Both ISO 21001 and ISO 9001 are standards developed by the International Organization for Standardization (ISO) for quality management systems. However, while ISO 9001 focuses on the general requirements for Quality Management Systems (QMS), ISO 21001 is specifically designed for educational institutions. ISO 9001 is a widely recognized standard for QMS applicable to almost industries, including manufacturing and services. It defines the requirements for establishing, implementing, maintaining, and continuing improvement of QMS to improve customer satisfaction by meeting customer requirements and improving overall performance. Meanwhile, ISO 21001 focuses specifically on educational institutions and is designed to develop and improve the curriculum efficiency by meeting trainees needs. It provides a system in which educational institutions can build, implement, maintain, and continuously improve the Education Management System (EMS) for the purpose of improving the satisfaction of trainees and other stakeholders. ISO 21001 covers a wide range of educational organizations, including schools, universities, and education providers. KINAC/INSA, the Center of Excellence in Korea, is an educational institution in the field of nuclear control. So It has been developed and operated various international and domestic curriculum. KINAC/INSA obtained ISO 9001 certification in November 2016 and has been certified so far. However, in the scope of ISO 9001 certification, curriculum development process is not included so KINAC/ INSA needs to obtain additional ISO certification specialized in education to improve the education quality. That is why KINAC/INSA is developing the ISO 21001 system, and aims to acquire certification in November 2023. This paper explains the necessity for educational institutions to obtain ISO 21001 in comparison with ISO 9001. It also introduces the process of developing ISO 21001 system of KINAC/INSA. By implementing EMS based on ISO 21001, KINAC/INSA can expect to improve the educational satisfaction of trainees and other stakeholders through effective curriculum development and educational operation.

In the recent business environment, risks related to product safety problems are increasing. These are arising from various factors such as increasing product and production complexity, supply chain diversification, enhanced PL (product liability) law and strengthening regulations of the government. Accordingly, ISO (international organization for standardization) published standards of PSMS (product safety management system) for suppliers such as ISO 10377 and ISO 10393. Meanwhile, the ISO 9001 QMS (quality management system) was revised in 2015, and it has established itself as an effective tool that can consistently meet the various requirements of stakeholders and promote customer satisfaction. This study aims to suggest an integration framework of QMS and PSMS based on the recent ISO international standards. To this end, firstly, the relationship between QMS and PSMS is studied based on the quality and product safety definitions, PDCA (plan-do-check-act) cycle and risk-based thinking. Secondly, the requirements of ISO 10377 and ISO 9001 are compared and classified as the common and ISO 10377 specific requirements. Finally, integration steps of two systems are suggested and guidelines that can systemize the integrated requirements are presented in the aspect of processes and documentation. This study is expected to be used as a guideline that helps companies those have already acquired QMS certification to build an international-level product safety management system early.

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.

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.

It is well known that ISO 9001 and TQM have significant effects on business success. We analyzed the effects of ISO 9001 requirements and TQM on financial performance with structural equation modeling. Hypotheses are proposed and tested based on existing

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.

The objective of this research is to analyze the effects of quality management system constructed by ISO 9001 certificates through BSC perspectives. Evaluation of quality management system based on BSC framework can consider short-term financial performan

It is well known that ISO 9001 and TQM have significant effects on business success. We analyzed the effects of ISO 9001 requirements and TQM on financial performance with Structural Equation Modeling. Hypotheses are proposed and tested based on existing beliefs, proposition and prior research concerning quality. Survey data were collected from 291 manufacturing companies with ISO 9001 certifications. The data show that ISO 9001:2008 requirements have significant positive direct effects on TQM practices, but do not have positive direct effects on financial performance. As expected, TQM has significant positive direct effects on financial performance. One of the important results is that efforts to meet ISO 9001:2008 requirements enhance TQM practices which, in turn, helps to improve financial performance. Findings in this study support the claims that ISO 9001:2008 would be a good step toward total quality management and is a meaningful component of TQM.

The objective of this research is to analyze the effect of quality management system constructed by ISO 9001 certificates through BSC perspectives. Evaluation of quality management system based on BSC framework can consider short-term financial performance as well as nonfinancial performance characteristics, which will derive future financial results. This results show that QMS has an indirect effect on business performance through quality performance and customer satisfaction, which are internal business process and customer perspective, rather than has a direct effect on financial performance. Finally we suggest implications of this study and future research direction.

In this era of globally competitive world market, many business firms have been using ISO 9000 quality management system, whose principles are leadership, customer focus, people involvement, etc., which are expected and desired to be attained for the various long/short term goals of the business firms. This paper studies whether and how those principles are implemented in the areas of service, manufacturing, etc., and researches the regression relations between business firm's performance and those principles. Using hypothesis testing, we found and showed results which can be referenced for the higher performance of business firms and those can be added to the pool of knowledge about the ISO principles implementation in service and manufacturing industries.

In today's society it is often required to state objectively conformity of products (including services) to specified requirements. Conformity assessment bodies (CABs). can objectively state such conformity. These CABs perform conformity assessment activities that include certification, inspection, testing and calibration. A system to accredit CABs conformity assessment services should provide confidence to the purchaser and regulator. Certification of management system is one of means of providing assurance that the organization has implemented a system for the management of the relevant aspects of its activities, in line its policy.

  This paper investigates the relative effect of each ISO 9001：2000 quality management system’s requirement and business performance. The empirical tests are conducted in ISO 9001 certification companies.   As a result, the 1<SUP>st</SUP>, it shows the re