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Author : Pamposh Kumar
Publisher : Unknown
Page : 213 pages
File Size : 52,7 Mb
Release : 2005-02-01
Category : Laboratories
ISBN : 8123912315
Author : World Health Organization
Publisher : Unknown
Page : 0 pages
File Size : 42,5 Mb
Release : 2011
Category : Laboratories
ISBN : 9241548274
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
Page : 246 pages
File Size : 46,7 Mb
Release : 2005-03-11
Category : Technology & Engineering
ISBN : 9780471721666
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 : Saverio Mannino
Publisher : Springer Nature
Page : 170 pages
File Size : 44,7 Mb
Release : 2022-11-22
Category : Technology & Engineering
ISBN : 9783031117244
This useful and extensive set of guidelines is designed to assist food control laboratories in gaining accreditation from an internationally recognized external body, providing all of the necessary information and practices in an easy-to-read, step-by-step fashion. Authored by an experienced consultant for laboratory accreditation in many different countries, with this text food control lab owners now have all of the up-to-date information they need to gain accreditation in a single source. Guidelines for Laboratory Quality Managers covers the essentials for quality management in the food control laboratory, from testing processes to current quality management systems. The ISO standards for accreditation are extensively explored, including managerial requirements, organizational aspects, complaint handling procedures, internal audits, and sampling. An entire section is dedicated to the implementation of managerial and technical requirements from quality control to program monitoring and evaluation. Analysis selection, preparation, and validation is covered extensively, and an entire section is dedicated to basic statistics from data presentation to distribution. Each section comes with helpful tips for lab managers plus definitions and terms. Comprehensive, easy-to-use and up-to-date, Guidelines for Laboratory Quality Managers is the guide for accreditation for food control laboratories.
Author : Camille McKay
Publisher : Springer Nature
Page : 241 pages
File Size : 50,9 Mb
Release : 2024-05-21
Category : Electronic
ISBN : 9783031524349
Author : Frederick M. Garfield,Eugene Klesta,Jerry Hirsch
Publisher : Association of Official Analytical Chemist
Page : 200 pages
File Size : 44,9 Mb
Release : 2000
Category : Medical
ISBN : UOM:39015055077930
Author : Kenneth N. Parson
Publisher : Xlibris Corporation
Page : 135 pages
File Size : 51,5 Mb
Release : 2012-12-29
Category : Business & Economics
ISBN : 9781479753963
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.
Author : James O. Westgard
Publisher : Unknown
Page : 286 pages
File Size : 43,5 Mb
Release : 2014-01-01
Category : Medical
ISBN : 1886958289
Author : D.H. Stamatis
Publisher : Routledge
Page : 284 pages
File Size : 44,9 Mb
Release : 2018-12-12
Category : Technology & Engineering
ISBN : 9781351406246
This work examines the evolution and rationale of the ISO 9000 series of standards, their structure, interpretation and relationship to other quality systems. Theory and applications are provided, and the author explains how to put the standards into place and achieve quality. Specific methods and tools for the implementation of the ISO standards that lead to certification and certification maintenance are supplied.
Author : Richard L. Hodinka,Stephen A. Young,Benjamin A. Pinksy
Publisher : John Wiley & Sons
Page : 622 pages
File Size : 40,5 Mb
Release : 2020-07-10
Category : Medical
ISBN : 9781555819156
The definitive clinical virology resource for physicians and clinical laboratory virologists The clinical virology field is rapidly evolving and, as a result, physicians and clinical laboratory virologists must have a reliable reference tool to aid in their ability to identify and diagnose viral infections to prevent future outbreaks. In this completely revised edition of the Clinical Virology Manual, Editor in Chief, Michael Loeffelholz, along with Section Editors, Richard Hodinka, Benjamin Pinsky, and Stephen Young, have complied expert perspectives of a renowned team of clinical virology experts and divided these contributions into three sections to provide the latest information on the diagnosis of viral infections, including ebola, HIV and Human papillomavirus state of the art diagnostic technologies, including next-generation sequencing and nucleic acid amplification methods taxonomy of clinically important viruses such as polyomaviruses and zoonotic viruses This comprehensive reference also includes three appendices with vital information on reference virology laboratories at the Centers for Disease Control and Prevention, state and local public health laboratories, and international reference laboratories and laboratory systems. Additionally, a new section "Diagnostic Best Practices," which summarizes recommendations for diagnostic testing, and cites evidence-based guidelines, is included in each viral pathogens chapter. Clinical Virology Manual, Fifth Edition serves as a reference source to healthcare professionals and laboratorians in providing clinical and technical information regarding viral diseases and the diagnosis of viral infections.
Author : Leonard Steinborn
Publisher : CRC Press
Page : 452 pages
File Size : 45,5 Mb
Release : 2004-12-30
Category : Medical
ISBN : 9780203026656
This well-known QA manual has been updated to provide the guidance readers need to assess their compliance with standard regulations. This Volume 2 of a three-part package contains the full text on: * FDA regulations* EC and IPEC guidelines* ISO/BSI standards referenced in the checklists furnished in volume 1Easy-to-read and organized to provide fa
Author : World Health Organization
Publisher : World Health Organization
Page : 156 pages
File Size : 54,5 Mb
Release : 2022-10-31
Category : Medical
ISBN : 9789240061507
Author : Joseph F. Lamond,J. H. Pielert
Publisher : ASTM International
Page : 661 pages
File Size : 41,7 Mb
Release : 2006
Category : Technology & Engineering
ISBN : 9780803133679
Author : M. Naveed,Kranti Dharkar,Ramesh Lakhe
Publisher : Unknown
Page : 101 pages
File Size : 53,9 Mb
Release : 2019-03-14
Category : Electronic
ISBN : 109048481X
This book presents the Quality System Procedure for implementation of ISO 17025:2017 Lab Quality Management System Standard. It covers all the mandatory procedures required by the standard and other relevant procedures. Total 25 procedures are included in this book. Each Procedure is formatted and the records related to it are specified. Diagrams are included in the procedure to understand the clause requirements. The organizations going for Lab Accreditation or wants improvement in the system will find this book useful for developing their own procedure manual which would suffice to the standard requirements.
Author : National Academies of Sciences, Engineering, and Medicine,Division on Earth and Life Studies,Board on Earth Sciences and Resources,Committee to Review the U.S. Geological Survey's Laboratories
Publisher : National Academies Press
Page : 89 pages
File Size : 41,8 Mb
Release : 2020-01-23
Category : Science
ISBN : 9780309495622
The U.S. Geological Survey (USGS) mission is to provide reliable and impartial scientific information to understand Earth, minimize loss of life and property from natural disasters, and manage water, biological, energy, and mineral resources. Data collection, analysis, interpretation, and dissemination are central to everything the USGS does. Among other activities, the USGS operates some 250 laboratories across the country to analyze physical and biological samples, including water, sediment, rock, plants, invertebrates, fish, and wildlife. The data generated in the laboratories help answer pressing scientific and societal questions or support regulation, resource management, or commercial applications. At the request of the USGS, this study reviews a representative sample of USGS laboratories to examine quality management systems and other approaches for assuring the quality of laboratory results and recommends best practices and procedures for USGS laboratories.