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 Quality Management for the Technology Sector written by Joseph Berk and published by Elsevier. This book was released on 2000-06-30 with total page 219 pages. Available in PDF, EPUB and Kindle. Book excerpt: There are many standards, methods and perhaps most confusing, but most importantly of all acronyms in use in the field of quality management, and especially so in the field of technology-based products. From the seemingly simple concepts of ISO 9000 (and the military MIL standards from which that grew) to statistical and analytical methods like Statistical Process Control (SPC) the range of complexity and compliance is staggering. What the average quality engineer or manager needs is a simple guide to what these are, how they relate to one another and most critically how to take advantage of and implement the benefits of each. This book provides that guidance. Written by a quality consultant with over 20 years experience in precisely these fields, including work with the US Defense Department, Boeing, Lockheed-Martin, Raytheon, and many other leading companies, this book provides an easily digestible toolbox of solutions to quality and management problems for every engineer, manager and even student looking for those answers for the medium to high-technology sector manufacturing company. This is a highly practical book which includes all the major topics in quality as well as case studies from relevant real-world situations yet without the need to wade through reams of reference materials and international standards verbiage. If you need to get to the bottom of problems like these, you need this book.Targetted at the Technology company engineer and quality managerHighly illustrated, comprehensive subject coveragePractical examples and case studies used throughout
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 Qualit en production written by Daniel Duret and published by Editions Eyrolles. This book was released on 2011-07-07 with total page 408 pages. Available in PDF, EPUB and Kindle. Book excerpt: Un ouvrage de référence et de synthèse Simple : les connaissances de base nécessaires à l'application des concepts qualité dans une entreprise de production Global : un panorama des différentes méthodes utilisées dans les entreprises Opérationnel : les outils indispensables à la mise en place d'un système qualité Concret et précis : de très nombreux exemples La qualité est une condition indispensable pour présenter un produit sur le marché. Pour obtenir cette qualité, l'entreprise doit structurer son organisation autour d'un modèle, souvent la norme ISO 9001. Mais elle doit également mettre en œuvre des méthodes et des outils pour accroître sa performance. Ce livre expose les connaissances de base nécessaires à l'application des concepts "qualité" dans une entreprise de production et donne une image globale des différentes méthodes actuellement utilisées dans les entreprises. La première partie de l'ouvrage est consacrée au système de management de la qualité fondée sur une démarche orientée client et sur la maîtrise des processus. Elle aborde notamment le modèle ISO 9001, "Systèmes de management de la qualité : Exigences", les référentiels de l'industrie automobile, la maîtrise des documents et l'automaîtrise au niveau du poste de travail. La seconde partie est axée sur les méthodes et les outils de la qualité : outils de résolution de problème, OFD, plans d'expériences, AMDEC, MSP, contrôle de réception, fonction métrologique (GRR, GUM) et l'approche "Six Sigma" qui permet d'obtenir l'amélioration par percée. Cet ouvrage s'adresse ainsi : aux professionnels, cadres et techniciens travaillant dans un contexte de production aux enseignants et étudiants pour la préparation des BTS, DUT, IUP des secteurs industriels et des écoles d'ingénieurs
Download or read book Le management de la qualit en sant written by Sofia Benchehida and published by . This book was released on 2020-08-27 with total page 86 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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 Developing an ISO 13485 Certified Quality Management System written by Ilkka Juuso and published by CRC Press. This book was released on 2022-03-20 with total page 331 pages. Available in PDF, EPUB and Kindle. Book excerpt: Developing an ISO 13485-Certified Quality Management System: An Implementation Guide for the Medical-Device Industry details the lessons learned from a real-world project focusing on building an ISO 13485:2016 Quality Management System (QMS) from scratch and then having it officially certified. It is a practical guide to building or improving your existing QMS with tried and tested solutions. The book takes a hands-on approach–first teaching the top 25 lessons to know before starting to develop a QMS and then walking you through the process of writing the quality manual and the standard operating procedures, training the staff on the QMS, organizing an internal audit, executing a management review, and finally passing the necessary external audits and obtaining certification. It helps you to progress from one task to the next and provides all the essential information to accomplish each task as quickly and efficiently as possible. It does not attempt to replicate the standard but instead drills into the standard to expose the core of each section of the standard and reorganize its contents into a practical workflow for developing, maintaining, and improving a Lean QMS. The book includes a wealth of real-world experience both from the author's personal dive into quality management, and from the experiences of other companies in the field and provides handy checklists for ensuring key documents and processes are fit for use–the emphasis here is to help ensure you have considered all relevant aspects. In addition, the book is not intended as a “cheat sheet” for the standard or as a review of the standard that only adds lengthy commentary on each of the clauses. Instead, the book fixes easy misunderstandings regarding QMS, provides insight into why the various clauses are written the way they are, and provides a great base to both understanding ISO 13485 QMS and developing your own QMS. The book is intended to serve both experts and novices audiences–it provides special insight on the most crucial and effective aspects of QMS.
Download or read book A Practical Field Guide for ISO 13485 written by Erik V. Myhrberg and published by ASQ Quality Press. This book was released on 2019-11-06 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The purpose of this expanded field guide is to assist organizations, step-by-step, in implementing a quality management system (QMS) in conformance with ISO 13485:2016, whether "from scratch" or by transitioning from variations of the ISO 13485 family. In keeping with ISO 9000:2015's definition of quality as the "degree to which a set of inherent characteristics fulfills requirements," Myhrberg, Raciti, and Myhrberg have identified the requirements and inherent characteristics (distinguishing features) for this expanded field guide. Within the guide, each subclause containing requirements is the focus of a two-page visual spread that consistently presents features that fulfill the requirements listed below. This guide will: Provide a user-friendly guide to ISO 13485:2016's requirements for implementation purposes -Identify the documents/documentation required, along with recommendations on what to consider retaining/adding to a QMS during ISO 13485:2016 implementation -Guide internal auditor(s) regarding what to ask to verify that a conforming and effective QMS exists -Direct management on what it must do and should consider to satisfy ISO 13485:2016's enhanced requirements, as well as on the responsibilities for top management -Depict step-by-step in flowchart form what must occur to create an effective, conforming QMS
Download or read book ISO 13485 2016 written by Itay Abuhav and published by . This book was released on 2018 with total page 877 pages. Available in PDF, EPUB and Kindle. Book excerpt: "This book will be a substantial revision, which will reflect the new version of the ISO 13485:2016. This represents the standard protocols that all medical device manufacturers must follow, in the fabrication of their products. It will focus on changes in the structure of the quality management system; change in the documentation for quality managemeent systems and finally, present the different methods of implementation of the standard requirements within the organization.This new version was initiated in 2016, thus all apprpriate enterprises using the old standard must convert to the new version, now available.The Second Edition will clarify, explain and demonstrate the new version."--
Download or read book How to Establish a Document Control System for Compliance with ISO 9001 2015 ISO 13485 2016 and FDA Requirements written by Stephanie L. Skipper and published by Quality Press. This book was released on 2015-10-14 with total page 155 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book explains the requirements for compliance with FDA regulations and ISO standards (9001/13485) for documented information controls, and presents a methodology for compliance. The document control system (DCS), or documented information control system (DICS), is the foundation of a quality management system. It is the first quality system element that must be implemented because the establishment and control of documented processes and information in a quality-controlled environment is dependent on the ability to proactively manage access to documents and the movement of documents through the document life cycle. A well-developed document control system benefits business by: Improving knowledge retention and knowledge transfer within and across business units Improving access to knowledge-based information Improving employee performance by providing standardized processes and communicating clear expectations Improving customer communication and satisfaction by providing documented information from which common understanding can be achieved Providing traceability of activities and documentation throughout the organization Improving organization of and access to documents and data Sample documents are included in the appendixes of this book to help clarify explanations, and a full set of formatted procedures and document templates are available for download to get you off to an even faster start. This book provides a process-based approach that can be used for controlling all forms of documented information that are required to be managed under the quality management system.
Download or read book A Practical Field Guide for ISO 13485 2016 written by Erik V. Myhrberg and published by Quality Press. This book was released on 2019-11-06 with total page 252 pages. Available in PDF, EPUB and Kindle. Book excerpt: The purpose of this expanded field guide is to assist organizations, step-by-step, in implementing a quality management system (QMS) in conformance with ISO 13485:2016, whether "from scratch" or by transitioning from variations of the ISO 13485 family. In keeping with ISO 9000:2015's definition of quality as the "degree to which a set of inherent characteristics fulfills requirements," Myhrberg, Raciti, and Myhrberg have identified the requirements and inherent characteristics (distinguishing features) for this expanded field guide. Within the guide, each subclause containing requirements is the focus of a two-page visual spread that consistently presents features that fulfill the requirements listed below. This guide will: Provide a user-friendly guide to ISO 13485:2016's requirements for implementation purposes -Identify the documents/documentation required, along with recommendations on what to consider retaining/adding to a QMS during ISO 13485:2016 implementation -Guide internal auditor(s) regarding what to ask to verify that a conforming and effective QMS exists -Direct management on what it must do and should consider to satisfy ISO 13485:2016's enhanced requirements, as well as on the responsibilities for top management -Depict step-by-step in flowchart form what must occur to create an effective, conforming QMS
Download or read book Qualit en sant vers un management int gr written by Sofia Benchehida and published by . This book was released on 2021-04-29 with total page 86 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book D marche qualit et norme ISO 9001 written by Eva Giesen and published by IRD Editions. This book was released on 2008 with total page 182 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book ISO 9001 written by Itay Abuhav and published by CRC Press. This book was released on 2017-02-17 with total page 374 pages. Available in PDF, EPUB and Kindle. Book excerpt: What is risk based thinking? Do you know how to address risks and opportunities? Did you ever analyzed risks? Are you sure it is that what the ISO 9001 expects? What do you really know about knowledge management? Can you identify the types of knowledge in your organization? How do you maintain knowledge? What is awareness in the eyes of the ISO 9001 Standard? Can you tell the relation between awareness and the effectiveness of the QMS? This book explains in details all the new issues and topics required by the ISO 9001:2015 Standard and gives you the tools and tricks to answer the new requirements. Just read and do. The table of contents in the book are identical to the table of contents of the standard so you can orient yourself quite easily and find the specific advice you are looking for.
Download or read book ISO 13485 The Quality Management System for Medical Devices written by Brendan Cooper and published by Createspace Independent Publishing Platform. This book was released on 2017-04-14 with total page 130 pages. Available in PDF, EPUB and Kindle. Book excerpt: This concise book is broadly divided into 3 manageable parts. The first part introduces the standard ISO 13485 and the basics of Quality management systems. Part two then examines the key area of Design controls and there application to medical devices. Finally, an overview of Quality Risk management is provided. In the first instance, providing safe and effective medical devices depends on a sound basis' of design. However, how we see and rate risks also impacts the safety of products produced. A holistic approach to medical device manufacturing ensures Quality from design conception to commercial manufacturing. Following the principles within this short book will put the reader on the right track. An ideal reference for industry or academics or those wishing to have a physical resource.
Download or read book Metals for Biomedical Devices written by Mitsuo Niinomi and published by Elsevier. This book was released on 2010-03-31 with total page 439 pages. Available in PDF, EPUB and Kindle. Book excerpt: Despite recent advances in medical devices using other materials, metallic implants are still one of the most commercially significant sectors of the industry. Given the widespread use of metals in medical devices, it is vital that the fundamentals and behaviour of this material are understood. Metals in biomedical devices reviews the latest techniques in metal processing methods and the behaviour of this important material.Initial chapters review the current status and selection of metals for biomedical devices. Chapters in part two discuss the mechanical behaviour, degradation and testing of metals with specific chapters on corrosion, wear testing and biocompatibility of biomaterials. Part three covers the processing of metals for biomedical applications with chapters on such topics as forging metals and alloys, surface treatment, coatings and sterilisation. Chapters in the final section discuss clinical applications of metals such as cardiovascular, orthopaedic and new generation biomaterials.With its distinguished editor and team of expert contributors, Metals for biomedical devices is a standard reference for materials scientists, researchers and engineers working in the medical devices industry and academia. - Reviews the latest techniques in metal processing methods including surface treatment and sterilisation - Examines metal selection for biomedical devices considering biocompatibility of various metals - Assesses mechanical behaviour and testing of metals featuring corrosion, fatigue and wear
Download or read book National Survey of Fishing and Hunting 1970 written by and published by . This book was released on 1972 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
