Lean Six Sigma and ISO 9001:2015 2019

Topics

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

Who should Attend

Attendees with responsibilities in:

• Diagnostic
• Medical Device
• Biologics fields
• Pharmaceutical