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ISO 9001 quality system 4.2

ISO 9001 quality system documentation requirements:

> other documents required for effective planning, operation and control

There is an urban myth that procedures must spell out everything in minute detail “..in case someone falls under a bus..”. This is a hangover from the Defence standards and has NEVER been a requirement of ISO 9000.

Take a look at the public documents on the ISO 9000 committee site

If you are building nuclear reactors (or if you have a high staff turn-over) it’s a good idea to spell out everything and back-up every decision with a series of checks and signatures.

If you are not in that type of business then do you really need that level of detail ?

To paraphrase 4.2.1 Note 2 –

> are we doing simple or complex tasks ?

> are we a large or small company ?

> do you consider that staff are competent ?

The answers to these questions will influence the amount of documentation required.

The modern way of documenting a quality system this is to have lightweight procedures balanced by heavy training records, which demonstrate competence.

Also, think about having flow-charts instead of text. You can draw adequate flow-charts using Word ‘s auto-shapes.

Whether you use text or flow-charts, generally aim (in artistic terms) for an impressionist painting, rather than a detailed engineering blue-print.

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