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Author: Gaffar Zaman
Publisher: BoD – Books on Demand
ISBN: 1789234123
Category : Business & Economics
Languages : en
Pages : 160
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Book Description
The book presents a qualitative and quantitative approach to understand, manage and enforce the integration of statistical concepts into quality control and quality assurance methods. Utilizing a sound theoretical and practical foundation and illustrating procedural techniques through scientific examples, this book bridges the gap between statistical quality control, quality assurance and quality management. Detailed procedures have been omitted because of the variety of equipment and commercial kits used in today's clinical laboratories. Instrument manuals and kit package inserts are the most reliable reference for detailed instructions on current analytical procedures.
Author: Gaffar Zaman
Publisher: BoD – Books on Demand
ISBN: 1789234123
Category : Business & Economics
Languages : en
Pages : 160
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Book Description
The book presents a qualitative and quantitative approach to understand, manage and enforce the integration of statistical concepts into quality control and quality assurance methods. Utilizing a sound theoretical and practical foundation and illustrating procedural techniques through scientific examples, this book bridges the gap between statistical quality control, quality assurance and quality management. Detailed procedures have been omitted because of the variety of equipment and commercial kits used in today's clinical laboratories. Instrument manuals and kit package inserts are the most reliable reference for detailed instructions on current analytical procedures.
Author: World Health Organization
Publisher:
ISBN: 9789241548274
Category : Laboratories
Languages : en
Pages : 0
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Book Description
Achieving, maintaining and improving accuracy, timeliness and reliability are major challenges for health laboratories. Countries worldwide committed themselves to build national capacities for the detection of, and response to, public health events of international concern when they decided to engage in the International Health Regulations implementation process. Only sound management of quality in health laboratories will enable countries to produce test results that the international community will trust in cases of international emergency. This handbook was developed through collaboration between the WHO Lyon Office for National Epidemic Preparedness and Response, the United States of America Centers for Disease Control and Prevention (CDC) Division of Laboratory Systems, and the Clinical and Laboratory Standards Institute (CLSI). It is based on training sessions and modules provided by the CDC and WHO in more than 25 countries, and on guidelines for implementation of ISO 15189 in diagnostic laboratories, developed by CLSI. This handbook is intended to provide a comprehensive reference on Laboratory Quality Management System for all stakeholders in health laboratory processes, from management, to administration, to bench-work laboratorians. This handbook covers topics that are essential for quality management of a public health or clinical laboratory. They are based on both ISO 15189 and CLSI GP26-A3 documents. Each topic is discussed in a separate chapter. The chapters follow the framework developed by CLSI and are organized as the "12 Quality System Essentials".
Author: Jeremie M. Gras
Publisher: Walter de Gruyter GmbH & Co KG
ISBN: 3110384531
Category : Medical
Languages : en
Pages : 105
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Book Description
Every clinical laboratory devotes considerable resources to Quality Control. Recently, the advent of concepts such as Analytical Goals, Biological Variation, Six Sigma and Risk Management has generated a renewed interest in the way to perform QC. However, laboratory QC practices remain highly non-standardized and a lot of QC questions are left unanswered. The objective of this book is to propose a roadmap for the application of an integrated QC protocol that ensures the safety of patient results in the everyday lab routine.
Author: Eamonn Mullins
Publisher: Royal Society of Chemistry
ISBN: 1847551939
Category : Science
Languages : en
Pages : 475
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Book Description
Statistical methods are essential tools for analysts, particularly those working in Quality Control Laboratories. This book provides a sound introduction to their use in analytical chemistry, without requiring a strong mathematical background. It emphasises simple graphical methods of data analysis, such as control charts, which are also a fundamental requirement in laboratory accreditation. A large part of the book is concerned with the design and analysis of laboratory experiments, including sample size determination. Practical case studies and many real databases from both QC laboratories and the research literature, are used to illustrate the ideas in action. The aim of Statistics for the Quality Control Chemistry Laboratory is to give the reader a strong grasp of the concept of statistical variation in laboratory data and of the value of simple statistical ideas ad methods in thinking about and manipulation such data, It will be invaluable to analysts working in QC laboratories in industry, hospitals and public health, and will also be welcomed as a textbook for aspiring analysts in colleges and universities.
Author: Piotr Konieczka
Publisher: CRC Press
ISBN: 9780367571825
Category :
Languages : en
Pages : 280
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Book Description
This book provides practical information about quality assurance/quality control (QA/QC) systems, including definition of all tools, understanding of their uses, and an increase in knowledge about the practical application of statistical tools during analytical data treatment. Clearly written and logically organized, this book delineates the concepts of practical QA/QC, taking a generic approach that can be applied to any field of analysis. Using an approach grounded in hands-on experience, the book begins with the theory behind quality control systems and then moves on to discuss examples of tools such as validation parameter measurements, the use of statistical tests, counting the margin of error, and estimating uncertainty. The second edition features newly added chapters covering changes in the regulatory environment, internal quality-control and equivalence method. Over 80 examples are featured in this new edition, including Excel spreadsheets for users to problem solve. Quality Assurance and Quality Control in the Analytical Chemistry Laboratory: A Practical Approach, Second Edition is a great reference for students, laboratory employees, and academics working in the fields of analytical chemistry, pharmaceuticals, or life sciences. With its comprehensive coverage, this book can be of interest to researchers in the industry and academic, as well as government agencies and legislative bodies. Book jacket.
Author: James O. Westgard
Publisher: Elsevier Health Sciences
ISBN: 1455772313
Category : Medical
Languages : en
Pages : 220
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Book Description
In October of 2011, CLSI published a new guideline EP23A on “Laboratory Quality Control Based on Risk Management. In March, 2012, CMS announced its intention to incorporate key concepts from EP23A into its Interpretative Guidelines and QC policy for “Individualized Quality Control Plans. Thus begins a new era of Quality Control in the Age of Risk Management. This issue is intended to help laboratories with the transition between traditional QC practices and the new risk management approach. Laboratories face a steep learning curve to apply risk analysis for identifying and prioritizing failure-modes, developing and implementing control mechanisms to detect those failure-modes, and assessing the acceptability of the residual risks that exist after implementation of a QC Plan. One of the main benefits of the new risk analysis based QC Plans should be an integration of all the control mechanisms that are needed to monitor the total testing process, including pre-analytic, analytic, and post-analytic controls. One of the main risks of the new approach is an expectation that Statistical QC is no longer important, even though SQC still remains the most useful and flexible approach for monitoring the quality of the analytic process. The key to the future is the successful integration of all these control mechanisms to provide a cost-effective quality system that monitors all phases of the total testing process. This issue should help laboratories understand the evolution of QC practices to include risk management, but also to recognize the need to maintain traditional techniques such as Statistical QC, especially during the transition to well-designed and carefully-validated QC Plans. Risk analysis may be risky business unless laboratories proceed carefully and cautiously.
Author: George S. Cembrowski
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 292
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Book Description
Discusses quality control practices in health care laboratories. Will help laboratory directors, managers, supervisors and technologists towards a more quantitative understanding of the performance capabilities of different quality control procedures.
Author: J. J. S. Snell
Publisher:
ISBN:
Category : Business & Economics
Languages : en
Pages : 180
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Book Description
This manual sets out the principles of quality control and provides clear, detailed information on the practical ways in which quality control can be achieved in the microbiology laboratory.
Author: Donnell R. Christian Jr.
Publisher: CRC Press
ISBN: 1420073052
Category : Business & Economics
Languages : en
Pages : 1434
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Book Description
In order to gain accreditation, every laboratory must have a superior quality assurance program. The keys to a successful program are the operational and technical manuals and associated documents which define the program and its various components. Written by experts with global experience in setting up laboratories, Implementing Quality in Labora
Author: James O. Westgard
Publisher:
ISBN: 9781886958302
Category :
Languages : en
Pages : 290
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Book Description
