Introduction

Risk-based thinking is a key concept that underpins ISO 9001 :2015. Risk-based thinking means considering risk and opportunity qualitatively as well as quantitatively when defining the rigour and degree of formality needed to plan and control the Quality Management System and its component activities. The possible benefits of a quality management system based on ISO 9001 :2015 include the organization being required to address risks associated with its context, objectives and strategic direction. The context changes through time, risk determination and evaluation are ongoing activities.
Hence an organization must evidence that they have determined, considered and, where necessary, taken proportionate action to address any risks and opportunities that may impact, either positively or negatively, their quality management system's ability to deliver its' intended results or that could impact customer satisfaction.

Objectives

• To gain a thorough knowledge in risk based thinking with organizational context and its strategic direction which may impact the quality management system and its planned results
• To increase positive effects, to avoid or minimize negative effects, and to achieve improvement
• To facilitate the alignment or integration of the QMS into the business management system
  through mitigating or preventing risks

For Whom

Those who have followed ISO 9001 Quality Management System Auditor/ Lead Auditor Course For

personnel who will conduct, manage and participate in internal quality audits

personnel who will conduct, manage and participate in internal quality audits

Course Content

• Introduction to Risks and Opportunities
• Risk severity and Impact analysis on the performance of the Quality management system
• Management approach in risk assessment
• Risk mitigation and prevention
• Assignments and Practical Sessions