Laboratory Quality Assurance
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Author | : World Health Organization |
Publisher | : |
Total Pages | : 0 |
Release | : 2011 |
Genre | : Laboratories |
ISBN | : 9789241548274 |
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 | : Thomas A. Ratliff |
Publisher | : John Wiley & Sons |
Total Pages | : 246 |
Release | : 2005-03-11 |
Genre | : Technology & Engineering |
ISBN | : 0471721662 |
Both the 17025:1999 standard and especially ANSI/ISO/ASQ,9001-2000 standard require that a laboratory document its procedures for obtaining reliable results. The Laboratory Quality Assurance Manual details to the user how to a prepare a new laboratory quality assurance manual, which will be appropriate to use as a procedures manual for a particular laboratory, a sales tool to attract potential customers, a document that can be to answer regulatory questions, and ultimately a tool to become a registered ISO 9001/2000 Lab and gain related certifications based on the standard. The Laboratory Quality Assurance Manual: -Incoporates changes to ANSI/ISO/ASQ 9001-2000 pertaining to laboratories. -Provides blank forms used in preparing a quality manual. -Provides information on the interrelationship of ANSI/ISO 17025:1999 and ANSI/ISO/ASQ 9001-2000.
Author | : Akshay Anand |
Publisher | : Springer Nature |
Total Pages | : 247 |
Release | : 2021-08-17 |
Genre | : Medical |
ISBN | : 9811630747 |
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”
Author | : George S. Cembrowski |
Publisher | : |
Total Pages | : 292 |
Release | : 1989 |
Genre | : Medical |
ISBN | : |
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 | : Gaffar Zaman |
Publisher | : BoD – Books on Demand |
Total Pages | : 160 |
Release | : 2018-08-22 |
Genre | : Business & Economics |
ISBN | : 1789234123 |
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 | : Maciej J. Bogusz |
Publisher | : CRC Press |
Total Pages | : 376 |
Release | : 2011-02-22 |
Genre | : Law |
ISBN | : 1439802351 |
Quality refers to the amount of the unpriced attributes contained in each unit of the priced attribute.Leffler, 1982Quality is neither mind nor matter, but a third entity independent of the two, even though Quality cannot be defined, you know what it is.Pirsig, 2000The continuous formulation of good practices and procedures across fields reflects t
Author | : Piotr Konieczka |
Publisher | : CRC Press |
Total Pages | : 280 |
Release | : 2020-06-30 |
Genre | : |
ISBN | : 9780367571825 |
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 | : Aiha Analytical Chemistry Committee |
Publisher | : Amer Industrial Hygiene Assn |
Total Pages | : 110 |
Release | : 1997-12-01 |
Genre | : Environmental laboratories |
ISBN | : 9780932627834 |
Author | : D. Brynn Hibbert |
Publisher | : Oxford University Press |
Total Pages | : 321 |
Release | : 2007-03-29 |
Genre | : Science |
ISBN | : 0198036728 |
Analytical chemical results touch everyones lives can we eat the food? do I have a disease? did the defendant leave his DNA at the crime scene? should I invest in that gold mine? When a chemist measures something how do we know that the result is appropriate? What is fit for purpose in the context of analytical chemistry? Many manufacturing and service companies have embraced traditional statistical approaches to quality assurance, and these have been adopted by analytical chemistry laboratories. However the right chemical answer is never known, so there is not a direct parallel with the manufacture of ball bearings which can be measured and assessed. The customer of the analytical services relies on the quality assurance and quality control procedures adopted by the laboratory. It is the totality of the QA effort, perhaps first brought together in this text, that gives the customer confidence in the result. QA in the Analytical Chemistry Laboratory takes the reader through all aspects of QA, from the statistical basics and quality control tools to becoming accredited to international standards. The latest understanding of concepts such as measurement uncertainty and metrological traceability are explained for a working chemist or her client. How to design experiments to optimize an analytical process is included, together with the necessary statistics to analyze the results. All numerical manipulation and examples are given as Microsoft Excel spreadsheets that can be implemented on any personal computer. Different kinds of interlaboratory studies are explained, and how a laboratory is judged in proficiency testing schemes is described. Accreditation to ISO 17025 or OECD GLP is nearly obligatory for laboratories of any pretension to quality. Here the reader will find an introduction to the requirements and philosophy of accreditation. Whether completing a degree course in chemistry or working in a busy analytical laboratory, this book is a single source for an introduction into quality assurance.
Author | : National Research Council |
Publisher | : National Academies Press |
Total Pages | : 270 |
Release | : 1996-12-12 |
Genre | : Science |
ISBN | : 0309134404 |
In 1992 the National Research Council issued DNA Technology in Forensic Science, a book that documented the state of the art in this emerging field. Recently, this volume was brought to worldwide attention in the murder trial of celebrity O. J. Simpson. The Evaluation of Forensic DNA Evidence reports on developments in population genetics and statistics since the original volume was published. The committee comments on statements in the original book that proved controversial or that have been misapplied in the courts. This volume offers recommendations for handling DNA samples, performing calculations, and other aspects of using DNA as a forensic toolâ€"modifying some recommendations presented in the 1992 volume. The update addresses two major areas: Determination of DNA profiles. The committee considers how laboratory errors (particularly false matches) can arise, how errors might be reduced, and how to take into account the fact that the error rate can never be reduced to zero. Interpretation of a finding that the DNA profile of a suspect or victim matches the evidence DNA. The committee addresses controversies in population genetics, exploring the problems that arise from the mixture of groups and subgroups in the American population and how this substructure can be accounted for in calculating frequencies. This volume examines statistical issues in interpreting frequencies as probabilities, including adjustments when a suspect is found through a database search. The committee includes a detailed discussion of what its recommendations would mean in the courtroom, with numerous case citations. By resolving several remaining issues in the evaluation of this increasingly important area of forensic evidence, this technical update will be important to forensic scientists and population geneticistsâ€"and helpful to attorneys, judges, and others who need to understand DNA and the law. Anyone working in laboratories and in the courts or anyone studying this issue should own this book.