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.

Environmental pollution including air, land, and water has become one of the most critical issues in global interest. The damages due to environmental pollution lead to serious disasters. Nations have realized the importance of environment protection and have been starting to force organizations to implement environmental management system (EMS) as way of protecting environment. ISO 14001 requirements that are the most popular standard as EMS have been developed to support continuous improvement to environment management. It has been revised once since publication and ISO 14001 : 2004 version is currently available. Organizations globally started to acquire the certificate of EMS to observe environment related laws, accept customers’ and stakeholders’ request, increase market share, and fulfill implementation motives. This article examines the audit data that were collected for several years from manufacturing companies including shipbuilding, machinery, metal, automobiles, and chemical companies in southeastern Korea on the basis of ISO 14001 : 2004 requirements. The audit data were classified into minor nonconformities based on factors such as business size, business type, and EMS implementation period. We conduct hypotheses test using statistical methods in order to see if there are any significant differences based on the factors. We draw conclusions for the results of hypotheses test and address the necessities of energy, greenhouse gas, green management, and continuous improvement to enhance the efficiency of EMS implementation.