Purpose: This study examined the effects of simulation-based education for high-risk maternity on evaluating problem-solving process, self-leadership, critical thinking disposition, and selfefficacy of nursing students. Method: This study was a one-group pretest-postest test design with 81 junior nursing students as participants. Data were collected from September 4 to December 11, 2019, after students completed their simulation practice class. Students completed a survey on their problem-solving process, self-leadership, critical thinking disposition, and self-efficacy at the beginning and end of the class. Data were analyzed using descriptive statistics, paired t-test, and Pearson’s correlation coefficients using the SPSS WIN 21.0 program. Results: Students’ problem-solving process (t=-7.06, p<.001), self-leadership (t=-3.08, p=.003), critical thinking disposition (t=-2.12, p=.037), and self-efficacy (t=-6.01, p<.001) showed significant improvement after the simulation-based education for high-risk maternity. There was a positive relation between problem-solving process and self-leadership (r=.52, p<.001), critical thinking disposition (r=.39, p<.001), and self-efficacy (r=.53, p<.001). Conclusion: There is a need to supplement the limitations of clinical practice education by providing a simulation-based education environment similar to a hospital since the experience of clinical practice alone is not sufficient to improve students' knowledge and skills. Results of this study may be used as a basic data for efficiently performing simulation-based education on high-risk maternity.

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.

ISO 9001 Quality Management Systems-Requirements has been revised in 2015. It has been updated four times since its publication in 1987. It is the most widely used International Standard in the world. There are over one million companies and organizations in over 170 countries certified to ISO 9001 from an ISO survey. Organizations are supposed to be certified to this new version by late 2018. The key changes in ISO 9001:2015 are to establish a High Level Structure (HLS) and focus on Risk-Based Thinking (RBT). Risk-Based Thinking means the process approach to decide how risk is addressed in establishing the processes to improve process outputs and prevent undesirable results. It pursues process planning and controls based on risks so that organizations can improve the effectiveness of the quality management system. It maintains and manages a Quality Management System that inherently addresses risks and meets objectives. In this article we firstly attempt to explain how to understand the fundamental concept of Risk-Based Thinking which is a systematic approach to consider risks rather than treating prevention as a separate component of a Quality Management System. We comment on the detailed requirements that contain risks in ISO 9001:2015 clauses. We also summarize recent advances on the risk assessment and management in line with ISO 31000:2009 Risk Management-Principles and Guidelines. We finally propose the practical risk management procedures for implementing ISO 9001:2015 with an emphasis on RBT. This article would contribute to help quality managers and practitioners convert to ISO 9001:2015.