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Simple Summary: Trichinella spp. is a nematode parasite that causes Trichinellosis worldwide, a foodborne zoonotic disease. To ensure high standards in food safety, a Quality Management System (QMS) was implemented in Satellite Laboratories (SLs) performing meat inspection of Trichinella spp. in southern Spain. The study analyzed how deviations from standard procedures may affect risk levels using Canonical Discriminant Analysis (CDA). Data were collected from audits of 18 SLs in Cordoba and Seville over six years. It was found that technical deviations, such as incorrect tests or calculations and failure to follow procedures, significantly increased risk levels. These deviations caused up to a 1.150-fold increase in risk levels, indicating their critical impact on risk determination. However, deviations related to records and documents, such as incomplete or erroneous data, did not significantly influence risk levels. The results emphasize the need to improve Trichinella spp. control strategies by addressing critical deviations in technique, trial information, and quality assurance to mitigate associated risks. Trichinellosis is a major foodborne zoonotic disease responsible for 41 human cases, according to the European Union One Health Zoonoses Report. In southern Spain, a quality management system (QMS) was applied to satellite laboratories (SLs) that conduct meat inspections of Trichinella spp. ensuring excellence practices. This study aimed to determine how eventual deviations from standard procedures may influence risk levels using Canonical Discriminant Analysis (CDA). Data were collected during slaughterhouses and game handling establishments' official audits in 18 SLs located in the provinces of Cordoba and Seville during a 6-year period. Technical requirement deviations regarding technique and trial information, such as performing tests or calculations incorrectly or not following technical procedures, significantly increased risk level differences. Imminent risk levels were detected if the above-mentioned deviations arose. Quality assurance compromising deviations were responsible for 1150 times risk level differences, suggesting finding such may be critical for risk determination. A lack of significant influence of records and documents compromising deviations (incomplete forms or missing-erroneous or illegible data) was found. These results strengthen Trichinella spp. control strategies by pinpointing crucial aspects within QMS that require improvement, particularly in addressing deviations related to technique, trial information, and quality assurance procedures to mitigate associated risks effectively. [ABSTRACT FROM AUTHOR]

Copyright of Formación Universitaria is the property of Centro de Informacion Tecnologica (CIT) and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

The development of a Micro-Credential Quality Management System (QMS) aims to ensure that micro-credentials are of high quality and aligned with industry needs. Micro-credentials provide formal recognition of specific competencies acquired through short-term, focused learning, offering an efficient means to address the rapidly evolving labor market and technological landscape. This research adopts a Research and Development (R&D) methodology, involving a preliminary study, system development, pilot testing, and validation, to create a robust QMS framework. The QMS focuses on establishing clear standards, rigorous assessment processes, continuous improvement, and collaboration with industry stakeholders to validate competencies. The pilot testing of the QMS in vocational high schools demonstrated its effectiveness in enhancing the relevance and recognition of micro- credentials. The system ensures that issued credentials are aligned with industry demands, improving graduates' employability and competitiveness. The findings indicate that a well-developed QMS for micro-credentials can address gaps in standardization and ensure that credentials are valid, reliable, and recognized across different sectors. The implementation of the QMS facilitates tailored skill acquisition, lifelong learning, and global recognition, making it a critical tool for enhancing workforce readiness and competitiveness. [ABSTRACT FROM AUTHOR]

INTRODUCTION. Bioanalytical laboratories in the Russian Federation should follow the requirements of both the Good Laboratory Practices (GLP), when performing tests for non-clinical studies, and the Good Clinical Practices (GCP), when analysing samples from clinical studies. The work of such laboratories requires a separate GxP system, the Good Clinical Laboratory Practices (GCLP). However, the GCLP system has not yet been created in the Russian Federation and the Eurasian Economic Union (EAEU).АIM. This study aimed to compare the current Russian and EAEU principles regulating the work of bioanalytical laboratories with the international GCLP principles and formulate general requirements for national laboratories.DISCUSSION. The author analysed the current regulation of the work of bioanalytical laboratories, as well as the EAEU regulatory standards for the development and validation of analytical procedures. In addition, the study covered the international GCLP principles that govern the management of human resources, process record keeping, the development of standard operating procedures, the validation of analytical procedures, and the management of biological samples and reference standards in a laboratory. The author considered the key functions of a bioanalytical laboratory and suggested tools to manage them in compliance with the international GCLP principles and the EAEU requirements. It should be noted that scientific publications describe the international practice of applying the GCLP principles fairly well, and the experience of its implementation could be of use to Russian laboratories.CONCLUSION. A bioanalytical laboratory that implements the GCLP principles will increase its competitiveness in the EAEU market for bioanalytical testing services and mitigate its risks of obtaining invalid data.

Professional development plays a key role in improving laboratory quality management by enhancing staff skills and knowledge to implement and maintain the quality management system (QMS). This research aims to identify and prioritize continuing training needs for Moroccan laboratory professionals in QMS and to formulate recommendations for suitable training programs.

This study summarizes the clinical application, technical characteristics, and production process of intravascular shockwave catheters. It collects statistics on adverse events of related products from the MAUDE database, analyzes the causes of adverse events and failure modes of intravascular shockwave catheters, and identifies risk points. Based on the whole life cycle management method of medical devices, combined with product risks and the requirements of Good Manufacturing Practice for Medical Devices and related appendices, the critical control points of such products in the design and development, manufacturing, sales, and use stages are discussed.

In modern-day conditions, organizations need to maintain a high standard of quality in order to meet the ever-growing demands of consumers. In this context, the relevance of implementing quality management systems among organizations is increasing over time. However, not all organizations are able to implement this system in their manufacturing facilities due to the complexity of the process. To solve this problem, an algorithm of quality management system implementation has been developed. This algorithm allows gradual implementation of the system in the organization, and this leads to business process optimization, allows organizations to maintain competitiveness and achieve success in a strategic perspective.

Abstract Biobanks are valuable service units that ensure the usage of high-quality biological samples. They contribute to translational research, and their support may improve future therapeutic approaches. They store biological samples that can be used to examine circulation biomarkers, immune cells, and immunohistochemistry aspects of illnesses and further in-depth examinations using NGS techniques. The IRCCS Synlab SDN Biobank has about 70,000 well-preserved cryopreserved human samples from various diseases, primarily oncological but also neurological and cardiovascular. These biospecimens were taken from 25,000 participants underwent imaging with a contrast agent. The goal is to propose quality control assays that meet the requirements of the international standard ISO 9001:2015 and ISO 20387:2020 accreditation. PBMCs viability was determined, and immune subset cells were analyzed by flow cytometry. Furthermore, the expression of ubiquitous miRNAs was used to assess plasma sample integrity. The quality controls demonstrated that the biological samples were correctly cryopreserved; the preservation of human biological samples did not affect the quality of the biological samples tested. Indeed, the cryopreserved PBMCs had a vitality of more than 80%, and the lymphocyte subsets could be selected for future immune cell investigations. Furthermore, miRNA expression was highest in thawed plasma samples compared to the positive and negative controls. We evaluated the quality of our randomly selected biobank-thawed human samples. Both PBMCs and plasma samples fulfill the high-quality standards needed for biomedical research, assuring their long-term preservation. However, further research is needed in the biobanking field to establish globally accepted procedures to confirm the quality of biological samples.

Abstract Cloud products from geostationary satellites are the main alternative to surface synoptic cloud observations (SYNOP), and have become the baseline products for the development and construction of the Quality Management System (QMS) of integrated meteorological observation in China. This study addresses the needs of the China Meteorological Administration (CMA) for such an operational reform, and it is carried out using real-time observations obtained from the Fengyun-2E (FY-2E) geostationary satellite in 2012 to derive cloud total amount and classification using two different methods. Compared to surface SYNOP observations, the cloud total amount estimated by FY-2E is generally significantly lower (about 30% lower on average). The cloud classification resulting from the two methods used in this study is also significantly different from the classification obtained from surface observations (difference between 22 and 32%). The difference is smaller for the classification method, which uses additional auxiliary temperature profiles.

ISO 9001:2015 is an international standard which defines the minimum requirements for the quality management system. It is part of an overall family of Standards known as ISO 9000ff. ISO 9001 standard is applicable to any type of business and companies of all sizes and can help organisations to provide consistent products and services leading to customer satisfaction, regulatory compliance and continual improvement. It is the most popular, best-selling and best-known standard in the world and the only standard in the ISO 9000 family to which organizations can certify. Since the first edition in 1987, there have been several revisions of ISO 9001 standard, and the last revision was made in 2015. The valid version of ISO 9001 standard was released in September 2015 and changes made in requirements of ISO 9001:2015 are much more significant than those made in the 2008 revision. The main changes are in structure of ISO 9001:2015, where the number of chapters increased from 8 to 10 and in completely new requirements which include context of organization, risk management, knowledge as resource and leadership. There were great expectations from these changes, and the paper explain whether these changes achieved the expected results on quality. [ABSTRACT FROM AUTHOR]

Cloud products from geostationary satellites are the main alternative to surface synoptic cloud observations (SYNOP), and have become the baseline products for the development and construction of the Quality Management System (QMS) of integrated meteorological observation in China. This study addresses the needs of the China Meteorological Administration (CMA) for such an operational reform, and it is carried out using real-time observations obtained from the Fengyun-2E (FY-2E) geostationary satellite in 2012 to derive cloud total amount and classification using two different methods. Compared to surface SYNOP observations, the cloud total amount estimated by FY-2E is generally significantly lower (about 30% lower on average). The cloud classification resulting from the two methods used in this study is also significantly different from the classification obtained from surface observations (difference between 22 and 32%). The difference is smaller for the classification method, which uses additional auxiliary temperature profiles. [ABSTRACT FROM AUTHOR]

Copyright of Chinese Medical Equipment Journal is the property of Chinese Medical Equipment Journal Editorial Office and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

An approximate 60 to 70% of all decisions about the diagnosis, treatment, admission to the hospital and discharge of a patient are based on laboratory results. Medical laboratory plays a key role in the early detection, diagnosis and treatment of disease in patients. Implementation of Good Laboratory practices becomes at most important in improving the quality in the laboratory. Therefore this study is undertaken to assess the good laboratory practices among tertiary care hospitals in Bengaluru and managerial challenges experienced during the implementation of good laboratory practices. This questionnaire based experimental study was conducted in 26 laboratories attached to tertiary care Hospitals in central Bengaluru, India, from July 2023 to December 2023. An online questionnaire containing 34 questions was administered to all the participants after taking consent. Data were collected through validated questionnaires and analyzed using Fisher-exact test to test the statistical significance of cross-tabulation between categorical variables. P value < 0.05 was considered statistically significant. Descriptive analysis was carried out by frequency and proportion for categorical variables. Continuous variable was presented as median (IQR). Findings revealed common infrastructure challenges across laboratories, with notable disparities between NABL accredited and non-accredited facilities. Challenges in GLP implementation included staffing constraints, resistance to change, and financial limitations. The challenges were mitigated through strategies such as teamwork, continuous training, and management support. [ABSTRACT FROM AUTHOR]

The implementation of a Quality Management System in the National Medical Arbitration Commission was a decision of senior management for the benefit of those involved in the matters that are dealt with in it. With the passage of time, 27 years for the Commission, the conditions of Mexicans and the laws that regulate their behavior in all spheres have been modified, so it is important to maintain the spirit of work of public servants and migrate towards a flexible management, which involves knowledge and compliance with human rights, the federal code of ethics and with it, benefiting citizens with the improvement of their living conditions, a harmonious society and institutions committed to their missions and visions. [ABSTRACT FROM AUTHOR]

Purpose -- The aim of the research was to apply the principles of the quality management system in order to establish a framework for implementing quality management practices within the construction industry. Research methodology -- The study involved analysing the global experience of certifying enterprises according to ISO 9001 standards. The research used a qualitative approach, analysing QMS documentation, case studies, and literature to gain a comprehensive understanding of QMS implementation in established companies. Findings -- It resulted in the development of a system model for introducing and implementing the quality management system in construction industry enterprises, following the ISO 9001 standard. Practical implications -- The enterprises of the Republic of Kazakhstan are not exceptions from world practice, including the enterprises of the construction industry. However, there are few construction industry enterprises that would be certified according to quality management standards, including the ISO 9001 standard. Some do not have the financial and human resources to implement a quality management system, others lack understanding of where to start. Originality/Value -- The study also focused on generalising and providing detailed insights into the processes involved in implementing the quality management system at construction industry enterprises. [ABSTRACT FROM AUTHOR]

This study analyzes the existing literature on ISO 9001 to identify trends, key scholars, influential journals, significant papers, and this body of work's overall intellectual, social, and conceptual landscape. The study also proposes potential avenues for further research based on its findings. Bibliometric and content analysis were used to examine 929 relevant journal articles published between 1987 and 2023 and indexed by Scopus or Web of Science (WoS). Bibliometric analysis and visualization of results were conducted using the Bibliometrix R package and Biblioshiny application. This investigation unveils the intellectual, social, and conceptual structures within the literature concerning ISO 9001, shedding light on bibliographic features such as prominent scholars, leading journals, and noteworthy papers. Nine distinct research clusters were identified: integrated management systems; the effects of ISO 9001 implementation and certification; the diffusion of management system standards; ISO 9001:2015; the effective implementation of ISO 9001; levels and difficulties in management system integration; internalization of ISO 9001, withdrawal of ISO 9001 certification, and critical success factor of ISO 9001 implementation; ISO 9001 implementation and lessons learned; and diffusion of ISO 9001-based quality management systems. Key findings from each cluster were synthesized. This research is a valuable resource for scholars and practitioners seeking insights into the current state of ISO 9001 research and areas that warrant further exploration. [ABSTRACT FROM AUTHOR]

The aim of this article was to analyze how organizations with an implemented ISO 9001 quality system responded to the crisis caused by the Covid-19 pandemic. For the purpose of the study, a set of questions was developed to enable a simplified assessment of the QMS maturity level. Next, it was verified how organizations with different levels of quality culture coped with the reorganization forced by the restrictions associated with the outbreak of the pandemic. As a result, it was confirmed that there is a relationship between QMS maturity and the implementation of actions that can be described as systemic. It was also found that the involvement of top management and the motivating and supporting role of the quality management representative were the factors that had the greatest impact on taking action in a crisis situation.

The article is devoted to the study of features of the introduction of a risk-oriented approach in the context of the development of quality management systems, which ensures the integration of risk management with the mechanism of enterprise management in compliance with the principles of consistency, economy and coherence of business processes to solve the problems of ensuring their risk tolerance and competitiveness. The article discloses economic essence of risk as an integral part of each business process in activity of an enterprise in the service sector under conditions of uncertainty and its essential characteristics – negative consequences, optional nature of occurrence and the impossibility of their complete exclusion. The features of the manifestation of risks of service enterprises, the main aspects of the process approach in quality management systems and its integration with the business processes of service enterprises, the implementation of risk management in the quality management system of service enterprises, introduced in accordance with ISO 9001:2015, are considered. The practical significance of the obtained results of the study lies in the possibility of using the proposed risk-oriented approach to management and its integration into the quality management system of an enterprise in the service sector through the allocation of responsibility centers for risk management within the framework of the implementation of the main groups of business processes of the Quality Management System in the context of the requirements of the international standard ISO 9001:2015.

The Occupational Health and Safety system enforces the continual improvement culture in industries for much safer processes and zero injuries. The Quality Management System also enforces the same philosophy of continual improvement within the processing system for zero defects, hence a high productivity rate. Good quality products always result from good Overall Equipment Effectiveness; hence, Process Re-Engineering is essential for the good functioning of machinery. This research is based on Integrated Management System requirements in terms of problem-solving, especially the opportunities that arise within Quality nonconformances, Safety Incidents, as well as Process Engineering related breakdowns. This study aims to develop a troubleshooting system that evaluates continual improvement projects. The method used to develop the troubleshooting system is based on Total Quality Management, where lean principles are combined with kaizen concepts and quality standards. The proposed troubleshooting system is separated into three development phases: the first phase is for recording the details of the fault that has been raised, where one will record full details of the nonconformance, the time and date, validation of the nonconformance by the lab test or any other form of validation depending on the nature of the problem as well as the details of the location of the problem. The second phase is for problem classification, whether it is a quality nonconformance, Safety incident, or engineering-related breakdown. The deeper root cause analysis is performed by an application of lean techniques, which are the eight types of waste, Five Whys and Ishikawa analysis. The eight types of waste identify the type of waste contributed by the problem, the Five Whys analysis assists in finding the reason for the problem occurrence, and the Ishikawa analysis classifies the problem accordingly, which assists the analyst in identifying the area to focus on for problem-solving. The third phase is for a database system and an application of the kaizen philosophy by evaluating continual improvement projects as well as status reports on the permanent solutions to the faults. The proposed troubleshooting model was applied in a case study company to upgrade the problem-solving model that the company was using which was assisting for corrective and preventive action. The study resulted in drastic improvements; hence, continual improvement projects were evaluated within the problem occurrences. [ABSTRACT FROM AUTHOR]

The construction industry is one of the economic sectors that has a vital role in infrastructure development and meeting housing needs. One approach that has received widespread attention in the construction industry is the principle of Lean Construction. Lean Construction is a management philosophy that focuses on reducing waste, increasing value streams, and empowering work teams to achieve maximum efficiency in the construction process. In this study, data will be obtained through secondary sources, which are data that are not obtained directly by researchers but have been collected or previously owned by other parties. The data collection method makes use of literature review and document analysis. Literature review is conducted by investigating a number of books, journals, or other research reports related to the principles of Lean Construction and their application in various building construction projects. Lean Construction is a translation and adjustment of lean manufacturing concepts originally developed by Toyota, in which Ohno played a key role in the development. Unlike lean manufacturing, the Lean Construction approach focuses more on the production process in a construction project. The concept encompasses the progress of the project in all aspects of construction and the environment, including design, execution of activities, maintenance, safety, and recycling. The goal of this approach is to organize and improve the construction process so that it delivers maximum value at a minimum cost that suits customer needs. Overall, to improve productivity and quality in construction projects through the application of Lean Construction, a joint effort is needed in improving understanding and technical capabilities, as well as strong support and commitment from all levels of the organization. This research provides important insights for practitioners and researchers in the construction industry to identify areas for improvement and develop more effective implementation strategies. [ABSTRACT FROM AUTHOR]

A quality management system for clinical and public health research operations is indispensable because it ensures the integrity and reliability of research outcomes. By implementing a robust quality management practice in research implementation and operation, research teams can uphold the highest standard of research conduct, thereby enhancing the credibility and trustworthiness of research findings. This paper elucidates the significance and role of a quality management system in clinical and public health research operations and its efficacy in minimising and eliminating protocol deviations and highlights the key steps in setting up a quality management system for research operations. [ABSTRACT FROM AUTHOR]

Purpose: Comparison of management system integration models. Design/methodology/approach: The analysis of management system integration models was based on a review of available literature. Findings: Systematizing current knowledge about models for integrating standard management systems. Indication of the differences in these models. Originality/value: The article schedules the further direction of research of integration of management systems. [ABSTRACT FROM AUTHOR]

Introduction and objective: The interest in improving the quality of care has led to the implementation of the International Organization for Standardization (ISO) 9001:2015 standard in the Child and Adolescent Psychiatry Unit of the Santiago de Compostela University Clinical Hospital (A Coruña, Spain). The objective of this work is to describe the methodology developed to obtain it, as well as the perceived experience of the process. Method: The steps carried out were: creation of a multidisciplinary quality work group and a work schedule; preparation of the Quality Manual, Process Map and definition of the scope of the Quality Management System; preparation and planning of satisfaction surveys; definition of operational and care processes; context and stakeholder analysis; definition of the risks and opportunities of the quality system; establishment of quality measurement indicators; establishment of actions to promote continued training; review of the quality system by the hospital management; and planning of the improvement objectives. Results: The agreed schedule was met, completing all the established tasks in a period of approximately 15 months. Finally, an evaluation of compliance with requirements/results was carried out through an internal and external audit, after which certification of the Unit was achieved according to the ISO 9001:2015 standard. Discussion and Conclusions: The implementation of the ISO standard should be considered the beginning of a working method that ensures continuous improvement, teamwork and establishes a culture of quality in the Unit through continuous monitoring of its activity. [ABSTRACT FROM AUTHOR]

Purpose: The aim of the article is to examine the reasons why organizations do not use the information obtained in the audit process. Design/methodology/approach: For the realization of the work we used the results of our own research of organizations that have certified quality management systems for compliance with the requirements of ISO 9001. The information obtained relates to organizations operating in the territory of Poland. Findings: Organizations conducting quality management system audits acquire a variety of information that should be used for management purposes. Some organizations have serious problems with acquiring data and processing it, and using the information for decision-making and improvement-oriented activities. The paper identifies 10 potential reasons why organizations do not use information from the audit process. A comparison was made between the causes found in internal and external audits. An analysis of each of the identified causes was carried out, paying attention to their origins. Attention was paid to the connections between the causes. Directions for eliminating problems were indicated. Practical implications: The results obtained have practical application. Organizations with an awareness of the causes of problems are able to take, both corrective action and preventive action. In the first case, it is about taking corrective actions to existing problems. In the second case, it is about preventive actions, which should prevent a problem from arising. Social implications: The results obtained have social implications. They draw attention to the need to build a pro-quality and improvement-oriented awareness. Originality/value: The article for the first time identifies the causes of problems arising in organizations in the context of the use of audit information. Attention is paid to the mechanism of disorders and ways to eliminate them are indicated. The article is especially recommended to the top management of organizations that conduct system audits. [ABSTRACT FROM AUTHOR]

The aim of this article was to analyze how organizations with an implemented ISO 9001 quality system responded to the crisis caused by the Covid-19 pandemic. For the purpose of the study, a set of questions was developed to enable a simplified assessment of the QMS maturity level. Next, it was verified how organizations with different levels of quality culture coped with the reorganization forced by the restrictions associated with the outbreak of the pandemic. As a result, it was confirmed that there is a relationship between QMS maturity and the implementation of actions that can be described as systemic. It was also found that the involvement of top management and the motivating and supporting role of the quality management representative were the factors that had the greatest impact on taking action in a crisis situation. [ABSTRACT FROM AUTHOR]

Purpose – The aim of the research was to apply the principles of the quality management system in order to establish a framework for implementing quality management practices within the construction industry. Research methodology – The study involved analysing the global experience of certifying enterprises according to ISO 9001 standards. The research used a qualitative approach, analysing QMS documentation, case studies, and literature to gain a comprehensive understanding of QMS implementation in established companies. Findings – It resulted in the development of a system model for introducing and implementing the quality management system in construction industry enterprises, following the ISO 9001 standard. Practical implications – The enterprises of the Republic of Kazakhstan are not exceptions from world practice, including the enterprises of the construction industry. However, there are few construction industry enterprises that would be certified according to quality management standards, including the ISO 9001 standard. Some do not have the financial and human resources to implement a quality management system, others lack understanding of where to start. Originality/Value – The study also focused on generalising and providing detailed insights into the processes involved in implementing the quality management system at construction industry enterprises.

Purpose Tourism is considered to be the leading generator of economic development in the world. For its growth it requires a clean and immaculate environment. The concept of sustainable tourism emerged as a possible solution to face that challenge. What sets sustainable tourism apart from other forms of tourism, in a special way, is how sustainable tourism encompasses ecological, economic and social aspects of sustainable development with the intention to establish a long-term balance of these three dimensions. With the aim to increase the long-term economic benefits from tourism, it is required to embrace and implement an adequate tourism development strategy focused on sustainable development and the increasing quality of tourist services in the tourist destinations. In a dynamic market conditions, hotel companies have to adapt their offer according to the tourist demand and provide a high-quality service that meets or exceeds tourists` expectations. In order to accomplish this goal, it is important to implement a quality management system (QMS) in hotel companies. This doctoral dissertation investigates the implementation of the quality management system (QMS) and Sustainable Development (SD) principles and their impact on the economical, environmental and social aspects within the context of hospitality. The investigation sheds light on how the adoption of QMS and SD principles can lead to enhanced economic outcomes. These outcomes manifest through increased operational efficiency, cost reduction, revenue growth, contributing to the overall financial sustainability of the hotel business. The environmental impacts of the implementation of QMS and SD principles in hospitality highlights how waste reduction, energy conservation, sustainable sourcing, and eco-friendly practices can not only reduce the ecological footprint of businesses but also enhance their reputation as environmentally responsible hotels. The social dimension reveals how the implementation of QMS and SD principles positively affect work conditions, employee satisfaction and employee motivation. By aligning economic, environmental, and social objectives, hotel companies can achieve sustainable competitive advantage, enhance their long-term viability, and contribute positively to society. Methodology When defining the hypotheses, domestic and foreign literature was extensively reviewed. All basic constructs are elaborated in accordance with theoretical background. The hypotheses are the following: „The implementation of the quality management system principles and the principles of sustainable development have a statistically significant impact on the economic, environmental and social aspects of hotel business performance“. The auxiliary hypotheses are the following: H1) the implementation of the quality management system principles and the principles of sustainable development have a statistically significant impact on the economic aspects of hotel business performance. H2) the implementation of the quality management system principles and the principles of sustainable development have a statistically significant impact on the environmental aspects of hotel business performance. H3) the implementation of the quality management system principles and the principles of sustainable development have a statistically significant impact on the social aspects of hotel business performance. A survey method using a structured questionnaire is applied in which all questions are mandatory. The respondents were managers (CEO, General managers and/or their deputies or assistants) of large and medium-sized hotel companies in the Republic of Croatia. The required minimum sample size was calculated using GPower software, which calculated that the minimum acceptable sample size is 118 respondents. All data that have been collected were analyzed using multivariate statistical methods: the exploratory factor analysis and the multiple linear regression method. Findings The total number of collected questionnaires was 154. Three factor analyses (FA) were applied in order to determine the dimensions that, according to respondents, best define the implementation of the principles of the QMS and the implementation of SD principles through the implementation of sustainable practices, and to examine the existence of a statistically significant impact of such implementation on the economic, environmental and social aspects of business. The Kaiser – Meyer – Olkin (KMO) test was applied as a statistical measure to identify the suitability of the data for factor analysis and the results of the KMO test for each performed factor analysis are greater than 0,6. The first factor analysis (EFA 1) identified three dimensions (factors) that according to the respondents’ perception, best describe and determine the implementation of the principles of the quality management system in hotel companies. The generated three factors explain 56,04 % of the total variance. The reliability of each generated dimension was determined by calculating the Cronbach alpha coefficient which was greater than 0,700. The second factor analysis (EFA 2) identified two dimensions (factors) which, according to the respondents’ perception, best describe and determine the implementation of the principles of sustainable development in hotel companies. Those two factors explain 50,95 % of the total variance. The reliability of each generated dimension was determined by calculating the Cronbach alpha coefficient which was greater than 0,700. The third factor analysis (EFA 3) identified three dimensions (factors) that, according to the respondents’ perception, best describe and determine the impact of the implementation of the principles of the quality management system and the principles of sustainable development on the economic, environmental and social aspects of the business performance of the studied hotel companies. The generated three dimensions explain 73,264 % of the total variance. The reliability of each generated dimension was determined by calculating the Cronbach alpha coefficient which was greater than 0,700. Three Ordinary Least Square regressions (OLS) were performed in order to test the hypotheses. In the regression model, the independent variables are the factors that were generated by the first and the second factor analysis (EFA 1 and EFA 2), and the dependent variables are the factors that were generated by the third factor analysis (EFA 3). In total three Ordinary Least Square regressions were performed, one regression model to test each hypothesis. In order to determine whether the independent variables are good predictors of the dependent variables for each regression model, the F-test was calculated using ANOVA. The F-test results in each regression model are significant. According to the results of the regression analysis and the established significance of the regression model, all three auxiliary hypotheses were confirmed. Furthermore, for all three regression models, the RESET test was applied and it confirmed that no variables were omitted in the regression models. According to the results of the research, the main hypothesis has been proven and confirmed: “The implementation of the quality management system and the principles of sustainable development have a statistically significant impact on the economic, environmental and social aspects of hotel business performance”. Originality of the research The results of the conducted research are in line with the following previously conducted researches: Tari, et al. (2020); Abbas et al. (2020); Sunil et al. (2021); Ghaderi et al. (2019); Fioru et al. (2019); Alipour et al. (2019); Nguyen et al. (2018) confirming that the implementation of quality management system and the principles of sustainable development have a positive impact on the economic, environmental and social aspects of business performance. From the theoretical perspective, the scientific contribution of the doctoral dissertation results from the development of the scientific thought that connects the principles of the quality management system and the principles of sustainable development, and the impact of their implementation on the economic, environmental and social aspects of hotel business performance. Furthermore, the scientific contribution derives from the expansion of the theoretical knowledge in the field of quality management and sustainable development, as well as the expansion of the theoretical knowledge of the economic, environmental and social aspects of hotel business performance. The results of the scientific research proved which dimensions of the quality management system and sustainable development are relevant according to the respondents’ perception in order to impact the economic, environmental and social aspects of hotel business performance, which represents the scientific contribution of the conducted research in an empirical sense. The applicable contribution of the research comes from the applicability of the results in the hotel practice. The results of the scientific research identified which factors are relevant for measuring and monitoring the impact of the implementation of the principles of quality management systems and the principles of sustainable development on the economic, environmental and social aspects of hotel business performance. The results of the conducted scientific research can help the hotel managers in creating guidelines for the efficient integration of the quality management system and the principles of sustainable development into everyday business practice.

This work aims to highlight the factors that characterize quality systems in the case of pressure equipment manufacturing. For the CE marking, according to the Pressure Equipment Directive (PED), the manufacturer may adopt conformity assessment modules based on the Quality System for production process, directly for the product, for its final inspection and testing or for full fabrication process, design included. At international level, the ISO 9001 standard is now consolidated and wide spread and was revised in 2015 with the introduction of new concepts. This article highlights the individual requirements of ISO 9001 which are directly and indirectly correlated with the Quality System factors required by PED. This allows to comply with the essential safety requirements of the directive following a Plan-Do-Check-Act approach and conforming to the formalization of the management systems provided by the High Level Structure.

Statement of the problem (relevance of the work): the article outlines the main advantages of using the network to improve the quality of the production processes of engineering products, which is especially important in the context of the formation of technological sovereignty. The purpose of the work: the purpose of the article is to systematize and analyze the models of product quality management in the engineering industry and develop, on their basis, an intersectoral model of a quality management system in a network. Methods used: the article uses general scientific methods of cognition, namely, the method of description, generalization, critical analysis, visualization. As a theoretical basis for the study, theories of process and network management in the industrial complex are used. Novelty: generalization and systematization of theoretical approaches to quality management in mechanical engineering made it possible to design an intersectoral model of a quality management system in a network, the use of which will make it possible to create and strengthen technological sovereignty. Result: as a result of a study on the analysis of quality management models of the production process, their distinctive characteristics are determined in relation to the network, the core of which is a machine-building enterprise, which made it possible to develop an intersectoral model of a quality management system, the use of which allows obtaining such network effects as the achievement of integrated production support at all stages of the life cycle; reducing transaction costs, increasing the flexibility of the design and production of new science-intensive and high-tech products, which makes it possible to increase the level of technological sovereignty of the industry by strengthening cooperation ties. Practical significance: the conclusions and results contained in the article can be used in the development of strategies for the formation and strengthening of technological sovereignty both in the machine-building industry and in the industrial complex as a whole.

SCIENTIFIC RELEVANCE. One of the challenges associated with the development of medicines lies in creating a quality management system (QMS) and tools to assess its performance.AIM. The study aimed to propose a QMS model for the development of biotechnology-derived medicinal products and a performance evaluation tool for this QMS universally applicable in the research centre of the company regardless of the specific activities of its individual divisions.MATERIALS AND METHODS. The study analysed internal audit outcomes, noncompliance responses, and the document flow of the research centre. Parameter values for quality index (QI) calculations were entered into validated Microsoft Excel spreadsheets. Data analysis and visualisation involved using the Microsoft Power Business Intelligence (BI) business analytics platform (mainly, the Power BI Desktop and Power BI Service components).RESULTS. The QMS was implemented, and the authors proposed their QMS performance evaluation tool universally applicable to all the divisions of the research centre. CONCLUSIONS. The authors proposed their QMS model for the development of biotechnology-derived medicinal products and the QI tool for collecting digital data, carrying out standardised monitoring, and tracking QMS status changes. The QI tool is universal for all company departments regardless of their requirements, easy to use, and customisable by adding individual company-specific quality parameters. This makes the QI tool applicable not only to drug development departments but also to other research units.

Through the effective application of Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices (EP), to continuously improve the corresponding management tools to ensure the safety and effectiveness of medical device in the quality management system, risk management system, evaluation of safety and effectiveness for the supervision departments and manufacturers. The current status of the application of EP and the application issues are analyzed in the study. Take artificial joint products for example, the idea of using EP in quality management system, risk management system and evaluation of safety and effectiveness is investigated, and several thoughts are proposed. Supervision departments should strengthen the unified understanding of EP, develop requirements according to the classification of medical device，and refine specific execution requirements.

The need to update an enterprise quality management system (QMS) seems to be more urgent each time. Without adequate updating, the system may not be capable of responding to market changes, generating delivery delays and increasing customer costs and losses instead of allowing industries to improve product quality and services, reduce costs, and increase customer satisfaction. Thus, the present research deals with a case study of a Mexican metal mechanics industry certified to ISO 9001:2015 with the need to update its operating QMS. Due to reasons for growth, the industry has added new activities to the processes and modified others, working in the integration area to improve efficiency and efficacy. Therefore, an analysis of strengths, opportunities, weaknesses, and threats (SWOT) was performed. The status of the processes was evaluated, creating a document with new activities and updating those that showed non-compliance. The results of this investigation have the purpose of contributing to the importance of QMS empirical evidence in emerging countries and increasing quality studies in Mexican industries.

This research is devoted to the development of innovative technology for automation of the quality management system (QMS) of enterprises in Kazakhstan and its adaptation to the management system of enterprises. This article deals with quality, as an important strategic tool in business. System effectiveness evaluation of quality management enterprises is of great importance connected with the formation of rational decisions in the management of QMSs, including specificity of quality indicators, multi-level system, the necessity to choose the optimal number of performance indicators, and system status evaluation. The objective and relevance of this research are related to the need to (1) solve the problems of quality management in the digital economy, following from the relevant National programs of the Government of the Republic of Kazakhstan, which are important at this step of in-depth scientific research; (2) guarantee the competitiveness of domestic enterprises with high-quality requirements for products and services; (3) improve the efficiency of automated QMSs; (4) save resources (human and timing) in data processing. The method and model of automated enterprise quality management and intelligent automated system of quality management of enterprise integrated with ruling MICS (Management Information and Control System) subsystems are offered allowing to automate QMS implementation and support processes and increasing the validity, efficiency and effectiveness of management decisions by automating a number of functions of decision makers and personnel.

The study compares an artificial intelligence technology with traditional manual search of literature databases to assess the accuracy and efficiency of retrieving relevant articles for post-market surveillance of in vitro diagnostic and medical devices under the Medical Device Regulation and In Vitro Diagnostic Medical Device Regulation. Over a 3-year period, literature searches and technical assessment searches were performed manually or using the Huma.AI platform to retrieve relevant articles related to the safety and performance of selected in vitro diagnostic and medical devices. The manual search involved refined keyword searches, screening of titles/abstracts / full text, and extraction of relevant information. The Huma.AI search utilized advanced caching techniques and a natural language processing system to identify relevant reports. Searches were conducted on PubMed and PubMed Central. The number of identified relevant reports, precision rates, and time requirements for each approach were analyzed. The Huma.AI system outperformed the manual search in terms of the number of identified relevant articles in almost all cases. The average precision rates per year were significantly higher and more consistent with the Huma.AI search compared with the manual search. The Huma.AI system also took significantly less time to perform the searches and analyze the outputs than the manual search. The study demonstrated that the Huma.AI platform was more effective and efficient in identifying relevant articles compared with the manual approach. • Post-market surveillance (PMS) is monitoring device safety and performance. • New EU in vitro diagnostic and medical device regulations impact PMS. • Searching the literature for safety signals is time-consuming. • AI assistance reduces human error, and increases search efficiency and precision. • These improvements are crucial for compliance. [ABSTRACT FROM AUTHOR]

The need to update an enterprise quality management system (QMS) seems to be more urgent each time. Without adequate updating, the system may not be capable of responding to market changes, generating delivery delays and increasing customer costs and losses instead of allowing industries to improve product quality and services, reduce costs, and increase customer satisfaction. Thus, the present research deals with a case study of a Mexican metal mechanics industry certified to ISO 9001:2015 with the need to update its operating QMS. Due to reasons for growth, the industry has added new activities to the processes and modified others, working in the integration area to improve efficiency and efficacy. Therefore, an analysis of strengths, opportunities, weaknesses, and threats (SWOT) was performed. The status of the processes was evaluated, creating a document with new activities and updating those that showed non-compliance. The results of this investigation have the purpose of contributing to the importance of QMS empirical evidence in emerging countries and increasing quality studies in Mexican industries. [ABSTRACT FROM AUTHOR]