ISO 9001 Training
Understanding ISO 9001:2008
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ISO 9001 TrainingUnderstanding ISO 9001:2008
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4 Quality Management System 4.2 Documentation Requirements 4.2.3 Control of Documents Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4. A documented procedure shall be established to define the controls needed: a) to approve documents for adequacy prior to issue, b) to review and update as necessary and re-approve documents, c) to ensure that changes and the current revision status of documents are identified, d) to ensure that relevant versions of applicable documents are available at points of use, e) to ensure that documents remain legible and readily identifiable, f) to ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the quality management system are identified and their distribution controlled, and g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose. |
ISO 9001 Training - Key Explanation Points and
Tips:
As mentioned
in clause 4.2.1 notes, a document is information that is written or
recorded on some medium such as paper or computer. A document may
specify requirements (e.g. a drawing or technical specification); provide direction (e.g. quality plan); or show
results or evidence of activities performed (e.g. records).
Clause 4.2.1 tells you what documents you must include in your QMS. All documents that you determine under clause 4.2.1
to be needed for your QMS processes must be controlled. This clause 4.2.3 provides requirements on
how these documents must be
controlled. Documents outside the QMS need not be subject to these controls.
This clause
requires you to have a documented
procedure. Your procedure must - define responsibility for and
description of the controls required by 4.2.3 a - 4.2.3g; methods to measure process document control performance;
and continual improvement of the document control process.
Ensure that
your procedure specifically addresses each of the control requirements, in terms of who, what when, where and how
as applicable. Your procedure must address new and old as well as internal and external documents used by the
QMS.
You must
approve all new QMS documentation prior to issue. Some degree of checking, examination or assessment is inherent in
‘approval for adequacy’. You must periodically determine if any updating or revisions of any QMS documentation
is needed, and if they are changed, they must be re-approved for
adequacy.
The frequency
of this review, responsibility and method must be defined in your procedure. This will be determined by events
within your organization and how mature or recent your QMS is. Auditors will explore this if they find that your
documents have not changed in years, while the nature of your business has changed significantly.
Identify changes made to documents so users
know exactly what has changed. There are many ways of doing this on printed as well as computerized documents. Your
procedure must cover how this is done.
Have a method
for revision control such as a revision log and master-list of documents which identifies the current revision
status. Again, there are other ways of doing this as well. Your procedure must cover how this is
done.