Quality Management System Standards Research Articles

From the Great Wall to great workflow: lean six sigma in Chinese listed companies

Purpose The efficiency-enhancing and performance-boosting benefits of lean six sigma (LSS) practices have been advocated in both academia and industry. However, their mediating and moderating effects remain unclear and the impact of LSS practices is underdeveloped in the Chinese context. Therefore, by focusing on publicly listed companies in China, this study aims to investigate whether, how and when LSS practices link to organizations’ innovation and financial performance. Design/methodology/approach Data from 66 Chinese publically listed companies spanning a period of 25 years (2000–2024) was analyzed using the difference-in-difference method which compared the changes in outcomes over time between a treatment group and a control group. Findings This research found that LSS practices are positively related to firm-level outcomes including innovation and financial performance. The authors also confirm the mediating effect of operational capability on these relationships. Moreover, the empirical evidence suggests that implementing the quality management systems (QMS) standard, ISO 9001, moderates the relationships between LSS practices and innovation and financial performance such that these relationships are stronger for firms in organizations with higher maturity levels in implementing the standard. Practical implications This study sheds light on LSS theory and offers valuable recommendations for lean managers on how to leverage LSS practices to improve their innovation and performance capabilities. Originality/value This research provides novel insights into the influence of LSS practices on firm-level outcomes such as the level of innovation and financial performance. To the best of the authors’ knowledge, this study is the first to theoretically propose and empirically validate how and when LSS practices influence firm outcomes by introducing the mediating mechanism of operational capability and the boundary condition of QMS standards.

Consensus of experts on clinical quality management for flow cytometry-based detection of lymphocyte subsets

Flow cytometry (FCM) is used to detect lymphocyte subsets and evaluate the level of cellular immunity in the body, which is one of the commonly used FCM detection projects in clinical practice. To date, numerous institutions and academic organizations, both domestically and internationally, have published guidelines and consensus documents covering various aspects, including the establishment of cytometry laboratories, standardized procedures for detecting lymphocyte subsets, and their clinical applications across different fields, each with a distinct focus. However, in clinical practice, laboratories continue to face challenges in establishing standardized quality management systems, implementing quality assurance activities, developing appropriate detection protocols and gating strategies for various scenarios, and identifying and resolving common issues encountered during detecting. Currently, there is no unified consensus on these issues. To standardize the development of quality management systems for lymphocyte subsets detecion via FCM, enhance laboratory quality management practices, and ensure the accuracy and reliability of results, the Laboratory Medicine Committee of Chinese Association of Integrative Medicine (LMC-CAIM) convened experts to formulate this expert consensus.

Quality Objectives in Standardized Quality Management Systems.

The effectiveness of a quality management system consistent with the ISO 9001 standard depends on how quality objectives are established and pursued. The aims of this article are to identify quality objectives in selected certified organizations providing medical services, assess their compliance with the requirements of the ISO 9001 standard, and determine factors influencing such objectives. The first theoretical part of the article is based on a systematic literature review. The empirical part contains an analysis of documentation related to quality management systems and conducted audits. The data were collected during 42 quality management system audits conducted in 16 health care organizations in the years 2015-2020. Uncategorized interviews were conducted with quality management system representatives. The data were verified by interviews with 6 management system auditors having at least 15 years' experience in auditing health care organizations. The assessment of the methodological correctness is based on the ISO 9001:2015 standard criteria. The most frequently formulated quality objectives include improving customer satisfaction, task-based objectives related to planned works, improvements, and development of new medical services. The quality objectives fulfill the requirements of the ISO 9001 standard. However, they are not ambitious. The most significant factors influencing the processes of goal setting are economic (financial incentives, available resources for modernization), social (community needs), and managerial (the scope of performed analyses, the quality of the audit process, and the calculation of necessary effort). Health care organizations need to pursue more ambitious objectives, intensify the use of performed medical analyses, and integrate quality objectives into management remuneration systems.

ИНТЕГРАЦИЯ СИСТЕМ УПРАВЛЕНИЯ КАЧЕСТВОМ УЧРЕЖДЕНИЙ ПРИ ОКАЗАНИИ МЕДИЦИНСКОЙ ПОМОЩИ – ВОЗМОЖНОСТИ И ПЕРСПЕКТИВЫ

Significance. Development of integrated quality management systems is a key direction in the development of management activity, ensuring achievement of the organization goals. For the first time ever, analysis of the experience of a federal medical research institution and a state clinical cardiology dispensary in the integration of quality management systems using project management approach has been undertaken. The results show practicability of the integration approach and synergy effect in achieving common goals. The limitations of the project approach can be eliminated along with accumulation of experts' experience and monitoring over effectiveness of activities. The purpose of the study was to present the experience of integrating quality management systems of two institutions providing medical care to patients with cardiovascular diseases. Material and methods. The base of the present study was the Research Institute for Complex Issues of Cardiovascular Diseases and Kuzbass Clinical Cardiology Dispensary named after Academician L.S. Barbarash. The objects of the study were the quality management systems of the two institutions. In order to achieve the intended goal, the project and system approaches were applied. Results. Cooperation between the two institutions made it possible to attain the target indicator of the regional program “Control over Cardiovascular Diseases” in terms of the number of coronary artery X-ray endovascular interventions (5,335 interventions in 2022 against the planed 5,721). An organizational and functional model has been developed to provide care to the most difficult category of patients requiring heart transplantation. Joint comprehensive audits have been organized in accordance with the requirements of international standards for quality management systems and internal quality and safety control of medical activities. The corporate culture of the institutions develops on the basis of common professional, social and cultural values through joint events (e.g. “Gifts of Nature” contest, courage insights, New Year, sports days, etc.). A unified procedure for personnel actions in various conditions of both peacetime and high readiness has been determined. Conclusion. The project made it possible for the first time ever to receive evidence of practicability of the integration approach to improve performance of several institutions complying with the requirements of the international standard series 9001:2015 “Quality Management Systems”. Administration of the two quality management systems provides a synergy effect in achieving common goals. They become interrelated elements of the system of medical care for circulatory diseases. Scope of application. The obtained results can be used by medical organizations, organizationally and functionally united by common goals and objectives.

СОВРЕМЕННЫЕ ТРЕНДЫ В СТРУКТУРНОЙ ТРАНСФОРМАЦИИ ЭКОНОМИКИ АРКТИЧЕСКИХ РЕГИОНОВ

The Arctic zone of the Russian Federation (AZRF) has attracted close attention in recent years from specialists in the field of economics and management, since this unique macro-region according to a number of indicators (geographical extent, large differences in territory, population, production potential, etc.) is of particular interest for the study of the principles and methods of interregional integration. The article substantiates the feasibility and timeliness of carrying out an economy’s structural transformation of the Arctic regions based on the use of the methodology of international standards for quality management systems widely used in the practice of forming organizational structures of large corporations. This principle is proposed to be used in the process of transforming regional economic management systems within the Arctic zone of the Russian Federation.

A conceptual framework for integrating QSHE in construction

Construction accidents become catastrophic in infrastructure development. Evidence shows that quality failures such as system, services, procedural, materials, equipment, and human failures within the business process of project delivery systems are contributing causes of construction accidents that negatively impact worker safety, public safety, building/asset, and environmental safety. The standardized quality management systems and safety management systems in construction are fragmented. The Indonesian authorities have integrated the Quality Safety Health and Environment (QSHE) management system since 2018, but the implementation of the integrated QSHE system is still questionable. This paper aims to propose a framework and methodology for integrating QSHE implementation. The framework is based on the literature review of international standards and the UK Construction Design & Management Regulation. This proposal is a part of research currently formulated to develop an operating system to integrate quality and construction safety best practices in the project delivery systems. This paper addresses the quality management framework, safety management framework and, the proposed conceptual framework for integrating quality and safety management systems. The development of an integrated QSHE management system has the potential to save resources and eliminate redundancy significantly. Thus, an organization’s net production, profitability, and efficiency can significantly be increased. The results of this paper are 51 key points that are needed for integrating QSHE in construction projects. In the pre-construction stage, there are 24 key points, which are the largest portion. During the construction stage, there are 19 key points, and during the post-construction stage, there are 8 key points. So, it is very important to carry out the QSHE integration during the pre-construction stage to minimize the defects and accidents in construction projects.

Design of Methodological Platform to Support the Integration of Standardized Quality Management Systems Applicable in the Mining Industry

Although quality management systems are discussed in the professional field, methodological recommendations guiding modification processes related to the integration or conversion of standardized quality management systems are absent in both scientific and professional circles. The presented paper reflects on these facts and offers an instance of the development and application of a new methodology that would help in decision-making processes in companies. Although the authors' methodology is presented in the context of educational institutions, given the aim of ISO 9001 and the need for changes in the sectors related to ensuring increasingly high-quality processes in companies, this methodology can also be applied in the mining industry, the manufacturing sector and service sector. The Slovak Accreditation Agency for Higher Education (SAAHE) issued new quality standards for Slovak universities in 2020 (SAAS 2020). The previous accreditation rules determined requirements and criteria for quality management system (QMS) implementation, maintenance and improvement. Therefore, some Slovak universities implemented ISO 9001 in the past. It is necessary to convert their QMS from ISO 9001 to SAAS 2020. The main objectives of this paper are: to identify selected common requirements of both standards, to define three basic dimensions of QMS conversion, to use vector analysis for quantifying conversion relevance (CR) and conversion strength (CS) and to recommend which requirement should be preserved or converted. Conversion is vector AB, where initial position A = (Ax, Ay, Az) represents ISO 9001 and the new position B = (Bx, By, Bz) represents SAAS 2020.

МЕТОДОЛОГІЧНІ ЗАСАДИ РОЗБУДОВИ СИСТЕМИ ВНУТРІШНЬОГО ЗАБЕЗПЕЧЕННЯ ЯКОСТІ У ВИЩИХ ВІЙСЬКОВИХ НАВЧАЛЬНИХ ЗАКЛАДАХ

B a c k g r o u n d . Recently approved by the Cabinet of Ministers of Ukraine Concept of the military education system transformation defines ensuring the quality of military education taking into account NATO standards as one of the urgent tasks. Today, not all military higher educational institutions of Ukraine completed the institutionalization of the internal quality assurance system, the mandatory implementation of which is established by the Ukrainian legislation. This process requires further improvement and methodological support. Therefore, the methodological basis of the development of the internal quality assurance system at the military HEIs need for research. The purpose of the study is to determine the methodological basis for the development of an internal quality assurance system at the Ukrainian military HEIs, taking into account the up-to-date experience of domestic higher education institutions and NATO quality standards. M e t h o d s . Theoretical analysis of scientific publications on the issues under study; statistical data analysis on the ISO 9001 standard implementation in Ukraine; comparative analysis of the laws of Ukraine, regulatory documents of the European Higher Education Area, NATO and higher education institutions on quality assurance issues; generalization and synthesis. R e s u l t s . The methodological concepts for the development of an internal quality assurance system in educational organizations are characterized: ESG-2015, ISO 9001, the EFQM excellence model. It is substantiated that the most acceptable methodological concept for the development of such a system at military HEIs are the ESG-2015 internal quality assurance standards and the NATO quality management system standards. On the basis of comparative analysis of these standards, as well as the requirements of the laws of Ukraine on the education quality, a list of the internal quality assurance procedures for the military HEIs is proposed. The levels of the structural model of the internal quality assurance system for military HEIs have been clarified. C o n c l u s i o n s . It has been established that the structure of the internal quality assurance system for military HEIs does not fundamentally differ from the model of such a system for any HEI in Ukraine except the procedure of contributing to NATO. But the implementation of the procedures related to ensuring student-centeredness and publicity in military HEIs, has features that require further research.

Quality management in organizations within the framework of standardized management systems

The article focuses on the area of quality management in organizations within standardized management systems. The aim of the research was to identify and assess the effectiveness of standardized quality management systems in organizations in Central Pomerania using a logistic regression model. The source of data were the results of 2 surveys conducted among 1623 business entities of the Central Pomeranian region in Poland. The obtained results prove that the standardized management systems functioning in organizations are effective, which increases the likelihood of effective quality management in all areas of the activities of the surveyed organizations.

Аудит бизнеса: обзор действующих стандартов в фокусе ESGрегулирования

The article provides an overview using certain provisions of the current auditing standards and quality management system standards for the purposes of confirming sustainability reporting. A comparison of Russian practice in the field of regulation of assurance of public reports of companies and European regulations obliging auditors to confirm the reliability of non-financial statements with the possibility of expressing a reasonable degree of confidence is given. On the basis of the analysis carried out, directions for improving the regulatory regulation of the procedure for confirming the reliability of non-financial reporting are proposed: regulation of the process of interaction between the auditor and other verifiers of non-financial reporting; introduction of a requirement for the mandatory audit of non-financial (and all corporate) reporting, which actually means a transition from the audit of financial statements to the audit of business. An approach has been formulated to define the concept of "corporate reporting" as a new object of audit.

Resource support of certified quality management systems of dental care

Abstract. Standards for quality management systems require support for the system resources: human, infrastructure, process environment, knowledge, competence, awareness, communication, documented information. Objective. To conduct a systematic analysis of resource management in certified quality management systems of dental institutions; suggest ways to improve it. Materials and Methods. Forms №№ 17, 20 of the state statistical reporting, internal documents of municipal non-profit enterprises: "Zhytomyr Regional Dental Medical Association"; Kharkiv Regional Council "Regional Dental Clinic"; "Chernihiv Regional Dental Clinic of the Chernihiv Regional Council" were used (a total of 37 units). Methods: medical and statistical; system approach; content and comparative analysis; graphic. Results. It has been established that the institutions are provided with highly qualified competent medical staff, but there are no dental hygienists among the positions and individuals of specialists, which overloads dentists with simpler preventive procedures. At the same time, preventive measures are important to prevent the development of caries, periodontitis and diseases of the oral mucosa. There is no widespread involvement of employees in freelance organizational structures, monitoring and internal audit of processes and quality management systems. Heads of institutions did not organize the development and implementation of local clinical protocols based on evidence data. Dental care technologies are regulated by industry standards developed in 2004 on the basis of professional consensus. Clinical pathway of the patient, as organizational regulations of dental care, are descriptive textual in nature, the direction of the patient's movement is not traced, as well as the sequence of interaction of structural units - participants in the treatment and diagnostic process. Clinical quality indicators are not implemented in institutions and are not subject to calculations and monitoring. This creates risks for the effectiveness of patient-centered dental care. External and internal interactions of institutions and their structural units are unclear; there is a shortage of medical equipment; modern digital technologies are used to a limited extent for internal and external communications. Conclusion. Opportunities for the implementation of quality management, laid down in the standard, in each dental institution in the real conditions of its operation are not fully used, which requires the attention of heads of institutions in problematic areas.

Analysis on the Relationship between Enterprise Standard System and Quality Management System

Analysis on the Relationship between Enterprise Standard System and Quality Management System

Критерії та індикатори якості стоматологічної допомоги: стан розробки та використання

Healthcare quality criteria and indicators allow the head of the health care facility to clearly orientate in the degree of achievement of targets and improvement of results for patients. Studies of approaches to the formation of criteria and indicators of quality in the conditions of real domestic clinical practice, in particular, dental, are isolated. At the same time, in Ukraine there are no clinical protocols of dental care based on evidence-based technologies, which contain clinical quality indicators. The purpose of the study was to conduct a research on approaches to the development and usage of criteria and indicators for the quality of dental care in dental health facilities. Materials and methods. Such materials were used in the study as work plans for 2010-2019, administrative documents (orders), maps of expert assessments, "Guidelines for quality", internal audit protocols (a total of 149 units) of the three regional health care institutions of the dental profile. Methods, which were used, are system and process approach, content analysis, comparative analysis, graphical method. Results and discussion. In each institution, criteria and quality indicators are developed and monitored at the level of the doctor, line managers, the head of the institution and the medical council. Line managers conduct expert quality assessment, generalized "models of end results" which are formed at the level of the head of the institution. Detailed sets of criteria for the quality of the dental care process, ancillary processes and quality management systems are formed. Quantitative evaluation of the corresponding results on a scale and individual percentages is carried out. In general, the set of quality criteria and indicators is excessive in number, which does not meet the quality criteria defined by the standards for quality management systems, it contains mainly indicators of traditional industry reporting. At the same time, the world's evidence-based technologies of dental practice contain clinical indicators that reflect the use of interventions that have a proven impact on the quality of dental care expected by the patient, and which ensure efficient use of resources. Conclusion. The introduction of evidence-based technologies in dental practice is appropriate to improve approaches to the development of quality criteria and indicators, monitoring of clinical processes and compliance audits should be used, expert assessment should be carried out in case of defects

Metrological support in the quality management system of a poultry enterprise

The article deals with the issues of metrological support of business processes of a poultry enterprise within the framework of the quality management system (QMS). On the basis of the systematization of international and national QMS standards and relevant methods, an industry-wide integrated model of QMS business processes has been developed, their characteristics are given, indicating their interaction. The role of the business process “Metrological support” in the efficiency of the functioning of the life processes of the QMS has been substantiated. A map and an algorithm for this process has been developed, which forms its regulations with an illustration of the main parameters of the presented schemes. The role of devices characterizing the quality of incubation and food eggs with the use of appropriate technical means and devices, indicating the results of research, the morphology of eggs in comparison with standard parameters, from which it can be seen that the existing individual violations of their values are not associated with metrological support, is highlighted.

The Concept of Lean Manufacturing as a Tool for Improving the Process of Education

Aim. The presented study aims to examine approaches to organizing the educational process in the system of general education in accordance with the basic principles of lean philosophy, better known in Russia as “lean manufacturing philosophy”, which has proven to be an effective tool for building business processes in industrial enterprises.Tasks. The authors determine the value created by applying the principles of lean education in the general education system, describing the value creation flow and its customer; examine the classification of losses in the value stream and identify losses in the educational process based on national standards for lean manufacturing and quality management systems; apply the described system to the educational process of Gorchakov MGIMO Lyceum.Methods. This study uses empirical (observation, measurement) and theoretical (abstraction, formalization, and modeling) research methods, as well as methods of grouping, comparative, structural, and functional analysis.Results. The study substantiates the authors’ hypothesis that the analysis of the educational process through the definition of value for the consumer/customer and the identification of different types of losses transforms the value creation flow into the “lean education” flow, which perfectly meets the needs of stakeholders. The maps of the current and future state of the value creation flow of the educational process of Gorchakov MGIMO Lyceum are modeled. A comparative classification of the types of losses in the manufacturing and educational processes is created. The results of testing the hypothesis in the educational process of the specified lyceum are presented.Conclusions. Application of lean philosophy (the concept of lean manufacturing) can improve various activities, including education. The study provides evidence for this by defining and constructing the value creation flow in accordance with the requests of all stakeholders in the educational process and also by identifying losses in the methods and processes of information transfer and further evaluation of the knowledge and skills of students.

The past, present and future ISO 9001 quality management system standard

The number of studies for the future improvement of the standard ISO 9001, which is the most used standard in many areas, is limited. Within this research scope, the number of ISO 9001 certificates registered between 1993 and 2019 in some G20 countries was evaluated, and the number of certificates for 2020-2026 was estimated using the Eviews 11 program. Time series regression and exponential smoothing methods are used in estimation calculation. According to the number of certificates estimated for 2026, country rankings were determined as India (43,947), Brazil (22,744), Canada (11,814), USA (37,235), Mexico (9,977), Argentina (8,433), Russian Federation (1,540), Australia (5,072), South Africa (4,626) and Saudi Arabia (2,785). Changes are expected in Canada, the Russian Federation, Australia and Mexico in 2026 when the 2019 certificate number of countries’ ranking is considered. A decrease in Australia and the Russian Federation’s certificate number was foreseen for 2026. It is thought that the research will contribute to the interpretation of ISO 9001 performance of nine countries and to how the future trend will be shaped.

No Iso-Fix for Human Rights: a Critical Perspective on Iso 2600 Guidance on Social Responsibility

No Iso-Fix for Human Rights: a Critical Perspective on Iso 2600 Guidance on Social Responsibility

Relationship of quality management system standards to industrial property rights in Indonesia using Spearman Correlation Analysis Method

This study examines the relationship between SNI ISO Quality Management System (QMS) Standards to Industrial Property Rights in Indonesia using Spearman Correlation Analysis. The focus of research is on the comparison of the correlation coefficient value of quality management system standards: SNI ISO 9001 QMS, SNI ISO 14001 EMS, SNI ISO 22000 FSMS, SNI ISO 13485 MD-QMS, SNI ISO 27001 ISMS, SNI ISO 16949 A-QMS with industrial property rights: patents, simple patents, industrial designs and brands in Indonesia. The test conducted was to see the data relationship between the number of QMS standard certificates to Indonesia’s industrial property rights for seven years, starting from 2009 to 2015. The Spearman Correlation method analyzes the correlation coefficient value on the development of certificate data held in Indonesia. The Spearman correlation test results show that several QMS standards have significant values that have entered the tolerance limit or have gone out of the tolerance limit for industrial property rights. This evidence suggests several quality management system standards able to contribute to the development of innovation in a country, especially Indonesia.

Sistem upravljanja kvalitetom i konkurentnost u savremenom poslovnom okruženju - pregled literature i poslovne prakse

The aim of this paper is to consider the role of Quality Management System (QMS) in achieving the competitiveness of business organizations in the modern business environment. For the development of domestic economy, it is important to improve the way of doing business of domestic companies, following the example of the best world practices. The paper presents the experiences of international experts in the field of Quality Management Systems and the application of ISO Quality Management Standards, with the purpose of improving business performance and competitiveness of companies in the international market. The success of companies for doing business in the global market, due to everyday technological,economic and social changes, is basically based on a Quality Management System and ISO standards. The ISO 9001:2015 standard has brought improvements in the direction of Risk Management. Achieving competitiveness is achieved through adequate change management in the organization, Quality Management, innovative thinking and action, and standardized products of the highest quality.

Research on Integration and Improvement of Different Software Quality Management Systems

This paper analyzes the characteristics of GJB 9001c and GJB 5000A military quality management system standards. Taking optimization and improvement as the guiding ideology, some specifications of GJB 9001c and GJB 5000A are integrated, in order to put forward the military software quality management system content to help them integrate and improve.