Applying Lean Principles to ISO Audit Documentation

Applying Lean Principles to ISO Audit Documentation

by Steve Gompertz, CMQ/OE, CMDA, RAC-US, CMII

The following is taken from the Guerrilla Tactics for Quality Managers webinar with Steve Gompertz. Watch the replay!

How Big Should Your ISO Quality Manual Be?

How Big is Yours?

Although most Quality Manuals are 20 – 30 pages long, some companies’ manuals are 50-100 pages long.

That’s a pretty hefty document. Interestingly, nowhere in the ISO requirements does it state how large or small your Quality Manual must be! In fact, ISO 9001 no longer even requires you to have a Quality Manual. This is clearly an opportunity to apply Lean Principles to ISO documentation.

Do you recall what’s specified regarding Quality Manuals for ISO 13485? There’re just four requirements.

I had this happen in an audit: The auditor walked in. And of course, the first thing he said was, “Can I see your Quality Manual?” So I slid a 39-page Quality Manual across the table to him, and he picked it up. And he did sort of that old professor thing, weighing the paper to see what the grade should be. He just held it in his hand, looked across the table at me, and said, “How many requirements are we satisfying?

And I said, “Four.” Those four requirements are fairly straightforward:

  • Describe the scope of the quality management system, including any exclusions (with justification)
  • Identify the documented QMS procedures
  • Describe the interaction between QMS processes
  • Outline the QMS documentation structure

He replied, “And it takes this much paper for you to explain how you’re meeting four requirements?”

When it comes to documentation, size (or length) is a trap we fall into. We overthink quality manuals, and we overthink much of our documentation because of our assumptions about what we think the auditors may want to see, which often has nothing to do with the requirements or what they really want to see.

Based on this, as an auditor, I would challenge a 15-page document. I’d challenge a 10-page quality manual. Now, readers are probably thinking, “Wait, wait, wait! You’re getting way too low.”

The million-dollar question

How small could a quality manual be, and still meet all four ISO requirements?

When I present this question in person to a group of people, the majority reply that it needs to be at least eight pages. I ask if it could be done in five; a few skeptics raise thier hands. Three? All hands disappear. Two? Everyone is shaking their heads ‘no‘ at this point.

There’s no way that you could create a quality manual on a single sheet of paper,” they tell me. “Absolutely no way you could make that happen.
Then, I show them this tri-fold brochure.

Steve Gompertz's example of a Lean quality manual, page 1

Steve Gompertz example of a Lean quality manual, page 2

Will this pass an audit?

Yes, it will, and it absolutely has passed an audit. I’ve implemented this at several companies, both ISO 9001 and 13485. FDA inspectors have also seen this.

Every auditor who has seen this has loved it.

I consulted at the same company with the 39-page Quality Manual mentioned above. I restructured their documentation and created a brochure like the example in this post. The next time they had an auditor show up, he asked for the Quality Manual, and I handed him the brochure. He opened it up, looked at it for a second, looked back at me, and said, “Finally.”

Somebody finally understood the intent of the Quality Manual.

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