Laboratory Quality Management System

Author : World Health Organization
Publisher : Unknown
Page : 0 pages
File Size : 46,7 Mb
Release : 2011
Category : Laboratories
ISBN : 9241548274

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Laboratory Quality Management System by World Health Organization Pdf

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 : James O. Westgard
Publisher : Unknown
Page : 286 pages
File Size : 46,8 Mb
Release : 2014-01-01
Category : Medical
ISBN : 1886958289

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Basic Quality Management Systems by James O. Westgard Pdf

Author : Ramesh R Lakhe,Rakesh L Shrivastava,Prakash H Bhave,Sapan Kumar Ganguly,M M Naveed
Publisher : Educreation Publishing
Page : 298 pages
File Size : 51,8 Mb
Release : 2018-12-30
Category : Education
ISBN : 8210379456XXX

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Iso 17025 2017 Lab Quality Management System by Ramesh R Lakhe,Rakesh L Shrivastava,Prakash H Bhave,Sapan Kumar Ganguly,M M Naveed Pdf

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.

Author : Thomas A. Ratliff
Publisher : John Wiley & Sons
Page : 246 pages
File Size : 40,5 Mb
Release : 2005-03-11
Category : Technology & Engineering
ISBN : 9780471721666

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The Laboratory Quality Assurance System by Thomas A. Ratliff Pdf

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 : Gaffar Zaman
Publisher : BoD – Books on Demand
Page : 160 pages
File Size : 47,7 Mb
Release : 2018-08-22
Category : Business & Economics
ISBN : 9781789234121

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Quality Control in Laboratory by Gaffar Zaman Pdf

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 : Russell T. Westcott
Publisher : Quality Press
Page : 460 pages
File Size : 41,7 Mb
Release : 2013-10-07
Category : Business & Economics
ISBN : 9780873898614

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The Certified Manager of Quality/Organizational Excellence Handbook, Fourth Edition by Russell T. Westcott Pdf

This handbook is a comprehensive reference source designed to help professionals address organizational issues from the application of the basic principles of management to the development of strategies needed to deal with the technological and societal concerns of the new millennium. The content of this fourth edition has been revised to reflect a more current global perspective and to match the updated Body of Knowledge (BoK) of ASQ’s Certified Manager of Quality/Organizational Excellence (CMQ/OE). In order to provide a broad perspective of quality management, this book has specifically been written to address: • Historical perspectives relating to the evolution of particular aspects of quality management, including recognized experts and their contributions • Key principles, concepts, and terminology relevant in providing quality leadership, and communicating quality needs and results • Benefits associated with the application of key concepts and quality management principles • Best practices describing recognized approaches for good quality management • Barriers to success, including common problems that the quality manager might experience when designing and implementing quality management, and insights as to why some quality initiatives fail • Guidance for preparation to take the CMQ/OE examination. Organized to follow the BoK exactly, throughout each section of this handbook the categorical BoK requirements associated with good quality management practices for that section are shown in a box preceding the pertinent text. These BoK requirements represent the range of content and the cognitive level to which multiple-choice questions can be presented. Although this handbook thoroughly prepares individuals for the ASQ CMQ/OE exam, the real value resides in post-exam usage as a day-to-day reference source for assessing quality applications and methodologies in daily processes. The content is written from the perspective of practitioners, and its relevance extends beyond traditional product quality applications.

Author : Sharon T. Mortimer,David Mortimer
Publisher : Cambridge University Press
Page : 241 pages
File Size : 51,8 Mb
Release : 2015-03-02
Category : Medical
ISBN : 9781107421288

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Quality and Risk Management in the IVF Laboratory by Sharon T. Mortimer,David Mortimer Pdf

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

Author : George S. Cembrowski,R. Neill Carey
Publisher : Unknown
Page : 292 pages
File Size : 52,8 Mb
Release : 1989
Category : Pathological laboratories
ISBN : UOM:39015017740971

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Laboratory Quality Management by George S. Cembrowski,R. Neill Carey Pdf

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 : Erhabor Osaro,Adias Teddy Charles
Publisher : AuthorHouse
Page : 349 pages
File Size : 45,9 Mb
Release : 2012-10
Category : Antiques & Collectibles
ISBN : 9781477231081

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Laboratory Total Quality Management for Practitioners and Students of Medical Laboratory Science by Erhabor Osaro,Adias Teddy Charles Pdf

This book will enable the production of reliable, accurate, reproducible (best possible care) results that satisfies the customer's requirements obtained from an accredited, process oriented, health and safety conscious laboratory that is cost effectively run (value for money) by qualified, certified and highly motivated biomedical staff (Joy and pride at work) using well maintained, validated and quality controlled equipments and appropriately stored reagents on the right sample drawn from the right patient that is appropriately communicated in a timely fashion to the requesting clinician to enable them render the best possible evidenced- based medical care to their patients.

Author : Akshay Anand
Publisher : Springer Nature
Page : 247 pages
File Size : 43,8 Mb
Release : 2021-08-17
Category : Medical
ISBN : 9789811630743

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Quality Assurance Implementation in Research Labs by Akshay Anand Pdf

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 : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Committee on the Return of Individual-Specific Research Results Generated in Research Laboratories
Publisher : National Academies Press
Page : 399 pages
File Size : 53,8 Mb
Release : 2018-09-23
Category : Medical
ISBN : 9780309475174

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Returning Individual Research Results to Participants by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Committee on the Return of Individual-Specific Research Results Generated in Research Laboratories Pdf

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.

Author : Moumtzoglou, Anastasius
Publisher : IGI Global
Page : 354 pages
File Size : 55,9 Mb
Release : 2014-07-31
Category : Computers
ISBN : 9781466663213

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Laboratory Management Information Systems: Current Requirements and Future Perspectives by Moumtzoglou, Anastasius Pdf

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.

Author : Sean Doyle
Publisher : Academic Press
Page : 426 pages
File Size : 47,9 Mb
Release : 2018-11-20
Category : Law
ISBN : 9780128094242

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Quality Management in Forensic Science by Sean Doyle Pdf

Forensic science has been under scrutiny for some time, since the release of the NAS report in 2009. The report cited the need for standardized practices and the accreditation of crime labs. No longer can the forensic community take the position that cross-examination in a courtroom will expose weaknesses in methodology and execution. Quality Management in Forensic Science covers a wide spectrum of forensic disciplines, relevant ISO and non-ISO standards, accreditation and quality management systems necessary in any forensic science laboratory. Written by a globally well-respected forensic scientist with decades of experience in the forensic science laboratory and on the stand, as an expert witness who is also a Fellow of both the Royal Society of Chemistry and the Chartered Society of Forensic Sciences. This book will be a must-have resource for all forensic science stakeholders, particularly law enforcement agents and lawyers less familiar with the impact of quality management on the reliability of scientific evidence. A comprehensive, multidisciplinary reference of scientific practices for use in the forensic laboratory Coverage from DNA to toxicology, from trace evidence to crime scene and beyond Extensive review of ISO and non-ISO standards, accreditation, QMS and much more Written by a foremost forensic scientist with decades of experience in the laboratory and as an expert witness

Author : Candis A. Kinkus
Publisher : Demos Medical Publishing
Page : 192 pages
File Size : 48,9 Mb
Release : 2011-11-01
Category : Business & Economics
ISBN : 9781936287451

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Laboratory Management by Candis A. Kinkus Pdf

A key issue for every laboratory and individual practitioner is the assessment of risk and current working knowledge of the standards of care established for diagnostic testing via guidelines, major studies and trials. the diagonstic Standards of Care series presents an overview of the key diagnoses in clinical pathology using case examples to illustrate effective analysis of the case in light of current evidence and standards for the problem discussed. In addition to being practical diagnostic guides, these volumes will have a unique emphasis on quality assurance and evidence-based testing pr

Author : Kenneth N. Parson
Publisher : Xlibris Corporation
Page : 135 pages
File Size : 42,7 Mb
Release : 2012-12-29
Category : Business & Economics
ISBN : 9781479753963

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LABORATORY QUALITY/MANAGEMENT by Kenneth N. Parson Pdf

This book should be of interest to the management of all types of laboratories supporting all types of scientifi c disciplines. Even though the scientifi c processes may be different the overall approach to management is very similar including how technical processes should be managed and controlled. The book addresses principal elements of laboratory management, technical and support operations and offers several detailed “how to” procedures designed to help laboratory management to establish and maintain control through a continuous low level internal audit, (self assessment) process. This activity enables management to take prompt corrective action, maintain control and provides the ability to measure improvement over time toward achieving a higher, more effi cient, cost effective level of quality services to its assigned customers. The objective of this book is to expand on the knowledge and understanding of laboratory quality/management system process.