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Can I use ONLY the six required procedures in my ISO 9001 QMS?

Gman2

Involved - Posts
#1
In keeping with efforts to LEAN out our new ISO 9001 QMS as much a humanly possible (and still remain effective) I am planning on ONLY writing up the six documented procedures required by the standard. Does this sound feasible? I plan on controlling other areas with Process Flowcharts and Work Instructions (which are kind of the same in our definitions). Example scenario: we were just asked by a potential customer to provide then with a copy of our "procedure" for die penetrant testing. We don't have one handy but are creating one as we speak. I am not planning on calling it a "procedure" but instead a "process work instruction" . This will basically map out the steps we take (and who takes them) in order to do this type of test.

I am planning on taking this approach with everything else as well. For one I don't like the written approach and find the visual/flowchart/infographics get more positive feedback with the people using them and like I said I want to cut down on the "written" stuff. The above example will be "written" steps but only because we are just whipping it together for the customer. I just don't want to have to include it in a L2 procedure and have to reference it in the Manual and all that Biz.


Anyone see any issues with this approach? I am thinking as long as our process work instructions are robust enough we don't really need "procedures" per say.

waddaya think?

G
 
#2
Re: Can I use ONLY the six required procedures in my QMS?

On the face of it, seems fine to me. I wish more people would throw the "pyramid" out of the window and just go with a process map and attached forms/instructions.

Go for it!
 
#3
Re: Can I use ONLY the six required procedures in my QMS?

As long as it works for you and your organization, I agree with AndyN. There are many different takes on the differences between "procedures" and "work instructions" - my own take on it is that procedures describe what needs to be done, and work instructions describe how to do it.

Flowcharts are quite useful in describing a procedure, as they show relationships with other processes, and their position in the overall QMS process flow.

As long as your staff do things in a consistent way and show that they understand the requirements fully, the minimum prescribed is all that you need under ISO 9001:2008.
 

John Broomfield

Staff member
Super Moderator
#4
Re: Can I use ONLY the six required procedures in my QMS?

Gman,

Many organizations use only flowcharts as their documented procedures supported by documented instructions where necessary for effective operation and control.

Why not flowchart your six documented procedures too and archive the textual versions?

Flowcharts can work well as procedures especially if they are deployment (aka swimlane) flowcharts as recommended Dr Myron Tribus. Unlike classic flowcharts, deployment flowcharts show authorities and responsibilities.

John
 

Pancho

wikineer
Super Moderator
#5
Hi Gman,

You are not required to write QMS documents in prose nor call them "procedures". They can be flow charts, diagrams, drawings, picture sets, videos or poems. You can call them "instructions", "methods", "recipes", "descriptions", "tutorials", "plans", "forms". etc. Document names or categories are frequently interchangeable, and not really important. What's important is that they ensure the effective planning, operation and control of your processes, as section 4.2.1d of the standard requires.

However you call them and show them, though, it is unlikely that you will ONLY have the six documented procedures named by the standard. You mention one document that you have to produce already because a client is asking for it. Other docs will be required to clarify to your own organization the way your key processes work and interrelate. Then, non-conformities, problems, arguments, are all valuable opportunities to learn, and the learning can and should be captured in your documents. That's the essence of continuous improvement.

So with a healthy QMS, your documentation likely to grow as you capture knowledge. You can always prune and optimize. Lean is good, but only when it's achieved from the distillation of lots of knowledge. Lean without knowledge is not good.

Good luck!
 
#8
So with a healthy QMS, your documentation likely to grow as you capture knowledge. You can always prune and optimize. Lean is good, but only when it's achieved from the distillation of lots of knowledge. Lean without knowledge is not good.
:applause: This is it in a nutshell. I copied and pasted this, and will use it at every opportunity.
 
R

Reg Morrison

#9
your documentation likely to grow as you capture knowledge. You can always prune and optimize. Lean is good, but only when it's achieved from the distillation of lots of knowledge. Lean without knowledge is not good.
:applause: Well said. That's what the new version of 9001 (2015) refers to as knowledge management. One key aspect is to "transform" knowledge into competence. Knowledge for knowledge sake is of limited use. You want to make sure knowledge is captured, managed, transferred, updated, etc... to make people competent for their respective functions.

Minimizing documentation for "ease" of operation and passing external audits more easily is a clear statement of failure to understand risk based thinking and knowledge preservation/management.

Not meant as a dart to anyone, but the repeated question if someone can comply with ISO 9001 with only six documented procedures just shows how much ignorance still exists about effective management of an organization. Yes, simple is better, AS LONG AS it is effective.
 
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