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ISO 9001 quality manual 4.2.2
The main difference in ISO 9001:2008 is that you do not need procedures to control the
activities - instead you simply have to prove that you have met the
requirements.
An ISO 9001 quality manual must describe:
> the scope of the Quality Management System
ie
what's included in the Quality System
> details and justification of any
exclusions ie what's excluded
> procedures (or make reference to them)
procedures may be a separate set of documents
> a description of the interaction of the
processes eg a flowchart of relevant business
activities
See our
quality manual products
IMPORTANT
Some exclusions are
permitted but the exclusions are
limited
to the Product Realization
requirements (ISO 9001:2008 Section 7).
Exclusions are
only permitted
where an element of Section 7 is genuinely
not relevant to the company.
Quality manual writing tips:
- check this link to
ISO 9000 history & terminology
- To pass a certification body
audit, a quality management system must be an auditable entity.
- Just
writing about it is not enough - the QMS must also be implemented
- Consider including
the mandatory procedures in the quality manual
- Aim for minimal documentation
-
Especially if you're a small business
- Start with the
assumption that you're currently doing all (or most) of what ISO 9001 asks.
- Keep the
documentation small and simple
Take a look at the public documents on the
ISO 9000 committee
site
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Use
ISONavigator
with ISO 9001 or ISO 9004.
While every effort is made to ensure the
accuracy of the information provided, you are solely responsible for
deciding its relevance and applicability given your unique situation. No
liability is accepted if you choose to act upon this information.
ISO 9000:2005 principles and ISO 9001:2008 requirements are indicated in
black.
Guidance and interpretation is in
green
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