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ISO 9001 - Clause 4 Explained
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Clause |
Control of: |
Meaning |
| 4 |
Quality Management System |
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| 4.1 |
General Requirements |
- You must have a quality system which is kept up to date
and continually improved.
- This clause requires that you :
- determine the processes involved, (was
"identify" in ISO9001:2000)
- determine the sequence of operations,
- determine ways by which you can be sure that the processes are
working correctly,
- ensure that you have sufficient resources for the processes and
their monitoring
- can show that you monitor and improve your system
The requirements for controls of outsourced products
have been clarified in ISO9001:2008, compared to ISO9001:2000).
The notes relating to these controls have been
significantly expanded, with two new sets being added.
The details of how you much meet each of these requirements are given in the following sections of my explanation of
ISO9001:2008.
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| 4.2 |
Documentation Requirements |
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| 4.2.1 |
General |
This clause defines that the types of documentation that you
must include in your system:
- statements of quality policy and quality objectives
- A Quality Manual This can be a single page
document, separate to everything else. It could be a part of some
other document. It could comprise every document and procedure in your
system)
- documented procedures, where required by the standard (see later on
for an overview of when procedures are needed and when they are not)
- the records required by the standard to prove that you meet its
requirements, plus any others that you decide that you need, in order to operate your business properly
A note in this section acknowledges that the extent of your
documentation will depend upon your processes, competence of personnel |
| 4.2.2 |
Quality Manual |
You must have an up to date Quality Manual, which addresses the following requirements.
Your Quality Manual must include details of any the
reasons why you think any clause of ISO 9001 does not apply to your
organisation. (Remember that only sub-clauses of Clause 7 can be excluded).
It should include the procedures that are required by ISO 9000 (see below), or else it must have references to those procedures.
Please
note that this does not mean that you must put everything into one huge
book. You can keep the procedures separate from the policy level manual,
and have separate collections of SOPs, Work Instructions, etc.
It should define the interaction between the various processes. (This
can be by diagrams - e.g. flow charts, etc - or in words. |
| 4.2.3 |
Control of Documents |
You must ensure that only the correct version of documents
is available for use. They must be reviewed and approved prior to use. You
should know what documents exist and which version is the correct one.
You must periodically review them for ongoing suitability (are they still legible, relevant, etc).
The 2008 version of this clause has been
restructured compared to ISO9001:2000, but the meaning is unchanged, except
that clause 4.2.3 (f) clarifies that for external documents, only those
that are required for the planning and operation of the system are meant
to be included.
So, ISO9001:2008 makes it clear that your daily
newspaper is probably of no concern here.
You must have a procedure to control these activities
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| 4.2.4 |
Control of Records |
You must make sure that you keep sufficient records to prove
that you are operating your quality management system correctly. You must
keep them for a defined minimum period. You must keep them in good
condition, in such a way that they can be easily found.
This
clause requires that you have a procedure which ensures that quality
records are suitably controlled with regard to:
- defining what records are required,
- how & where they are stored,
- ensuring that they can be retrieved,
- describing their retention time and subsequent disposal
The 2008 version of this clause has been
restructured compared to ISO9001:2000, but the meaning is unchanged.
You must have a procedure to control these activities
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on Oct 04, 2009