The Modern Quality Manual

It is hard to believe that so many years after the release of ISO 9001:2000 there are still a lot of “old school” perspectives and misconceptions about the role, form, and function of the “quality manual” (ISO 9001:2008 sub-clause 4.2.2).  I developed the Lean QMS® Map (a 2-page graphical version of a quality manual) in 1999 and have registered countless companies to ISO 9001, TS 16949, TL 9000, AS9100, and ISO 13485 with it.  Nevertheless, the use of a very small quality manual is still a hotly contested topic, even among my professional colleagues.

Perhaps one of the reasons that many of us are still divided on the concept of a small quality manual is that we have not truly considered and understood the actual requirements.  ISO 9001 requirements for a quality manual are: 

  1. It must describe/define the scope of the quality management system,
  2. It must explain any excluded elements/clauses,
  3. It must define or reference the “documented procedures” that make up your quality management system, and
  4. It must describe/show the interaction of the quality management system processes

At no point does ISO 9001 stipulate how long the quality manual should be.  It does not even say that it should be a singe document.  Nor does it suggest that it should even be in text format.

Another possible source of confusion and diverging opinions is the use of the terms “procedure” and “processes”.  We can all agree that the intent of ISO 9001 is to serve as a process management platform.  However, it only applies the word “documented” to procedures.  This begs the question: should we not document our processes?  For those of us that practice more that just ISO compliance, the answer is: of course we should.  If you agree, then replace the word “procedure” with “process” and think about the requirements again.  Now the QMS must:

  1. Define or reference the “documented processes” that make up your quality management system, and
  2. Describe/show the interaction of quality management system processes.

Why not draw a picture of this on one or two pieces of paper?  Why use paper? In my practice I do this all the time.  Hundreds of clients have embraced this approach and never has this been an issue with any registrar.  Granted, customers may want to see the details of the actual “documented process,” which is fine.  Show them the process(es) and show them how that process fits into the overall process based quality management system with your new short quality manual or Lean QMS® Map.

Kirill Liberman, President

8 Responses to “The Modern Quality Manual”

  1. mike h says:

    Very unorthodox approach. I like it. Anything to minimize the bureaucracy of a typical ISO system. In my experience most people think of ISO as a documentation system.

    The Lean QMS Map is cool. Does it really work for getting certified?

    Mike

  2. Kirill Liberman says:

    Mike,

    I am glad you like my approach to eliminating the traditional quality manual (and EMS Manual). It does work for certification. Every one of our clients uses it and we have never had a single nonconformance or observation written against it. If fact, it has only received praise from third party auditors.

    Nevertheless, the Lean QMS® Map is essentially a graphical interface. It is one small element of the Lean QMS approach, but it is not where the real value of the Lean QMS is. If you are interested in seeing how the Lean QMS works with the Lean QMS® Map, please contact me and we will schedule a web meeting/demo.

    Kirill Liberman

  3. Barbet says:

    I tried to get my boss to go to a two or three page quality manual using the requirements listed and he didn’t think the customer would like it. He has now read your article and sent me the link.
    1. It must describe/define the scope of the quality management system,
    2. It must explain any excluded elements/clauses,
    3. It must define or reference the “documented procedures” that make up your quality management system, and
    4. It must describe/show the interaction of the quality management system processes

  4. Kirill says:

    Hello Barbet. Welcom to the blog.

    I am so glad that your boss finally saw the light.

    If you or your boss want to see a three page quality manual in action, give me a call. I will be glad to show both of you how to take the Lean QMS approach to the next level.

    Kirill Liberman

  5. Emmitt Bacot says:

    Im going to start up a blog on the same theme in the near future, that is why Im so interested in your posting. Would you mind if I used some of your thoughts for my personal weblog? Ill certainly refer to you as the original source and set up the link pointing back to your web blog. Appreciate it!

  6. Kirill says:

    Welcome to the blog, Emmit.

    I am flattered that you would like to use some our content. As you can probably tell, our content is competely original and we do not borrow from others. I don’t mind you quoting any content you find helpful here, as long as you clearly identify Pinnacle Enterprise Group as the author and provide a direct link to the appropriate page on our site or blog.

    Good luck with your blog.

    Kirill Liberman

  7. A B says:

    Hi, I am in the process of leaning out our Quality System staring with our Quality manual. We are ISO 13485 certified, and I’d love to see an example of a lean Quality Manual and flowchart.

    Thanks!

  8. Kirill says:

    Hello A B. Thank you for visiting our blog.

    Please feel free to contact me directly and I will set up an online meeting during which I will show you and ISO 13485 compliant Lean QMS.

    Kirill Liberman

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