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Engineering accreditation agencies and governmental educational bodies worldwide require programs to evaluate specific learning outcomes information for attainment of student learning and establish accountability. Ranking and accreditation have resulted in programs adopting shortcut approaches to collate cohort information with minimally acceptable rigor for Continuous Quality Improvement (CQI). With tens of thousands of engineering programs seeking accreditation, qualifying program evaluations that are based on reliable and accurate cohort outcomes is becoming increasingly complex and is high stakes. Manual data collection processes and vague performance criteria assimilate inaccurate or insufficient learning outcomes information that cannot be used for effective CQI. Additionally, due to the COVID19 global pandemic, many accreditation bodies have cancelled onsite visits and either deferred or announced virtual audit visits for upcoming accreditation cycles. In this study, we examine a novel meta-framework to qualify state of the art digital Integrated Quality Management Systems for three engineering programs seeking accreditation. The digital quality systems utilize authentic OBE frameworks and assessment methodology to automate collection, evaluation and reporting of precision CQI data. A novel Remote Evaluator Module that enables successful virtual ABET accreditation audits is presented. A theory based mixed methods approach is applied for evaluations. Detailed results and discussions show how various phases of the meta-framework help to qualify the context, construct, causal links, processes, technology, data collection and outcomes of comprehensive CQI efforts. Key stakeholders such as accreditation agencies and universities can adopt this multi-dimensional approach for employing a holistic meta-framework to achieve accurate and credible remote accreditation of engineering programs.

With the development of Internet and information technology, data has become an important asset related to the development prospects of society and all walks of life. At present, there are many quality problems in the use of educational data, which has brought great obstacles to exerting the value of educational data. Only by using scientific statistical methods, obtaining real, objective, comprehensive, scientific and effective basic data, and carrying out systematic and comprehensive analysis on the obtained data, can we give full play to its command and decision-making role. The development of big data and artificial intelligence technology provides new ideas for the analysis and evaluation of educational data quality, and is committed to restoring the overall picture of the education system and promoting the change of regional educational ecology. In this paper, an educational data quality analysis model based on multiple constraint model is proposed, which classifies the data in the database, divides the information in the database into several different categories according to the data characteristics, and establishes a quality management system for educational data in universities, so as to effectively improve the quality of educational data.

Rejection of some Information Systems, among others, is because users do not have experience in using them so that the Information System is said to fail to be implemented. In Village Administration Office, there are many problems related to supporting the use of Information Systems, especially regarding user experience. The purpose of this study is to measure the success of an Information System project based on User Experience. The model used is the result of integrating the User Experience model with the Information System Project Success model. 73 samples were collected through online surveys with a simple random sampling method. The least partial structural equation modeling method with Smartpls 3.3.3 was used to analyze the data. The results of the study found that the character of the experience of users of Information Systems in Village Administration Office stated that they were able to use Information Systems by 49%. 51% of the respondent's educational background is High School graduates, and 34% of the positions are operators. Meanwhile, the most influential factor of Information System Projects Success based on User Experience is the Quality System, while the quality of the system itself is influenced by the constructs of Usability, Affect, and User Value. The findings in this study will contribute to research in the field of Information Systems, particularly research on the success of Information Systems projects and User Experience. In addition, research results will contribute to policymakers in the application of Information Systems, especially in rural areas.

In the context of deepening social and reform processes taking place in Ukraine, the dominant feature of the development of national education is the introduction of requirements in accordance with which the European emphasis on the assessment and quality standarts and control of education is growing. Improving the process of education quality is a new and main direction in the development of higher education in Europe, which is recognized by European governments, academia, international and intergovernmental organizations, the media. This process is accompanied by changes in the specialized education system and necessitates a scientific search for new mechanisms and methods of managing the educational process, bringing the content of higher education to the requirements and needs of the educational market. In particular, it concerns the application of the principles of Total Quality Management (TQM) and the requirements of international standards ISO 9001 series for the construction of internal quality management systems in educational institutions. The existence of a quality management system is a generally accepted guarantee and confirmation of the quality indicators of education.

This paper presents an approach to document ISO 9001:2015 quality management systems (QMS) using ArchiMate. The research is done in cooperation with a research and technology development institute developing ISO 9001:2015-compliant information systems. The models and the steps needed to adopt an enterprise architecture approach to ISO 9001:2015 are demonstrated for the aeronautical setting. ISO 9001:2015 suggests a process approach to management. However, the increasing digitalization of organizational practices raises difficulties for auditing and calls for a deeper alignment between processes, strategy, applications, technologies, and physical infrastructure. Shifting to an Enterprise Architecture (EA) approach to ISO 9001:2015 documented information can contribute to a unified view of quality management and digital transformation.

Over the past decade, power high quality is now an issue that is imminent. Power quality is just one of the major and factor that is significant be looked at by energy system utilities while satisfying the needs of energy provider and clients. Therefore, it becomes excessively important to evaluate the impact quality system to discern the disruptions in energy quality. A number of research studies in connection with power high quality are done previously focusing on the assortment of information for any analysis this is certainly extra. The repercussions regarding the different disturbances in power systems could be examined and examined because of this. In our work this is certainly suggested have developed a technique that naturally relates to the utilization of a hardware model of tiny demonstration transmission line. The range of sending voltage is between compared to 25 to 50 V AC. The transmission range variables are then measured making use of transformers that are current (CT) and potential transformers (PT) sensors. That values measured from CT and PT detectors are then used in the MATLAB Simulink logic this is certainly fuzzy where in fact the energy quality is further detected and reviewed. Following the recognition and evaluation, then each one of these types of power high quality disturbance signals are further classified using logic that is fuzzy Controller (FLC). The device this is certainly total designed in MATLAB 2015R pc software atmosphere or utilizing hardware design implementation whose analysis done in MATLAB 2015R computer software. In the long run, we have contrasted the logic this is certainly fuzzy Controller (FLC) system with for energy quality analysis.

Automation of control methods of necessary requirements fulfilment or non-fulfilment while ensuring dependability and quality for wireless devices (WD) are necessary at design stages. However, this approach is not used in enterprises. Companies are limited only to expert assessment (non-automated external audit) and assessment of efficiency private criteria in the quality management system (QMS). The existing statistics of failures of radio engineering devices installed on unmanned automatic spacecraft indicates that there are shortcomings of ensuring the dependability and quality of the WD strategy. Therefore, in this paper, the method of dependability assessment of the WD considering the quality management system is proposed. The paper presents a mathematical model of dependability assessment of the WD considering not only the categories of the WD failures but also the private criteria contribution of the QMS functioning efficiency. Automation of the method is achieved by using the developed software.

In the past two decades, third language education has become increasingly important in various universities in China. In the curriculum of many universities, it is no longer just a compulsory second foreign language course for foreign language majors, but also gradually becomes a university-wide elective course for other non-foreign language students. The question of how to guarantee the overall quality of third language teaching has become a question of reflection for every foreign language department and an important issue for the sustainable development of foreign language teaching in universities. This paper analyzes the difficulties of teaching process monitoring in the context of a full credit system, applies the PDCA model of a quality management system to the management of third language teaching, and adopts measures such as reasonable use of information platform, test and evaluation means, and focus on feedback from multiple subjects in the two key monitoring stages of instruction and implementation (D) and inspection and evaluation (C), to provide a kind of reference standard for monitoring the process of third language teaching in colleges and universities. The aim is to provide a reference standard for monitoring the process of third language teaching in universities.

Implementing Quality Management Systems to meet the requirements of ISO/IEC 17025 is a vital initiative in accrediting that a laboratory has the competency requirements to perform testing and calibration activities. This work presents the perception of various stakeholders regarding the key elements that facilitate or impede the implementation and use of such standard in Angolan public laboratories. The results obtained show that senior management participation, resource availability, and staff training contribute to successfully achieve and maintain the standard in order to improve their competence and to promote confidence on their services.

As a rule, the management of complex organizational-technical facilities is implemented through the creation of automated control systems, and to ensure continuity and maintain the required level of the quality management system of the automated control system provides information subsystem, which provides officials control and automation systems providing the required item of information services that guarantee make informed correct decisions for the organization management system. At the same time, the functioning of the information subsystem itself as a complex system, including in emergency conditions, provides for its management, for which a dedicated management system is created, which is assigned to solve a number of management tasks, among which the most important is the task of ensuring effective functioning, including on the basis of creating and implementing methods for managing the processes of providing information services. At the same time, the constantly increasing complexity of information subsystems and their functioning processes makes it extremely difficult to organize the management processes of the subsystem itself. Among all the tasks of managing an information subsystem, the task of managing its functioning is the most complex, since it is associated with the need to take into account many factors, characteristics and parameters of complex processes occurring in the subsystem. Therefore, when developing methods of management of functioning of the information subsystem, it is advisable to consider the control problem as a complex, involving the application of complex methods, each of which is used in the control loop of the control system under certain operating conditions and provides either the highest efficiency or efficiency not lower than required

The article presents the results of the development of the concept of a digital quality management system in the automotive industry. The transition, in the context of logistics cooperation of assembly production, to the digitalization of quality management and monitoring processes is based on a system of data collection and intelligent processing at key stages of the production process. Equipping with digital tools, switching from defect indices to performance quality indices. Digital transformation of production quality management using statistical tools, probabilistic modeling, logistics, as well as real production process indices. Creating models based on the definition of the most important technical characteristics with integration into the management system, taking into account the efficiency and flexibility of control actions.

ISO 9001 is the most widely recognized standard boasting the world economy development: more than 200 countries are involved and over 1 million organizations are certified. ISO 9001 sets out requirements for quality management systems (QMS) and is applicable for all types of organization. QMS can bring significant benefits for organizations' competitiveness and success. The motivation for implementation mainly deals with changes and improvement, contribution to growing of sales, increasing of exports and reducing barriers to international trade due to improvements in product quality and differentiation, better market visibility. Software development is one of the leading industries of the world economy. Foreign software sales of Russian companies have been on the rise for the last 20 years, but the share of software export lag far behind developed countries. Though many Russian software companies are planning to increase exports, they do not connect this task to improvement of management. The research is focused on performance of Kaspersky Lab, one of the largest software companies in Russia, that implemented ISO-9001 in 2016. We used modified principal component analysis to calculate the indices of the company's performance for the several years, that allows to make assessment of the progress or regress in its development due to ISO 9001 certification.

Due to the problems presented by university higher education programs in Peru, the senior executives of the universities must take the necessary measures that allow them to identify institutional procedures to subsequently implement correct activities that contribute to growth in university education service quality and thus meet the standards necessary to achieve the accreditation of university programs. The main objective is to identify and offer a relevant description of some accreditation models, which allow the development of an institutional culture based on quality management to obtain accreditation in university higher education in Peru, as well as digital platforms used for education. The methodology used was the literature review. As a main conclusion is the identification of 15 publications selected, during the full review of each of the papers, we found 5 accreditation models and 7 digital platforms that support university quality management systems.

Industrial training courses require students to gain sufficient practical engineering experience that confirms theoretical knowledge by application to field work. The courses expose students to real life engineering activity involving problem solving, design, experimentation and manufacturing. Students get introduced to entrepreneurship, diverse collaborative work environments and quality systems that instill world class safety standards and professional ethics. Preventive measures and lockdowns during prolonged pandemic conditions have severely limited students’ capability for in-person participation of onsite industrial training programs, thereby, adversely affecting the scope of training courses. This paper presents some plausible solutions to challenges faced by both instructors and students in fulfillment of essential outcomes for remote offerings of industrial training courses during the COVID19 pandemic. Essential aspects of an outcome based digital platform used for remote management, assessment and evaluation of industrial training courses are presented. A course template that facilitates virtual engineering roles as viable alternative to students’ in-person participation in industry settings is explained. This study compares two course models offered prior to and during pandemic conditions for fulfillment of course outcomes, makes observations of required skills and knowledge, related deficiencies and some recommendations to help engineering programs enhance student learning in remotely offered industrial training courses.

This paper represents a state-of-the-art study related to reasons that drive companies to adopt a quality approach according to the ISO 9001 standard. It also presents a literature review of the various research works on the link between the type of motivation for the ISO 9001 certification and thus helps to clarify to what extent this certification has a positive impact on of companies' performance.

This paper uses the mathematical technique AHP-BP and applicates the blockchain technology. First, it constructs a comprehensive quality management system conclusing everyone from raw material suppliers to consumers base on the advantages and characteristics of blockchain technology in view of the difficult problems in quality management. Then in order to test the effect of the system, it constructs the evaluation system of quality management system, it uses AHP-BP method to give the weight of evaluation indicators scientifically. Through scoring, it proves that the quality management system proposed has obvious advantages in this paper.

This paper aims at evaluating the implementation of lean manufacturing 4.0 and quality 4.0 to eliminate waste in an FMCG packaging organization in South African. The paper attempts to find a connection between quality, lean, and industry 4.0 that will promote organizational success. The importance of this research investigation was to provide proper results that will help the organization understudy in finding better methods of improving its operations. A mixed approach where both quantitative and qualitative methodologies were used to gather the information for the research. The population of the study included all the organization’s departments, employees, and machinery. A purposive sample of 20 employees that operate in the cup’s department was used together with 130 cups that were randomly selected for inspection. The results showed that variability was a major downfall for the organization that was caused by a malfunction in the system (1); the influx of bins at the waste station (2); the difference in the bins used (3) as well as some machine not being uploaded in the system (4) are some of the key sources of variability. Thus, the use of lean and quality 4.0 which are combinations of the traditional lean and quality practices together with technology to have proper control over the production. Suggestions such as ERP software and define digitalized Standard Operating Processes would improve the operating process of the organization.

Today, to give the customer a multiple choice of products, the market tends towards diversity and increasing variation of products, this phenomenon is applied also on the automotive sector. Several luxury options are added, cars are becoming more and more intelligent... the thing that increases the profits and competitiveness of companies. From a marketing view, the variation of the products is an advantageous opportunity, whereas the complexity resides in the realization and the management of this variation all along the supply chain, mainly in the production planning process, considering the fact that in the automotive industry the demand is constantly changing following a make to order strategy. This leads us to introduce the subject of this paper which deals with the issue of the dynamic production planning considering the diversity of the products and the impact of these on their quality in the scope of the automotive industry in a tactical planning horizon. To carry out our research we started by understanding the planning process components and how it's managed by referring to the literature review including the international quality management system standard IATF 16949, and the company's generic planning process. And as a result, we concluded that the quality indicators are not included in the production planning process elements. However this one is very important part of the supply chain, since the product quality is a critical factor, as any defective product may impact the safety of the end customer (car driver), also the not compliant product impact the production planning as we are not delivering the desired quantities at the right time. For this reason, the key performance indicators of dynamic production planning must be aligned with those of quality, which is to satisfy the customer's order on time while delivering a product of desired quality, for that we present a case study on an automotive company, where we elaborate a model of production planning in the tactical horizon and included the quality factor which represent the uniqueness of our study as we are studying the planning process considering the productivity and quality performance, we worked with a linear model that includes the cost of non-quality, cost of production, stock level, product manhour and customer demand in order to define the necessary production orders. Our model is simulated and gives satisfying results and we could demonstrate that the production orders are more real according to the production constraints.

Quality defects are a significant source of the costs and challenges of project management in the construction industry. Due to the project delivery nature of on-site construction, they occur inevitably and are the primary causes of project schedule and cost overruns. A construction product manufacturer determined customer satisfaction warranty- based feedback can be a solution to mitigate the defects in the sense that it can help to identify the root causes of defects more systematically. The motivation of this study is to analyze and improve a quality control program for a major construction system manufacturer based on customer satisfaction warranty- based feedback. Customer satisfaction feedback was obtained on a 10-point Likert scale and analyzed. Statistical process control techniques were applied to check for root causes of defects. Analysis of contractor experience within the data set supports the principle of Best Value Procurement Information Systems (BV PIS), which emphasizes contractor performance and experience to manage project risks. The case study finding provides support that the warranty-based quality control system can enhance project efficiency. The study concludes with a description of the main findings, which can be efficient and effective when implemented in the construction industry.

This article is about introducing Total Quality Management (TQM) philosophy into complex projects. The analysis of the introduction of TQM in higher education institutions with the possibility of adapting this approach to projects for the creation of complex equipment is carried out. The analysis of ISO standards in the framework of the quality management system. An approach to the transition from the postulates prescribed in the ISO standards to the actual implementation in practice is proposed. A process approach based on the PmBoK standard is proposed, which allows you to monitor the quality of the product and implement the results in both theoretical and practical form when implementing the TQM approach in higher education. A modification of the "Quality House" method is proposed, intended for planning and tracking changes in the product quality level during the implementation of the project by changing the method for determining weight coefficients and using the multiplicative calculation of the generalized normalized indicator for the project.

A new edge-cloud collaboration architecture for small and medium sized enterprises (SME) manufacturers is introduced in this work. Lager manufacturers with sufficient resources already invested heavily in smart manufacturing system. There are rapidly emerging needs to help small and medium sized enterprises manufacturers with limited resources to implement smart and highly adaptable manufacturing systems to compete and sustain in global economy. We present an illustrative case study of how to implement and manage AI projects in practice for SME manufacturers. We demonstrated how our proposed architecture can help accelerate one of the United Nations Sustainable Development Goals, i.e. Goal 9: Industry, Innovation and Infrastructure, by exhibiting the practicality and scalability of our proposed solution. In particular, we elaborate on the key manufacturing issues concerning company-wide resource distribution, problem solving and decision making. It will be demonstrated that more advanced AI systems such as deep learning and deep reinforcement learning emerge naturally with one's quality management system which already in place and come with a well-defined semantics of their process functions in the context of collaborative edge-cloud architecture. Furthermore, equipment used in the smart factory includes manufacturing equipment, functional testing equipment and defect detection equipment. In this work, we will present the management and implementation of on-device AI defect detection and classification to show the feasibility and effectiveness of the edge-cloud collaboration architecture approach.

The article considers the improvement of management mechanisms for the main integrated business processes of construction complex enterprises at the stage of the real estate object life cycle (construction stage), including IT-systems, information security management Systems and risk management Systems. Methodology and methods for designing and creating an ISM.

Implementing digital transformation in an enterprise is a complex process. The basis for forming recommendations on digital transformation and increasing enterprise readiness for digitalization is an approach that involves the identification of three enlarged stages, each of which determines the answer to one key question: stage No. 1 - why to transform; stage number 2 - what to transform; stage number 3 - how to transform. This article analyzes the main problems that companies and their quality management systems face in the process of introducing modern digital technologies, as well as tools for preliminary diagnostics of the company's readiness for such transformations. A comparative analysis of the models for its assessment was carried out, according to the results of which five integrated assessment areas were identified: strategy and business model, consumers, organizational culture and personnel, operational processes and information technologies.

The desire to increase productivity and at the same time reduce production costs has led to the active introduction of automation in all its manifestations. In general, the digitalization of an organization (that is, the introduction of digital technologies) is the process of its transformation, aimed at creating a unified information environment throughout the life cycle of product creation, combining various methods and tools for data management. This article analyzes the problems that exist when integrating modern digital technologies into the quality management system of aerospace enterprises. In general, studies show that the integration of modern digital technologies is a complex process. Many companies in different countries face certain problems in their integration due to different barriers, among which five main ones can be distinguished: violation of employment; high financial costs; security concerns; lack of digital strategy along with lack of resources; problems in ensuring data quality.

The article raises the problem of the formation of a common base of mathematical modelling of the tasks of quality management systems and processes of a complex nature. Analysis of the problems that arise in the mathematical modeling of control problems of objects of great complexity shows the systematization of modeling methods is possible through the use of the concept of synthetic qualimetry. The significance of the proposed approach is determined by the fact that synthetic qualimetry is based on the synthesis of existing measurement theories. This makes it possible to carry out a systematic analysis of modeling methods and the choice of mathematical structures for objects of different nature within the framework of special qualimetry. This determines the novelty of the proposed approach. Identifies ways to build a common base of the formal description of the process of control of complex objects and processes.

This article addresses the issue of changes in the quality management system, with the digitalization of the company. More specifically, changes regarding the process of managing non-conforming products. The article reflects how the use of digital tools and new technologies affects the process of detecting non-conformities and how the procedure for working with non-conforming products changes: how is the collection of data on the characteristics of the facility, what decisions need to be made regarding the inconsistencies, how the structure of work with non-conformances is changing and to what extent the use of information tools is beneficial.

The key task of the organization's top management is the ability to make adequate and timely management decisions based on the analysis of information about changes in external and internal factors of the organization's environment (context). Management decisions are made by management based on the development of programs to mitigate significant risks and use existing opportunities for business development. All actions of the organization's owners and managers must be aimed at meeting these conditions. The speed of decision-making, the speed of reaction to changing market requirements, the development of an innovative product, and finally, the speed of fulfilling contractual obligations determine the main goal-to increase the competitiveness of the organization. To achieve this goal, it is necessary to solve problems related to the rational organization of information flows of the quality management system and the processing of all information relevant to the context of the organization. Solving these tasks is necessary to achieve effective management. Moreover, it is obvious that the solution of the first task is aimed at solving the second, and here it is necessary to note the predominant role of information systems and technologies that must be integrated into the quality management system (QMS) of the organization.

The article discusses product quality management issues for intelligent transport systems, as well as defines the role of the quality management system in the overall management system in the enterprise. With the help of the software complex, strategic planning, enterprise processes were automated with the definition and consolidation of performers and key indicators, generation of regulatory documentation, monitoring of processes, mandatory documented procedures.

The development of digital technologies can give a new impetus to the development of quality management (QM). The development of new approaches based on the integration of quality management methods and digital technologies creates prerequisites for the digital transformation of the entire product lifecycle. The difficulty of creating an effective quality management system using digital technologies is not only in the absence of specialists in two areas of knowledge simultaneously, but also in the lack of integration of modern quality management methods with existing software products. In most ready-made solutions, quality management is limited to controlling process parameters and product quality. Automatic registration of process parameters with real-time data analysis should be additionally enabled in DQMS. This will allow you to organize monitoring and control of processes at each automated workplace. The accumulated analysis results will help you make decisions in difficult situations. A set of processes with digital control and analysis ensures quality assurance at all stages of the product lifecycle.

This paper presents the methodology for assessing the «production quality factor» for the failure rate model of electronic means (EM) of artificial earth satellites (AES) in the design. The use of a quality management system (QMS) and activities regulated by regulatory and technical documentation (RTD) for the creation, production and operation is a distinctive feature of the proposed methodology. Implementation consists in applying an ontological approach to the formation of the questionnaire for subsequent expert evaluation for external and internal audits. The methodology allows to timely identify the advantages and disadvantages of a specific event, approved by the dependability program and specified in a certain section of the RTD, including QMS. The methodology let it possible to increase the effectiveness of the numerical evaluation when the target level of dependability indicators is achieved, also, to enhance the of the AES EM system and relieves the manufacturing organization from the procedure for additional tests. It is planned to use the developed methodology at the enterprises of the rocket and space industry and in private non-state manufacturing companies of the small AES.

The traditional construction structure construction quality management method ignores the mutual influence of various factors, divides the construction period into relatively independent links, and conducts quality management separately, resulting in poor management effectiveness of the traditional management method. In order to solve the above problems and improve the feasibility of the quality management method, the green construction engineering structure quality management method based on the BIM model is studied. Analyze the factors that affect the construction quality in the green building construction project, and determine the correlation between the factors. Use the BIM model to improve the three-dimensional spatial information of the building, and combine the PDCA quality management system to achieve the management of the construction quality of the project. The experimental results show that, compared with the traditional construction quality management method, the quality management method based on BIM model is more feasible and effective.

At present, there is a large amount of information in colleges and universities, and the traditional information management methods cannot meet the needs of the reform and development. On the current teaching management pattern characteristics of mining information acquisition, information construct diversified teaching quality management system, further to a comprehensive evaluation of information management in colleges and universities teaching quality evaluation specification parameters, combined with analytic hierarchy process and weighted TOPSIS method to optimize the evaluation method, the realization of information management system of higher education quality evaluation. The experimental results show that this method has high practical value and fully meets the research requirements.

In 2019, the company put forward the development strategy of building a "three-type, two-network" world-class energy internet enterprise. The next three years will be a key breakthrough period for the company's development. As the company's core assets, equipment's stable and reliable quality is an important prerequisite for the company's development and grid security. This paper studies the equipment quality management mode and system optimization of power grid enterprises, on this basis, puts forward the optimization ideas of the company equipment quality management mode, establishes the equipment quality management system framework, and in order to ensure the effective implementation of equipment quality management, summarizes and proposes to optimize and improve the company Key measures of quality management.

Cost-effectiveness analysis of equipment is a process of comprehensive optimization of life cycle cost and effectiveness of equipment in the whole life cycle of equipment. It is an important index to evaluate the comprehensive performance of equipment. Based on the principle that equipment efficiency is the embodiment of equipment availability, credibility and inherent capability, this paper introduces the concept of "six indexes" of equipment quality system into equipment efficiency evaluation model, and a cost-effectiveness evaluation model which based on the "six indexes" of equipment is established. The calculation steps of the model are demonstrated in detail by example calculation, which also shows that the model is theoretically feasible on the basis of enriching the content of ADC effectiveness evaluation model. Also the evaluation results have important guiding significance for equipment selection, parameter optimization design and operation support in the whole life cycle of equipment.

As device integration continues to expand across the global market of the healthcare industry, the threats of data loss, exploitation and device control by nefarious actors are negative outcomes we are seeking to avoid. Medical device manufacturers in the U.S. market are required to comply with federal regulations like quality system regulations (QSRs) however, the U.S. Food and Drug Administration (FDA) does not conduct premarket testing or evaluations of implemented software on said devices, and is even less concerned with it once the hardware has been officially launched into the marketplace. The responsibility for validation of software design changes, penetration testing, and simulations regarding IoT security falls upon the manufacturer. Smart healthcare is the integration of digital solutions to improve patient outcomes and the operational efficiency of the facility. Privacy in the healthcare sector is the practice of ensuring the security and confidentiality of patient records, dependent upon the discretion of healthcare providers and the communication methods that are employed. Complex problems are those in which solutions can be derived from differing perspectives to achieve multiple results applicable to the scenario.We approach this subject from a systems perspective and emphasize taking actionable steps to achieve long term change in the policy, technical and social aspects of this complex problem. Due to the scale of the industry, individual scrutiny for each revision and update of all healthcare sector products by a third party is an unrealistic expectation. The keystone of our solution is to encourage the instantiation of a new NIST standard that would encompass the healthcare sector and the medical devices that are used within it. This categorization change positively influences device manufacturers’ access to the standards that are currently relevant within their domain.

The current level of the information technologies, economy digitalization development indicates the need to improve the system of interaction between universities and enterprises, which are potential employers of graduates. The urgency of the problem reinforces the need of enterprises for the prompt selection of specialists who satisfy the required level of competencies. The authors proposed the information module «University plus Employer», which interacts with students, graduates and employers. Based on the methodology of system analysis, quality systems, methods for evaluating technical and economic efficiency, the approach to evaluating the integral indicator of module efficiency at the design stage (according to functional indicators) and at the operation stage (according to operational indicators)is offered. A methodology has been developed for evaluating the integral indicator of the effectiveness of the "University plus Employer" module, which takes into account that operating indicators change over time and, therefore, characterize the module effectiveness in dynamics. The possibility of developing and implementing the new information module "University + Employer" is confirmed by an increase in the integral quality indicator by functional indicators by more than four times.

With the rapid development of the Internet, the era of science and technology has arrived, and big data in information technology has become the driving force behind scientific and technological progress. Applying big data and intelligence to the clinical nursing quality management system, constructing a nursing management and control platform that integrates nursing quality indicators, nursing event reporting, and nursing risk management, and realizes the dynamic and intelligent management and control of nursing quality throughout the process. After applying big data to the nursing quality management system, the time for entering and analyzing nursing quality problems is significantly shortened, the quality of nursing services is improved, and patient satisfaction is effectively improved. The establishment and application of mobile nursing quality management system reduces time cost, improves nursing work efficiency, promotes the full participation of nursing quality management, and improves the effectiveness of nursing quality management and patient satisfaction.

Although the quality of IT projects deliverables are critically governed by project activities within its quality improvement processes, it is important for the management team to understand the core values concepts, goals, suitability, level of flexibility, cultural changes etc. when in search for a comprehensive quality improvement methodology (QIM) or software process improvement (SPI). Six Sigma is well known as a “metric”, “methodology” and “management system”; which comprises various methods of data-driven and effort-driven for achieving process improvement to near perfect quality. This paper aims to discuss the onboarding of Six Sigma initiatives and efforts into IT project implementation which begins with a changes to culture, decisions to learn, flexibility to change and eventually to evaluate how such initiative can potentially integrated into quality management system. Thus, it is important to assess the practicality, efficiency and appropriateness of such QIM prior investing time, resources, commitments to avoid project pitfalls and failure.

Medical device development is Complex. Products must be designed and engineered, keeping safety and performance as priorities. This paper introduces a Product engineering and development (PED) platform used by the authors to develop a portfolio of products. The purpose of the paper is to analyse the effectiveness of the platform to create medical devices. A retrospective review of the development cycle and post-market clinical performance was the method used. Usability and end-user interaction was also a focus of this study. The company's quality management system (QMS) records were used as source material. The results of this study showed that the PED platform was suitable to develop FDA, CE and/or India Regulatory compliant medical devices. The different types of products created using this platform indicates its suitability across medical device types.

The analysis of actual methods for controlling reliability indicators is carried out. The features of their application in quality management systems are considered. The advantages of automated methods of statistical control based on modern intelligent technologies are formulated and a conclusion is made on their priority for usein instrumentation.

In the quality management system, it is necessary to select the instruments with stable performance as the periodic inspection standard, and regularly carry out the periodic inspection on the standard. At present, PTB210 air pressure sensor produced by Vaisala company is easy to be used in our station, and there are corresponding verification regulations. We test and evaluate PTB210 air pressure sensor from two aspects of repeatability and stability by combining the analysis of uncertainty evaluation and laboratory verification. Finally, we verify the validity of data by transfer comparison method.

Emergency patient identification system (EPIS) will enable the more powerful quality system in the health industry. This research study was conducted to develop an EPI system, which is a complete patient-based medical information recording system. This system will help to identify the patients uniquely. Doctors can get patients' latest situation and can make quick decisions to do the treatments in emergencies. To achieve this approach, authors use the patient's fingerprint, face recognition technology, and eye recognition to identify the person. The patient can view his medical records; system reminds the notifications. The system helps the patients in storing and tracking the diet weight, medications, allergies, health history, fitness, lab results, x-rays, blood pressure, ongoing surgeries, drug reminders, doctor visits, doctor's appointments, images and more. The system helps the user in receiving and sending necessary health-related information to the doctors and hospitals. This system has many unique features; an emergency will help to find nearest hospitals. This can add patient's family member's history so it can help to remind his present medical situation. The main system is working on web interface; another part is offered as a mobile application.

this paper reviews and focuses on various aspects and feasibilities of modern technologies in the manufacturing sector. Smart factory features are the production of smart, personalized products achieved by networks, which mainly based on the supply and demand, and networks are reinforced with advanced information technologies (IT). Modern technologies are smart manufacturing. Which includes Infrastructure of the real industrial system, elements of smart manufacturing, integration of production with supply chain networks in real and virtual fronts need to develop, Industry 4.0 fourth Industrial revolution is ushered by the Internet of Things (IoT). Key elements of smart manufacturing are listed to understand and implement its concepts across enterprises. Integration of manufacturing, supply chain operations with computer-aided technologies (CAT), Enterprise Resource Planning (ERP), Manufacturing Execution Systems (MES), Manufacturing Control Systems (MCS), and Quality Management System (QMS) will enhance the performance of manufacturing. It will operate to control manufacturing and bring better results. The life cycle testbed is used to collect and analyze data and formulation across the manufacturing enterprises by mathematical modeling and simulation tools. Cloud manufacturing enhances the availability of required resources to both service seeker and provider. The introduction of image processing and machine vision system increases the quality of the component.

Any quality process has some weaknesses, and let non-conformities run through production process. Sometimes it reaches the final customer. Organizations give their operational managers the mission to improve the quality system in order to minimize the risk of delivering non-conform products to customers. In this work, a decision tool is developed and presented to determine how to improve an existing quality control process. Firstly, a probabilistic modeling of the propagation of non-conformities is proposed and used to evaluate the Average Outgoing Quality (AOQ). Then, an iterative method is presented, based on the AOQ estimation, aimed to determine the most profitable improvements to perform. The proposed method help managers to reach their global quality target by guiding the improvement process. The proposed tool determines which particular control operation should be improved for maximizing the impact on the Average Outgoing Quality.

Quality management system (QMS) is an organization management system that is planned and built based on documentation procedures in an organization in order to meet customer needs and expectations (Natarajan, 2017). Meanwhile, Indonesian National Standard (SNI) is a requirement of technical or something that is standardized, including procedures and methods, are compiled based on the consensus of all parties/government/international decision. The importance of certification is to achieve customer needs and expectations. Every companies must be able to ensure the products and services offered can meet customer satisfaction. The number of Certification Bodies accredited by KAN in Indonesia, makes companies must be conscientious in choosing the certification body, the fallacy caused financial or nonfinancial losses can be minimized. Research to determine the ranking criteria in selection for certification body is needed in order to find out the most decisive criteria in the selection of certification bodies. Thus, companies can decide the appropriate certification body which results cost efficiency, increasing competitiveness, and customer satisfaction. Companies were randomly selected for participation in this study. Besides, a regulator, an auditor and a certification body were participated to share their experience about the customer preference. There were seven respondents from industries who filled out the questionnaire. They are managers in every organization who have the knowledge and responsibility for implementing and maintaining a company's quality management system. The criteria are divided into four dimensions, cost, quality, reputation, and management. The decision making framework resulting from this research, especially the selection of certification bodies, is expected to assists companies choosing the appropriate quality management system and the Indonesian National Standards (SNI) certification body.