This study is motivated by the fluctuating number of participants at LPK Takemura Indonesia, Bandung Regency, and the urgent need to improve its quality management system in order to compete in the digital era and meet industry requirements. The purpose of this research is to examine how the implementation of Total Quality Management (TQM) can enhance the performance of LPK Takemura, particularly in terms of sales (training participant enrollment), customer satisfaction, and internal institutional management. This study employs a qualitative descriptive approach, with data collected through observation, in-depth interviews, and documentation. Informants were selected using purposive sampling, involving the founder, director, administrative staff, and active training participants. The findings indicate that most TQM principles have been implemented at LPK Takemura, including customer focus, employee involvement, and continuous improvement. This implementation has positively impacted institutional performance, especially in increasing the number of participants (sales), improving customer satisfaction, and strengthening internal management. Moreover, the integration of a gender perspective in training contributes to women’s empowerment, promotes inclusive entrepreneurship, and fosters a more equitable and participatory work environment. The implementation of TQM is proven not only to improve the institution’s sales performance but also to generate broader social and economic implications.

This article provides a high-level overview of regulatory considerations for medicinal aerosol products around the world. It builds on our previous review and reflects developments related to more recent trends and innovations in science, business, technology, and regulation. All medicines, including medicinal aerosol products, must be approved by an appropriate government agency prior to marketing authorization. Knowing and complying with the requirements of an appropriate regulatory agency (or agencies) is a prerequisite to successful commercialization of any aerosol therapy. The range of governmental regulatory oversight is broad, including inspections of manufacturing sites, evaluations of preliminary data and study protocols before the start of trials in human subjects, evaluations of the sponsor's clinical and in vitro data for the proposed product, approval of final labeling and of postapproval changes to any aspect of the product or manufacturing process, monitoring of adverse event reports, and other areas. The specific regulatory requirements vary by the product type and by country, and they also change over time as the science and technology involved in the development, manufacture, and characterization of pharmaceutical and biological products evolve. In general, in order to obtain marketing authorization, the sponsor must demonstrate to regulators, using data from appropriately designed studies and other relevant documentation, (1) that the product is safe and efficacious for the proposed therapeutic indication in the target patient population, (2) that the product's manufacturing facility follows current good manufacturing practice2-4 and/or quality management systems,5,6 and (3) that appropriate quality control and quality assurance programs are in place, including programs to verify that the product released to the market, as well as product kept in stability-testing environmental chambers, complies with preset quality specifications. For aerosol delivery devices and drug-device or biological-device combination products, the sponsor must also assess the influence of human factors, device robustness, and materials' (bio)compatibility. The sponsor's responsibility to regulators continues after a product's approval in the form of, for example, required compliance with ongoing quality testing, pharmacovigilance monitoring, any postapproval commitments, and qualification of any postapproval changes. This article provides an overview of the regulatory considerations for inhaled and nasal products.

ObjectiveAnalyze and compare the characteristics of nonconformities (NCs), root causes, and corrective actions generated from internal assessments and ISO 15189 external assessments in a medical laboratory, identify high-risk points and evaluate the role and contribution of different assessments to the medical laboratory’s quality performance.MethodsA total of 35 NCs from internal assessments and 67 NCs from external assessments were documented in a medical laboratory between 2021 and 2024. The NCs were categorized according to clause requirements, while root causes and corrective actions were classified based on their content. The recurrence rate of NCs, effectiveness of corrective actions and characteristics of recurring NCs were statistically analyzed. The flow relationships were shown by Sankey diagrams. The laboratory quality monitoring model was illustrated by a double-helix diagram.ResultsIn internal assessments, the top three NC categories were Examination processes (n = 8, 22. 86%), Personnel management (n = 7, 20. 00%), Document and record control (n = 6, 17. 14%);in external assessments the top categories were were Examination processes (n = 19, 28. 36%), Document and record control (n = 10, 14. 93%), Others(Evaluation, Complaints, Information system, Risk Management)(n = 8, 11. 94%), Personnel management (n = 6, 8. 96%). Regarding root causes, the most frequent in internal assessments were Personnel Negligence (n = 14, 40. 00%), Training deficiencies (n = 11, 31. 43%);in external assessments, the tops were Training deficiencies (n = 27, 40. 30%), Document and Record Deficiencies(n = 15, 22. 39%). The The most frequently implemented corrective action across both assessment types was Personnel training(internal [n = 35, 47. 29%] and external [n = 67, 41. 36%]). The numbers of Managment NCs, Technical NCs, total NCs, and Corrective Actions in external assessments were significantly higher than in internal assessments.ConclusionThe high-risk points primarily lie in Examination processes, Document/record and Personnel management during the initial implementation of the ISO 15189. External assessments help identify deviations, contributing to quality performance improvement. Internal assessments enable continuous monitoring of quality issue corrections, supporting the ongoing enhancement of the QMS. The ‘Double Helix’ Model of Quality Monitoring ensures the stability and accelerated advancement of the quality management system in the medical laboratory.

This study explores the barriers to ISO 9001 implementation in Resident Welfare Associations (RWAs) within the Delhi NCR region, focusing on the multidimensional challenges that hinder the adoption of structured quality management systems. Despite the growing relevance of ISO 9001 in improving community-level governance and service delivery, RWAs continue to face significant obstacles rooted in organizational limitations, cultural resistance, financial constraints, regulatory ambiguity, and technological inadequacies. A mixed-methods research design was adopted to gain comprehensive insights, utilizing structured questionnaires to collect quantitative data and semi-structured interviews for qualitative exploration. Data collection tools included Google Forms for surveys and digital meeting platforms such as Google Meet and Zoom for interviews. Quantitative analysis involved descriptive and inferential statistical techniques, while thematic analysis was applied to qualitative responses. The findings underscore the urgent need for targeted policy support, digital literacy enhancement, financial assistance, and community sensitization to facilitate effective ISO 9001 implementation in RWAs. The study contributes to the discourse on urban governance and highlights practical pathways to improve quality standards in resident-led organizations.

Analyze and compare the characteristics of nonconformities (NCs), root causes, and corrective actions generated from internal assessments and ISO 15189 external assessments in a medical laboratory, identify high-risk points and evaluate the role and contribution of different assessments to the medical laboratory's quality performance. A total of 35 NCs from internal assessments and 67 NCs from external assessments were documented in a medical laboratory between 2021 and 2024. The NCs were categorized according to clause requirements, while root causes and corrective actions were classified based on their content. The recurrence rate of NCs, effectiveness of corrective actions and characteristics of recurring NCs were statistically analyzed. The flow relationships were shown by Sankey diagrams. The laboratory quality monitoring model was illustrated by a double-helix diagram. In internal assessments, the top three NC categories were Examination processes (n = 8, 22. 86%), Personnel management (n = 7, 20. 00%), Document and record control (n = 6, 17. 14%);in external assessments the top categories were were Examination processes (n = 19, 28. 36%), Document and record control (n = 10, 14. 93%), Others(Evaluation, Complaints, Information system, Risk Management)(n = 8, 11. 94%), Personnel management (n = 6, 8. 96%). Regarding root causes, the most frequent in internal assessments were Personnel Negligence (n = 14, 40. 00%), Training deficiencies (n = 11, 31. 43%);in external assessments, the tops were Training deficiencies (n = 27, 40. 30%), Document and Record Deficiencies(n = 15, 22. 39%). The The most frequently implemented corrective action across both assessment types was Personnel training(internal [n = 35, 47. 29%] and external [n = 67, 41. 36%]). The numbers of Managment NCs, Technical NCs, total NCs, and Corrective Actions in external assessments were significantly higher than in internal assessments. The high-risk points primarily lie in Examination processes, Document/record and Personnel management during the initial implementation of the ISO 15189. External assessments help identify deviations, contributing to quality performance improvement. Internal assessments enable continuous monitoring of quality issue corrections, supporting the ongoing enhancement of the QMS. The 'Double Helix' Model of Quality Monitoring ensures the stability and accelerated advancement of the quality management system in the medical laboratory.

Chronic kidney disease (CKD) is one of the rapidly growing kidney complications in U. S. citizens. The purpose of this study is to affect the calculation of the sigma metric in laboratory settings based on the analytical performance specification (APS), given its influence. In our investigation, we look into various levels of APS and their impact on different test performance metrics. The findings suggest that the appropriate sigma metric calculation emphasizes the laboratory test quality as it is within the laboratory performing the tests. Laboratory performance metrics are key for achieving the testing’s precision, accuracy, and control standards. The diagnostic accuracy and reliability depend on how optimally APS values are selected relative to clinically significant target values. This study aims to underscore selectively tailored APS values for clinically specified targets so that not only accuracy but also precision of diagnostics is achieved. Laboratory practices and patient safety are improved by underscoring APS’s involvement in sigma metric calculations as a control improvement strategy. It was noted that selecting APS needs integration into the logic of planning clinical laboratory quality management systems

The management quality of Corporate Social Responsibility (CSR) programs has become a critical concern, particularly for environmental initiatives that are often implemented symbolically and lack long-term sustainability. From an operations management perspective, such programs can be viewed as community-based operations that require systematic quality management to ensure consistent performance and impact. This study aims to evaluate the quality management practices of an environmental CSR program implemented through the Kampung Ramah Lingkungan (KRL) initiative in Bogor Regency, Indonesia, using a Total Quality Management (TQM) framework. A qualitative descriptive approach with an evaluative case study design was employed. Data were collected through in-depth interviews, field observations, and document analysis involving corporate CSR representatives, program managers, and beneficiary communities. The evaluation focused on five TQM dimensions: continuous improvement, employee empowerment, just-in-time, knowledge of TQM tools, and customer focus. The findings indicate that the CSR program has moderately implemented TQM principles, particularly in continuous improvement, community empowerment, and alignment with local needs. However, limitations remain in the standardisation of performance indicators and the systematic use of data for monitoring and evaluation. This study contributes to the operations management literature by extending the application of TQM to community-based and non-profit operational contexts. Practically, the findings provide insights for CSR managers and practitioners on how quality management principles can enhance the sustainability and effectiveness of environmental CSR programs.

ISO 9001 is a widely adopted quality management standard that aims to improve patient safety, care organization, and risk control in hospital settings. Despite its proven effectiveness in numerous healthcare institutions worldwide, its application in low- and middle-income countries remains limited due to structural constraints, limited resources, and a lack of context-specific implementation strategies. A systematic review was conducted following PRISMA guidelines. Electronic databases, including PubMed and ScienceDirect, were searched for studies published between 2014 and 2024. Eligible studies included original research and systematic reviews assessing ISO 9001 implementation in hospital departments providing direct clinical care. Data were extracted and analyzed thematically according to study objectives, methodology, reported outcomes, and implementation challenges. Of 246 records screened, 23 studies met inclusion criteria. Most originated from Europe, with minimal representation from resource-limited settings. Three main findings emerged from the analysis: (1) ISO 9001 adoption was associated with improved care quality, patient safety, and organizational efficiency; (2) common implementation barriers included limited funding, staff resistance to change, and difficulty adapting this industry-derived standard to clinical practice; (3) key success factors included strong leadership commitment, staff engagement, and external support from accreditation or certification bodies. Based on these findings, we propose a three-phase implementation framework: (i) initial gap analysis and contextualization of ISO 9001 requirements, (ii) stepwise establishment of a hospital quality management system, and (iii) evaluation of impact and sustainability. ISO 9001 demonstrates strong potential to enhance quality of care and organizational performance in hospital clinical services, including in resource-limited settings. However, effective implementation requires a context-sensitive, participatory, and phased approach. The proposed three-phase framework offers a practical roadmap for clinical services in resource-limited settings to initiate structured, sustainable quality improvement aligned with ISO 9001 principles.

Aim. To assess the implementation of international standards in Russian biobanking — members of National Association of Biobanks and Biobanking Specialists (NASBIO), as well as the willingness and interest of specialists in certification and accreditation of Russian biobanks. Material and methods. To assess the level of standardization of Rus­sian biobanks in June 2025, a questionnaire was developed con­sisting of four sets of questions on biobanking standardization, the im­plementation of quality management systems, and the prospects for certification. A survey was conducted from July to August 2025 among representatives of Russian biobanks — NASBIO members. Descriptive statistics were used to analyze the survey results. Results . Representatives of 20 organizations participated in the survey. All participants provided written consent to personal data processing. The majority of survey participants represented biobanks established at state research and medical institutions. The survey results showed that Russian biobanks apply and actively implement mandatory quality management procedures. However, only four biobanks are certified according to the International Organization for Standardization (ISO) 9001 standard. High interest among specialists in obtaining ISO 20387 certificates of conformity was noted. Conclusion. The survey results showed that Russian biobanking spe­cialists generally demonstrate a commitment to quality and an interest in standardizing biobank operations. The lack of a clear legal framework in Russia for research biobanks of human samples and accredited bo­dies for biobank certification according to ISO 20387 remain limiting fac­tors for the exchange of collections and their shared use in research and development.

Background In response to the development of higher education quality management in the 1990s, institutions all over the world have set up equivalent internal teaching quality management systems based on local, regional, and global contexts. On the basis of the pertinent documents released by the Chinese Ministry of Education, this research also builds a teaching quality management system combined with neural networks. Methods GA-BP neural network and convolutional neural network are used to improve the evaluation method of teaching quality management and the monitoring method of classroom teaching quality. Results The improved results show that the accuracy of the upgraded GA-BP network for evaluating teaching quality is 89.62%, which is 11.45% higher than the baseline network. Convolutional neural network behavior recognition has high stability and repeatability, and the accuracy rate of classroom teaching quality supervision is 82.8% and the accuracy is 85.2%. Discussion GA-BP network optimizes the initial weight and structure of the neural network through genetic algorithm, and convolutional neural network provides a new technical path for the intelligent transformation of the internal quality management system of colleges and universities by monitoring the classroom behavior of teachers and students.

This article examines the key success factors and barriers to implementing Total Quality Management (TQM) through an in-depth review of existing research. The analysis begins with a literature review on the key factors determining the success of TQM, followed by the application of the Pareto principle to the results of this review to identify the most critical factors. This approach highlights the priority levers to maximize TQM effectiveness. In addition, the article examines the main obstacles to TQM implementation by conducting a systematic review of the barriers identified in the literature. The use of the Fuzzy DEMATEL method allows for an analysis of the interdependencies among these barriers and the identification of the most influential ones. This comprehensive analysis aims to promote a more sustainable approach to TQM by introducing the concept of GREEN TQM, a new label designed to integrate environmentally responsible practices into quality management systems. In the next phase of this research, the identified key success factors will be further analyzed in terms of their contribution to the achievement of the Sustainable Development Goals (SDGs). This will enable the identification of new sustainability-oriented success factors, so-called “Green” success factors, which will serve as the foundation for defining the Green TQM framework. This forward-looking approach positions Green TQM as a strategic tool to enhance both quality and sustainability in organizational performance.

There is a growing demand for environmental sustainability in the medical device industry. Globally, the healthcare systems' carbon emissions are largely attributable to complex supply chains, including raw materials extraction, product manufacture, distribution, and disposal. Today, ERP has evolved into sustainability intelligence software for monitoring and measuring environmental performance, enabling real-time carbon footprint tracking in procurement, manufacturing, and distribution. Modern ERP may deliver ESG modules for Scope 1, 2, and 3 emissions management, and help organizations meet quality management system regulations of medical device manufacturing. Artificial intelligence algorithms can increase the accuracy of emission factors and promote carbon accounting through the automatic classification of procurement data, classification of supplier features, and natural language processing of environmental documentation. Regulatory frameworks such as the EU Corporate Sustainability Reporting Directive (CSRD) and voluntary frameworks such as CDP climate disclosure are pressuring medtech companies to develop carbon accounting capability. ERP-enabled dashboards provide product-level carbon footprints, supplier engagement platforms, and hotspots for focused decarbonization activities while automating carbon accounting and reporting in compliance with global standards. Medical device companies adopting integrated ESG intelligence systems have a competitive advantage in regulatory compliance, operational efficiency, sustainability-linked funding, and distinguishing themselves in the sustainable healthcare market. By extending from retrospective environmental reporting to predictive carbon management, medical technology companies are positioned to lead healthcare, accelerate change, and meet growing stakeholder demand for climate transparency and assurance across global value chains.

Source plasma centers sustain hematology therapeutics by safeguarding testing, traceability, and cold-chain integrity before fractionation. Despite regulatory requirements (21 CFR 606/640; EU Directive 2005/62/EC), published pre-operational validation frameworks demonstrating deviation-readiness before first collections remain sparse. We conducted a simulation-based pre-operational validation of an electronic quality management system (eQMS) with an Incident → Deviation → Corrective Action and Preventive Action (CAPA) pathway at a new source plasma center, performing 20 chairside mock runs, 3 freezer-alarm drills, and a document-control stress test. Primary endpoints were anomaly rate, alarm-response time relative to a 15 min service-level agreement (SLA), and deviation-closure SLA compliance. Analyses were descriptive and designed to demonstrate system functionality, not long-term process stability. Minor anomalies occurred in 6/20 mock runs (30.0%; 95% CI 11.9–54.3); no major/critical events were observed (0/20; 95% CI 0–16.8). Deviation-closure SLAs were met in 6/6 tests (100%; 95% CI 54.1–100). Alarm-response times averaged 7.0 min (SD 1.0; range 6–8 min; 95% CI 4.5–9.5), and all drills met the 15 min vendor SLA, illustrating a preliminary readiness margin (Cpu ≈ 2.7) rather than a statistically stable capability estimate. Simulation-based pre-operational validation produced inspection-ready documentation and quantitative acceptance criteria aligned to U.S./EU expectations, supporting reproducible multi-site deployment. By protecting cold-chain integrity and traceability before first collections, the validated QMS helps preserve supply reliability for plasma-derived therapeutics central to hematology care and establishes the measurement infrastructure for post-operational performance validation.

General Background: The acceleration of globalization and intensification of competition in industrial sectors have positioned product quality as a key determinant of market position and long-term development prospects, particularly in the construction materials industry where quality directly affects public safety and structural reliability. Specific Background: The construction materials industry represents a technologically complex, multi-stage system requiring strict adherence to technological regimes, yet traditional management approaches focus primarily on finished product inspection rather than addressing root causes of quality deficiencies. Knowledge Gap: While foreign scholars have extensively addressed theoretical foundations and universal models of quality management, and domestic researchers have examined technological and standardization aspects, the comprehensive organization of production processes in the construction materials industry based on quality management principles remains insufficiently systematized. Aims: This study provides a comprehensive analysis of organizing production processes in the construction materials industry through quality management principles, examining theoretical foundations, scientific approaches, practical state, and recent statistical data to develop specific practical recommendations. Results: The research demonstrates that implementing quality management systems—including ISO 9001 standards, statistical quality control methods, and process-based approaches—stabilizes quality indicators, optimizes production costs, and enhances competitiveness while positively impacting environmental sustainability and social responsibility. Novelty: This study systematically integrates quality management principles with resource efficiency and environmental requirements as essential components of sustainable production organization in construction materials enterprises. Implications: The findings confirm that quality-oriented management strengthens enterprise positions in domestic and international markets, enhances investment attractiveness, and constitutes a critical direction for ensuring sustainable development of the construction materials sector and national economic competitiveness.Keywords : Quality Management Systems, Construction Materials Industry, Production Process Organization, ISO 9001 Implementation, Statistical Quality ControlHighlight : Process-based quality control reduces defects more effectively than traditional post-production inspection methods. Statistical analysis integration enables forecasting of quality variations in cement and concrete manufacturing. ISO 9001 implementation requires strategic alignment and active management involvement beyond documentation compliance.

Introduction: Blood transfusion services play a crucial role in patient healthcare management. The quality of blood and blood components, as well as their judicious use, directly impacts healthcare outcomes. Ensuring high-quality transfusion services can be achieved through the implementation of a Quality Management System (QMS). QMS performance can be monitored using performance measures known as Key Performance Indicators (KPI). This study was planned to assess the quality standards of our blood centre through evaluation of KPI. Aim: To analyse the quality performance of the blood centre through evaluation of KPI. Materials and Methods: This cross-sectional analytical study was conducted from November 2023 to May 2024 and from September 2024 to January 2025 in the Department of ImmunoHaematology and Blood Transfusion, Sri Venkateswara Institute of Medical Sciences Blood Centre, Tirupati, Andhra Pradesh India. Data were collected systematically, and root causes for any deviations were assessed. Corrective and preventive action measures were implemented accordingly. The key variables required for calculating KPI were extracted from various registers maintained at the blood centre. All KPI were calculated and analysed using the standard formulas prescribed by the National Accreditation Board for Hospitals and Healthcare Providers (NABH). Results: The KPI observed during the study period were as follows: Donor deferral rate: 11.03%; Adverse donor reaction Rate: 0.128%; Percentage of components prepared: 98.25%; Seroreactivity of donors: 1.24%; Turnaround Time for elective cases: 40.73 minutes; Turnaround Time for emergency cases: 7.27 minutes; Quality control failure rates: 0.62%; Adverse Transfusion reaction rate: 0.024%; Wastage rate of components: 1.21%; Percentage of outdated units: 0.44%. All of these KPI were within NABH benchmarks. However, the seroreactivity for syphilis (0.33%), the percentage of component usage (99.3%), and the percentage of whole blood wastage (5.29%) did not meet NABH benchmarks. Conclusion: All KPI were within NABH benchmarks except for the seroreactivity rate for syphilis, the percentage of blood component usage, and the percentage of whole blood wastage. These issues can be addressed through effective pre-donation screening procedures, particularly for syphilis. Uniform adoption of national policies across all states can help achieve 100% blood component usage. Additionally, involving adequately trained personnel can reduce instances of under-collection, which was identified as a major contributing factor to whole blood wastage in our study

Biological sample storage in biomedical research.

A national biobank framework for rare diseases: Standardized infrastructure and cross-institutional collaboration accelerating translational innovation in China.

The competitiveness of U.S. export-oriented production increasingly depends on consistent quality performance, regulatory compliance, and operational resilience in global markets. Quality Management Systems (QMS), such as ISO 9001, ISO 14001, and sector-specific standards, play a critical role in ensuring product conformity, customer satisfaction, and international trade acceptance. However, many U.S. manufacturers implement these systems in isolation, resulting in fragmented processes, duplicated documentation, and limited strategic impact. This study examines the integration of multiple Quality Management Systems into a unified framework to strengthen export-oriented production in the United States. Using a structured methodological approach that combines process mapping, performance indicators, and compliance alignment, the paper demonstrates how integrated QMS can improve operational efficiency, reduce non-conformance risks, and enhance global market access. The findings indicate that organizations adopting integrated QMS experience measurable improvements in export readiness, cost control, and customer trust. The study contributes to both academic literature and industrial practice by providing a scalable integration model applicable across manufacturing sectors. The results highlight the strategic importance of quality integration in supporting U.S. economic competitiveness and sustainable export growth.

Purpose This study aims to examine the journey of embedding sustainability within organizational culture in educational institutions, focusing on Ciputra Education. It explores how core values are transformed into sustainable practices by identifying the internalization mechanisms and the key factors that influence the successful implementation of a sustainability corporate culture (SCC). Design/methodology/approach The research is grounded in the resource-based view (RBV) theory and the 4I framework of organizational learning. It employs a qualitative single-case study approach. Primary data were collected through in-depth interviews with ten informants and were triangulated with expert reviews to enhance trustworthiness. Data analysis was conducted using NVivo 14 software. Findings The findings revealed that the SCC internalization mechanism occurred through a systematic learning process of core values – intuiting, interpreting, integrating and institutionalizing. Key internal and external factors influencing this process included founder wisdom, entrepreneurial leadership, quality management systems, human capital, government regulations, information and technology and competition. A comprehensive SCC model emerged by integrating these internalization mechanisms with enabling contextual factors. Practical implications The model offers practical guidance for educational leaders in navigating the journey “from values to practice” by fostering sustainability through cultural transformation. Originality/value This study contributes a novel approach by integrating RBV and the 4I framework of organizational learning to develop a contextualized SCC model for educational institutions. It positions organizational culture as a strategic, non-replicable resource for long-term sustainability.

With the rapid development of the national economy and the continuous improvement of residents' consumption levels, cosmetics have increasingly become an indispensable consumer product in people's daily lives. In recent years, cosmetic safety issues have become a social hotspot, making more consumers pay attention to cosmetic production technology, raw materials, and quality, and putting forward higher requirements for the production technology and quality control of cosmetic manufacturing enterprises. This paper conducts an in-depth study on the production technologies of different types of cosmetics, and elaborates on four aspects: improving quality control measures such as raw material management, establishing and implementing traceability management systems, conducting self-inspections of quality management systems, and optimizing sample retention and monitoring systems. The aim is to improve the quality of cosmetic production and promote the healthy development of the cosmetics industry.