Overview:

One of the most significant changes in ISO 9001:2015 is the increased emphasis on risk-based thinking in requirements for planning, auditing and improvement of the quality management system (QMS) and its processes. What is risk-based thinking? Do you know how to address risks and opportunities? Did you ever analyze risks and opportunities? This course will provide insight to help you understand these requirements and compare them to the risk management process for the phase Plan-Do-Check-Act (PDCA) cycle and some commonly used models and tools. It will then focus on applying these concepts within a quality management system with the intent of helping an organization achieve quality objectives. Failing to apply risk-based thinking in an organization’s QMS may decrease customer satisfaction, caused by non-conformity in products and services.

Key Session Topics: 

• ISO 9001:2015 Standard – elements addressing risk management
• Key risk definitions
• Principles and fundamentals of risk-based thinking and the process approach
• Understanding quantitative and qualitative approaches
• Important control measures / implementation methods (improvement opportunities)
• Monitoring, management review, and communication requirements
• Question and answers with the Instructor

In addition, all students receive a copy of the training materials and certificate of attendance.

Who Should Attend:

This course is acceptable to individuals or organizations involved with ISO 9001:2015 quality management system implementation. There are no formal prerequisites required prior to taking this course. However, it is helpful if the learner has some prior experience / knowledge of ISO 9001:2015 either through professional work or academically.