4.2 Documentation requirements

ISO 9001 quality system documentation requirements:

There's 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.

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 competen ?

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.

4.2 Documentation Requirements

Define and document your quality management system (e.g. using a quality manual).

All the mandatory procedures and documentation requirements are explained in our Quality Manual Template and guidance document.

>> View Quality Manual Template sample
>> View guidance document sample

4.2.1 General

  • Develop the quality policy document (5.3)
  • Develop and establish the quality objectives (5.4.1)
  • Develop and establish the quality manual (4.2.2)
  • Develop procedures to implement your quality system (4.2.3. 4.2.4, 8.3, 8.2.2, 8.5.2, 8.5.3)
  • Develop documents that reflect what your organisation does

Use this documentation hierarchy:

  • Level 1: Policies - key system objectives
  • Level 2: Quality Manual - approach and responsibility
  • Level 3: Procedures - methods (Who, What, Where and When)
  • Level 4: Work Instructions - description of processes (How)
  • Level 5: Forms, Data and Records - evidence of conformance