Lean Six Sigma and ISO 9001:2015

This course teaches any employee the Lean Six Sigma philosophy and how to apply it in their job on a day-to-day basis. Participants will learn each phase of Six Sigma’s DMAIC methodology and their use as a part of the continuous improvement program. Students will understand how implementation of Lean Six Sigma method ties directly to and demonstrates compliance with the core principles of ISO 9001 and its sister ISO Quality Management System (QMS) standards. Participants will also leave this course with an understanding of overview of Lean Six Sigma tools, methods and their application as well as, effectively engage under supervision in their organization’s continuous improvement program.

Areas Covered in the Session : 

• Overview of Lean Six Sigma
• The meaning and use of Lean Six Sigma philosophy
• Communicate using Lean Six Sigma concepts.
• Relate Lean Six Sigma concepts to the overall business objectives.
• How Lean Six Sigma demonstrates alignment with core ISO qms principles
• How to use the five-step D-M-A-I-C method to improve processes.
• How to map a process and understand its inputs and outputs
• How to draft a project charter
• Overview of design of experiments (DOE)
• Overview of failure mode and effects analysis (FMEA)
• Overview of measurement system evaluation (MSE)
• How to engage in a meaningful way in ongoing continuous improvement projects

Who Should Attend:

This webinar will provide valuable assistance to all regulated companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

• Those seeking to improve their process improvement skills
• Those wanting a basic understanding of Lean Six Sigma philosophy, tools and methods
• Those who want to demonstrate effective compliance to ISO core principles
• Those who want to be able to actively participate in their organization’s six sigma program

Course Director: LANCE B. COLEMAN ‎

Lance B. Coleman 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, Six Sigma Green Belt, Quality Auditor and Biomedical Auditor.  He is also an Exemplar Global Principal QMS Auditor. Lance is Chair of US TAG 302 – guidelines for auditing management systems as well as a voting member of US TAG 176- quality management and quality assurance. He is the author of  “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)”, as well as many articles on quality, risk management and Lean implementation. Additionally, Lance is an instructor for the ASQ Certified Quality Auditor Exam Preparatory and FMEA courses.  As Principal Consultant of Full Moon Consulting, he has presented, trained and consulted throughout the United States and abroad.