scholarly journals CLSI's The Key to Quality Released: The Fundamentals for Implementing a Quality Management System in the Clinical Laboratory

2007 ◽  
Vol 38 (6) ◽  
pp. 376-376
Author(s):  
Melissa D'Archangelo
Keyword(s):  
Quality Management ◽  
Management System ◽  
Quality Management System ◽  
Clinical Laboratory

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.

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 Review and comparison of quality standards, guidelines and regulations for laboratories

2011 ◽  
Vol 1 (1) ◽  
Author(s):  
Tjeerd A.M. Datema ◽  
Linda Oskam ◽  
Paul R. Klatser
Keyword(s):  
Quality Management ◽  
Low Income ◽  
Management System ◽  
Quality Management System ◽  
Clinical Laboratory ◽  
National Laboratory ◽  
Quality Standards ◽  
Ethical Behaviour ◽  
Clinical Quality ◽  
Almost All

Background: The variety and number of laboratory quality standards, guidelines and regulations (hereafter: quality documents) makes it difficult to choose the most suitable one for establishing and maintaining a laboratory quality management system. Objectives: There is a need to compare the characteristics, suitability and applicability of quality documents in view of the increasing efforts to introduce quality management in laboratories, especially in clinical diagnostic laboratories in low income and middle income countries. This may provide valuable insights for policy makers developing national laboratory policies, and for laboratory managers and quality officers in choosing the most appropriate quality document for upgrading their laboratories. Method: We reviewed the history of quality document development and then selected a subset based on their current use. We analysed these documents following a framework for comparison of quality documents that was adapted from the Clinical Laboratory Standards Institute guideline GP26 Quality management system model for clinical laboratory services. Results: Differences were identified between national and international, and non-clinical and clinical quality documents. The most salient findings were the absence of provisions on occurrence management and customer service in almost all non-clinical quality documents, a low number of safety requirements aimed at protecting laboratory personnel in international quality documents and no requirements regarding ethical behaviour in almost all quality documents. Conclusion: Each laboratory needs to investigate whether national regulatory standards are present. These are preferred as they most closely suit the needs of laboratories in the country. A laboratory should always use both a standard and a guideline: a standard sums up the requirements to a quality management system, a guideline describes how quality management can be integrated in the laboratory processes.

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

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

Development of a Quality Management System for Electric Power applied to Small Wind Turbines

2012 ◽  
pp. 1083-1088
Author(s):  
O.H. Ando Junior ◽  
M.O. Oliveira ◽  
J.M. Neto ◽  
A.D. Spacek ◽  
R.C.B. Leborgne ◽  
...  
Keyword(s):  
Quality Management ◽  
Electric Power ◽  
Wind Turbines ◽  
Management System ◽  
Quality Management System ◽  
Small Wind Turbines
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