Our organization has a mature Lean Six Sigma culture, but we are now pursuing ISO 9001:2015 certification. I am worried that the rigid documentation required for ISO might stifle our Lean agility and continuous improvement speed. Has anyone successfully mapped ISO clauses to Lean tools without creating a massive amount of redundant paperwork?
3 answers
Integrating ISO 9001 into a Lean environment is actually easier than it looks if you focus on the "Process Approach." You don't need new documents; you just need to show how your existing Lean tools satisfy ISO clauses. For example, your Gemba walks and Kaizen events are perfect evidence for "Improvement" (Clause 10). Use your Value Stream Maps as your process documentation. The key is to treat ISO as the "what" and Lean as the "how." By using your existing SIPOC diagrams to define process boundaries, you satisfy ISO 4.4 without adding any extra administrative burden to your operational teams.
That sounds like a solid plan, but are you finding it difficult to get your internal auditors to accept Lean visual boards as formal "controlled documented information"? I’ve seen auditors insist on traditional manuals which completely defeats the purpose of a paperless Lean office.
The most important part is the "Risk-Based Thinking" requirement. Use your existing FMEA (Failure Mode and Effects Analysis) sessions to prove you are identifying and mitigating risks.
Exactly, Sarah. FMEA is the perfect bridge between Lean Six Sigma's technical rigor and the high-level risk management expectations found in the ISO 9001:2015 standard.
Christopher, the trick is to define your "Control of Documented Information" procedure to explicitly include digital displays and visual boards. Once it is written into your QMS manual that a Kanban board is a controlled record of work-in-progress, auditors are generally much more accepting. We did this last year and it saved us from printing hundreds of unnecessary logs.