Implementation of Quality Management System for Laboratory Investigations in a Medical Research Institution

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.

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

Wellcome Open Research ◽

10.12688/wellcomeopenres.14860.1 ◽

2018 ◽

Vol 3 ◽

pp. 137 ◽

Cited By ~ 1

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.

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

Health Care of the Russian Federation ◽

10.18821/0044-197x-2017-61-1-22-28 ◽

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.

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

Archives of Industrial Hygiene and Toxicology ◽

10.2478/aiht-2020-71-3449 ◽

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.

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ANALYSIS THE IMPACT OF THE IMPLEMENTATION OF QUALITY MANAGEMENT SYSTEM (QMS) AND SAFETY AND HEALTHY AT WORK MANAGEMENT SYSTEM (SHWMS / SMK3) ON THE JOB PERFORMANCE OF EMPLOYEES

The Management Journal of Binaniaga ◽

10.33062/mjb.v3i1.240 ◽

2018 ◽

Vol 3 (01) ◽

pp. 45

Author(s):

Nur Hidayat ◽

Indah Kusuma Hayati

Keyword(s):

Quality Management ◽

Job Performance ◽

Latent Variables ◽

Management System ◽

Quality Management System ◽

Partial Least Square ◽

Least Square ◽

Global Challenges ◽

The Impact ◽

Work Management

Recently, the evolvement of globalization era has been the global challenges that cannot be avoided either by private or government sectors, and they are requested to be survived encountering such the condition. The implementation of Quality Management System (QMS) in the operational company is the way how to guarantee the quality of products or services offered to the people. One of the purposes of QMS implementation is to provide a prime satisfaction to the customers. The impact of QMS implementation is expected to increase job performance of the employees. Besides the implementation of Quality Management System (QMS), the impact of global challenges has been increasing the competitive efforts to execute more effective production process. However, it has required manpower protection accordingly. This research aims to find out whether the implementation of quality management system and safety and healthy at work management system have impacted on the job performance of employees. Objects of this research are the employees in the production department at PT Guna Senaputra Sejahtera Plant 1 Bogor. Data analysis technique of this research has applied software Smart PLS (Partial Least Square). PLS has estimated a model of correlation among the latent variables and correlation between latent variables and its indicators. Result of data processing has indicated that the implementation of Quality Management System (QMS) and system of safety and healthy at work have positively and significantly impacted job performance of employees.Keywords : Quality Management System (QMS), Safety and Healthy at Work System ( SHWS / SMK3), and Job Performance of Employees

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