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".

Quality Management Systems

Quality Management Systems PDF

Author: Ray Tricker

Publisher: Routledge

Published: 2019-11-05

Total Pages: 302

ISBN-13: 1000728129

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This book provides a clear, easy to digest overview of Quality Management Systems (QMS). Critically, it offers the reader an explanation of the International Standards Organization’s (ISO) requirement that in future all new and existing Management Systems Standards will need to have the same high-level structure, commonly referred to as Annex SL, with identical core text, as well as common terms and definitions. In addition to explaining what Annex SL entails, this book provides the reader with a guide to the principles, requirements and interoperability of Quality Management System standards, how to complete internal and external management reviews, third-party audits and evaluations, as well as how to become an ISO Certified Organisation once your QMS is fully established. As a simple and straightforward explanation of QMS Standards and their current requirements, this is a perfect guide for practitioners who need a comprehensive overview to put theory into practice, as well as for undergraduate and postgraduate students studying quality management as part of broader Operations and Management courses.

Building Quality Management Systems

Building Quality Management Systems PDF

Author: Luis Rocha-Lona

Publisher: CRC Press

Published: 2017-08-21

Total Pages: 201

ISBN-13: 1466565004

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Quality has quickly become one of the most important decision-making factors for consumers. And although organizations invest considerable resources into building the right quality management systems (QMSs), in many instances, the adoption of such quality improvement tools are just not enough. Building Quality Management Systems: Selecting the Righ

Achieving Customer Experience Excellence through a Quality Management System

Achieving Customer Experience Excellence through a Quality Management System PDF

Author: Alka Jarvis

Publisher: Quality Press

Published: 2016-07-04

Total Pages: 228

ISBN-13: 1953079687

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For the past decade, process validation issues ranked within the top six of Food and Drug Administration (FDA) form 483 observation findings issued each year. This poses a substantial problem for the medical device industry and is the reason why the authors wanted to write this book. The authors will share their collective knowledge: to help organizations improve patient safety and increase profitability while maintaining a state of compliance with regulations and standards. This book was written to assist quality technicians, engineers, managers, and others that need to plan, conduct, and monitor validation activities. To that end, the intent of this book is to provide the quality professional working in virtually any industry a quick, convenient, and comprehensive guide to properly conducting process validations that meet regulatory and certification requirements. It provides an introduction and background to the requirements necessary to perform process validations that will comply with regulatory and certification body requirements.

ISO 9001 Quality Management Systems

ISO 9001 Quality Management Systems PDF

Author: Dhanasekharan Natarajan

Publisher: Springer

Published: 2017-03-24

Total Pages: 160

ISBN-13: 3319543830

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This book explains the requirements of ISO 9001 for establishing quality management system (QMS) for an organization. The requirements are illustrated with examples from industries for understanding the requirements and preparing the documents of QMS with high clarity. Methods of integrating ISO 9001 requirements with enterprise resource planning (ERP) software are presented. The software integrated approach enables process owners to focus on their core tasks of achieving the planned outputs of processes and the software generates quality records automatically.

The Global Quality Management System

The Global Quality Management System PDF

Author: Suresh Patel

Publisher: CRC Press

Published: 2016-02-24

Total Pages: 223

ISBN-13: 1498788319

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The Global Quality Management System: Improvement Through Systems Thinking shows you how to understand and implement a global quality management system (GQMS) to achieve world-class business excellence. It illustrates the business excellence pyramid with the foundation of management systems at the system level, Lean System at the operational level,

Handbook of Total Quality Management

Handbook of Total Quality Management PDF

Author: Christian N. Madu

Publisher: Springer Science & Business Media

Published: 2012-12-06

Total Pages: 830

ISBN-13: 1461552818

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Quality issues are occupying an increasingly prominent position in today's global business market, with firms seeking to compete on an international level on both price and quality. Consumers are demanding higher quality standards from manufacturers and service providers, while virtually all industrialized nations have instituted quality programs to help indigenous corporations. A proliferation in nation-wide and regional quality awards such as the Baldridge award and certification to ISO 9000 series are making corporations world-wide quality-conscious and eager to implement programs of continuous improvement. To achieve competitiveness, quality practice is a necessity and this book offers an exposition of how quality can be attained. The Handbook of Total Quality Management: Explores in separate chapters new topics such as re-engineering, concurrent engineering, ISO standards, QFD, the Internet, the environment, advanced manufacturing technology and benchmarking Discusses the views of leading quality practitioners such as Derning, Juran, Ishikawa, Crosby and Taguchi throughout the book Considers important strategies for quality improvement, including initiation and performance evaluation through auditing, re-engineering, and process and design innovations. With contributions from 47 authors in 13 different countries, the Handbook of Total Quality Management is invaluable as a reference guide for anyone involved with quality management and deployment, including consultants, practitioners and engineers in the professional sector, and students and lecturers of information systems, management and industrial engineering.

Quality Management System Handbook for Product Development Companies

Quality Management System Handbook for Product Development Companies PDF

Author: Vivek Nanda

Publisher: CRC Press

Published: 2005-01-27

Total Pages: 352

ISBN-13: 1420025309

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Quality Management System Handbook for Product Development Companies describes a systematic approach for quality management and continuous improvement via a formal management system. The approach centers on a high-level process for defining a QMS from essential prerequisites to improvement mechanisms. The book outlines the five major QMS