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Quality System
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Book Synopsis Zero Quality Control by : Shigeo Shingo
Download or read book Zero Quality Control written by Shigeo Shingo and published by Taylor & Francis. This book was released on 2021-12-16 with total page 330 pages. Available in PDF, EPUB and Kindle. Book excerpt: A combination of source inspection and mistake-proofing devices is the only method to get you to zero defects. Shigeo Shingo shows you how this proven system for reducing errors turns out the highest quality products in the shortest period of time. Shingo provides 112 specific examples of poka-yoke development devices on the shop floor, most of them costing less than $100 to implement. He also discusses inspection systems, quality control circles, and the function of management with regard to inspection.
Book Synopsis Crossing the Quality Chasm by : Institute of Medicine
Download or read book Crossing the Quality Chasm written by Institute of Medicine and published by National Academies Press. This book was released on 2001-07-19 with total page 359 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis The Strategic Quality Manager by : Cathy Balding
Download or read book The Strategic Quality Manager written by Cathy Balding and published by Arcade Custom Publishing. This book was released on 2011 with total page 193 pages. Available in PDF, EPUB and Kindle. Book excerpt: Are you a quality professional working in health and aged care (or other service industry) who wants to: design and implement quality systems that make a real, positive difference to consumers? • develop your role to be more strategic and influential? • create sustained change and improvement? • build your credibility and expertise? • play a key role in your organisation’s strategic direction? • increase your job satisfaction? The Strategic Quality Manager synthesises theory, research and real world experience into a handbook developed specifically for those in quality management roles. As the pressure on our health and aged care services grows, so do the demands on the quality professional and continuing to increase the quality and transparency of healthcare will require new and savvier ways of working. If you have looked for assistance within this challenging environment, you’ll know that there is no shortage of material on quality management, but very little on being a quality manager. The Strategic Quality Manager contains theory, tips, step by step models and practical examples to assist every quality professional to more easily and proactively navigate the many of challenges of their roles – and to enjoy the journey!
Book Synopsis The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices by : Amiram Daniel
Download or read book The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices written by Amiram Daniel and published by Quality Press. This book was released on 2008-01-01 with total page 355 pages. Available in PDF, EPUB and Kindle. Book excerpt: How have recent changes in domestic and international regulations affected quality management in the development and marketing of medical devices in the US and abroad? Consultants Daniel and Kimmelman take a close look at the Quality System Regulation (QsReg), the ISO 13485: 2003 standard and the ISO/TR 14969: 2004 guidance document as well as a number of US Food and Drug Administration (FDA) and Global Harmonization Task Force (GHTF) guidance documents. The authors provide extensive commentary and notes an update their material to include such topics as the incorporation of principles of risk management into the medical device organizations' quality management systems (QMSs) and considerations of combination products. Daniel and Kimmelman include full coverage of the QSReg requirements, descriptions of comparable requirements in the ISO documents, excerpts of the FDA's responses to the QSReg preamble and excerpts from FDA guidance documents related to QMSs.
Book Synopsis Laboratory Quality Management System by : World Health Organization
Download or read book Laboratory Quality Management System written by World Health Organization and published by . This book was released on 2011 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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".
Book Synopsis The Global Quality Management System by : Suresh Patel
Download or read book The Global Quality Management System written by Suresh Patel and published by CRC Press. This book was released on 2016-02-24 with total page 166 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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,
Book Synopsis Achieving Customer Experience Excellence through a Quality Management System by : Alka Jarvis
Download or read book Achieving Customer Experience Excellence through a Quality Management System written by Alka Jarvis and published by Quality Press. This book was released on 2016-07-08 with total page 245 pages. Available in PDF, EPUB and Kindle. Book excerpt: We are in what many call The Age of the Customer. Customers are empowered more than ever before and demand a high level of customer attention and service. Their increasing expectations and demands worldwide have forced organizations to transform themselves and prepare for the customer experience (CX) battlefield. This landmark book addresses: What customer experience really means Why it matters Whether it has any substantial business impact What your organization can do to deliver and sustain your CX efforts, and How we got to this particular point in CX history This book is the result of exhaustive research conducted to incorporate various components that affect customer experience. Based on the research results, the authors make a case for seeing CX and associated transformations as the next natural evolution of the quality management system (QMS) already in place in most companies. Using an existing QMS as the foundation for CX not only creates a more sustainable platform, but it allows for a faster and more cost effective way to enable an organization to attain world-class CX.
Book Synopsis The ISO 9000 Quality System by : Debby L. Newslow
Download or read book The ISO 9000 Quality System written by Debby L. Newslow and published by John Wiley & Sons. This book was released on 2001-02-26 with total page 260 pages. Available in PDF, EPUB and Kindle. Book excerpt: Author is a certified Quality Assurance Lead Auditor who has worked with more than 100 companies seeking ISO 9000 certification. * One of the only books on ISO 9000 compliance written exclusively for the food industry. * Examples are based on real-world cases (although company names and other identifying details are not included to protect privacy). These examples can be invaluable to food companies who want to avoid potential pitfalls. * Relates ISO 9000 to other quality and safety assurance management systems.
Book Synopsis Guidance on implementation of a quality system in blood establishments by : World Health Organization
Download or read book Guidance on implementation of a quality system in blood establishments written by World Health Organization and published by World Health Organization. This book was released on 2024-02-23 with total page 102 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Create a Great Quality System In Six Months by : Cathy Balding
Download or read book Create a Great Quality System In Six Months written by Cathy Balding and published by Cathy Balding Qualityworks PL. This book was released on 2013-08-28 with total page 138 pages. Available in PDF, EPUB and Kindle. Book excerpt: Are you looking for a quality system that drives great experiences for your consumers - and your staff? ‘Create a Great Quality System In Six Months: A blueprint for building the foundations of a great consumer experience’ is a step by step, month by month blueprint for building and implementing a quality system that staff will want to use to create a great consumer experience for every person, every time. The ‘3P’ quality system blueprint is based on the literature, applied research and real world experience that formed the basis of my first book ‘The Strategic Quality Manager’. It builds in buy-in: instead of developing your quality system and then starting on the long journey to gaining staff co-operation, ‘Create a Great Quality System’ does both at once – merging quality mechanics with quality mindsets to achieve great results for consumers. CGQS is primarily written for health and aged care, but the principles and steps apply equally to other service industries such as education and hospitality.
Book Synopsis The FDA and Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals by : José Rodríguez-Pérez
Download or read book The FDA and Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals written by José Rodríguez-Pérez and published by Quality Press. This book was released on 2014-08-15 with total page 246 pages. Available in PDF, EPUB and Kindle. Book excerpt: This guidance book is meant as a resource to manufacturers of pharmaceuticals, providing up-to-date information concerning required and recommended quality system practices. It should be used as a companion to the regulations/standards themselves and texts on the specific processes and activities contained within the QMS. This book includes chapters on US current Good Manufacturing Practice (GMP); international GMP; global GMP guides and harmonization; detailed analysis of the requirements and guidances; missing subparts; what inspectors are looking for; and the price of noncompliance. It also includes an appendix with two tabulated comparisons: the first compares US, European-PIC/S, Canadian, and WHO cGMPs, while the second compares US cGMPs with effective quality system elements. The companion CD contains cGMP regulations for sterile products produced by aseptic processing; it also includes updated data of statistical enforcement by the FDA, both domestically and abroad; a detailed glossary; and dozens of FDA guidance documents as well as international regulations (EU and Canada) and harmonization documents (WHO, PIC/S, and ICH). A very comprehensive checklist for a cGMP audit that is based on risk management criteria is also included. Finally, a comprehensive GMP exam is also included.
Book Synopsis The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices by : Amiram Daniel
Download or read book The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices written by Amiram Daniel and published by Quality Press. This book was released on 2008-02-21 with total page 344 pages. Available in PDF, EPUB and Kindle. Book excerpt: This new and expanded second edition maintains the organizational approach of the first and includes the requirements and guidance contained in the Quality System Regulation (QSReg), the ISO 13485:2003 standard, the ISO/TR 14969:2004 guidance document, and, as appropriate, a number of the FDA and Global Harmonization Task Force (GHTF) guidance documents.This second edition also addresses a number of additional topics, such as the incorporation of risk management into the medical device organization’s QMS, QMS issues related to combination products, the key process interactions within a QMS, effective presentation of and advocacy for a QMS during FDA inspections and third-party assessments, and future FDA compliance and standards activities. The organization of the guidebook is based on the order of the requirements in the QSReg. For each substantive requirement section there is: A verbatim statement of the QSReg requirement. A description of the comparable requirement in ISO 13485:2003, focusing on any additions to or differences from the requirements contained in the QSReg.Excerpts of the FDA responses to relevant comment groups contained in the Preamble to the QSReg. Excerpts from various FDA guidance documents related to quality management systems. A description of the relevant guidance contained in ISO/TR 14969:2004, focusing on any additions to or differences from the guidance in the Preamble and other FDA guidance documents, and, if useful, excerpts from relevant GHTF guidances. Authors’ notes giving guidance derived from the authors’ sixty years of regulatory compliance experience. This guidance book is meant as a resource to manufacturers of medical devices, providing up-to-date information concerning required and recommended quality system practices. It should be used as a companion to the regulations/standards themselves and texts on the specific processes and activities contained within the QMS.
Book Synopsis Firing on All Cylinders: The Service/Quality System for High-Powered Corporate Performance by : Jim Clemmer
Download or read book Firing on All Cylinders: The Service/Quality System for High-Powered Corporate Performance written by Jim Clemmer and published by Jim Clemmer. This book was released on 1992 with total page 422 pages. Available in PDF, EPUB and Kindle. Book excerpt: Firing on All Cylinders is based on the experiences of hundreds of public sector and business organizations improving their service/quality to master a rapidly changing world. This book brings together three organizational performance fields that have, until now, been distinct and separate. These are: 1. Customer Service - developing high perceived value and responsiveness 2. Quality Improvement - reducing defects and mistakes while increasing productivity through improved process and system control 3. Organization Development - building leadership skills and sustaining cultural change
Download or read book The Quality System Compendium written by and published by . This book was released on 2015 with total page 395 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Choosing a Quality Control System by : Merton R. Hubbard
Download or read book Choosing a Quality Control System written by Merton R. Hubbard and published by CRC Press. This book was released on 1998-12-09 with total page 218 pages. Available in PDF, EPUB and Kindle. Book excerpt: There are over 24 quality control systems recommended for the control and improvement of quality and process; there are over 30 techniques and buzzwords suggested for implementing these systems and to assist in learning about these systems and techniques; there are well over 200 courses, seminars, programs, and conferences available. This book disc
Book Synopsis To Err Is Human by : Institute of Medicine
Download or read book To Err Is Human written by Institute of Medicine and published by National Academies Press. This book was released on 2000-03-01 with total page 312 pages. Available in PDF, EPUB and Kindle. Book excerpt: Experts estimate that as many as 98,000 people die in any given year from medical errors that occur in hospitals. That's more than die from motor vehicle accidents, breast cancer, or AIDSâ€"three causes that receive far more public attention. Indeed, more people die annually from medication errors than from workplace injuries. Add the financial cost to the human tragedy, and medical error easily rises to the top ranks of urgent, widespread public problems. To Err Is Human breaks the silence that has surrounded medical errors and their consequenceâ€"but not by pointing fingers at caring health care professionals who make honest mistakes. After all, to err is human. Instead, this book sets forth a national agendaâ€"with state and local implicationsâ€"for reducing medical errors and improving patient safety through the design of a safer health system. This volume reveals the often startling statistics of medical error and the disparity between the incidence of error and public perception of it, given many patients' expectations that the medical profession always performs perfectly. A careful examination is made of how the surrounding forces of legislation, regulation, and market activity influence the quality of care provided by health care organizations and then looks at their handling of medical mistakes. Using a detailed case study, the book reviews the current understanding of why these mistakes happen. A key theme is that legitimate liability concerns discourage reporting of errorsâ€"which begs the question, "How can we learn from our mistakes?" Balancing regulatory versus market-based initiatives and public versus private efforts, the Institute of Medicine presents wide-ranging recommendations for improving patient safety, in the areas of leadership, improved data collection and analysis, and development of effective systems at the level of direct patient care. To Err Is Human asserts that the problem is not bad people in health careâ€"it is that good people are working in bad systems that need to be made safer. Comprehensive and straightforward, this book offers a clear prescription for raising the level of patient safety in American health care. It also explains how patients themselves can influence the quality of care that they receive once they check into the hospital. This book will be vitally important to federal, state, and local health policy makers and regulators, health professional licensing officials, hospital administrators, medical educators and students, health caregivers, health journalists, patient advocatesâ€"as well as patients themselves. First in a series of publications from the Quality of Health Care in America, a project initiated by the Institute of Medicine
Book Synopsis Quality Management System Handbook for Product Development Companies by : Vivek Nanda
Download or read book Quality Management System Handbook for Product Development Companies written by Vivek Nanda and published by CRC Press. This book was released on 2005-01-27 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
