Download or read book ICH Quality Guidelines written by Andrew Teasdale and published by John Wiley & Sons. This book was released on 2017-10-09 with total page 740 pages. Available in PDF, EPUB and Kindle. Book excerpt: Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. • Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies • Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines • Uses case studies to help readers understand and apply ICH guidelines • Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines • Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)
Download or read book Improving Healthcare Quality in Europe Characteristics Effectiveness and Implementation of Different Strategies written by OECD and published by OECD Publishing. This book was released on 2019-10-17 with total page 447 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume, developed by the Observatory together with OECD, provides an overall conceptual framework for understanding and applying strategies aimed at improving quality of care. Crucially, it summarizes available evidence on different quality strategies and provides recommendations for their implementation. This book is intended to help policy-makers to understand concepts of quality and to support them to evaluate single strategies and combinations of strategies.
Download or read book Clinical Practice Guidelines We Can Trust written by Institute of Medicine and published by National Academies Press. This book was released on 2011-06-16 with total page 217 pages. Available in PDF, EPUB and Kindle. Book excerpt: Advances in medical, biomedical and health services research have reduced the level of uncertainty in clinical practice. Clinical practice guidelines (CPGs) complement this progress by establishing standards of care backed by strong scientific evidence. CPGs are statements that include recommendations intended to optimize patient care. These statements are informed by a systematic review of evidence and an assessment of the benefits and costs of alternative care options. Clinical Practice Guidelines We Can Trust examines the current state of clinical practice guidelines and how they can be improved to enhance healthcare quality and patient outcomes. Clinical practice guidelines now are ubiquitous in our healthcare system. The Guidelines International Network (GIN) database currently lists more than 3,700 guidelines from 39 countries. Developing guidelines presents a number of challenges including lack of transparent methodological practices, difficulty reconciling conflicting guidelines, and conflicts of interest. Clinical Practice Guidelines We Can Trust explores questions surrounding the quality of CPG development processes and the establishment of standards. It proposes eight standards for developing trustworthy clinical practice guidelines emphasizing transparency; management of conflict of interest ; systematic review-guideline development intersection; establishing evidence foundations for and rating strength of guideline recommendations; articulation of recommendations; external review; and updating. Clinical Practice Guidelines We Can Trust shows how clinical practice guidelines can enhance clinician and patient decision-making by translating complex scientific research findings into recommendations for clinical practice that are relevant to the individual patient encounter, instead of implementing a one size fits all approach to patient care. This book contains information directly related to the work of the Agency for Healthcare Research and Quality (AHRQ), as well as various Congressional staff and policymakers. It is a vital resource for medical specialty societies, disease advocacy groups, health professionals, private and international organizations that develop or use clinical practice guidelines, consumers, clinicians, and payers.
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".
Download or read book ISO 9001 2015 Explained written by Charles A. Cianfrani and published by Quality Press. This book was released on 2015-09-21 with total page 158 pages. Available in PDF, EPUB and Kindle. Book excerpt: The 2015 edition of ISO 9001 has been modernized to update terminology and content to meet current and anticipated user needs. The major emphasis of ISO 9001:2015 is still consistent provision of products and services that meet customer and applicable statutory and regulatory requirements. This book explains the meaning and intent of the requirements of ISO 9001:2015 and discusses the requirements as they relate to each of the product categories. Where appropriate, it includes an elaboration of why the requirements are important. It also includes typical audit-type questions that an organization may consider to assess conformity to internal needs and ISO 9001 requirements. Recommendations for implementation are also included. This book addresses the needs of: Users and organizations seeking a general understanding of the contents of ISO 9001:2015 Users and organizations desiring guidance to ensure their ISO 9001:2015 QMS meets the new version requirements Users and organizations considering the use of ISO 9001:2015 as a foundation for the development of a comprehensive QMS Educators who require a textbook to accompany a training class or course on ISO 9001:2015 Auditors who desire to increase their level of auditing competence Authors Cianfrani and West, members of the expert group that developed ISO 9001:2015, strive to provide a context for all requirements to enable you to develop and deploy processes that will strengthen your QMS. Getting or retaining a certificate is not the real objective. Satisfied customers and organizational sustainability should be primary objectives for the organization.
Download or read book ISO 9001 2015 Handbook for Small and Medium Sized Businesses Third Edition written by Denise E. Robitaille and published by Quality Press. This book was released on 2016-03-24 with total page 99 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook was developed to help small and medium-sized organizations better understand ISO 9001:2015. It is intended to facilitate implementation and improvement. The establishment, implementation, and maintenance of an ISO 9001compliant quality management system (QMS) should allow the organization to experience multiple benefits beyond the achievement of certification. Organizations should also see improvements in the quality of products, customer satisfaction, and process effectivenessall of which ultimately have a positive impact on the bottom line. It is expected that some readers will have already established a QMS. This handbook will serve to reinforce good practices and will help you better understand the intent and value of some of the requirements of ISO 9001. Since the handbook is especially focused on small and medium-sized organizations, the examples that are provided will have greater applicability and will enhance comprehension, again resulting in increased value. Implementing a QMS in a small organization is not easier or harder than it is in a large one. Resources are different; each organization has its own unique challenges, constraints, and advantages. The thing to always bear in mind is that this is your organization and these are your processes. ISO 9001:2015 defines the requirements, but it does not dictate the method of application. Utilizing this handbook should allow you to develop or rejuvenate your QMS so that it is a benefit to both you and your customer.
Download or read book Guide to Preparing the Corporate Quality Manual written by Bernard Froman and published by CRC Press. This book was released on 2020-11-26 with total page 252 pages. Available in PDF, EPUB and Kindle. Book excerpt: Utilizes advanced concepts, guidelines and requirements from the latest ISO 9000 and 10000 series of standards, as well as other models, including TQM (Total Quality Managment). The text shows how to define a policy and explain it clearly. It offers procedures for developing a quality manual, to be used by personnel performing quality-related functions and for external auditors and customers.
Download or read book Practical Guidelines for Integrated Quality Management in Tourism Destinations written by World Tourism Organization and published by World Tourism Organization. This book was released on 2017 with total page 134 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Guidebook offers a comprehensive and pragmatic approach to the improvement of quality of tourism destinations. It clarifies tourism concepts developing basic tools for improving quality at tourism destinations.
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.
Download or read book American National Standard written by and published by . This book was released on 1994 with total page 24 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Practitioner s Guide to Data Quality Improvement written by David Loshin and published by Elsevier. This book was released on 2010-11-22 with total page 423 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Practitioner's Guide to Data Quality Improvement offers a comprehensive look at data quality for business and IT, encompassing people, process, and technology. It shares the fundamentals for understanding the impacts of poor data quality, and guides practitioners and managers alike in socializing, gaining sponsorship for, planning, and establishing a data quality program. It demonstrates how to institute and run a data quality program, from first thoughts and justifications to maintenance and ongoing metrics. It includes an in-depth look at the use of data quality tools, including business case templates, and tools for analysis, reporting, and strategic planning. This book is recommended for data management practitioners, including database analysts, information analysts, data administrators, data architects, enterprise architects, data warehouse engineers, and systems analysts, and their managers. Offers a comprehensive look at data quality for business and IT, encompassing people, process, and technology. Shows how to institute and run a data quality program, from first thoughts and justifications to maintenance and ongoing metrics. Includes an in-depth look at the use of data quality tools, including business case templates, and tools for analysis, reporting, and strategic planning.
Download or read book The ISO 14001 2015 Implementation Handbook written by Milton P. Dentch and published by Quality Press. This book was released on 2016-04-14 with total page 132 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book explains how an organization can use a management system to both control and improve its environmental performance. It provides guidance in building the environmental management system (EMS) in support of the organizations operations---linking the management system to the requirements of ISO 14001 to support third-party certification to ISO 14001:2015. Included in the text are best practices as well as common pitfalls and weaknesses the author has observed in various organizations. He is an environmental auditor and EMS internal auditor trainer and consultant. He has audited EMSs of over 100 companies to ISO 14001. For those organizations already certified to ISO 14001:2004, the book highlights the changes required to upgrade to the new 2015 version. In addition, included on an accompanying CD are comprehensive check sheets to be used by internal auditors in auditing an EMS's conformance to ISO 14001:2015.
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.
Download or read book DAC Guidelines and Reference Series Quality Standards for Development Evaluation written by OECD and published by OECD Publishing. This book was released on 2010-03-11 with total page 24 pages. Available in PDF, EPUB and Kindle. Book excerpt: This reference guide lays out standards for each phase of a typical evaluation process: from defining purpose, to planning, designing, implementing, reporting, and learning from and using evaluation results.
Download or read book WHO Guidelines for Indoor Air Quality written by and published by World Health Organization. This book was released on 2010 with total page 488 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book presents WHO guidelines for the protection of public health from risks due to a number of chemicals commonly present in indoor air. The substances considered in this review, i.e. benzene, carbon monoxide, formaldehyde, naphthalene, nitrogen dioxide, polycyclic aromatic hydrocarbons (especially benzo[a]pyrene), radon, trichloroethylene and tetrachloroethylene, have indoor sources, are known in respect of their hazardousness to health and are often found indoors in concentrations of health concern. The guidelines are targeted at public health professionals involved in preventing health risks of environmental exposures, as well as specialists and authorities involved in the design and use of buildings, indoor materials and products. They provide a scientific basis for legally enforceable standards.
Download or read book ICH Quality Guidelines written by Andrew Teasdale and published by John Wiley & Sons. This book was released on 2017-09-29 with total page 624 pages. Available in PDF, EPUB and Kindle. Book excerpt: Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. • Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies • Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines • Uses case studies to help readers understand and apply ICH guidelines • Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines • Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)
Download or read book Using Clinical Practice Guidelines to Evaluate Quality of Care written by and published by . This book was released on 1995 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt:
