scholarly journals Experiences with the accreditation of the Institute for Medical Research and Occupational Health, Zagreb, Croatia

2020 ◽  
Vol 71 (4) ◽  
pp. 312-319
Author(s):  
Zdenko Franić ◽  
Tomislav Bituh ◽  
Ranka Godec ◽  
Mirjana Čačković ◽  
Tomislav Meštrović ◽  
...  
Keyword(s):  
Quality Management ◽  
Occupational Health ◽  
Medical Research ◽  
Radiation Protection ◽  
Management System ◽  
Quality Management System ◽  
Ambient Air ◽  
Objective Evidence ◽  
Accreditation Agency ◽  
Calibration Laboratories

AbstractAccreditation in accordance with the international General Requirements for the Competence of Testing and Calibration Laboratories (HRN EN ISO/IEC 17025 standard) has become a widely accepted method of quality management and objective evidence of technical competence, knowledge, and skills of testing and calibration laboratories. In 2010, the Institute for Medical Research and Occupational Health (IMROH) had its management system accredited against the HRN EN ISO/IEC 17025 standard for the following scopes: determination of radioactivity, testing of ambient air quality, and testing in the scope of ionising radiation protection. This accreditation encompassed three laboratories: Radiation Protection Unit, Environmental Hygiene Unit, and the Radiation Dosimetry and Radiobiology Unit. In accordance with the rules of the Croatian Accreditation Agency, the second re-accreditation is due in 2020. This paper describes and discusses the quality management system at IMROH over the ten years of its implementation. We share our experiences about non-conformities discovered during regular work, internal audits, and external audits performed by the Croatian Accreditation Agency. The accredited management system significantly improved the performance of the accredited units, and the Institute increased its visibility and marketing advantage, consequently improving its market position.

Организация системы менеджмента качества лабораторий с учетом требований ГОСТ ISO/IEC 17025-2019 с применением ЛИМС

2021 ◽  
pp. 569-575
Author(s):  
Konstantin S. Varaksin ◽  
Artem S. Makarov ◽  
Svetlana V. Gabova ◽  
Alexander Y. Alexander
Keyword(s):  
Quality Management ◽  
Management System ◽  
Quality Management System ◽  
Information Management System ◽  
Risk Identification ◽  
Control Measures ◽  
Laboratory Activities ◽  
Process Implementation ◽  
Calibration Laboratories ◽  
Laboratory Information Management

The updated version of the ISO/IEC 17025 standard has introduced substantial changes to the structure, terminology, requirements to resources, processes, and quality management system of testing and calibration laboratories. New requirements were established for organization of laboratory activities – the process based approach and risk-targeted thinking, which provides for the cutting of some part of the prescriptive requirements and introduction of requirements based upon analysis of actions performed. In accordance with GOST ISO/IEC 17025-2019, the laboratory is required to provide risk identification and assessment processes, develop risk control measures and expand opportunities to achieve the established purposes and objectives. The standard requires the laboratory to plan and perform actions to manage risks and opportunities associated with laboratory activities. This article deals with organization of the quality management system of Transneft system organizations’ laboratories in the aspects of risk management, management of opportunities, corrective actions with the use of laboratory information management system (LIMS). The model of the process implementation is described, subject to requirements of GOST ISO/IEC 17025-2019. Обновленная редакция стандарта ISO/IEC 17025 внесла существенные изменения в структуру, терминологию, требования к ресурсам, процессам, системе менеджмента качества испытательных и калибровочных лабораторий. Были установлены новые требования к организации деятельности лабораторий – процессный подход и риск-ориентированное мышление, что предусматривает сокращение части предписывающих требований и введение требований, основанных на анализе выполнения действий. В соответствии с ГОСТ ISO/IEC 17025-2019 от лаборатории требуется обеспечить процессы идентификации и оценки рисков, разработку мер по контролю рисков и расширению возможностей для достижения поставленных целей и задач. Стандарт требует от лаборатории планирования и реализации действий по управлению рисками и возможностями, связанными с лабораторной деятельностью. В настоящей статье рассматривается организация системы менеджмента качества лабораторий организаций системы «Транснефть» в части управления рисками, возможностями, корректирующими действиями с применением лабораторной информационной менеджмент-системы (ЛИМС). Описана модель реализации процесса с учетом соблюдения требований ГОСТ ISO/IEC 17025-2019.

Experiences With Implementation, Application and Improvement of an Integrated Management System

2009 ◽  
Author(s):  
H. P. Berg ◽  
I. A. Beckmerhagen
Keyword(s):  
Quality Management ◽  
Radiation Protection ◽  
Management System ◽  
Safety Management ◽  
Quality Management System ◽  
Integrated Management ◽  
Management Systems ◽  
Operational Effectiveness ◽  
Integrated Management System ◽  
Preventive Actions

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.

scholarly journals Implementing a quality management system using good clinical laboratory practice guidelines at KEMRI-CMR to support medical research

2019 ◽  
Vol 3 ◽  
pp. 137 ◽  
Author(s):  
Horace Gumba ◽  
Joseph Waichungo ◽  
Brett Lowe ◽  
Alfred Mwanzu ◽  
Robert Musyimi ◽  
...  
Keyword(s):  
Quality Management ◽  
Medical Research ◽  
Management System ◽  
Quality Management System ◽  
Clinical Laboratory ◽  
Research Programme ◽  
Good Clinical Practice ◽  
Laboratory Practice ◽  
Laboratory Personnel ◽  
Middle Income

Background: Good Clinical Laboratory Practice (GCLP) is a standard that helps ensure the quality and reliability of research data through principles of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP). The implementation of GCLP includes careful documentation of procedures, competencies and safety measures. Implementation of GCLP is influenced by existing resources and quality systems, thus laboratories in low- and middle-income countries may face additional challenges. Methods: This paper describes implementation of GCLP at the Kenya Medical Research Institute-Center for Microbiology Research (KEMRI-CMR) as part of a quality system to support medical research. This study employed assessment, twinning (institutional mentorship) model, conducting relevant training workshops and Kaizen 5S approaches to implement an effective quality management system using GCLP standard. This was achieved through a collaboration between the KEMRI/Wellcome Trust Research Programme (KWTRP) and KEMRI-CMR. The aim was compliance and continuous monitoring to meet international GCLP standards in a way that could be replicated in other research organizations. Results: Following a baseline assessment in March 2017, training, mentorship and a cycle of quality audit and corrective action using a Kaizen 5S approach (sorting, setting in order, shining, standardizing and sustaining) was established. Laboratory personnel were trained in writing standard operating procedures and analytical plans, microbiological techniques, and good documentation practice. Mid-term and exit assessments demonstrated significant declines in non-conformances across all GCLP elements. KEMRI-CMR achieved GCLP accreditation in May 2018 by Qualogy Ltd (UK). Conclusions: Involving all the laboratory personnel in implementation of quality management system processes is critical to success. An institutional mentorship (twinning) approach shows potential for future collaborations between accredited and non-accredited organizations to accelerate the implementation of high-quality management systems and continuous improvement.

Implementation of a Quality Assurance System in Radioactive Waste Management in Cuba

2003 ◽  
Author(s):  
M. M. Salgado ◽  
J. C. Benitez Navarro ◽  
I. M. Ferna´ndez ◽  
M. M. Marrero
Keyword(s):  
Quality Management ◽  
Radioactive Waste ◽  
Waste Management ◽  
Radiation Protection ◽  
Management System ◽  
Quality Management System ◽  
Control Mechanisms ◽  
Management Service ◽  
Radioactive Waste Management ◽  
Record Keeping

The Centre for Radiation Protection and Hygiene is the institution responsible for Radioactive Waste Management Service in Cuba. This Service comprises: centralized collection, transportation, treatment, conditioning, long term storage, and disposal of radioactive waste, as well as dismantling, decontamination and decommissioning of small nuclear facilities. Radioactive waste should be managed in such a way as to ensure adequate safety and protection of both human health and the environment. In order to fulfil this principle a Quality Management System has been implemented for the Radioactive Waste Management Service, based on the ISO 9000 Standards. The Quality System provides, as appropriate: • adequate assurance that the requirements specified by the Regulatory Authority relating to protection and safety are satisfied; • adequate assurance that the customer requirements are satisfied; • control of all kind and inventories of radioactive waste through the implementation of a comprehensive system for record keeping; • continuous improvement to guarantee the cost minimization related with the radioactive waste management; • and quality control mechanisms and procedures for reviewing and assessing the overall effectiveness of the system. In the year 2002, as a conclusion of a certification audit performed by the direction of the Centre for Radiation Protection and Hygiene, the Quality Management System implemented for the Radioactive Waste Management Service was successfully certified according to the requirements of the ISO 9001:2000 Standard.

Critical factors and performance indicators: accreditation of testing- and calibration-laboratories

2017 ◽  
Vol 24 (7) ◽  
pp. 1814-1833 ◽  
Author(s):  
Nagarajan Karthiyayini ◽  
Chandrasekharan Rajendran
Keyword(s):  
Quality Management ◽  
Management System ◽  
Quality Management System ◽  
Laboratory Accreditation ◽  
Extensive Literature ◽  
Critical Factors ◽  
Content Type ◽  
And Performance ◽  
The Impact ◽  
Calibration Laboratories

Purpose The purpose of this paper is to determine the critical factors (CRFs) of IS/ISO/IEC 17025:2005 laboratory accreditation and indicators of the performance (IOPs) in the testing/calibration laboratories. The impact of accreditation on the performance is analyzed using the level of presence of critical factors that can be used to benchmark the best practices in the accredited testing and calibration laboratories. Design/methodology/approach A questionnaire is designed on the basis of an extensive literature review on laboratory accreditation and performance. Based on the responses from pilot study, the developed instrument is tested for its unidimensionality, reliability and validity. Multiple regression analysis is carried out to analyze the impact of critical factors on the IOPs. Findings The findings reveal that the six distinct critical dimensions of laboratory accreditation (which are the independent variables) have a significant impact on the performance of the accredited testing/calibration laboratories. The performance is measured by the dependent variables which are the IOPs. The customer satisfaction, employee satisfaction, laboratory performance, image of the laboratory, the number of increased customers and loyalty of the existing customers are highly influenced by the accreditation which in turn improves the performance to gain the competitive advantage. Research limitations/implications Contribution to research is in the area of laboratory accreditation and the performance measurement by the development of a comprehensive instrument to analyze the Laboratory Quality Management System. The results are dependent on the number of respondents who are the quality/technical managers. Practical implications This instrument would enable the accredited laboratories to analyze their performance through the feedback from the quality/technical managers to gain credibility and to continually improve and benchmark the quality management system in alignment with the quality policies. Originality/value This paper proposes an instrument to measure and benchmark the performance of the accredited testing and calibration laboratories.

scholarly journals Implementing a quality management system using good clinical laboratory practice guidelines at KEMRI-CMR to support medical research

2018 ◽  
Vol 3 ◽  
pp. 137 ◽  
Author(s):  
Horace Gumba ◽  
Joseph Waichungo ◽  
Brett Lowe ◽  
Alfred Mwanzu ◽  
Robert Musyimi ◽  
...  
Keyword(s):  
Quality Management ◽  
Medical Research ◽  
Management System ◽  
Quality Management System ◽  
Clinical Laboratory ◽  
Research Programme ◽  
Good Clinical Practice ◽  
Laboratory Practice ◽  
Laboratory Personnel ◽  
Middle Income

Background: Good Clinical Laboratory Practice (GCLP) is a standard that helps ensure the quality and reliability of research data through principles of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP). The implementation of GCLP includes careful documentation of procedures, competencies and safety measures. Implementation of GCLP is influenced by existing resources and quality systems, thus laboratories in low- and middle-income countries may face additional challenges. Methods: This paper describes implementation of Good Clinical Laboratory Practice (GCLP) at the Kenya Medical Research Institute-Center for Microbiology Research (KEMRI-CMR) as part of a quality system to support medical research. This study employed assessment, twinning (institutional mentorship) model, conducting relevant training workshops and Kaizen 5S approaches to implement an effective quality management system using GCLP standard. This was achieved through a collaboration between the KEMRI/Wellcome Trust Research Programme (KWTRP) and KEMRI-CMR. The aim was compliance and continuous monitoring to meet international GCLP standards in a way that could be replicated in other research organizations. Results: Following a baseline assessment in March 2017, training, mentorship and a cycle of quality audit and corrective action using a Kaizen 5S approach (sorting, setting in order, shining, standardizing and sustaining) was established. Laboratory personnel were trained in writing standard operating procedures and analytical plans, microbiological techniques, and good documentation practice. Mid-term and exit assessments demonstrated significant declines in non-conformances across all GCLP elements. KEMRI-CMR achieved GCLP accreditation in May 2018 by Qualogy Ltd (UK). Conclusions: Involving all the laboratory personnel in implementation of quality management system processes is critical to success. An institutional mentorship (twinning) approach shows potential for future collaborations between accredited and non-accredited organizations to accelerate the implementation of high-quality management systems and continuous improvement.

scholarly journals CHARACTERISTICS OF INTERNAL AUDITS IN IMPROVEMENT OF QUALITY GOALS IN CALIBRATION LABORATORIES

2018 ◽  
Vol 18 (2) ◽  
pp. 91
Author(s):  
Jimmy Pusaka ◽  
Budhy Basuki
Keyword(s):  
Quality Management ◽  
Strong Correlation ◽  
Management System ◽  
Quality Management System ◽  
Internal Audit ◽  
Calibration Laboratories

The Quality Goals and Internal Audits are two important links in the quality management system. These two interrelated points are in many cases surprisingly not considered as they should be. Quality goals aren’t often subject to internal audits. Similarly with quality goals scarcely describe the improvement of internal audits as a tool to strengthen the quality management system. The fact, recent audit findings found no more than 11 out of 165 findings in 18 accredited calibration laboratories operated on the basis of ISO/IEC 17025 that relates to quality goals. This paper proves no strong correlation between quality goals and internal audit statistically. The importan thing for the improvement of quality goals – internal audits relationship is giving more clarification to clause 4.10 Improvements and add internal audit-based items on the quality goals.

scholarly journals The experience of involvement of personnel of the medical research organization into management of its functioning

2019 ◽  
Vol 61 (1) ◽  
pp. 22-28
Author(s):  
G. V. Artamonova ◽  
Yana V. Danil’Chenko ◽  
D. V. Karas’ ◽  
T. S. Kostomarova ◽  
D. V. Kryuchkov ◽  
...  
Keyword(s):  
Quality Management ◽  
Medical Research ◽  
Management System ◽  
Quality Management System ◽  
Vascular Diseases ◽  
Iso 9001 ◽  
Active Involvement ◽  
Complex Problems ◽  
Cardio Vascular ◽  
Research Institute

The active involvement of personnel to management of functioning of organization at all levels has an economic usefulness and social value. The article presents experience of involvement of personnel into management as exemplified by medical research organization using international tool standard ISO 9001. Purpose ofstudy. To represent experience of involvement ofpersonnel to management of functioning research medical organization by force of implementation of quality management system corresponding to requirements of ISO 9001. The system ofmanagement ofmain types of functioning ofthe research institute of complex problems of cardio-vascular diseases was used as a study object. The worker of organization as a subject of management system was used as a unit of observation. Out of personnel of organization was organized a team of leaders trained to quality management. The model of quality management in the research institute of complex problems of cardio-vascular diseases was presented by such processes as research and curative diagnostic activities. The workers in a different way assess usefulness of implementation of quality management system for their professional work - positive responses gave 26% of junior medical personnel and up to 77% of administrators. This occurrence indicates to different purposes of involvement of personnel to management. The experience of implementation of quality management system in the research institute of complex problems of cardio-vascular diseases testifies that work ofpersonnel of any professional category in one way or another impact the achievement of targets of organization. At the expense of active involvement of personnel to process of management of activities the organization ameliorates its functioning on systemic level. To comprehend usefulness of quality management system by members of particular professional groups it is expedient to develop and implement innovative methods of personal interest in the results of work considering characteristics of particular team, its targets and aims in the area of quality.

scholarly journals PSYCHOPHYSIOLOGICAL PREDICTORS OF HUMAN AND SYSTEM INTEGRATION ON MODERN NAVAL SHIPS OF THE RUSSIAN NAVY

2018 ◽  
Vol 4 (3) ◽  
pp. 64-74 ◽  
Author(s):  
A. M. Bilyi ◽  
A. M. Vasilkov
Keyword(s):  
Information Processing ◽  
Expert System ◽  
Quality Management ◽  
Occupational Health ◽  
System Integration ◽  
Management System ◽  
Quality Management System ◽  
Comprehensive Analysis ◽  
Private Company ◽  
Type Of Behavior

The article demonstrates that demands of modern ergonomics in man-machine combination mean scientific-based «machine» requirements as well as man-requirements since they limit reliability of whole system. Comparative study was held among operators (learning network), persons affected by asthenoneurotic syndrome, survey was carried out in private company. It has been discovered that besides usual procedure of job specification and recruiting it is necessary to assess dominating type of behavior, perception and information processing. Compatibility of the type with work requirements affects the effectiveness of mastering of profession and burnout and occupational health. This theory was tested in private company when developing quality management system using Expert system of human comprehensive analysis. Observation was held within six years. The result is that quantity of days because of illness reduced in 2,9 times. It can be said that this parameter is the objective index of human integration and properly developed quality management system in a company. The quality management system worked out in the base of Expert system of human comprehensive analysis allows to reduce burnout of personnel and keep up their occupational health. Basing on survey results the main profiles of operator performance were analyzed taking into account dominating type of behavior, perception and information processing. Thus psychophysiological predictors for potential naval operators were identified. This objective is relevant in naval construction of Russia.

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