Quality management system in flow cytometry unit from a clinical laboratory. Implementation of international organization for standardization (ISO) 15189

Series of ISO 9000 quality system was developed by the International Organization for Standardization ISO (International Organization for Standardization) in order to create uniform requirements for quality management processes and formation based on these requirements of quality systems in all organizations. The aim is investment features quality management system implementation in the Bureau of forensics. Summary. Quality management system - is the foundation of organizational management in any organization. During its development in accordance with international standards for quality management systems refers to the development and implementation of this system in the organization, and we are creating a system of management is the processes that affect the level of services to conduct forensic examinations. The implementation of this system in the bureau forensics requires a new system of governance, and requires detailed documentation and regulation of all processes, procedures and services. On the basis of the test material can confirm the importance and utility of implementing a quality management system according to the requirements of ISO 9001: 2009 in the Bureau of forensics. The advantages of implementing QMS are: ordering and regulation (implementation of action sequences according to approved procedures) of the implementation of forensic examinations; ability to enhance internal workflow, a clearer division of responsibilities, tasks and responsibilities through the prescription process and management; improve the quality of services for forensic examination; rational and efficient use of resources, especially

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Employees’ process and risk-oriented thinking

Russian Journal of Industrial Economics ◽

10.17073/2072-1633-2020-2-206-217 ◽

2020 ◽

Vol 13 (2) ◽

pp. 206-217

Author(s):

V. P. Soloviev ◽

T. A. Pereskokova

Keyword(s):

Quality Management ◽

Management System ◽

System Analysis ◽

Quality Management System ◽

Iso 9000 ◽

International Organization ◽

Analysis Method ◽

Preventive Action ◽

National Organizations ◽

Potential Risks

The authors of the article explore the problem of introducing process and risk-oriented thinking in national organizations. In 2000 the International Organization for Standartization, ISO, announced process approach as the basis principle of management in any organization. It became the embodiment of Deming’s postulate who recommended to consider any activity as a technological process. The authors show the practicability of transition from the functional structure of an organization to integrated process. New ISO 9000:2015 standards reflect presentday challenges and require that organizations should carry out risk assessment and accounting. One of the key objectives of the quality management system is to act as the prevention tool. Preventive action lies in using riskoriented thinking in formulating requirements to the quality management system. The authors introduce the system analysis method in risk management to reveal potential risks and plan preventive action.

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The Design and Implementation of a Clinical Laboratory Quality Management System Model in a Research and Development Biotechnology Setting to Comply with Industry-specific Regulations

American Journal of Clinical Pathology ◽

10.1093/ajcp/144.suppl2.188 ◽

2015 ◽

Vol 144 (suppl 2) ◽

pp. A188-A188

Author(s):

Ashraf Dehlawi ◽

Meghan Gentilini ◽

Angela Via ◽

Patricia Lawman ◽

Michael Lawman

Keyword(s):

Quality Management ◽

Research And Development ◽

Management System ◽

Quality Management System ◽

Clinical Laboratory ◽

System Model ◽

Design And Implementation

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

Laboratory Medicine ◽

10.1309/v34wxxk52cka2n87 ◽

2007 ◽

Vol 38 (6) ◽

pp. 376-376

Author(s):

Melissa D'Archangelo

Keyword(s):

Quality Management ◽

Management System ◽

Quality Management System ◽

Clinical Laboratory

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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.14860.2 ◽

2019 ◽

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 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 Impact of the Implementation of the ISO 9000 Quality Management System Upon the Perception of the Performance of the Organizations Workers

Global Journal of Management and Business Research ◽

10.34257/gjmbrvol11is8pg11 ◽

2011 ◽

pp. 11-22

Author(s):

Dr. Omer Abdel Aziz El Tigani

Keyword(s):

Quality Management ◽

Management System ◽

Quantitative Research ◽

Research Study ◽

Quality Management System ◽

Iso 9000 ◽

The State ◽

International Organization ◽

Effective Implementation ◽

The Impact

Organizations in the region implement the ISO 9000 Quality Management System and obtain the consequent approvals, rewards and certificates, but unfortunately, without the actual and effective implementation on the ground. The purpose of this research study was to assess the impact of the implementation of the ISO Quality Management System upon the performance of participating workers. Qualitative as well as quantitative research was conducted. Data were collected using a quantitative survey administered to 150 participants from either governmental or private and both sectors in the State of Qatar. Findings include the implementation of the ISO 9000 QMS has no impact on the performance of the participating organizations' workers. This research study also revealed some important points related to the organizations' workers and their performances under the umbrella of the ISO 9000 Quality Management System, which leads the Researcher to raise some questions to the concerned people in the International Organization for Standardization (ISO).

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