The International Organization for Standardization (ISO) published ISO 9001 Quality Management System (QMS)-Requirements in 1987 and has revised four times since then. ISO 9001:2015 is the latest edition. 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 (HLS) with Annex SL. The companies obtained the certificate of new ISO 9001:2015 QMS by September 15, 2018 in order to maintain as an ISO QMS registered firm. In this article we collected transition audit data from more than 100 companies that registered ISO 9001:2015 QMS for recent three years. We performed a statistical analysis to disclose the relationships between the characteristics of companies and the minor nonconformities found in ISO 9001:2015 requirements during transition audit processes. We also aim to interpret the findings and deduce the implications of the statistical results.

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. 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 aim to statistically analyze minor nonconformities found in different types of transition audits. We try to interpret the findings and summarize the implications of the statistical results.

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.

The ISO (International Organization for Standardization) 9000 QMS (Quality Management System) standards specify requirements that need to demonstrate an organization’s ability to consistently provide products or services. Korean companies have been implementing ISO 9000 QMS to compete in global markets. ISO 9000 QMS standards have been revised in 1994, 2000, 2008, and 2015 since the first release in 1987. The key change in ISO 9001:2015 is focused on risk-based thinking. It means that risk inherent within an organization is early identified and proactively controlled by use of all aspects of QMS rather than taking preventive actions. In this article we did literature review mainly on empirical study related to motivation and operation performance of ISO 9000 implementation. We present the necessity of changeover, features of new version, and comparison between new and old version. In order to see how well organizations can implement the new ISO 9001:2015 we focus on manufacturing companies that are going to convert to ISO 9001:2015 registration. We collect their key characteristics such as yearly sales, the number of MPI (Management Performance Indicators), the number of KPI (Key Performance Indicators), the number of quality control engineers, quality control engineer work experience, and the degree of adaptiveness between new ISO 9001:2015 QMS and QMS currently operating in manufacturing companies. Especially the degree of adaptiveness is analyzed by correlation analysis, regression analysis, ANOVA, and t-tests to discover the relationships among their characteristics. We found out that the degree of adaptiveness is linearly related to quality control engineer work experience and the number of MPI and KPI that is practically utilized in manufacturing companies. We summarize the implications discovered to help manufacturing industry convert to ISO 9001:2015 registration.

본 논문은 ISO에서 2008년 규격이 최근 2015년 규격으로 개정 발행됨에 따라 ISO인증이 필요한 조직들은 필수적으로 2018년 9월까지는 전환심사를 통하여 개정 인증을 받아야 한다. 2015년 개정 규격의 가장 중요한 특징은 리스크 기반 사고에 근거한다는 점과 2008년 규격의 5개 Sectors를 7개 Sectors로 확장하여 요구사항 들을 구체화시켜서 과거의 예방조치의 개념에서 리스크의 개념으로 전환하고 PDCA 싸이클속에 내재하는 품질경영시스템의 요소들을 시스템적으로 관리하는 것이다. 이에 따라 개정규격의 인증이 필수적인 여러 조직들 가운데서 동남지역에 위치한 제조업체들을 선택하여 제조업체 여러 가지 특성들에 대한 자료들과 개정규격의 적합성을 통계적으로 분석함으로써 그들의 관련성을 발견하고 개정규격이 용이하게 운용될 수 있도록 제안하고자 한다.