Download or read book Using ISO 9001 in Healthcare written by James M. Levett and published by Quality Press. This book was released on 2014-05-04 with total page 172 pages. Available in PDF, EPUB and Kindle. Book excerpt: ISO 9001 offers an orderly, disciplined approach to managing a healthcare organization. When applied conscientiously, an ISO management system will provide a framework for improvement efforts and the discipline to demonstrate outcomes. A lot has changed since the first edition of this book was published in June of 2011. Most notably, the Affordable Care Act (ACA) was passed and is being implemented throughout the country. Although the long-term effects of the ACA will not be determined for several years, it is clear that most Americans will be affected in some way and that that the provider and payer communities are undergoing rapid changes. Even amongst all this uncertainty, the challenges faced by provider organizations can be dealt with most effectively by using an ISO 9001 quality management system. Each of the authors in this book has instituted ISO 9001:2008 as a management system: one in a multi-specialty group practice, the other in a global government healthcare system. Their reasons were different, but in both cases, they established a management system that could respond to diverse needs without adding expenses to their organizations.
Download or read book Using ISO 9001 in Healthcare written by James M. Levett and published by Asq Press. This book was released on 2011 with total page 120 pages. Available in PDF, EPUB and Kindle. Book excerpt: Healthcare providers deal with quality concepts and tools on a regular basis, but the idea of a quality system or quality management system (QMS) is not a familiar term. Most are familiar with control charts, Lean, the PDSA cycle, Six Sigma, and the Baldrige criteria, but ISO 9001 is not usually recognized and most have no experience with a systematic program to implement quality objectives within an organization. This book explains the overall value of an ISO 9001 based QMS, its value in implementing a quality culture within an organization, using other quality tools within the ISO framework, clinical integration, accreditation, and performance improvement. Several case studies of ISO implementation in healthcare organizations are described, including a large multi-specialty group, a community hospital and hospital system, and the State Department Medical Unit in D.C.
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 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 The ISO 9001 2015 Implementation Handbook written by Milton P. Dentch and published by Quality Press. This book was released on 2016-05-02 with total page 119 pages. Available in PDF, EPUB and Kindle. Book excerpt: The handbook is structured to guide organizations new to ISO 9001 through the process necessary to connect their current practices to the requirements of ISO 9001:2015. For organizations already certified to ISO 9001, it advises how to use your upgrade to ISO 9001:2015 as an opportunity to rebuild your QMS into a helpful asset in managing your business.
Download or read book ISO 9001 2000 a New Paradigm for Healthcare written by Bryce E. Carson and published by . This book was released on 2004 with total page 187 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Meeting Accreditation Standards A Pharmacy Preparation Guide written by John P Uselton and published by ASHP. This book was released on 2019-12-31 with total page 723 pages. Available in PDF, EPUB and Kindle. Book excerpt: Meeting Accreditation Standards: A Pharmacy Preparation Guide is the only book to cover all the latest major accreditation standards. Highlights include: Major changes including revised survey processes and streamlined standards to emphasize CMS’s focus on safety and improving the quality of patient care New chapters for the fourth accreditation organization CIHQ, Antimicrobial Stewardship, and Pain Management Addresses the standards and requirements effective from July 2019 to the extent that they are known Contains the most up-to-date medication management (MM) standards and requirements and the medication-related 2019 NPSGs and their requirements
Download or read book Integrated Management Systems written by Chad Kymal and published by Quality Press. This book was released on 2015-05-13 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt: Updated to the latest standard changes including ISO 9001:2015, ISO 14001:2015, and OHSAS 18001:2016 Includes guidance on integrating Corporate Responsibility and Sustainability Organizations today are implementing stand-alone systems for their Quality Management Systems (ISO 9001, ISO/TS 16949, or AS 9100), Environmental Management System (ISO 14001), Occupational Health & Safety (ISO 18001), and Food Safety Management Systems (FSSC 22000). Stand-alone systems refer to the use of isolated document management structures resulting in the duplication of processes within one site for each of the management standardsQMS, EMS, OHSAS, and FSMS. In other words, the stand-alone systems duplicate training processes, document control, and internal audit processes for each standard within the company. While the confusion and lack of efficiency resulting from this decision may not be readily apparent to the uninitiated, this book will show the reader that there is a tremendous loss of value associated with stand-alone management systems within an organization. This book expands the understanding of an integrated management system (IMS) globally. It not only saves money, but more importantly it contributes to the maintenance and efficiency of business processes and conformance standards such as ISO 9001, AS9100, ISO/TS 16949, ISO 14001, OHSAS 18001, FSSC 22000, or other GFSI Standards.
Download or read book ISO 13485 written by Itay Abuhav and published by CRC Press. This book was released on 2011-10-20 with total page 376 pages. Available in PDF, EPUB and Kindle. Book excerpt: Although complex and lengthy, the process of certification for the ISO 13485 can be easily mastered using the simple method outlined in ISO 13485: A Complete Guide to Quality Management in the Medical Device Industry. Written by an experienced industry professional, this practical book provides a complete guide to the ISO 13485 Standard certification for medical device manufacturing. Filled with examples drawn from the author’s experience and spanning different sectors and fields of the medical device industry, the book translates the extra ordinary requirements and objectives of the standard into feasible activities and tasks. The book provides a full analysis of each clause and sub clause through quality perspectives: the implications on an organization, its processes, management, human resources, infrastructures, work environment, control and effectiveness, documentations and records. The book is organized like the standard itself — the table of contents is identical to the ISO 13485 Standard’s table of contents — making it user friendly, familiar, and unintimidating. You can use the book as a consulting session — read it, explore it ,extract ideas — and draw on the information and knowledge that suits you and your organization, and then apply it effectively to your quality management system and processes.
Download or read book Assuring the Quality of Health Care in the European Union written by Helena Legido-Quigley and published by World Health Organization. This book was released on 2008 with total page 242 pages. Available in PDF, EPUB and Kindle. Book excerpt: People have always travelled within Europe for work and leisure, although never before with the current intensity. Now, however, they are travelling for many other reasons, including the quest for key services such as health care. Whatever the reason for travelling, one question they ask is "If I fall ill, will the health care I receive be of a high standard?" This book examines, for the first time, the systems that have been put in place in all of the European Union's 27 Member States. The picture it paints is mixed. Some have well developed systems, setting standards based on the best available evidence, monitoring the care provided, and taking action where it falls short. Others need to overcome significant obstacles.
Download or read book Essentials for the Improvement of Healthcare Using Lean Six Sigma written by D.H. Stamatis and published by CRC Press. This book was released on 2012-02-02 with total page 391 pages. Available in PDF, EPUB and Kindle. Book excerpt: Essentials for the Improvement of Healthcare Using Lean & Six Sigma is all about real and immediate quality improvement. Written by D.H. Stamatis, a renowned expert in organizational development and quality, the book addresses concerns that can be ameliorated with minimal government intervention. Detailing immediate paths for improvement fundamental to primary care, hospitals, and managed care, the book: Introduces much-needed mechanics of change, including transitioning from hierarchical groups to interactive inclusionary teams Focuses on customer satisfaction as a key indicator of quality Explains how Lean and Six Sigma tools can be readily applied to healthcare Spotlights primary care, including how to define and redesign its process and develop better metrics Presents IT applications that will improve billing, documentation, and patient care Examines Malcolm Baldrige National Quality Award criteria as it applies to healthcare Illustrates quality improvements and best practices through real world case studies Includes a companion CD with Six Sigma forms and formulas, Lean improvement tools, and other quality tools and worksheets Whether you think advances in technology and medicine, coupled with freedom of choice, makes the U.S. healthcare system the best in the world, or whether you believe growing costs, regulatory morass, and a tort-obsessed culture drop it to the bottom; it is evident that the processes currently employed and the subsequent defensive medicine philosophy that has resulted will not be able to meet the future demands of our aging society. Through Six Sigma and Lean, this text moves the focus from reactive controls to the proactive efficiency required to implement real and sustainable quality improvements that will allow us to forge a system that is all about wellness.
Download or read book Clinical Engineering Handbook written by Joseph F. Dyro and published by Academic Press. This book was released on 2004-08-27 with total page 696 pages. Available in PDF, EPUB and Kindle. Book excerpt: As the biomedical engineering field expands throughout the world, clinical engineers play an ever more important role as the translator between the worlds of the medical, engineering, and business professionals. They influence procedure and policy at research facilities, universities and private and government agencies including the Food and Drug Administration and the World Health Organization. Clinical engineers were key players in calming the hysteria over electrical safety in the 1970s and Y2K at the turn of the century and continue to work for medical safety. This title brings together all the important aspects of Clinical Engineering. It provides the reader with prospects for the future of clinical engineering as well as guidelines and standards for best practice around the world.
Download or read book ISO 9001 ISO 14001 and New Management Standards written by Iñaki Heras-Saizarbitoria and published by Springer. This book was released on 2017-10-10 with total page 214 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is a comprehensive reference on ISO management system standards and their implementation. The impacts that ISO 9001 and ISO 14001 have had on business performance are analyzed in depth, and up-to-date perspectives are offered on the integration of these and other management standards (e.g. SA8000, ISO/TS 16949). Detailed information is provided on the signaling value of different management standards and on the new ISO standards for management systems, such as ISO 50001 and ISO 45001, relating to energy management and occupational health and safety. The role of audits in ensuring compliance with the standards and achievement of objectives is also carefully considered. The volume examines avenues for further research and emerging challenges. In offering an integrated, holistic perspective on ISO management system standards, this book will have wide appeal for academics, public decision-makers, and practitioners in the field of quality and environmental management.
Download or read book Process Improvement Essentials written by James R. Persse, PhD and published by "O'Reilly Media, Inc.". This book was released on 2006-09-14 with total page 353 pages. Available in PDF, EPUB and Kindle. Book excerpt: Today, technology has become too much a part of overall corporate success for its effectiveness to be left to chance. The stakes are too high. Fortunately, the idea of 'quality management' is being reinvigorated. In the last decade process programs have become more and more prevalent. And, out of all the available options, three have moved to the top of the chain. These three are: The 9001:2000 Quality Management Standard from the International Standards Organization; The Capability Maturity Model Integration from the Software Engineering Institute; and Six Sigma, a methodology for improvement shaped by companies such as Motorola, Honeywell, and General Electric. These recognized and proven quality programs are rising in popularity as more technology managers are looking for ways to help remove degrees of risk and uncertainty from their business equations, and to introduce methods of predictability that better ensure success. Process Improvement Essentials combines the foundation needed to understand process improvement theory with the best practices to help individuals implement process improvement initiatives in their organization. The three leading programs: ISO 9001:2000, CMMI, and Six Sigma--amidst the buzz and hype--tend to get lumped together under a common label. This book delivers a combined guide to all three programs, compares their applicability, and then sets the foundation for further exploration. It's a one-stop-shop designed to give you a working orientation to what the field is all about.
Download or read book Medical Device Regulations written by Michael Cheng and published by World Health Organization. This book was released on 2003-09-16 with total page 54 pages. Available in PDF, EPUB and Kindle. Book excerpt: The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.
Download or read book ISO 13485 2016 written by Itay Abuhav and published by CRC Press. This book was released on 2018-05-11 with total page 735 pages. Available in PDF, EPUB and Kindle. Book excerpt: Summary: This book provides valuable, effective guidance for understanding, interpreting and implementing ISO 13485:2016 standard requirements. Despite its more than 800-page length, the author has specifically designed its contents to maximize usability for the reader with a table of contents identical to that of the ISO standard itself, which enables easy navigation and orientation. Pragmatic in style and down to earth in tone, this book draws real-life examples and case-studies from the author’s many years of experience in consulting to illustrate even the most complex of ISO 13485:2016 standard requirements and their implementation. Identifying relevant requirements and how they harmonize with quality management systems, developing processes for design and development, as well as product realization and validation are just a few of the issues covered in-depth by this publication. In addition, the author constantly reviews the distinctive characteristics and aspects of the medical device manufacturing industry, so that the reader can also appreciate the subject of this book in an everyday context. Features: A pragmatic and down to earth approach towards the reader’s understanding of ISO 13485:2016 standard requirements implementation. Uses examples and cases from real-life based on the author’s many years of experience in quality management. A table of contents structured identically to that of ISO 13485:2016 itself, allowing easier navigation and orientation for the reader. Emphasises guidance for ISO 13495:2016 standard requirements which are difficult to interpret and implement Constantly reviews the aspect of medical device industry characteristics and distinctive so the reader can reflect the content with its daily work.
Download or read book Planning Quality Project Management of EMR EHR Software Products written by Richard Chamberlain and published by HIMSS Book Series. This book was released on 2017 with total page 126 pages. Available in PDF, EPUB and Kindle. Book excerpt: When hospitals began implementing their electronic medical records/electronic health records systems (EMR/HER) the pharmaceutical companies that were conducting clinical trials at those hospitals wanted to sue the date from those systems instead of having the hospitals enter the data in their EHR systems and also in the study data entry system. However, the FDA regulations would require that the hospital systems be "validated." The hospitals and the companies developing the systems argued that was "over-regulation." HIMSS published their Developer Code of Conduct where they said instead they would use Quality Management techniques. This book covers how to use Quality Management (ISO 9001) to develop computer systems, specifically EMR systems. It gives a basic introduction to how to implement computer systems. It also covers the topic of compliance because the hospitals are required to comply with regulations other than FDS regulations. The book also discusses the topics of risk management and conducting audits, both of which are part of ISO 9001 quality management of computer systems. The book is designed to give the reader an introduction to the things you have to do when implementing a computer system that has to satisfy some standards and where the accuracy of the information could impact the accuracy of a person's medical treatment.
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".
