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The International Organization for Standardization published ISO 9001 Quality Management System – Requirements in 1987 and has revised four times since then. ISO 9001:2015 is the latest edition and organizations are supposed to obtain the certificate of the new version registration by late 2018. This latest edition has two most noticeable changes. The first major change of new edition focuses on performance with an emphasis on Risk-Based Thinking (RBT) to enhance the process approach. The new edition consists of ten clauses whose first three clauses are largely same as older edition but risks are clearly stated and stressed in last seven clauses, emphasizing on Plan-Do-Check-Act cycle at all levels in the organization. The second major change is that the new edition has the same overall structure as other ISO management system standards known as High Level Structure with Annex SL.In this article we pursue to explain the basic concept of Risk-Based Thinking and describe six steps of Risk-Based Thinking using a realistic example. We enumerate all possible risks that can be occurred in organizations and propose a specific risk management procedure that the quality managers of organizations can systematically implement.
