Laboratory Quality Management System

Laboratory Quality Management System
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".

The Laboratory Quality Assurance System

The Laboratory Quality Assurance System
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.

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

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”

Laboratory Quality Management

Laboratory Quality Management
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.

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

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.

Quality Assurance in the Pathology Laboratory

Quality Assurance in the Pathology Laboratory
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

Handbook of Quality Assurance in Laboratory Medicine

Handbook of Quality Assurance in Laboratory Medicine
Author: Shubangi Tambwekar
Publisher: Wolters kluwer india Pvt Ltd
Total Pages: 209
Release: 2015-01-01
Genre: Medical
ISBN: 9351293319

Quality Assurance (QA) is an integral and very important part of laboratory medicine. Pathologists, microbiologists, biochemists and laboratory technicians all need to be proficient in this subject. QA is also mandatory for obtaining accreditation, which ensures a certain level of quality in services being provided. The subject of Quality Assurance (QA), though not new, is a relatively neglected entity and is looked at with some degree of apprehension. This book is addressed to those entrusted with implementing Quality Assurance (QA) in laboratory medicine; generally, these are persons with basic training as pathologists. This handbook is meant as a beginner and handy guide to Quality Assurance; all the basics of Quality Assurance have been incorporated to encourage the beginner to make a start.

Quality Assurance in the Analytical Chemistry Laboratory

Quality Assurance in the Analytical Chemistry Laboratory
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.

Quality Assurance and Quality Control in the Analytical Chemical Laboratory

Quality Assurance and Quality Control in the Analytical Chemical Laboratory
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.

Handbook of Quality Assurance for the Analytical Chemistry Laboratory

Handbook of Quality Assurance for the Analytical Chemistry Laboratory
Author: J. Dux
Publisher: Springer Science & Business Media
Total Pages: 205
Release: 2013-11-11
Genre: Medical
ISBN: 1475753772

xii a second edition might be in order, and readily agreed. Although the basic principles remain the same, discussions with analysts, laboratory supervisors, and managers indicated many areas where improve ments could be made. For example, new chapters have been added on sampling and quality assurance; laboratory facilities and quality assurance; and auditing for quality assurance. Very little of the first edition has been discarded, but many topics have been expanded considerably. The chapter on computers has been completely rewritten in view of the rapid changes in that field. The chapter in the first edition on planning and organizing for quality assurance has been split into two chapters, one on planning for quality assurance and the other on organizing and establishing a quality assurance program, and new material on mandated quality assurance programs has been combined with the material on laboratory accreditation. Numerous examples, especially those involving mathematical calculations, have been added at the suggestion of some readers. In short, this edition is very nearly a new book, and I can only hope it is as well received as the first edition. CHAPTER 1 Quality, Quality Control, and Quality Assurance One of the strongest trends in modem society is the continuing ev olution from a manufacturing to a service-oriented economy.