Can Six sigma support ISO9001? If yes, in what ways?



Hello all,

I would like to have some inputs regarding,

How does implementation of six sigma effect ISO 9001?

What software can be used to make this implementation easier?
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Don't know that it requires any software, but DFSS should support the design/development process, the Control phase of DMAIC should support most processes (after all, 9001 is basically a list of processes and what are considered minimum controls required), and DMAIC certainly supports corrective action and continual improvement.


The following is from a discussion in the Quality Forum Online titled Improvement ideas: Six Sigma, Power BI to support ISO9001. The text below is by Bev D (Post 4 in the discussion).

Six Sigma is part of our QMS but it is not sufficient on its own though. It is our 'corrective action' system for physics based product quality problems and of course many of the tools are used for specific aspects of our control plans; we also use it for change assessment and V&V process. Additionally we use 'design for six sigma' or some will refer to it as 'quality by design' as part of our R&D processes and statistical data analysis and modeling for marketing, medical affairs and all other KPI tracking.

we use Lean continuous improvement, waste reduction and 5-whys (Apollo) for our people based problems
We use JMP and SAS for heavier analysis and report automation.​
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Quite Involved in Discussions
Six Sigma is not necessarily related to ISO9001. Are you already a Six Sigma practicing company?
IMHO, as I said, if the organization already has a Continuous Improvement initiative in place, there is no need to develop another just for ISO.
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