Risk and Change

Concurrent Session

T25 - LSS+ISO 9001:2015 = Maybe at Risk, but Not in Peril

Tuesday, May 1
4:00 PM - 5:00 PM
Location: WSCC 618-620

Level: Intermediate

Division: Lean Enterprise Division

So what does Lean Six Sigma (LSS) implementation have to do with ISO 9001:2015? Organizational risk often hides in the "hidden factory" where waste is produced. Lean processes are transparent and make it easier to spot risk. LSS implementation can be used to eliminate or mitigate both product and process risk, thus fulfilling the requirements of key elements of ISO 9001:2015. "Respect for the individual," a cornerstone of LSS, is also important when it comes to risk management, from two very important perspectives: 1.) Protecting individuals within the organization from risk; and 2.) Tapping into their collective knowledge to identify and mitigate existing risks. These benefits support the new ISO 9001:2015 requirement of capturing and utilizing organizational knowledge. They also support the quality principle of "employee engagement." The relationship between process improvement and risk management will be explored—creating an understanding that managing performance successfully also means managing risk effectively. Attendees will also discuss how risk-based thinking helps create an environment where LSS and other improvement activities can thrive.

Learning Objectives:

Lance B. Coleman


Senior Quality Systems Engineer
Natus Medical
Kent, Washington

Lance B. Coleman is a Senior Quality Systems Engineer for Natus Medical in Seattle where he manages the CAPA and internal audit programs. He has over 20 years of leadership experience in the areas of quality engineering, Lean implementation, quality and risk management in the Medical Device, Aerospace and other regulated industries. He has a degree in Electrical Engineering Technology from the Southern Polytechnical University in Marietta, GA and is an American Society for Quality Senior Member as well as, Certified Quality Engineer, Quality Auditor, Biomedical Auditor and Six Sigma Green Belt,. He is also an Exemplar Global Principal QMS Auditor. Lance is the author of three books – “Managing Organizational Risk Using the Supplier Audit Program (Quality Press 2018), “Advanced Quality Auditing: An Auditor’s Review of Risk Management, Lean Improvement and Data Analysis (Quality Press 2015)” and “The Customer Driven Organization: Employing the Kano Model (Productivity Press 2014)” and as well as, many articles on quality, Lean implementation and risk management. He is 2018 ASQ Lean Enterprise Division Chair and 2016-2018 TAG 302 Chair. Lance is also an instructor for the ASQ FMEA and Certified Quality Auditor Preparatory courses. He has presented, trained and consulted throughout the United States and abroad.


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Benjamin Trujillo


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T25 - LSS+ISO 9001:2015 = Maybe at Risk, but Not in Peril


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