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Wednesday, 28 October 2009

Quality Manual

I am often asked about quality manuals and what they should contain. The ISO9001 Standard states that the quality manual should have as a minimum:
  • The scope of the quality management system, including details of and justification for any exclusions;

  • The documented procedures established for the quality management system, or reference to them:

    • Document control;
    • Control of records;
    • Internal Audit;
    • Control of non-conforming product;
    • Corrective Action;
    • Preventive Action.

  • A description of the interaction between processes of the quality management system.

This meets the requirements of ISO 9001 but would have little benefit to the company. It would get the badge on the wall but little else.

I was once asked to produce a quality manual on a single sheet, and I did so, although it was A3 on two sides. The company took my advice and produced a number of work processes to back this up.

The largest quality manual I ever saw was in seventeen lever arch files and was so comprehensive that it even included instruction on how to make tea. It was never used as a serious document and was almost impossible to keep up to date. It was also so specific that it set the user up to fail if he used his left hand rather than his right.

Fortunately we no longer produce documentation by weight.

A modern manual contains the mandatory scope, six procedures, a description of the interaction of the processes, a number of work processes and an index of current forms. This along with records would not only meet the requirements of 9001 but would also be a valuable tool for the company.

My view is that the manual should be as comprehensive as needed but not overly complicated. It should be suitable for the company and not imposed by a consultant. It should be designed to be used and not just stored for use during assessment. And finally it should work for the company and not make the company work for it.

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