Laboratory Quality Management System

Laboratory Quality Management System
Author: World Health Organization
Publisher:
Total Pages: 0
Release: 2011
Genre: Laboratories
ISBN: 9789241548274

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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".

Basic Quality Management Systems

Basic Quality Management Systems
Author: James O. Westgard
Publisher:
Total Pages: 286
Release: 2014-01-01
Genre: Medical
ISBN: 9781886958289

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Iso 17025 2017 Lab Quality Management System

Iso 17025 2017 Lab Quality Management System
Author: Ramesh R Lakhe
Publisher: Educreation Publishing
Total Pages: 298
Release: 2018-12-30
Genre: Education
ISBN:

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Laboratory accreditation has assumed immense importance in recent years because of the need to assure the customer that the laboratory is capable of providing the valid test results reliably. ISO 17025:2017 Lab Quality Management System has become part of the requirement of all the laboratories, small to large. Over the years, ISO 17025:2017 Lab Quality Management System has evolved, as per the laboratory and customer requirements, and has become very important for improving laboratory systems and processes in order to sustain competitive advantages. This book focuses on requirements and key features of ISO 17025:2017 Lab Quality Management System such as risk-based thinking, PDCA approach, process management, and continual improvement. The readers would find it easier to understand the standard requirements and implement these in their work place.

Quality Control in Laboratory

Quality Control in Laboratory
Author: Gaffar Zaman
Publisher: BoD – Books on Demand
Total Pages: 160
Release: 2018-08-22
Genre: Business & Economics
ISBN: 1789234123

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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.

Returning Individual Research Results to Participants

Returning Individual Research Results to Participants
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
Total Pages: 399
Release: 2018-08-23
Genre: Medical
ISBN: 0309475201

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When is it appropriate to return individual research results to participants? The immense interest in this question has been fostered by the growing movement toward greater transparency and participant engagement in the research enterprise. Yet, the risks of returning individual research resultsâ€"such as results with unknown validityâ€"and the associated burdens on the research enterprise are competing considerations. Returning Individual Research Results to Participants reviews the current evidence on the benefits, harms, and costs of returning individual research results, while also considering the ethical, social, operational, and regulatory aspects of the practice. This report includes 12 recommendations directed to various stakeholdersâ€"investigators, sponsors, research institutions, institutional review boards (IRBs), regulators, and participantsâ€"and are designed to help (1) support decision making regarding the return of results on a study-by-study basis, (2) promote high-quality individual research results, (3) foster participant understanding of individual research results, and (4) revise and harmonize current regulations.

Quality and Risk Management in the IVF Laboratory

Quality and Risk Management in the IVF Laboratory
Author: Sharon T. Mortimer
Publisher: Cambridge University Press
Total Pages: 241
Release: 2015-03-02
Genre: Medical
ISBN: 1107421284

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Updated edition of this bestselling book, now extended to include quality and risk management in the ART clinic.

Laboratory Management Information Systems: Current Requirements and Future Perspectives

Laboratory Management Information Systems: Current Requirements and Future Perspectives
Author: Moumtzoglou, Anastasius
Publisher: IGI Global
Total Pages: 384
Release: 2014-07-31
Genre: Computers
ISBN: 1466663219

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Technological advances have revolutionized the way we manage information in our daily workflow. The medical field has especially benefitted from these advancements, improving patient treatment, health data storage, and the management of laboratory samples and results. Laboratory Management Information Systems: Current Requirements and Future Perspectives responds to the issue of administering appropriate regulations in a medical laboratory environment in the era of telemedicine, electronic health records, and other e-health services. Exploring concepts such as the implementation of ISO 15189:2012 policies and the effects of e-health application, this book is an integral reference source for researchers, academicians, students of health care programs, health professionals, and laboratory personnel.

Quality Assurance Implementation in Research Labs

Quality Assurance Implementation in Research Labs
Author: Akshay Anand
Publisher: Springer Nature
Total Pages: 247
Release: 2021-08-17
Genre: Medical
ISBN: 9811630747

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This book is a comprehensive and timely compilation of strategy, methods, and implementation of a proof of concept modified quality module of Good Laboratory Practices (GLP). This text provides a historical overview of GLP and related standards of quality assurance practices in clinical testing laboratories as well as basic research settings. It specifically discusses the need and challenges in audit, documentation, and strategies for its implications in system-dependent productivity striving research laboratories. It also describes the importance of periodic training of study directors as well as the scholars for standardization in research processes. This book describes different documents required at various time points of a successful Ph.D and post-doc tenure along with faculty training besides entire lab establishments. Various other areas including academic social responsibility and quality assurance in the developing world, lab orientations, and communication, digitization in data accuracy, auditability and back traceability have also been discussed. This book will be a preferred source for principal investigators, research scholars, and industrial research centers globally. From the foreword by Ratan Tata, India “This book will be a guide for students and professionals alike in quality assurance practices related to clinical research labs. The historical research and fundamental principles make it a good tool in clinical research environments. The country has a great need for such a compilation in order to increase the application of domestic capabilities and technology”

Implementing Quality in Laboratory Policies and Processes

Implementing Quality in Laboratory Policies and Processes
Author: Donnell R. Christian, Jr.
Publisher: CRC Press
Total Pages: 1434
Release: 2009-11-24
Genre: Science
ISBN: 1420073052

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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