ISO 15189:2003 – Quality management, evaluation and continual improvement

Author(s):  
David Burnett

AbstractThe requirements of ISO 15189:2003 are discussed in the context of a process- and outcome-based quality management model in which the user's needs are the central focus. The requirements of ISO 15189:2003 are examined in terms of organisation and a quality management system, stressing the importance of evidence, document control, and control of records and clinical material. Examples are provided from the areas of resource management, and pre-examination, examination and post-examination processes. In the final section the importance of evaluation and continual improvement is presented in relation to internal audit and external assessment, non-conformity, corrective and preventative action and management review.

2005 ◽  
Vol 24 (3) ◽  
pp. 193-200 ◽  
Author(s):  
David Burnett

The requirements of ISO 15189:2003 are discussed in the context of a process and outcome based quality management model in which the user?s needs are the central focus. The requirements of ISO 15189:2003 are examined in terms of organization and a quality management system and stress the importance of evidence, document control and control of records and clinical material. Examples are provided from the areas of resource management, pre examination, examination and post examination processes. In the final section the importance of evaluation and continual improvement is presented in relation to internal audit and external assessment, non-conformity, corrective and preventative action and management review.


Author(s):  
Petros Karkalousos

The new version of the ?SO 15189:2007 Standard was published in 2012, and it is called ISO 15189:2012. The new version is more specific to clinical laboratories as compared to the old one. The present chapter emphasizes in the most important changes between the two versions of the standard, especially in those that reveal the “spirit” of the new version. Some of these refer to ethics, quality management system, encouragement of the staff, risk management, evaluation of staff performance, purchase and withdraw of equipment, laboratory facilities, reagents and consumables, communication between the laboratory and its stakeholders, verification of the results by trained personnel, procedures of reporting the results, metrological procedures and traceability, function of laboratory information system, and responsibilities of laboratory director.


2018 ◽  
Vol 19 (1) ◽  
pp. 74-105
Author(s):  
Rohmat Rohmat

Abstract: The quality of madrasah education needs to get serious attention both from process aspect and its result. The quality of madrasah education is also influenced by the family and community environment. This brings with it the need for a review and mapping of the quality management model of education in Madrasah Ibtidaiyah. The Madrasah Ibtidaiyah of Purwokerto and MI Ma'arif Pageraji Purwokerto were chosen to be the subject of this study with the consideration that the school has a good quality management system. This study aims to find the typology of quality management education in MI that is effective so that it can be replicated. Based on the findings of the data, it can be concluded as follows: (1) Quality planning conducted in MIN and MI Ma’arif pageraji Purwokerto through (a) improvement of teacher competence, through OJT activity (on the job trainning), (b) teacher. (c) Development of natural competence matrix. (d) Parent and community cooperation in establishing some madrasah programs. (2) Quality control system conducted in MIN and MI Ma’arif pageraji Purwokerto done through supervision activities. (3) Quality assurance conducted in MIN and MI Ma’arif pageraji Purwokerto done internally by madrasah and audited through accreditation activities run by the accreditation bodies of madrasah or other institutions externally. Keywords: Management model, quality of madrasah.


Author(s):  
E.A. Kovrigin ◽  
◽  
V.A. Vasilyev ◽  

Given the trends in the modern world, as well as the rapid growth of digitalization, it is safe to say that it will inevitably affect almost all areas of human life and activities. Dmitriev’s English dictionary defines the word readiness: «It is a state where everything is done to start doing something.» Accordingly, an assessment of the company’s readiness to integrate modern digital technologies will identify opportunities, risks and threats, strengths and weaknesses of the enterprise, as well as to formulate a list of initial measures that need to be implemented. Thus, there is an urgent need to find an answer to the following questions: «How (by, what criteria and indicators) to measure readiness?», «What are the approaches to readiness assessment?» The purpose of this article is to develop a model and algorithm to assess the company’s readiness to integrate modern digital technologies. Modelling techniques were used to achieve this goal, as well as to analyze and generalize information. As a result of the research, a model for assessing the company’s readiness to integrate modern digital technologies has been developed and tested, based on the quality management model presented in the ISO 9000 series standards. A particular example shows how to use it and what it ultimately allows you to see and evaluate.


2011 ◽  
Vol 3 (4) ◽  
pp. 113-119
Author(s):  
Romualdas Vitkauskas

The interaction of quality management and knowledge man­agement are analyzed quite widely in scientific literature and discussed with reference to various models integrating these two management theories. However, there are not enough precise tools that could provide a possibility of improving the quality of products and services through knowledge management. To this end, the article examines the already existing models for the interaction between quality management and knowledge management. The results of a survey on Lithuanian industry show what organizational knowledge is the most important while implementing quality management principles aimed at improving quality. The correlation analysis method showed the relationship between quality management principles (process approach, continual improvement, management, facts) and the factors defining the product and process quality (the extent of determining process execution time, process resources, costs of process stages, indicators for products and/or services, the dura­tion of the process, the extent of measuring indicators, the extent of collecting information on indicators, the extent of collecting information about the costs of the process). Santrauka Kokybės vadybos ir žinių vadybos sąveika mokslinėje literatūroje analizuojama gana plačiai, aptariami įvairūs sąveikos modeliai integruojant šias dvi vadybos teorijas. Tačiau nepakankamai nagrinėjamos konkrečios priemonės, kuriomis būtų galima pagerinti produktų ir paslaugų kokybę pasitelkiant žinių vadybą. Tuo tikslu straipsnyje analizuojami jau egzis­tuojantys kokybės vadybos ir žinių vadybos sąveikos modeliai bei pateikiami Lietuvos pramonės įmonių tyrimo rezultatai, parodantys, kokios organizacinės žinios svarbiausios įgyvendinant kokybės vadybos principus, skirtus kokybei gerinti. Taikant koreliacinės analizės metodą nustatyta, kad egzistuoja ryšys tarp kokybės vadybos principų (procesinio požiūrio, nuolatinio gerinimo, valdymo remiantis faktais) įgyvendinimo lygio ir veiksnių, apibūdinančių produktų ir procesų kokybę (procesų įvykdymo laiko nustatymas, procesų išteklių nustatymas, procesų etapų išlaidų nustatymas, produktų ir (ar) paslaugų rodiklių nustatymas, rodiklių matavimas, rodiklių informacijos rinkimas, informacijos apie proceso trukmę nustatymas ir informacijos apie proceso išlaidas rinkimas).


2021 ◽  
Vol 5 (1) ◽  
pp. 1-16
Author(s):  
E Odiba ◽  
P Demian ◽  
K Ruikar

Effective quality management practices are critical to successful project delivery. However, the quality challenges in developing countries such as Nigeria, which is the focus of this research, have been a concern to construction practitioners and other interested parties such as clients and regulatory bodies. Some scholars suggest that part of these challenges can be attributed to ineffective quality management systems; thus, leading to consequences such as building collapse, poor organisational/industry reputation, poor/lack of traceability, poor documentation process, and lack of planned audit. This research aims to develop a contextual model that is intended to improve the culture of quality that can facilitate effective quality management practices in construction organisations in Nigeria. A mixed (quantitative and qualitative) methodological approach was deployed based on a pragmatic research philosophy paradigm. A questionnaire (quantitative) survey was adopted to gather data and results from the data analysis and reviewed literature were discussed, and the findings supported the development of a conceptual quality management model in construction as the outcome of this research. The designed model comprises eight integrated components. The model is a quality system that construction organisations can use: to identify some typical barriers hindering effective QMSs implementation; to assist them to develop cultural values that can drive effective QMSs implementation; to undertake effective QMSs practices as they relate to construction, and to recognise the potential results and longer-term benefits obtainable from implementing effective QMSs. The model was evaluated and validated by professional construction practitioners and academic experts for its usefulness and applicability. Future study should focus on the practical validation of the model. Keywords: ISO 9001; Quality Management Practices; Quality Management System.


2016 ◽  
Vol 5 (3) ◽  
pp. 62-82 ◽  
Author(s):  
Eleftherios Vavoulidis ◽  
Stavros Archondakis ◽  
Maria Nasioutziki ◽  
Ourania Oustambasidou ◽  
Angelos Daniilidis ◽  
...  

Modern cytopathology laboratories offer an outstanding portfolio of testing services that are vital for patients. Due to their clinical importance, such laboratories have to provide results of high quality and credibility. Accreditation status and the implementation of a Quality Management System according to ISO15189 requirements are usually the most effective strategies to reach the optimum quality standards. However, laboratory quality should be constantly monitored and assessed in order to avoid potential deviations from the pre-defined values. The design of a unified system of Quality Control and Assurance procedures that will guarantee excellent performance and results is essential. The authors present their experience on the implementation of such a system and describe in detail strategies for efficient quality management. Useful recommendations for the design of such a system are provided. Finally, a mobile health application that could potentially enhance the entire quality control and assurance system is also presented.


2010 ◽  
Vol 26-28 ◽  
pp. 817-820
Author(s):  
Hong Yu Yang ◽  
Tong Ji Yang ◽  
Ting Xin Wen

According to the existing problems and shortcomings of the manufacturing enterprise quality management, integrating with enterprises’ new needs of quality management in the recent implementation of QHSE( Quality, Health, Safety, and Environment) system, this paper built an EII( Enterprise Information Integration)- Oriented QMS( Quality Management System) model, discussed the integrating problems involved in the system, then proposed the overall EII model. By analyzing the information integration relations between QMS and other enterprise applications, this paper put forward some practical ideas and principles of system integration, then built the framework of EII- Oriented QMS solutions. The aim of this paper is making full use of quality information, improving the quality of management and control, and helping manufacturing enterprises to better understand what EII- Oriented QMS is and how to make it a successful project.


2014 ◽  
Vol 1 (6) ◽  
pp. 117
Author(s):  
Maija Krūze

The paper explores the quality management system of Rezekne Social service and its perfection employing internal audit and self-evaluation methodology. The aim of the present study is to find out how the quality of provided services of social service and social service providers is ensured in accordance with the ISO 9001:2008 quality standard, exploring the processes of management, basic activity, internal audit and prevention of non-compliance as well as focusing on the measures to be taken in order to improve the quality management system (QMS). When elaborating the article, the economic and legal literature on quality management terminology, its application and effective social services management have been studied according to the ISO 9001:2008 standard. The paper examines the measures which ensure quality of social aid and provision of social services of Rezekne Social service highlighting the quality management system, elimination of non-compliance, QMS report results, customer level of satisfaction and self-evaluation methodology. The author has worked out proposals to improve the processes of quality management system and quality results, consequently ensuring the development of Rezekne Social service. With the help of practical examples, the hypothesis proved that internal audit of the quality management system, management processes to address non-compliance, management reports and self-evaluation provide an objective assessment of the quality and create favourable conditions to ensure the provision of qualitative social services, contributing to a better controlled social policy.


2019 ◽  
Vol 4 (1) ◽  
pp. 47-55
Author(s):  
Adina Sârb ◽  
Liliana Itul ◽  
Maria Popa

The issues approach in this research show the benefits of the implementation of ISO 9001 standard in different companies as well as the importance of certain criteria with respect to customer satisfaction and confidence. This standard specifies requirements for a quality management system and it is based on a number of quality management principles including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement. The criteria taken into account help to improve the quality management system of the organization. The purpose of this paper is to identify the changes due to the implementation of a quality management system based on ISO 9001 standard in a porcelain factory, named S.C. Apulum S.A. and to analyse the customer satisfaction and confidence within the company considered through the implementation of the standard mentioned above. The analysis of customer satisfaction and confidence was achieved by taking into account certain measurable criteria established in the company considered, criteria that have been introduced into a formula. In conclusion, it is obvious that after the implementation of the requirements of ISO 9001 standard the situation regarding the quality process and product has been improved considerably. Also, the results show that there were several variations in the period considered (2010-2017).


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