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One
of the goals of the ISO 9000 Quality Management System standard
is to bring control and consistency to your processes. The year
2000 revision of the standard asks you to identify your key processes,
and manage and improve those processes. Documentation is one of
the ways you manage and control your processes. By writing procedures
and work instructions you will make sure that everyone is performing
the process the same way.
ISO
9000 documentation comprises four tiers. Each tier should point
to the next.
- The
Quality Manual
Your quality manual briefly describes how you meet the requirements
of the standard via the system you implemented. Write this document
last. It will be hard to write it before you implement your
system, and it will have to be rewritten as you fine-tune your
system. If you write the quality manual at the end of your project
it will be a simple summary of what you have implemented for
each clause. Your quality manual must include or reference your
procedures.
- Procedures
Procedures describe how to perform a task in general, outlining
the key steps and their order. A purchasing procedure may describe
who is responsible for approving purchases, and what records
need to be kept, for example. Procedures can be described as
looking at "what" you do (not necessarily how you
do it). Procedures should reference related work instructions.
- Work
Instructions
Work instructions provide detailed step-by-step descriptions
of a task, not just an outline. They should describe "how"
you perform a task. A purchase order work instruction would
tell you how to fill out a purchase order, line by line. Work
instructions should reference related records.
- Records
Records are the documents you keep to show that you follow your
quality system. Your completed purchase order would be a record.
Records are a history of what has occurred and as such should
not change.
Note:
Write your documents in present tense. Something "is"
done not "should be". It is a much stronger statement
and removes some ambiguity. Try not to use "where appropriate",
"when needed" or other phrase that makes the document
less clear.
More
on Document Control
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