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.

ISO 9001, quality management system, is widely known as advancing internal efficiency and productivity in various industry. As a result, the number of companies that have adopted ISO 9001’s certification have been increasing continuously year by year since ISO 9000’ family standard was published in 1987s. This fact shows that a lot of businesses are trying to get the accreditation for improving the competitiveness of quality. The purpose of this study is to present that ISO 9001’s certification motives affect to the requirement’s implementation and show that the execution of requirements influences on management performance in the small manufacturer. In order to carry out this research, we obtained 96 survey sheets and inspected twenty assumptions based on the reliability, validity of the questionnaires. The results of regression analysis are summarized as follows; First, the factors of certification motive influence on the requirement’s implementation except resources management. Second, the two elements of ISO 9001 requirement, resources management and product realization, have an important effect on the operational performance and financial performance considerably in the companies that choose the internal motive. Finally, the two requisites of ISO 9001 requirement, resources management and measurement, analysis and improvement, affect to the operational performance and financial performance significantly in the businesses that select the external motive. Based on the results, the companies that choose the internal motive have a good performance to execute the ISO 9001 requirements. Also, to implement the requirements of ISO 9001 is helpful for the companies to produce the operational and financial performance.

Single PPM Quality Innovation Program is to pursuit of defects below 10ppm in outgoing quality for strengthen the small and medium enterprise's competitiveness. This study aims to find that whether quality innovation promotion is significant or not in the ISO 9001 certification enterprises. To perform this research, we surveyed CEOs, managers and workers working for manufacturing business, we distributed 250 sheets totally and withdrew 171 sheets. We analyzed 135 sheets that we could use for this research using SPSS 15.0 and AMOS 18.0 program.

Single PPM Quality Innovation Program is to pursuit of defects below 10ppm in outgoing quality for strengthen the small and medium enterprise's competitiveness. This study aims to find that whether quality innovation promotion is significant or not in the ISO 9001 certification enterprises. To perform this research, we surveyed CEOs, managers and workers working for manufacturing business, we distributed 250 sheets totally and withdrew 171 sheets. We analyzed 135 sheets that we could use for this research using SPSS 15.0 and AMOS 18.0 program.