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 4.2.2 Quality Manual The organization shall establish and maintain a quality manual that includes: a) the scope of the quality management system, including details of and justification for any exclusions (see 1.2), b) the documented procedures established for the quality management system, or reference to them, and c) a description of the interaction between the processes of the quality management system. |
ISO 9001 Training - Key Explanation Points and
Tips:
The
quality manual is a special type of document that describes your QMS. Besides describing your QMS, your quality
manual could provide information on organizational background and capabilities. It may be used by customers,
regulatory bodies, suppliers and company personnel for a variety of purposes. There are many acceptable ways to
document your quality manual.
You must define
the scope of your QMS in
your quality manual. Your QMS scope should include - facilities (manufacturing and support locations), products, processes, Quality
Management and other standards, etc. Customers will want to know the extent of your capabilities and the Registrar
will want to determine the time and effort needed to audit your organization.
Provide details
of any clause exclusions from your scope, e.g. 7.3 Product Design and Development, and
justification for it. You must justify all exclusions and remember, exclusions can only be made from
clause 7.
You have
flexibility in whether or not to include your procedures and lower level documentation with your quality manual or
organize them in some other fashion. You may include all or some of your procedures in your Quality Manual or
reference them to your Quality
Manual. Keep a listing or index at the front or back of your Manual showing the complete list of your procedures
whether included or referenced.
The
practicality of all this would depend, of course, on the size of your organization, complexity of products and
processes; competency of personnel, media used for documentation (hard copy versus computerized); ease of use and
understanding by personnel; etc. So go ahead and organize your documentation to facilitate ease of use;
availability and maintainability.
Your quality manual must include a description of the interaction of your QMS processes. This was
discussed above under clause 4.1
As a controlled
document (see 4.2.1), the quality manual is subject to all of the controls in clause
4.2.3.