scholarly journals Expert Assessment of Conditions for Accredited Quality Management System Functioning in Testing Laboratories

2018 ◽  
Vol 26 (1) ◽  
pp. 42-48 ◽  
Author(s):  
Joanna Mytych ◽  
Mariusz J. Ligarski

Abstract The quality management systems compliant with the ISO 9001:2009 have been thoroughly researched and described in detail in the world literature. The accredited management systems used in the testing laboratories and compliant with the ISO/IEC 17025:2005 have been mainly described in terms of the system design and implementation. They have also been investigated from the analytical point of view. Unfortunately, a low number of studies concerned the management system functioning in the accredited testing laboratories. The aim of following study was to assess the management system functioning in the accredited testing laboratories in Poland. On 8 October 2015, 1,213 accredited testing laboratories were present in Poland. They investigated various scientific areas and substances/objects. There are more and more such laboratories that have various problems and different long-term experience when it comes to the implementation, maintenance and improvement of the management systems. The article describes the results of the conducted expert assessment (survey) carried out to examine the conditions for the functioning of a management system in an accredited laboratory. It also focuses on the characteristics of the accredited research laboratories in Poland. The authors discuss the selection of the external and internal conditions that may affect the accredited management system. They show how the experts assessing the selected conditions were chosen. The survey results are also presented.

Author(s):  
O. I. Kutsenko ◽  
V. D. Yakovenko ◽  
Ye. O. Yakovenko

The article defines the essence of the concepts “assessment” and “internal audit” of the quality assurance system, the requirements of international ISO standards for the formation of an internal system for evaluating the effectiveness of management systems are analyzed, highlights the main aspects of the formation of the program and plan of internal audit, the competence of auditors, proposes a method of expert assessment in the quality management system of educational institutions in the context of a real educational process, proposes automated information and analytical management system. The authors noted that the effectiveness of the conducted internal audit (hereinafter IA) depends on an effective audit program, the competence of auditors and further improvement actions. The purpose, criteria and methods of the audit program are also determined, the example of the “Program of internal audit of structural units of the college” is given. The requirements for auditors were selected and substantiated. Attention is drawn to the fact that the functioning of the quality management system (hereinafter QMS) directly depends on the systematic nature and effectiveness of the IA and, as a consequence, the systematic improvement of the system itself. The proposed system of expert assessment of QMS is considered on the example of the management of the professional pre-higher education institution of the separate structural subdivision “Kherson Polytechnic College of the Odessa National Polytechnic University”. The basic requirements for the formation of a group of experts are defined, also for obtaining a quality forecast the requirements for the competence of experts are defined. The authors of the article concluded that obtaining a general assessment of all processes and identifying the most problematic aspects without automated management is very difficult, so it is proposed to use the suggested system of expert assessment of QMS.


Author(s):  
Budiman Sutrisno ◽  
Wendy Wendy

This research aims to analyze the moderating effects of profitability and leverage on the relationship between the quality management system and eco-efficiency toward the firm’s performance. The research sample consists of 75 firms listed on the Indonesia Stock Exchange as of 2017. Data concerning eco-efficiency and the quality management system are collected from the firm's annual report. This research utilizes a multiple linear regression model. The result shows that eco-efficiency and quality management system do not affect the firm’s performance. Profitability has a negative and significant moderating effect on the relationship between eco-efficiency toward the firm’s performance. Further, the moderating variable also positively and significantly moderates the relationship between the quality management system and the firm's performance. Leverage, on the other hand, is found to have no moderating effect on the relationship between eco-efficiency and quality management systems toward the firm's performance.  This study contributes and extends previous research by exploring eco-efficiency and quality management systems toward the firm’s performance simultaneously. Besides, it also examines the moderating relation of profitability and leverage in relationship with eco-efficiency and quality management system toward a firm's performance by using the sample from all firms which are listed on the Indonesia Stock Exchange and have implemented the system.


Pomorstvo ◽  
2019 ◽  
Vol 33 (1) ◽  
pp. 11-21 ◽  
Author(s):  
Goran Kutnjak ◽  
Dejan Miljenović ◽  
Ana Mirković

In a modern global economy, small and medium-sized enterprises (SMEs) have inviolable importance and inclusion in the overall social development and economic growth. Regarding the high share of SMEs in the total number of companies, given the number of employees and the share in export orientation, the question of SMEs existence, as well as their market share and competitiveness in the global environment, represents prime relevance to any national economy. Therefore, the issue of quality becomes a critical component of achieving competitiveness in delivering products and services to their consumers (customers.) Due to this extremely delicate issue, each company establishes and implements a systematic process relationship or a quality management system as a part of its general management mechanism. This is a reason for SMEs management to strategically decide on the challenges of introducing a quality management system; thus, to improve their competitiveness on the domestic and foreign markets, which is a very demanding, exhaustive and time absorbing process requiring detailed preparation and collective engagement. The basic reasons for applying a quality management system are apostrophised in any business objectives – improving business processes, product quality and services, increasing spending as a factor of developing higher market share, better reputation (image) and sustainable business results. Due to the measurable quantitative and qualitative attributes and features that can significantly enhance the introduction of quality management systems into practice of SMEs, numerous studies have been carried out, some of which are conducted within the last two decades. For the authors, this was an initiative to conduct a survey, within this paper, in the Primorsko-goranska county (Croatia) during the month of July 2018, in which a number of SMEs were analysed in the crucial areas of quality management systems. The authors’ objective was to assess the viability of SMEs regarding their application of a quality management system. The basic hypothesis was that introducing quality management systems into SMEs contributes to their foreign competitiveness i.e. strengthening their export activity in general. Beside positive outputs of applying quality management, the authors’ research presented in this paper also established some relatively high and negative quantifications in relation to the application of the quality management system. Such outcomes represent justified reasons for future scientific research in this area.


2020 ◽  
Vol 32 (Supplement_1) ◽  
pp. 35-42
Author(s):  
Natalie Taylor ◽  
Robyn Clay-Williams ◽  
Hsuen P Ting ◽  
Gaston Arnolda ◽  
Teresa Winata ◽  
...  

Abstract Objective Little is known about the influence that hospital quality systems have on quality at department level, in Australia and elsewhere. This study assessed the relationships between organizational-level quality management systems, and the extent to which hospital-level quality management systems and department-level quality management strategies are related. Design A multi-level, cross-sectional, mixed-method study. Setting and participants As part of the Deepening our Understanding of Quality in Australia (DUQuA) project, we invited all large hospitals in Australia (~200 or more beds) which provided acute myocardial infarction (AMI), hip fracture and stroke care. The quality managers of these hospitals were the respondents for one of seven measures of hospital quality management systems and strategies. Data across the six remaining measures were collected through site visits by external surveyors assessing the participating hospitals. Main outcome measures Relationships were assessed between three organization-level quality management system measures: a self-report measure assessing organization-level quality activities (quality management systems index, QMSI); externally assessed organization-level compliance to procedures used to plan, monitor and improve quality of care (quality management compliance index, QMCI); and externally assessed implementation of quality systems (clinical quality implementation index, CQII). Associations were also assessed between organization-level quality management systems and department-level quality management strategies: how clinical responsibilities are assigned for a particular condition; whether department organization processes are organized to facilitate evidence-based care recommendations; compliance with selected recommendations of international agencies; and whether clinical reviews are performed systematically. Results Of 78 invited hospitals, 32 participated in the study. QMSI was positively associated with QMCI and CQII, but after controlling for QMSI, no relationship was found between QMCI and CQII. There appears to be a cluster of relationships between QMSI and department-level measures, but this was not consistent across all departments. Conclusion This is the first national study undertaken in Australia to assess relationships within and between organization-level and department-level quality management systems. These quality management system tools align with many components of accreditation standards and may be useful for hospitals in continuously monitoring and driving improvement.


Author(s):  
H. P. Berg ◽  
I. A. Beckmerhagen

An integrated management system encompasses all management and assessment activities. The organizational structure of the Federal Office for Radiation Protection (BfS) quality management system is able to merge existing and future requirements. In this context the BfS management system encompasses quality management and radiation protection requirements as well as safety management, mining requirements and those of testing and calibration laboratories. Its structure allows the integration of function-specific management systems as well as specific requirements. The quality management system has taken into account the existing structure of documents to improve acceptability for the extended approach. Integrating management systems should enhance managerial and operational effectiveness. Whether or not this goal can or has been achieved is still a lingering question. A well-proven method to assess the effectiveness of any management system is auditing. Audits are designed to determine adequate compliance with applicable standards and guidelines. Moreover, they can and should be instrumental in identifying problem areas and potential improvements, along with corrective and preventive actions.


2020 ◽  
Author(s):  
Siew Kim Ong ◽  
Grant T Donovan ◽  
Nayah Ndefru ◽  
Sophanna Song ◽  
Chhayheng Leang ◽  
...  

Abstract Background: Laboratory diagnostic testing service delivery and compliance with international standards for laboratory quality are directly influenced by laboratory workforce competency. Many hospital laboratories in constrained resource settings such as Cambodia struggle to cope with the training needs of laboratory professionals in an environment of competing healthcare development priorities. Resource limited countries need an adaptable and effective approach to provide laboratory professionals with job-specific quality oversight training to ensure the accuracy, timeliness and reliability of diagnostic services. Case Presentation: Here we describe the results of an in-service training and mentoring program conducted with the Cambodia Ministry of Health at 12 tertiary level hospital laboratories to drive improvements in laboratory quality management systems toward ISO 15189 accreditation, which demonstrated significant progress between baseline and outcome audits in a concurrent study. This case study describes the program, and evaluates how the four primary activities, including actionable gap assessments and planning, centralized and in-situ training curriculum, in-person mentoring, and remote tele-mentoring via video communication technologies, contributed towards quality improvement in the participating laboratories.We evaluated participant responses to Likert scale and free response questions from program and training evaluation surveys, and we used thematic analysis to develop a model of best practices within the program’s four primary activities to inform future training approaches. Of these activities, participants agreed most highly that in-person visits and planning based on gap assessments contributed to their learning and ability to improve laboratory operations. Tele-mentoring was rated lowest by participants, who were critical of excessive group dialogue and distraction during web-conferencing; however, feedback suggests both in-person and remote mentoring contribute to continuing education, accountability to action, and peer collaboration and problem solving to improve workforce efforts toward improved quality management systems.Conclusions: We recommend here a package of in-service training activities for laboratory quality management system improvement initiatives in resource constrained settings that includes needs-based curricula and personalized action plans for participants; interactive and on-site training workshops; and in-person mentoring, complemented with well managed and regular tele-mentoring that focuses on knowledge retention, accountability to goals, and collaborative problem solving. Our model presents an adaptable approach to human resource development for quality improvement in medical laboratories.


Author(s):  
Chyrkova Yu. ◽  
Petryshyn N. ◽  
Bortnikova M.

The article focuses on examining the problems of developing the quality management systems at the enterprises engaged in foreign economic activities. Today, companies operate in constantly changing market conditions. The formation of a new competitive environment forces companies to pay attention again to the efficiency and quality of goods and services, because in a fierce competition only those com-panies survive that could quickly adapt to such conditions. Globalization of markets, on the one hand, gives the consumer the right to choose the best, and, on the other hand, forces the manufacturer to look for new means to improve quality at the lowest cost. All these factors lead to the active development of quality management systems and methods, considering the wishes of consumers, the search for weaknesses in production and the best adjustment of the whole process for further successful development. Considering the above mentioned, the pur-pose of the article is to study the development and implementation of quality management system, as well as to identify the main problems of formation of quality management systems at enterprises-subjects of foreign economic activity and provide theoretical recommendations for their solution. The article reveals the essence of “quality” notion and discloses the concept of “quality management of the enterprise”. The description of modern quality management systems is implemented on the example of quality management system ISO 9001, food safety management system ISO 22000, environmental management system ISO 14001 and occupational safety and health management system OHSAS 18001. It has been studied the experience of world leaders in forming quality management systems on enterprises, namely the United States, Japan and European countries. Statistics on the number of ISO quality certificates received in 2013–2019 in Ukraine is presented to reveal the dynamics of developing the processes of business entities quality certification in our state. The problems that arise in domestic enterprises engaged in foreign economic operations during the formation of quality management systems are generalized.Keywords: quality, quality management, quality management system, international quality standards, certification, enterprise com-petitiveness. Статтю присвячено вивченню проблем формування систем менеджменту якості на підприємствах-суб’єктах зовнішньо-економічної діяльності. Розкрито сутність понять «якість» та узагальнено категорію «управління якістю діяльності підприємства». Охарактеризовано сучасні системи менеджменту якості підприємницьких структур, зокрема: систему управління якістю ISO 9001, систему управління безпечністю харчових продуктів ISO 22000, систему екологічного керування ISO 14001 та систему управління безпекою та гігієною праці OHSAS 18001. Відстежено досвід світових лідерів щодо формування систем менеджменту якості, а саме Сполучених Штатів Америки, Японії та європейських країн. Простежено динаміку розвитку процесів сертифікації якості бізнес-одиниць, зокрема за кількістю отриманих сертифікатів якості групи ISO у 2013–2019 роках в Україні. В результаті, узагальнено проблеми, які виникають у вітчизняних підприємств-суб’єктів ЗЕД під час формування систем управління якістю, а також наведено рекомендації щодо їх вирішення. Ключові слова: якість, управління якістю, система менеджменту якості, міжнародні стандарти якості, сертифікація, конкурентоспроможність підприємства.


Author(s):  
Oksana Sheremetynska ◽  
Artem Zakharchenko

The introduction of a quality management system is important because it leads to improved productivity, optimization of business processes of the organization, and also leads to a reduction in production costs. The article considers the theoretical aspects of the quality management system at the enterprise, outlines the methods and classification of existing quality management systems. The essence of legal regulation of the quality management system is investigated and its current state is characterized. It is noted how some experts classify quality management methods. Recommendations for improving the quality management system at a domestic enterprise are offered. Emphasis is placed on the fundamental standards of ISO 9000 and how they are integrated into the state standards of Ukraine. When developing quality management systems, it should be borne in mind that the quality management system covers all processes that occur in the enterprise and on which the quality of products or services depends. According to the capabilities of the production process, the stages of the product life cycle are considered, which should be used at the appropriate stages of development and certification of the quality management system. The task of improving the quality and expanding the range of products is relevant in modern production conditions. This task is multifaceted and includes a number of scientific and technical, environmental, economic and social problems. An interdisciplinary approach is needed for an effective solution. One of the ways is product quality management based on assortment analysis and its innovative development. The experience of developed countries shows that the health of the nation, primarily through food, their safety, is more reliable when it is achieved by improving the quality of products based on standardization worldwide and internationally. At the international level, quality requirements are regulated by ISO standards, strictly focused on the consumer. The first such standards were the standards of the 9000 series, which came out in the late 80's pp. XX century More than half of the world's countries have implemented national standards identical to ISO standards, as well as certified enterprises in accordance with ISO standards.


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