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With the publication of the Final CLIA Rule, new method validation responsibilities came to the laboratory. Previously, moderately complex methods did not need to be validated. But the Final Rule combined moderately and highly complex methods into a category of non-waived methods. Now Laboratories must validate all non-waived methods introduced after April 24, 2003. To help laboratory professionals comply with these new regulatory changes, a second edition of this manual was prepared. Book jacket.
"This book is about the use of modern statistical methods for quality control and improvement. It provides comprehensive coverage of the subject from basic principles to state-of-the-art concepts. and applications. The objective is to give the reader a sound understanding of the principles and the basis for applying them in a variety of situations. Although statistical techniques are emphasized. throughout, the book has a strong engineering and management orientation. Extensive knowledge. of statistics is not a prerequisite for using this book. Readers whose background includes a basic course in statistical methods will find much of the material in this book easily accessible"--
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".
This comprehensive reference on software development quality assurance addresses all four dimensions of quality: specifications, design, construction and conformance. It focuses on quality from both the micro and macro view. From a micro view, it details the aspect of building-in quality at the component level to help ensure that the overall deliverable has ingrained quality. From a macro view, it addresses the organizational level activities that provide an environment conducive to fostering quality in the deliverables as well as developing a culture focused on quality in the organization. Mastering Software Quality Assurance also explores a process driven approach to quality, and provides the information and guidance needed for implementing a process quality model in your organization. It includes best practices and valuable tools and techniques for software developers.Key Features • Provides a comprehensive, inclusive view of software quality • Tackles the four dimensions of quality as applicable to software development organizations • Offers unique insights into achieving quality at the component level • Deals comprehensively with all aspects of measuring software quality • Explores process quality from the standpoint of implementation rather than from the appraiser/assessor point of view • Delivers a bird's eye view of the ISO and CMMI models, and describes necessary steps for attaining conformance to those models
Second in a series of publications from the Institute of Medicine's Quality of Health Care in America project Today's health care providers have more research findings and more technology available to them than ever before. Yet recent reports have raised serious doubts about the quality of health care in America. Crossing the Quality Chasm makes an urgent call for fundamental change to close the quality gap. This book recommends a sweeping redesign of the American health care system and provides overarching principles for specific direction for policymakers, health care leaders, clinicians, regulators, purchasers, and others. In this comprehensive volume the committee offers: A set of performance expectations for the 21st century health care system. A set of 10 new rules to guide patient-clinician relationships. A suggested organizing framework to better align the incentives inherent in payment and accountability with improvements in quality. Key steps to promote evidence-based practice and strengthen clinical information systems. Analyzing health care organizations as complex systems, Crossing the Quality Chasm also documents the causes of the quality gap, identifies current practices that impede quality care, and explores how systems approaches can be used to implement change.
This definitive new book should appeal to everyone who produces, uses, or evaluates scientific data. Ensures accuracy and reliability. Dr. Taylor's book provides guidance for the development and implementation of a credible quality assurance program, plus it also provides chemists and clinical chemists, medical and chemical researchers, and all scientists and managers the ideal means to ensure accurate and reliable work. Chapters are presented in a logical progression, starting with the concept of quality assurance, principles of good measurement, principles of quality assurance, and evaluation of measurement quality. Each chapter has a degree of independence so that it may be consulted separately from the others.
Food quality control and management has been an important issue since the time when ancient people dried meat, vegetables and fruits to be used in the next season. Over the years, people became more involved in the processing and production of safe and sustainable food items that brings better taste and quality to the consumer. But the fact is that the processing methods, the results and the way in which food was preserved for later use became even more complicated and sophisticated. One of the first preservation techniques used in ancient times was salting. Salt was used to reduce the risk of developing fungus and other microorganisms in food. Though, the lack of knowledge in microbiology and food pathology hindered the development of more techniques to preserve quality, texture, taste and aroma. For this reason, as the time passed, people started to develop new techniques that preserved food in it natural characteristics. It was studied how to control the decay process and how to improve the food quality by controlling various risk factors effectively. These methods were introduced with the help of increasing knowledge in the field of microbiology and biotechnology. The findings helped to develop different substances, methods and equipment to reduce the risks in preserved and packaged food. These techniques were useful for improving shelf life and for providing sustainable food items that stay healthy for a longer period of time. Nowadays, advancements in food quality and control have brought the innovative features of quality management that collect: management, checks, inspection and testing procedures. There is a great emphasis on managing the quality factor through multiple aspects and implementing the highest standards of HACCP and ISO so that consumers take safe and healthy food. The more recent developments are towards the environmentally friendly packaging and use of healthy methods to reduce risks to the ecosystem. This book covers all the basic concepts regarding the history, present practices and all the future possibilities affecting quality control in the food industry. This will help readers in the understanding of the importance of food quality control in the food industry and its evolution towards the highest standard of consumer-focused production.