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.

scholarly journals TransCelerate’s Clinical Quality Management System: From a Vision to a Conceptual Framework

2016 ◽  
Vol 50 (4) ◽  
pp. 397-413 ◽  
Author(s):  
Ann Meeker-O’Connell ◽  
Leslie M. Sam ◽  
Nanci Bergamo ◽  
Janis A. Little
Keyword(s):  
Quality Management ◽  
Conceptual Framework ◽  
Management System ◽  
Quality Management System ◽  
Clinical Quality

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 TransCelerate’s Clinical Quality Management System: Issue Management

2016 ◽  
Vol 50 (5) ◽  
pp. 530-535 ◽  
Author(s):  
Susan Callery-D’Amico ◽  
Leslie M. Sam ◽  
Timothy H. Grey ◽  
Daniel J. Greenwood
Keyword(s):  
Quality Management ◽  
Management System ◽  
Quality Management System ◽  
Issue Management ◽  
Clinical Quality ◽  
System Issue

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.

RESOURCE MANAGEMENT EVOLUTION IN THE QUALITY MANAGEMENT SYSTEM

2020 ◽  
Vol 10 (9) ◽  
pp. 2026-2035
Author(s):  
I.M. Pozharitskaya ◽  
Keyword(s):  
Resource Management ◽  
Quality Management ◽  
Management System ◽  
Quality Management System ◽  
Market Competition ◽  
Methodological Approach ◽  
Quality Standards ◽  
Management Tools ◽  
Resource Management System

The article examines the genesis of resource management in the system of standards dedicated to quality management. It was found that most publications consider the quality management system as a tool to improve the organizations’ efficiency without detailing the elements of this system. Basing on the analysisof different versions of quality standards, the differences in the methodological approach of different versions of standards from 1994 to 2015 were identified. Various approaches to the place and role of resource management have been identified, ranging from mere mention to assigning a leading role in financing the implementation and operation of quality management systems. At the same time, national adaptations of international versions of quality standards have their own nuances of translation and interpretation. The terminology and differences between resource control and resource management are identified, since the latter term is broader. However, in the latest version of the quality management system standards, the term resource management has been simplified and replaced by resource provision. The constituent elements of the resource management system are identified. The original composition this system, in addition to human resources, organizational environment and infrastructure, was supplemented with knowledge and resources for monitoring and measurement. It is the last elements that come to the fore for the successful long-term functioning of the organization in the conditions of market competition. The goals of the leadership in the genesis of different versions of the standards are established and the terminology in the resource management system is clarified. The interconnection of the process approach based on risk-based thinking in the latest version of the standard allows re-evaluating the role of resource management. The use of risk management tools and a systematic approach will allow the company’s managers to focus on the strategy and tactics of implementing the quality management system.

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