveness in accordance with the
requirements of this International Standard”. Clause 4.2.1
General of the ISO 9001:2008 standard explains that the quality
management system documentation shall include:
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documented statements of
a quality policy and quality objectives;
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a quality manual;
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documented procedures
required by this International Standard;
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documents needed by the
organization to ensure the effective planning, operation and
control of its processes, and
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records required by this
International Standard.
All the documents that form
part of the QMS have to be controlled in accordance with clause
4.2.3 of ISO 9001:2008, or, for the particular case of records,
according to clause 4.2.4. The following comments are intended
to assist users of ISO 9001:2008 in understanding the intent of the
general documentation requirements of the International Standard:
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Documented statements of
a quality policy and objectives
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Requirements for the
quality policy are defined in clause 5.3 of ISO 9001:2008.
The documented quality policy has to be controlled according
to the requirements of clause 4.2.3.
Note: Organizations that are revising their quality policy
for the first time, or in order to meet the amended
requirements in ISO 9001:2008, should pay particular
attention to clause 4.2.3 (c), (d) and (g).
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Requirements for
quality objectives are defined in clause 5.4.1 of ISO
9001:2008. These documented quality objectives are also
subject to the document control requirements of clause
4.2.3.
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Quality Manual
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Clause 4.2.2 of ISO
9001:2008 specifies the minimum content for a quality
manual. The format and structure of the manual is a decision
for each organization, and will depend on the organization’s
size, culture and complexity.
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A small organization
may find it appropriate to include the description of its
entire QMS within a single manual, including all the
documented procedures required by the standard.
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Large, multi-national
organizations may need several manuals at the global,
national or regional level, and a more complex hierarchy of
documentation.
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The quality manual is
a document that has to be controlled in accordance with the
requirements of clause 4.2.3.
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Documented procedures
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These documented
procedures have to be controlled in accordance with the
requirements of clause 4.2.3
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Some organizations
may find it convenient to combine the procedure for several
activities into a single documented procedure (for example,
corrective action and preventive action). Others may choose
to document a given activity by using more than one
documented procedure (for example, internal audits). Both
are acceptable.
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Some organizations
(particularly larger organizations, or those with more
complex processes) may require additional documented
procedures (particularly those relating to product
realization processes) to implement an effective QMS.
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Other organizations
may require additional procedures, but the size and/or
culture of the organization could enable these to be
effectively implemented without necessarily being
documented. However, in order to demonstrate compliance with
ISO 9001:2008, the organization has to be able to provide
objective evidence (not necessarily documented) that its QMS
has been effectively implemented.
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Documents needed by the
organization to ensure the effective planning, operation and
control of its processes
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In order for an
organization to demonstrate the effective implementation of
its QMS, it may be necessary to develop documents other than
documented procedures. However, the only documents
specifically mentioned in ISO 9001:2008 are:
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Quality policy
(clause 4.2.1.a)
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Quality
objectives (clause 4.2.1.a)
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Quality manual
(clause 4.2.1.b)
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There are several
requirements of ISO 9001:2008 where an organization could
add value to its QMS and demonstrate conformity by the
preparation of other documents, even though the standard
does not specifically require them. Examples may include:
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Process maps,
process flow charts and/or process descriptions
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Organization
charts
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Specifications
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Work and/or test
instructions
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Documents
containing internal communications
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Production
schedules
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Approved supplier
lists
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Test and
inspection plans
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Quality plans
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All such documents
have to be controlled in accordance with the requirements of
clause 4.2.3 and/or 4.2.4, as applicable.
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Records
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Requirements for the
control of records are different from those for other
documents, and all records have to be controlled according
to those of clause 4.2.4 of ISO 9001:2008.
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Records required by ISO
9001:2008 are (where applicable):
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Management reviews
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Education, training,
skills and experience
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Evidence that the
realization processes and resulting product fulfil requirements
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Design and development
inputs relating to product requirements
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Results of design and
development reviews and any necessary actions
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Results of design and
development verification and any necessary actions
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Results of the review of
requirements related to the product and actions arising from the
review
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Results of the review of
design and development changes and any necessary actions
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Results of supplier
evaluations and any necessary actions arising from the
evaluations
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Results of design and
development validation and any necessary actions
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The unique identification
of the product, where traceability is a requirement
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Customer property that is
lost, damaged or otherwise found to be unsuitable for use
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As required by the
organization to demonstrate the validation of processes where
the resulting output cannot be verified by subsequent monitoring
or
measurement
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Validity of the previous
measuring results when the measuring equipment is found not to
conform to requirements
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Results of calibration
and verification of measuring equipment
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Internal audit results
and follow-up actions
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Indication of the
person(s) authorizing release of product.
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Basis used for
calibration or verification of measuring equipment where no
international or national measurement standards exist
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Nature of the product
nonconformities and any subsequent actions taken, including
concessions obtained
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Results of corrective
action
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Results of preventive
action
Read on to:
How to plan
and implement your ISO 9001:2008 QMS
How to
document your ISO 9001:2008 QMS
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