ISO 9001:2015, Lean, and Six Sigma - More than Compliance!

Richard Maclin, Master Black Belt, Continuous Improvement Solutions, LLC, Centerton, AR, USA

Keywords: ISO 9001:2015, Lean, Six Sigma

Industry: All

Level: Intermediate


Companies have, for years, pursued process performance excellence through Lean and Six Sigma or other approaches. Organizations have sought quality excellence with quality management systems (QMS) like ISO 9001. Many businesses compartmentalize these approaches. Lean is all about speeding up processes and reducing Non-Value Added activities. Six Sigma focuses on reducing Variation by "over-complicated" statistic methods. ISO 9001 is commonly perceived as a costly set of rules we have to follow.

These approaches look and feel like separate programs as they compete for the same internal resources like people and money. We use different terms to describe how each approach is the next best thing . All three approaches claim to focus on process improvement but seem to produce little in actual savings or performance. There are many reasons for this mix of less-than-desired results. Rather than focus on why, this session will focus on connecting the dots of Lean, Six Sigma, and ISO 9001:2015.

We will explore several key clauses in ISO 9001:2015 and illustrate effective applications of Lean and DMAIC as part of the QMS. The basic ISO 9001 road map requires that businesses of all sizes establish objectives to affect customer satisfaction. Those objectives must be communicated throughout the organization. Plans must be developed and resources must be provided to support the objectives. Risks associated with those plans, processes and resources must be assessed and addressed by Top Management.

All ISO clauses, PDCA phases, and DMAIC phases rely on Leadership (Clause 5) that supports the Organization s Context (Clause 4). The ISO requirements manual includes a suitable graphic to show the relationship of ISO 9001:2015 to PDCA and will be included in the presentation.

At a minimum, ISO 9001:2015 Requirements match up with PDCA (Lean) and DMAIC (Six Sigma) as shown here using the format, ISO (Clause #) = PDCA = DMAIC:

Planning (6) = Plan = Define / Measure / Analyze

Support (7) / Operation (8) = Do = Improve

Performance Evaluation (9) = Check = Control

Improvement (10) = Act = Control

This session s title, ISO 9001:2015, Lean, and Six Sigma - More than compliance! suggests that there is a common compliance theme to ISO 9001:2015. In truth, there has been a general perception that ISO requirements are primarily a set of rules with which we must comply. However, that has never been the intent of the ISO family of documents. They have always been focused on business process improvement to drive increased customer satisfaction. Both internal and external customers have been in the scope of ISO requirements from the start.

This focus on process improvement and customer satisfaction meshes very well with Lean and Six Sigma methodologies because they indicate the same focus areas.

For businesses that define the context of their organization (Clause 4) and work to understand the needs of all interested parties (Clause 4), the next logical phase is for Top Leadership (Clause 5) to set the strategic direction for the organization. Based on that direction, the organization can begin to PLAN (Clause 6) to move the organization in the strategic direction, identifying and addressing risks along the way. Then, Support (Clause 7) and Operation (Clause 8) work together to ensure that the appropriate processes, resources, and information are provided and implemented to achieve the strategic direction or, DO the work. Performance evaluation (Clause 9) leads us to CHECK our progress toward the strategy and Improvement (Clause 10) drives us to ACT in an appropriate manner to keep the organization moving toward the strategy objectives.

At the QMS level, DMAIC can be applied to improve the overall system performance and to target those tough to meet objectives. For instance, all of the PLAN (Clause 6) activities match up with Define, Measure, and Analyze. Then Support and Operation (Clauses 7 & 8) team up for DO and Improve. To wrap it all up, CHECK and ACT line up with the Control phase.

When all three approaches are coordinated and used to form one management system then resources can be adequately allocated to support the highest priority initiatives to make the most process improvement with greatest return on investment. With organizational efforts synchronized and working toward the overall strategic objectives, as well as overcoming the known risks then organizations focus less on compliance and more or growth and performance!

All three approaches bring specific structures, tools, thought processes that allow a focused work team (all levels) to set and achieve breakthrough performance! Such breakthroughs are not possible when the organization only sees ISO 9001 as a compliance trap and is unsure how to provide direction, processes and resources to support Lean and Six Sigma campaigns.

Finally, such campaigns must break free from the label of program or campaign. Lean and Six Sigma blended with Quality Management Systems must become the organizational DNA and support the overall Organization Strategy by integrating with the QMS and solving meaningful problems with lasting results. This approach can foster the growth of a culture of excellence that transcends mere compliance and drives stellar performance!

Download a copy of the ISO Conference Brochure
Please select the relevant Registrant Type from: a) Conference & Workshops; b) Exhibits & Sponsorship; c) Speakers & Co-Speakers

Submit your PowerPoint by
January 31, 2019
Speakers’ Orientation Meeting:
Sunday, March 10, 2019, 6 PM-7 PM
Please download the Speaker Instructions here

Conference Chair's Message

Robert Freeman

The 2019 ISO 9000 & AUDITS WORLD CONFERENCE is focused on providing you and your organization with the information and tools needed to continue this drive toward excellence. This year’s conference will not only continue to prove relevant topics with leading experts in their respective fields, but it more