Quality management in medical laboratories

2010 ◽  
Vol 30 (02) ◽  
pp. 55-62
Author(s):  
M. Fritzer-Szekeres
Keyword(s):  
Quality Management ◽  
Medical Laboratory ◽  
Management Systems ◽  
The European Union ◽  
Quality Management Systems ◽  
Iso 17025 ◽  
Iso 15189 ◽  
Medical Laboratories ◽  
Systems Quality ◽  
Standard Iso 15189

SummaryDuring the 20th century understanding for quality has changed and international and national requirements for quality have been published. Therefore also medical branches started to establish quality management systems. Quality assurance has always been important for medical laboratories. Certification according to the standard ISO 9001 and accreditation according to the standard ISO 17025 have been the proof of fulfilling quality requirements. The relatively new standard ISO 15189 is the first standard for medical laboratories. This standard includes technical and management requirements for the medical laboratory. The main focus is the proof of competence within the personnel. As this standard is accepted throughout the European Union an increase in accreditations of medical laboratories is predictable.

Medical laboratory quality systems – a management review

2015 ◽  
Vol 28 (3) ◽  
pp. 267-273 ◽  
Author(s):  
Dimitris Theodorou ◽  
Padelis Giannelos
Keyword(s):  
Quality Management ◽  
Process Approach ◽  
Medical Laboratory ◽  
Management Systems ◽  
Quality Management Systems ◽  
Content Type ◽  
Iso 15189 ◽  
Laboratory Staff ◽  
Management Review ◽  
Top Managers

Purpose – The purpose of this paper is to highlight changes in ISO 15189:2012 and ISO 15189:2007 concerning management review requirements and to present a management review checklist, which includes all the revised ISO 15189’s requirements. Design/methodology/approach – The recent revised and updated ISO 15189:2012 standard recommends a management review using a process approach and includes some additional topics. Findings – The management review is a key element in many quality management systems, including medical laboratory management systems in accordance with ISO 15189. The process approach enables laboratory top managers and personnel to achieve all the quality management system’s important inputs and outputs. Originality/value – As laboratory staff often encounter difficulties fully exploiting the management review process, this checklist helps laboratory staff carry out an effective management review covering all the quality management system’s important aspects.

FOOD SAFETY AND QUALITY MAMAGEMENT SYSTEMS AND THEIR IMPLEMENTATION IN THE POLISH FOOD INDUSTRY

2017 ◽  
Vol XIX (2) ◽  
pp. 102-107
Author(s):  
Agnieszka Judzińska
Keyword(s):  
Quality Management ◽  
Food Industry ◽  
Safety Management ◽  
Management Systems ◽  
Animal Origin ◽  
The European Union ◽  
Animal Products ◽  
Quality Management Systems ◽  
Haccp System ◽  
Food Safety And Quality

The aim of the paper was to present the state of implementation of obligatory and non-obligatory food quality and health safety management systems in polish food industry. The research included all food companies operating in Poland and subject to supervision of the Veterinary Inspection and are State Sanitary Inspection. Since the Polish accession to the European Union, the number of companies that have implemented and maintained obligatory quality management systems has significantly increase. The study have shown that in 2015 obligatory HACCP system was maintained by 83% companies processing non-animal origin products and by 66% of companies processing animal products. Non-obligatory quality management systems have implemented a very small number of food companies (2-5%) mainly industry leaders.

scholarly journals Measurement data analysis in quality management systems

2015 ◽  
Author(s):  
Δημήτριος Θεοδώρου
Keyword(s):  
Data Analysis ◽  
Quality Management ◽  
Measurement Data ◽  
Management Systems ◽  
Quality Management Systems ◽  
Iso 15189 ◽  
Iso Guide 34

Τα αποτελέσματα των αναλύσεων των καυσίμων θα πρέπει να είναι αξιόπιστα και αποδεκτά από όλα τα ενδιαφερόμενα μέρη, έτσι ώστε να μειωθούν οι κίνδυνοι προϊόντων εκτός προδιαγραφών, να συντομεύσει ο χρόνος διάθεσης των καυσίμων στην αγορά και να αποδεικνύεται η ποιότητα και η ασφάλεια αυτών. Η αξιολόγηση της «καταλληλόλητας για χρήση» μιας αναλυτικής μεθόδου είναι άρρηκτα συνδεδεμένη με την εκτίμηση της αβεβαιότητας της μέτρησης η οποία ουσιαστικά χαρακτηρίζει την ποιότητα ενός αποτελέσματος συνυπολογίζοντας τόσο συστηματικά όσο και τυχαία σφάλματα. Επιπλέον η εκτίμηση της αβεβαιότητας των μετρήσεων με τη χρήση μιας επιστημονικά τεκμηριωμένης και έγκυρης μεθοδολογίας είναι μια βασική απαίτηση συγκεκριμένων διεθνών προτύπων ποιότητας βάσει των οποίων διαπιστεύονται εργαστήρια και φορείς (ISO/IEC 17025, ISO 15189, ISO/IEC 17043 ή ISO Guide 34). Στα κεφάλαια της παρούσας Διδακτορικής Διατριβής παρουσιάζεται η ανάπτυξη και εφαρμογή στατιστικών και αριθμητικών μεθόδων για την εκτίμηση και χρήση της αβεβαιότητας μετρήσεων σε συγκεκριμένα στάδια του κύκλου της μέτρησης των καυσίμων: προ-αναλυτικά (δειγματοληψία), αναλυτικά (κυρίως μετρητική διαδικασία) και μετα-αναλυτικά (αξιολόγηση της συμμόρφωσης βάσει εργαστηριακών αποτελεσμάτων).

An Integrated Fuzzy VIKOR Method for Performance Management in Healthcare

2017 ◽  
pp. 40-61 ◽  
Author(s):  
Ehsan Shekarian ◽  
Salwa Hanim Abdul-Rashid ◽  
Ezutah Udoncy Olugu
Keyword(s):  
Performance Management ◽  
Evaluation Method ◽  
Multiple Criteria Decision Making ◽  
Poor Quality ◽  
Medical Laboratory ◽  
Iso 15189 ◽  
Medical Laboratories ◽  
Laboratory Services ◽  
Standard Iso 15189

Poor quality control has become a major threat to medical laboratory services, especially in the developing countries. It has become necessary to assess and rank the quality of diagnostic services in medical laboratories using systematic approaches. The main aim of this research is to develop and apply a quantitative method in ranking medical laboratory services. This method is based on a combination of Vlsekriterijumska Optimizacija I Kompromisno Resenje (VIKOR) with fuzzy set theory. VIKOR is a multiple criteria decision making technique which focuses on ranking and selection from a set of alternatives, and determines the compromise solution for a problem with different criteria. This approach aids decision makers to achieve the most acceptable decision amidst numerous alternatives. In the present evaluation method, international standard ISO 15189 (Medical Laboratories Particular Requirements for Quality and Competence) proposed by International Organization for Standardization (ISO) is used as a fundamental source of selected attributes of a medical laboratory. The study compares three medical laboratories to each other and ranks them. This study will be a valuable and effective contribution in enhancing both qualitative and quantitative criteria in the field of medical laboratory services. Finally, some directions for further studies are proposed.

scholarly journals Patients’ (Clients) Satisfaction with Medical Laboratory Services Contributes to Health and Quality Improvement

2021 ◽  
Author(s):  
Nkereuwem S. Etukudoh ◽  
Uchejeso M. Obeta
Keyword(s):  
Quality Improvement ◽  
Quality Management ◽  
Quality Management System ◽  
Heart Beat ◽  
Iso 9001 ◽  
Medical Laboratory ◽  
Iso 17025 ◽  
Iso 15189 ◽  
Laboratory Services ◽  
Customer Services

Patients’ (clients/customer) services and satisfaction in Medical Laboratory Services and general healthcare is one of the twelve (12) quality essentials of Total Quality Management System (TQMS) emphasized by quality standards as seen in ISO 17025, ISO 15189 and ISO 9001. The patients otherwise referred to as customers or clients to Medical Laboratory and healthcare in general, is the heart-beat and kings to the healthcare system. This chapter looks into the quality aspect of medical laboratory services from the patients’ angle towards thorough satisfaction or dissatisfaction index and otherwise creates room for improvement in the services and healthcare in general. The chapter therefore, identified medical laboratory clients to include patients and patients’ relations, physicians and other healthcare workers, public health and government, communities and interested parties, and medical laboratory profession. There is a need to administer services satisfaction survey developed by Director of Medical Laboratory Services or human resources/quality officers in line with the ISO 15189, ISO 17075 and ISO 9001 to customers/clients from time to time so the outcome can be used to correct services errors and cause quality improvement. It is believed that patients’ satisfaction causes improvement in healthcare, quick recovery of patients and willingness of the patient to return to the healthcare facility in future. Patients’ and customers’ in medical laboratory feedback contributes to quality management and improvement to Medical Laboratory services and healthcare as an ingredient of TQMS.

Quality Management and Quality Assurance in Medical Laboratories

2015 ◽  
pp. 136-153
Author(s):  
Kyriacos C. Tsimillis ◽  
Sappho Michael
Keyword(s):  
Quality Assurance ◽  
Quality Management ◽  
Comprehensive Analysis ◽  
Small Country ◽  
Iso 15189 ◽  
Medical Laboratories ◽  
Certification And Accreditation ◽  
Recent Developments ◽  
Laboratory Examinations ◽  
Standard Iso 15189

This chapter deals with issues of quality management and quality assurance in medical laboratories. Basic terms and their role in quality assurance in laboratory examinations are analyzed and discussed. Clarifications on certification and accreditation are given with a comprehensive analysis of the procedures they refer to and their implementation for particular tasks. The implementation of the international standard ISO 15189 is presented with reference to some recent developments. The chapter has been prepared to help medical laboratories in an introductory understanding of quality assurance issues and encourage them to proceed with the implementation of the standard ISO 15189 and not as a detailed guide. Some practical considerations rising from the experience of a small country such as Cyprus are also discussed.

An Integrated Fuzzy VIKOR Method for Performance Management in Healthcare

2018 ◽  
pp. 1100-1121
Author(s):  
Ehsan Shekarian ◽  
Salwa Hanim Abdul-Rashid ◽  
Ezutah Udoncy Olugu
Keyword(s):  
Performance Management ◽  
Evaluation Method ◽  
Multiple Criteria Decision Making ◽  
Poor Quality ◽  
Medical Laboratory ◽  
Iso 15189 ◽  
Medical Laboratories ◽  
Laboratory Services ◽  
Standard Iso 15189

Poor quality control has become a major threat to medical laboratory services, especially in the developing countries. It has become necessary to assess and rank the quality of diagnostic services in medical laboratories using systematic approaches. The main aim of this research is to develop and apply a quantitative method in ranking medical laboratory services. This method is based on a combination of Vlsekriterijumska Optimizacija I Kompromisno Resenje (VIKOR) with fuzzy set theory. VIKOR is a multiple criteria decision making technique which focuses on ranking and selection from a set of alternatives, and determines the compromise solution for a problem with different criteria. This approach aids decision makers to achieve the most acceptable decision amidst numerous alternatives. In the present evaluation method, international standard ISO 15189 (Medical Laboratories Particular Requirements for Quality and Competence) proposed by International Organization for Standardization (ISO) is used as a fundamental source of selected attributes of a medical laboratory. The study compares three medical laboratories to each other and ranks them. This study will be a valuable and effective contribution in enhancing both qualitative and quantitative criteria in the field of medical laboratory services. Finally, some directions for further studies are proposed.

scholarly journals Accreditation

2005 ◽  
Vol 24 (3) ◽  
pp. 187-192 ◽  
Author(s):  
Willem Huisman
Keyword(s):  
European Union ◽  
Continuous Improvement ◽  
Accreditation Process ◽  
Assessment Process ◽  
Medical Laboratory ◽  
The European Union ◽  
Iso 15189 ◽  
National Accreditation ◽  
Medical Laboratories ◽  
Medical Laboratory Professionals

ISO 15189 is very well accepted as the principle standard for accreditation of medical laboratories in the European countries. In cooperation with the EA linked national accreditation bodies mutual lateral agreement is well accepted for this standard. It makes it possible that the accreditation is accepted in other countries. Medical laboratory professionals play a key role in the assessment process. Their choice, training and constant education are essential to ascertain that accreditation adds value in the treatment of the patients. It should contribute to the continuous improvement of all laboratories. Some preliminary results of a questionnaire concerning the present status of accreditation in the countries of the European Union are presented. It shows quite diversity in the accreditation process in relation to the interval between assessment visits and the frequency of surveillance visits. The Working Group on Accreditation of the EC4 will use the input of this questionnaire and the content of some ILAC and EA guidelines, to offer Essential Criteria on some of these aspects. .

Sign in / Sign up

Export Citation Format

Share Document