Laboratory Accreditation and Data Certification

Laboratory Accreditation and Data Certification PDF

Author: Carla H. Dempsey

Publisher: CRC Press

Published: 2020-08-26

Total Pages: 258

ISBN-13: 1000157741

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This book provides descriptions of current laboratory accreditation schemes and explains why these schemes fall short of assuring data purchasers that the data produced from accredited laboratories are always quality products. The book then presents a system for laboratory accreditation in conjunction with data certification that assures data purchasers their data are useful for the purposes for which they are intended. Simple quality assurance and quality control techniques, in addition to concepts of total quality management, are described and then applied to the environmental laboratory industry. This "System For Success" was developed from real problems and real solutions within the industry and represents an integration of proven techniques that offer a better way to ensure quality laboratory data is obtained. Laboratory Accreditation: A Workable Solution is a must for government officials, environmental professionals, independent environmental laboratories, hazardous waste disposal industries, chemical manufacturers, QA professionals, and testing laboratories.

Accreditation and Quality Assurance in Analytical Chemistry

Accreditation and Quality Assurance in Analytical Chemistry PDF

Author: Helmut Günzler

Publisher: Springer Science & Business Media

Published: 2012-12-06

Total Pages: 279

ISBN-13: 364250079X

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Quality assurance and accreditation in analytical chemistry laboratories is an important issue on the national and international scale. The book presents currently used methods to assure the quality of analytical results and it describes accreditation procedures for the mutual recognition of these results. The book describes in detail the accreditation systems in 13 European countries and the present situation in the United States of America. The editor also places high value on accreditation and certification practice and on the relevant legislation in Europe. The appendix lists invaluable information on important European accreditation organizations.

Laboratory Quality Management System

Laboratory Quality Management System PDF

Author: World Health Organization

Publisher:

Published: 2011

Total Pages: 0

ISBN-13: 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".

GALP Regulatory Handbook

GALP Regulatory Handbook PDF

Author: Sandy Weinberg

Publisher: CRC Press

Published: 1994-06-02

Total Pages: 470

ISBN-13: 9781566700252

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The GALP Regulatory Handbook is an easy-to-use manual to assist laboratories in applying the Good Automated Laboratory Practice guidelines published by the Environmental Protection Agency in 1990. The proliferation of computerized data collection has resulted in new problems of corruption, loss, and inappropriate modification in data provided to the EPA. The EPA published its GALP guidelines to aid laboratories replacing manual operations with computer technology. The eight chapters of this handbook provide a "how-to" framework for complying with those guidelines. The book looks at the extent and seriousness of those control issues for automated data collection systems, the intent of the GALPs in solving and preventing those problems, and the implementation guidelines that can help laboratory management maintain the compliance and quality that are fundamental to effective operation.

Implementing ISO/IEC 17025:2005

Implementing ISO/IEC 17025:2005 PDF

Author: Bhavan "Bob" Mehta

Publisher: Quality Press

Published: 2013-04-16

Total Pages: 225

ISBN-13: 0873898540

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The purpose of this book is to demystify the requirements delineated within ISO/IEC 17025:2005 while providing a road map for organizations that wish to receive/maintain accreditation for their laboratories. AS9100, ISO 9001, and ISO 13485 are standards that support the development and implementation of effective approaches to quality management and are recognized blueprints for the establishment of a quality management system (QMS) for diverse industries. Although similar to these recognized QMS standards, ISO/IEC 17025 serves a unique purpose: laboratory accreditation. It is not unusual for laboratories to retain dual certification to ISO 9001 and ISO/IEC 17025.

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