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 GMP ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers Volume 1 With Checklists and Software Package written by Leonard Steinborn and published by CRC Press. This book was released on 2019-04-23 with total page 633 pages. Available in PDF, EPUB and Kindle. Book excerpt: Volume 1 of this two-part package provides a complete set of checklists for internal and contract device and drug manufacturers and developers, contract software developers, and suppliers of chemical, printed material, electronic component, and general supplies. It also includes a simulated QSIT audit, and a new-product market launch. All of these

Download or read book Private International Law Aspects of Corporate Social Responsibility written by Catherine Kessedjian and published by Springer Nature. This book was released on 2020-03-06 with total page 697 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book addresses one of the core challenges in the corporate social responsibility (or business and human rights) debate: how to ensure adequate access to remedy for victims of corporate abuses that infringe upon their human rights. However, ensuring access to remedy depends on a series of normative and judicial elements that become highly complex when disputes are transnational. In such cases, courts need to consider and apply different laws that relate to company governance, to determine the competent forum, to define which bodies of law to apply, and to ensure the adequate execution of judgments. The book also discusses how alternative methods of dispute settlement can relate to this topic, and the important role that private international law plays in access to remedy for corporate-related human rights abuses. This collection comprises 20 national reports from jurisdictions in Europe, North America, Latin America and Asia, addressing the private international law aspects of corporate social responsibility. They provide an overview of the legal differences between geographical areas, and offer numerous examples of how states and their courts have resolved disputes involving private international law elements. The book draws two preliminary conclusions: that there is a need for a better understanding of the role that private international law plays in cases involving transnational elements, in order to better design transnational solutions to the issues posed by economic globalisation; and that the treaty negotiations on business and human rights in the United Nations could offer a forum to clarify and unify several of the elements that underpin transnational disputes involving corporate human rights abuses, which could also help to identify and bridge the existing gaps that limit effective access to remedy. Adopting a comparative approach, this book appeals to academics, lawyers, judges and legislators concerned with the issue of access to remedy and reparation for corporate abuses under the prism of private international law.

Download or read book ISO 13485 2016 Medical Devices Quality Management Systems Requirements for Regulatory Purposes written by and published by . This book was released on 2016 with total page 36 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book CE Conformity Marking written by Ray Tricker and published by Elsevier. This book was released on 2000-05-01 with total page 301 pages. Available in PDF, EPUB and Kindle. Book excerpt: CE Marking can be regarded as a product's trade passport for Europe. It is a mandatory European marking for certain product groups to indicate conformity with the essential health and safety requirements set out in the European Directive. The prime aim of the CE Directive is to ensure that "all industrial products that are placed on the market do not compromise the safety and health of users when properly installed, maintained and used in accordance with their intended purpose. Users and third parties should be provided with a high level of protection and the devices should attain the performance levels claimed by the manufacturer." This book explains the meaning of CE Marking, its history, how the Directive can affect all manufacturers of industrial products, its current status, its associated quality management requirements, and how manufacturers can easily and cost-effectively meet the requirements for CE Conformance. - Essential information for any manufacturer or distributor wishing to trade in the European Union - Practical and easy to understand

Download or read book Fiber Optic Sensors for Biomedical Applications written by Daniele Tosi and published by Artech House. This book was released on 2017-12-31 with total page 311 pages. Available in PDF, EPUB and Kindle. Book excerpt: This authoritative new resource presents fiber optic sensors and their applications in medical device design and biomedical engineering. Readers gain an understanding of which technology to use and adopt, and how to connect technologies with their respective applications. This book explores the innovation of diagnostics and how to use diagnostic tools. Principles of fiber optic sensing are covered and include details about intensity-based sensors, fiber bragg gratings, distributed sensors, and fabry-perot interferometers. This book explores interrogation software, standards for medical sensors, and discusses protocols and tools for validation. Various medical device engineering and applications are examined, including sensor catheterization, cardiovascular sensors, diagnostic in gastroscopy, urology, neurology, sensing in thermal ablation. Applications and detection of SPR sensors are presented, along with minimally invasive robotic surgery, smart textiles, wearable sensors and fiber-optic spectrometric sensors. This is a one-stop reference on fiber optic sensors for biomed applications.

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 218 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 ISO 9001 2015 Internal Audits Made Easy written by Ann W. Phillips and published by Quality Press. This book was released on 2015-09-21 with total page 95 pages. Available in PDF, EPUB and Kindle. Book excerpt: Implementing the requirements of ISO 9001 can be a daunting task for many organizations. In an attempt to develop a system that will pass the registration audit, we are tempted to establish processes with the primary purpose of conforming to the requirements of ISO 9001. In doing so, however, it is easy to lose sight of the primary intent of the standard: to continually improve the effectiveness of the quality management system (QMS) implemented at our organization. This book is intended to help managers, quality professionals, internal audit coordinators, and internal auditors implement a practical internal audit process that meets the requirements of ISO 9001:2015 while adding significant, measurable value to the organization. The tools, techniques, and step-by-step guidelines provided in this book can also be used by those organizations that have a well-established internal audit process but are looking for easy ways to make that process more effective.

Download or read book Standards Systems written by Canada and published by . This book was released on 1998 with total page 100 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Medical Devices written by George Dennis Green and published by . This book was released on 2005 with total page 179 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical equipment, Medical instruments, Medical technology, Quality management, Quality assurance systems, Quality, Acceptance (approval), Quality auditing, Management Quality and Management

Download or read book Practical Engineering Process and Reliability Statistics written by Mark Allen Durivage and published by Quality Press. This book was released on 2022-03-31 with total page 313 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is a convenient and comprehensive guide to statistics. A resource for quality technicians and engineers in any industry, this second edition provides even more equations and examples for the reader—with a continued focus on algebra-based math. Those preparing for ASQ certification examinations, such as the Certified Quality Technician (CQT), Certified Six Sigma Green Belt (CSSGB), Certified Quality Engineer (CQE), Certified Six Sigma Black Belt (CSSBB), Certified Reliability Engineer (CRE), and Certified Supplier Quality Professional (CSQP), will find this book helpful as well. Inside you’ll ­find: • Complete calculations for determining confidence intervals, tolerances, sample size, outliers, process capability, and system reliability • Newly added equations for hypothesis tests (such as the Kruskal-Wallis test and Levene’s test for equality of variances), the Taguchi method, and Weibull and log-normal distributions • Hundreds of completed examples to demonstrate practical use of each equation • 20+ appendices, including distribution tables, critical values tables, control charts, sampling plans, and a beta table

Download or read book Textile written by and published by . This book was released on 1996 with total page 460 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Technical Specifications for Oxygen Concentrators written by World Health Organization and published by World Health Organization. This book was released on 2016-10-25 with total page 68 pages. Available in PDF, EPUB and Kindle. Book excerpt: The purpose of this guidance document is for the appropriate selection procurement utilization and maintenance of oxygen concentrators. This document also focuses on recommendations for the appropriate use and maintenance of oxygen concentrators in an effort to increase the availability management and quality of oxygen concentrators and ultimately to improve health outcomes in LRS. This document is intended to serve as a resource for the planning and provision of local and national oxygen concentrator systems for use by administrators clinicians and technicians who are interested in improving access to oxygen therapy and reducing global mortality associated with hypoxaemia.

Download or read book How to Audit ISO 9001 2015 written by Chad Kymal and published by Quality Press. This book was released on 2016-04-22 with total page 136 pages. Available in PDF, EPUB and Kindle. Book excerpt: ISO 9001:2015 includes many changes that not only affect the companies aiming to achieve certification to it, but also auditors. This book is the resource auditors need to fully understand ISO 9001:2015 and help them perform audits to it. This book integrates two different types of audit strategies, conformance audits and performance audits, into one process approach audit. Conformance audits confirm that the organization is meeting the requirements of the standard, while performance audits confirm that the QMS is achieving its intended results. The book includes: An introduction to ISO 9001:2015 An auditing strategy for ISO 9001:2015 How to conduct a Stage 1 audit for ISO 9001:2015 How to conduct a Stage 2 on-site audit for ISO 9001:2015 Appendices include an introduction to process focus, an assessment report template for Stage 1 audits, a confidential assessment report template for Stage 2 audits, and an ISO 9001:2015 conformance checklist.

Download or read book Management Systems Standards written by Pavel Castka and published by Foundations and Trends (R) in Technology, Information and Operations Management. This book was released on 2015-05-27 with total page 234 pages. Available in PDF, EPUB and Kindle. Book excerpt: The literature on ISO standards is scattered around a broad collection of journals, making it difficult to get an overview of what we know about Management Systems Standards. This monograph fills that gap by providing an integrated perspective on the entire body of academic literature related to ISO 9000, ISO 14000, and related standards.

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 Guidelines on Occupational Safety and Health Management Systems written by International Labour Office and published by . This book was released on 2001 with total page 44 pages. Available in PDF, EPUB and Kindle. Book excerpt: These guidelines have been prepared by the International Labour Office in order to assist employers and national organisations with practical advice on implementing and improving occupational safety and health (OSH) management systems, in order to reduce work-related injuries, occupational ill health and diseases and unsafe working conditions. The guidelines may be applied on two levels: they provide a national OSH framework for legal and voluntary regulatory standards; and encourage the integration of OSH management principles with overall policy management at the organisational level.