It is hard to believe that 8 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 9001:2000 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 processional 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 then 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

Filed under: Quality Management System, AS9100, ISO 13485, ISO 9000, ISO 9001, qms, Quality Management System, quality manual, TL 9000, TS 16949