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The Abominable Quality Manual, Part Two

How to write an ISO- or API-compliant quality manual

Miriam Boudreaux
Thu, 04/10/2014 - 12:54
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In part one of this series I described how many auditors want your quality manual to repeat what is in ISO 9001, API Spec Q1, or API Spec Q2. Since auditors don’t always make the connection between how you wrote the quality manual (in a way that’s useful for you) and the standards in question, your choice is either to go to battle with them or learn how to build the perfect quality manual that will appease them. By that, I mean a quality manual that meets the requirements of the relevant standards and the auditors who interpret them, yet still provides value to your company and its employees.

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Comments

Submitted by Dan Nelson on Wed, 04/09/2014 - 13:28

Fantastic

After reading part one, I was looking forward to part two. I'm happy to see that part two is just as good as part one was. Really well done. Thanks, Miriam. Great article.
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Submitted by kutselev on Thu, 04/10/2014 - 10:43

It is a Legacy Issue

I am old and Grey so I can tell you that the paint by number manual has its origin in old versions of the ISO 9001 standards (1994,and older) where it "forced" auditors to confirm that all element of the standard were addressed (or so it was thought).  The current standard "forces" companies to lay out their business process - a job that most companies fail miserably at.  I agree with the author that a proper business process map and detailed explanation that refers to the forms, checkpoints, and procedures is far more valuable than any paint-by-number manual. I suggest interviewing auditors to gain their understanding of what they will be looking for and simply not hiring those auditors and firms that want paint-by-numbers manuals.  Bruce Velestuk

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Submitted by Dan Nelson on Thu, 04/10/2014 - 18:49

In reply to It is a Legacy Issue by kutselev

Legacy Issue

I agree Bruce. I like her point that a manual describes the system instead of the standard (or conformity to the standard in a clause-by-clause fashion). Defining every unique system according to the same standard-based structure is like giving each organization the same bad bowl haircut. "Yes, the hairline conforms perfectly to the bowl--isn't that attractive?" "Oh, yes," would reply many auditors, "it conforms nicely to the bowl--almost perfect conformity--good manual." Miriam has encountered auditors, apparently, as have I, who seem to want QMS documentation to parrot the standard in order for them to find conformity. They WANT the documentation to nicely align with checklists based on ISO 9001 requirements (instead of management's own processing requirements). Many manuals are standard-based, it's almost an expectation. A manual should be written not for auditors--as they seem to often expect--but for management purposes first. While QMS procedures are more clearly for organizational personnel, the manual itself is written not only from a management perspective--to help view and manage the system of processes--but with the expectation that customers will be the customers of the manual, too. If a customer requesting a quality manual wanted to know how you control your operations, an actual description of the responsible processes and some general description of the policies or controlling provisions to ensure adequate control over operations seems more appropriate than a manual simply regurgitating the standard. A manual demonstrating that you have your act together (by stating how you run the show) should be more valuable and confidence-instilling to a customer than a manual effectively failing to say how you keep your act together, but only succeeding in promising to meet ISO 9001 requirements.
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