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			<h1 class="page-title">Medical Laboratory Quality Management Programs</h1>
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								<h4>Medical Laboratory Quality Management Programs</h4>
								<div>
								<ul class="review-list"> 
									<li>ISO 15189:2022 Awareness Course</li> 
									<li>ISO 15189:2022 Internal Audit Course</li> 
									<li>Method Validation, Measurement Uncertainty & Metrological</li> 
									<li>Statistics for Medical Laboratory Scientists course</li> 
								</ul> 								
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								<h5>ISO 15189:2022 Awareness Course</h5>
								<h5>Overview</h5>
								
								<p>
								To assure the quality of test results, a medical laboratory needs to implement a sound quality management system. 
								ISO 15189-2022 describes the quality management system (QMS) for medical laboratories.  
								Implementing effective, QMS not only guarantees patient safety but also ensures needthe s of various users of laboratory services are met.
								</p>

								<p>
									Of particular interest to organizations considering embarking on their accreditation journey, 
									this course will equip the participants with deeper understanding of ISO 15189:2022 relating to the competence and quality of Medical Laboratories.
								</p>
								
								<h5>Why ISO 15189-2022 Awareness course</h5>
								
								<p>
									Participants will gain a practical understanding of the standard, including how this relates to their roles in a laboratory setting.
								</p> 
								
								
								<ul class="review-list"> 
									<li>Knowledge of QMS, document  and  record  control  with  information management;</li> 
									<li>Establishing structural, organizational and personnel requirements including roles and responsibilities management;</li> 
									<li>Understanding   of   management of   nonconformities, evaluation, and preventive/corrective activities to ensure the effectiveness of the QMS </li> 
									<li>Practical skills on actions to address risks, opportunities and improvement</li> 
									<li>Knowledge of maintenance of laboratory environment, equipment and, reagents;</li> 
									<li>Knowledge of the key processes including pre-examination, examination, and post-examination processes</li> 
								</ul> 
								<p>
									<b>Learning outcomes of this course</b>
								</p>
								<p>
									By the end of this course, participants will:
								</p>
								<ul class="review-list"> 
									<li>Understand how ISO 15189 standard is used as a framework for business processes, management systems and conformance to quality requirements</li> 
									<li>Understand the purpose, as well as the benefits of a quality management system</li> 
									<li>Have insight into the key areas of management systems and how they impact patient safety </li> 
									<li>Understand how to introduce quality culture in their organizations</li> 
								</ul> 
								
								<h5>Who May Attend</h5>
								
								<p>
								This course is designed for any individuals responsible for, and involved in, the quality and/or technical support activities 
								relating to biological sample examination and result generation activities within their organization. 
								This could include:

								</p>
								<ul class="review-list"> 
									<li>Laboratory technical staff;</li> 
									<li>Laboratory non-technical including administrators, biomedical engineers, and support staffs;</li> 
									<li>Laboratory managers;</li> 
									<li>Users of laboratory services (clinicians and other clinical personnel);</li> 
									<li>Researchers;</li> 
									<li>Laboratory auditors/assessors.</li> 
								</ul> 
								
								<h5>Key topics</h5>
								
								<ul class="review-list"> 
									<li>Organization & Management Structure</li> 
									<li>Impartiality & Confidentiality</li> 
									<li>Management Requirements</li> 
									<li>Technical requirements</li> 
								</ul> 
								
								
								
								<h5>ISO 15189:2022 Internal Audit Course</h5>
								<h5>Overview</h5>
								<p>
									ISO 15189 2022 requires laboratories to conduct a self-evaluation of their activities.This forms the basis of internal Quality Audits.
									The audits are required to ensure that laboratory activities; conform to the requirements of the Quality Management System (QMS), 
									are conducted in a manner that meets the needs of users, are implemented, effective, and maintained. This course equips the participants 
									with practical skills and knowledge on audit techniques to identify gaps in the QMS and initiate continuous improvement cycle
								</p>
								<h5>Why ISO 15189 Internal Audit</h5>
								<ul class="review-list"> 
									<li>pre-examination, examination, and post-examination processes</li> 
								</ul> 
								
								<h5>Learning outcomes of this course</h5>
								
								<p>
									By the end of this course, participants will:
								</p>
								
								<ul class="review-list"> 
									<li>Learn how to use audits to measure the effectiveness of the QMS</li> 
									<li>Apply their knowledge and understanding of auditing principles to a wide variety of situations to allow the design, planning, 
									justification, and delivery of internal audits</li> 
									<li>Learn  how  to  use  internal  audit  outcomes  to  create  public  trust  in the laboratory's reputation</li> 
									<li>Understand how risk & opportunity inform internal  audits  and  non- conformities</li> 
									<li>Categorize   non-conformity   cause, impact, and   action   to   address underlying issues</li> 
									<li>Undertake a structured preparation for the internal audit process, including feedback to relevant stakeholders </li> 
									<li>Learn how to use the internal audit to gain the agreement audits employee commitment</li> 
								</ul> 

								<h5>Who May attend</h5>								
								<ul class="review-list"> 
									<li>Personnel specifically designated as auditors</li> 
									<li>Laboratory management staff</li> 
									<li>Laboratory technical staff </li> 
									<li>Those who maintain and support the quality management systems of the services delivered</li> 
									<li>Those who manage, coordinate, and/or deliver internal audits within the organizations</li> 
								</ul>
								
								<h5>Key topics</h5>
								<ul class="review-list"> 
									<li>Principles of auditing</li> 
									<li>Internal Audit program</li> 
									<li>Audit planning, execution and follow-up</li> 
									<li>Auditors attributes</li> 
									<li>Audit methods/techniques</li> 
									<li>Raising audit findings</li> 
									<li>Evaluation of audit program</li> 
								</ul> 			



								<h5>Method Validation, Measurement Uncertainty & Metrological</h5>
								<h5>Overview</h5>
								<p>
									Method validation is a prerequisite for all methods/equipment involved in processing patient results.
									This is to guarantee the validity of test results in a medical laboratory. As a rule, the method/equipment developer conducts validation.
									However, laboratories are required to conduct independent verification of, and validate methods to confirm that the method/equipment can 
									produce the intended results.
								</p>
								<p>
									Measurement uncertainty on the other hand represents the doubt associated with test results due analytical and non-analytic factors that
									affects measurements in the laboratory. As rule, laboratory measurements provide a best estimate of a quantity of interest
									(such as Blood glucose test value or therapeutic drug measurements). Because these are estimates, there is always some uncertainty about how 
									closely they represent the true value of the quantity. This forms the basis the for estimation of Measurement Uncertainty (MU).
									It is essential to account for measurement uncertainty to enable healthcare givers to determine the clinical significance of a test result
									value given the analytical factors that may have an influence on it.
								</p>
								<p>
									Metrological traceability is used as the basis the for comparability of test results across different, methods/equipment and locations. 
								</p>								
								
								<h5>Why conduct Method validation/verification and estimate measurement uncertainty</h5>
								<ul class="review-list"> 
									<li>Guarantees validity of test results</li> 
									<li>A prerequisite for ISO 15189 accreditation </li> 
									<li>Confirms that intended test results (by method developer) can be obtained by the lab</li> 
									<li>Verification is necessary for equipment that has been subjected to reports, service and transportation to confirm acceptable functionality</li> 
									<li>Helps clinicians make informed decisions on the clinical significance of test results</li> 
									<li>Metrological   traceability   and   MU   are   essential   in   determining   the acceptability of calibration results for laboratory equipment</li> 
									<li>MU is important in assessing the quality of results the lower the MU the better the results</li> 
									<li>MU is essential in determining the performance of a method/equipment or even a laboratory compared to others</li> 
									<li>It is an important aspect of Metrological traceability</li> 
								</ul> 

								<h5>Learning outcomes of this course</h5>
								<p>
									By the end of this course, participants will:
								</p>
								<ul class="review-list"> 
									<li>Understand the importance of method validation/verification</li> 
									<li>Understand the application of metrological traceability in laboratory medicine</li> 
									<li>Identify sources of MU</li> 
									<li>Recognize how and when to report and use MU</li> 
									<li>Be able to explain all of this to users of laboratory services and colleagues how to apply MV/MU</li> 
								</ul> 

								<h5>Who May attend<h5>
								<p>
									This course is designed for any individual requiring an understanding of the importance of measurement uncertainty, the principles involved 
									and how to develop simple uncertainty calculation models 
								</p>
								<ul class="review-list"> 
									<li>Laboratory and quality managers</li> 
									<li>Technical staffs</li> 
									<li>Users of laboratory services (clinicians and other clinical personnel)</li> 
									<li>Researchers and scientists</li> 
									<li>Principle investigators</li> 
								</ul> 
								
								<h5>Key topics</h5>
								<p>
									Terms and definition associated with MV/MU
								</p>
								<ul class="review-list"> 
									<li>Basic statistics</li> 
									<li>Precision</li> 
									<li>Accuracy</li> 
									<li>Linearity</li> 
									<li>Biological reference intervals</li> 
									<li>Diagnostic sensitivity and specificity</li> 
									<li>Describing what Measurement Uncertainty is</li> 
									<li>Metrological traceability</li> 
									<li>Types of Measurement Uncertainty</li> 
									<li>Sources of uncertainty</li> 
									<li>The principles for estimation of measurement uncertainty</li> 
								</ul>
								
								
								
								
								
								<h5>Statistics for Medical Laboratory Scientists course</h5>
								<h5>Overview</h5>
								<p>
									This course – delivered over one- day in the classroom or two days online – is designed to help delegates to understand some of the most
									important statistical concepts used by medical laboratory scientists, calculate the most common statistics, apply significance testing,
									and use linear regression in calibration.
								</p>	

								<h5>Learning outcomes of this course</h5>
								<p>
									Participants participating in this course will gain knowledge and confidence in calculating and interpreting statistics and gain access to
									experts in the field in order to get straightforward answers to complex questions.
								</p>
								
								<h5>Key topics</h5>
								<ul class="review-list"> 
									<li>Introduction to Statistics</li> 
									<li>Significance Testing T-Tests and the F-Test</li> 
									<li>Analysis of Variance (ANOVA)</li> 
									<li>Linear Regression</li> 
									<li>Control Charts</li> 
								</ul>
								
								<h5>Who may attend?</h5>
								<p>
									Anyone seeking to develop their understanding of statistics for Analytical Scientists in a medical laboratory setting.
									This might include:
								</p>
								<ul class="review-list"> 
									<li>Quality Managers and those aspiring to be quality managers</li> 
									<li>Laboratory Managers and those who are aspiring to be laboratory managers.</li>
								</ul>								
								
								
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