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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".
The issue of data quality is as old as data itself. However, the proliferation of diverse, large-scale and often publically available data on the Web has increased the risk of poor data quality and misleading data interpretations. On the other hand, data is now exposed at a much more strategic level e.g. through business intelligence systems, increasing manifold the stakes involved for individuals, corporations as well as government agencies. There, the lack of knowledge about data accuracy, currency or completeness can have erroneous and even catastrophic results. With these changes, traditional approaches to data management in general, and data quality control specifically, are challenged. There is an evident need to incorporate data quality considerations into the whole data cycle, encompassing managerial/governance as well as technical aspects. Data quality experts from research and industry agree that a unified framework for data quality management should bring together organizational, architectural and computational approaches. Accordingly, Sadiq structured this handbook in four parts: Part I is on organizational solutions, i.e. the development of data quality objectives for the organization, and the development of strategies to establish roles, processes, policies, and standards required to manage and ensure data quality. Part II, on architectural solutions, covers the technology landscape required to deploy developed data quality management processes, standards and policies. Part III, on computational solutions, presents effective and efficient tools and techniques related to record linkage, lineage and provenance, data uncertainty, and advanced integrity constraints. Finally, Part IV is devoted to case studies of successful data quality initiatives that highlight the various aspects of data quality in action. The individual chapters present both an overview of the respective topic in terms of historical research and/or practice and state of the art, as well as specific techniques, methodologies and frameworks developed by the individual contributors. Researchers and students of computer science, information systems, or business management as well as data professionals and practitioners will benefit most from this handbook by not only focusing on the various sections relevant to their research area or particular practical work, but by also studying chapters that they may initially consider not to be directly relevant to them, as there they will learn about new perspectives and approaches.
Quality Systems Handbook is a reference book that covers concepts and ideas in quality system. The book is comprised of two parts. Part 1 provides the background information of ISO 9000, such as its origin, composition, application, and the strategies for registration. Part 2 covers topics relevant to the ISO 9000 requirements, which include design control, internal quality audits, and statistical techniques. The text will be useful to managers, auditors, and quality practitioners who require reference in the various aspects of quality systems.