ISO 13485

Author: Itay Abuhav
Publisher: CRC Press
ISBN: 9781439866115
Release Date: 2011-10-20
Genre: Medical

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.

ISO 13485 2016

Author: Itay Abuhav
Publisher: CRC Press
ISBN: 9781351000772
Release Date: 2018-05-11
Genre: Medical

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.

Medical Devices

Author: Seeram Ramakrishna
Publisher: Woodhead Publishing
ISBN: 9780081002919
Release Date: 2015-08-18
Genre: Medical

Medical Devices and Regulations: Standards and Practices will shed light on the importance of regulations and standards among all stakeholders, bioengineering designers, biomaterial scientists and researchers to enable development of future medical devices. Based on the authors’ practical experience, this book provides a concise, practical guide on key issues and processes in developing new medical devices to meet international regulatory requirements and standards. Provides readers with a global perspective on medical device regulations Concise and comprehensive information on how to design medical devices to ensure they meet regulations and standards Includes a useful case study demonstrating the design and approval process

ISO 9001

Author: Itay Abuhav
Publisher: CRC Press
ISBN: 9781315352787
Release Date: 2017-02-17
Genre: Business & Economics

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.

Anforderungen an Medizinprodukte

Author: Johann Harer
Publisher: Carl Hanser Verlag GmbH Co KG
ISBN: 9783446450646
Release Date: 2016-06-06
Genre: Business & Economics

Extra: E-Book inside Als Hersteller von Medizinprodukten oder als deren Zulieferer müssen Sie eine immer größere Zahl an gesetzlichen Vorgaben und Qualitätsanforderungen erfüllen: ISO-Normen, EU-Richtlinien sowie länderspezifische Gesetze und Ausführungsbestimmungen. Dieses Buch navigiert Sie durch diese vielschichtigen Anforderungen an Medizinprodukte. Die einzelnen Anforderungen werden dabei praxisorientiert vorgestellt, und Sie erhalten einen konkreten Leitfaden zu deren Umsetzung. Viele Beispiele, Tipps und Hinweise auf Stolpersteine erleichtern das Praxisverständnis. Highlights - Konkreter Leitfaden zur Umsetzung der Anforderungen - Berücksichtigt u. a. ISO 13485, MDD, IVDD, cGMP - Auf CD: Praktische Arbeitshilfen und weiterführende Information

Medical Device Quality Management Systems

Author: Susanne Manz
Publisher: Academic Press
ISBN: 9780128142226
Release Date: 2018-09-27
Genre: Science

Medical Devices Quality Management Systems: Strategy and Techniques for Improving Efficiency and Effectiveness is written for the needs of quality, compliance, and regulatory professionals in medical device companies. It includes secrets for developing an effective, yet efficient, Quality Management System (QMS) and explains how to create a vision, strategy, and tactical plans. Author Manz shares lessons on leadership, key roles and responsibilities within a medical device company, while also exploring the concepts of process ownership, individual accountability, and how to cultivate a culture of quality and compliance. This book is useful for all executive, functional leaders, and organizations in the highly regulated medical device industry. Provides practical, real-world guidance on developing an effective and efficient Quality Management System Presents a roadmap for QMS development Covers techniques to assess current state Includes discussions on tools, such as CAPA and Six Sigma that help define vision, strategy and quality plans

Juran s Quality Handbook The Complete Guide to Performance Excellence Seventh Edition

Author: Joseph A. Defeo
Publisher: McGraw Hill Professional
ISBN: 9781259643620
Release Date: 2016-11-11
Genre: Technology & Engineering

The cornerstone text onquality management and performance excellence – thoroughly revised to reflectthe latest challenges and developments The “body of knowledge” for the science ofquality management and performance excellence for more than half-a-century, Juran’s Quality Handbook has been completely updated to meetthe ever-changing needs of today’s business and quality professionals. Underthe guidance of a team of top experts, this authoritative resource demonstrateshow to apply the right methods for delivering superior results and achievingexcellence in any organization, industry, or country. Juran’s Quality Handbook, Seventh Edition provides you with a complete roadmap forthe discipline -- clearly written to make sure you know where you are in theprocess and what you must do to reach the next level. Within its pages, youwill find A-Z coverage – from key concepts, methods, research, and tools topractical applications on the job. Here’s why this is the best edition yet: • Updated chapters on Lean, Six Sigma and the Shingo Prize • NEW chapters on Risk Management and Building a Quality Management System • NEW material on the history of quality management • All ISO and other regulatory standards have been updated • NEW statistical tables, charts, and data • Examples and case studies throughout demonstrate how others have appliedthe methods and tools discussed in real-world situations

Juran s Quality Handbook The Complete Guide to Performance Excellence 6 e

Author: Joseph A. Defeo
Publisher: McGraw Hill Professional
ISBN: 9780071629720
Release Date: 2010-09-05
Genre: Technology & Engineering

The definitive quality management compendium--revised for the first time in a decade For more than 50 years, Juran's Quality Handbook has been the singular essential reference to quality management and engineering. The Sixth Edition--the first revision of the Handbook in 10 years--forges a new standard in tools for quality. Bringing leaders, managers, master and black belts, and engineers the most up-to-date methods, research, and tools, under the guidance of a team of the world's top experts, this authoritative resource shows how to apply universal methods for delivering superior results and organizational excellence in any organization, industry, country, or process. Juran's Quality Handbook, sixth edition covers: Leadership--what everyone needs to know about managing for superior quality and results Methods--the most effective methods and tools for attaining superior results, such as Lean, Six Sigma, Root Cause Analysis, Continuous Innovation, and more Industry applications--effectively applying quality management The roles of key functions--such as quality professionals, research and development, supply chain, and governance--and what they must carry out to attain superior results in an organization Performance excellence--pragmatic roadmaps, templates, and tools to aid in developing an effective and sustainable performance excellence system

ISO 9001

Author: Itay Abuhav
Publisher: CRC Press
ISBN: 1498733212
Release Date: 2017-02-07

This book covers all of the new ISO 9001 requirements in detail, including examples and demonstrations from various fields and industries. In the practice of industry, the changes will demand from the ISO 9001 standard certified organizations to initiate massive adjustments to their quality management system. The adjustments are to be seen in the structure of their management systems, the documentation of the quality management system and the different methods of implementation related to the ISO.

Qualit tssicherung f r Dummies

Author: Larry Webber
Publisher: John Wiley & Sons
ISBN: 9783527817689
Release Date: 2018-11-26
Genre: Business & Economics

"Qualitätssicherung für Dummies" führt Sie in die Grundlagen des Qualitätsmanagements ein und zeigt, wie Sie durch strukturiertes, systematisches Vorgehen die operative Umsetzung des Qualitätsmanagements unterstützen. Die Autoren Larry Webber und Michael Wallace definieren zunächst den Begriff "Qualität", erklären die Bedeutung von Qualitätsstandards und wie sich diese auf die Produkte und Strategien in einem Unternehmen auswirken. Anhand von vielen Methoden und Instrumenten wie Six Sigma, Kanban, Kaizen, Lean, 5S und der Meinung der Kunden erfahren Sie, wie Sie Prozessqualität messen können und bei der Umsetzung dieses Systems die Mitarbeiter nicht außen vor lassen.

Das Lean Six Sigma Toolbook

Author: Michael L. George
Publisher: Vahlen
ISBN: 9783800648535
Release Date: 2016-08-12
Genre: Business & Economics

Die Referenz zum Verständnis der Konzepte und Werkzeuge von Lean Six Sigma: Six Sigma ist ein statistisches Qualitätsziel und zugleich ein Instrument des Qualitätsmanagements. Ausgangspunkt dieser auf Effizienz und Qualität ausgerichteten Methode ist die Zieldefinition. Danach wird die Fehlerabweichung von diesem Idealziel ermittelt. Ihr Kernelement ist also die Beschreibung, Messung, Analyse, Verbesserung und Überwachung von Geschäftsprozessen unter anderem mit statistischen Mitteln. Dabei orientieren sich die Ziele an Prozesskennzahlen eines Unternehmens und an den Kundenbedürfnissen. In diesem Buch werden alle wichtigen Werkzeuge zur Anwendung von Lean Six Sigma vorgestellt und systematisch auf ihre Einsatzgebiete hin eingeordnet. Detaillierte Erläuterungen helfen zu verstehen, welches Werkzeug wann, wie und warum einzusetzen ist. Aus dem Inhalt: - Voice of the Customer - Wertstromanalyse und Prozessflussdiagramme - Datenerhebung und Abweichungsanalysen - Fehlerursachen identifizieren und verifizieren - Minderung der Durchlaufzeiten und der nicht-wertschöpfenden Kosten - Komplexität und Komplexitätsanalyse - Auswahl und Pilotierung von Lösungen Michael L. George ist Chairman der George Group, der weltweit führenden Six-Sigma-Beratung. David Rowlands ist Vice President für Six Sigma bei der North American Solution Group, einer Division von Xerox. Marc Pice und John Maxey sind Mitarbeiter der George Group. Die Übersetzung dieses Buchs wurde vom Six-Sigma-Experten Dirk Dose, Partner bei der PPI AG (, und seinem Team vorgenommen. Er verfügt über umfangreiche Beratungspraxis mit Prozessoptimierungsprojekten, bei denen Six Sigma zur Verbesserung von Geschäftsprozessen eingesetzt wurde. Lean Six Sigma ist eine der führenden Techniken zur Maximierung der Prozesseffizienz und zur Steuerung jedes Schritts eines Geschäftsprozesses. Mit dem Lean Six Sigma Toolbook werden Sie entdecken, wie Sie Ihr Unternehmen auf ein neues Niveau der Wettbewerbsfähigkeit heben können.

The Medical Device Industry

Author: John Burton
Publisher: Cambridge Scholars Publishing
ISBN: 9781443808392
Release Date: 2009-03-26
Genre: Law

The Medical Device industry is one of the fastest growing industries in the world. Device manufacturers are producing increasingly sophisticated and complex medical device software to differentiate themselves in the battle for dominance in this sector. The increase in the complexity of medical device software has introduced new challenges with respect to making medical devices and their associated software safe. Risk management has emerged as key in addressing these challenges. Existing literature on risk management for medical devices has been slow to adequately account for the complex nature of software in modern medical devices. Conversely, excellent progress has been made in the broader Software Engineering community with the production of holistic software risk based models such as the Capability Maturity Model Integration (CMMI®) and SPICE™. However, these models do not account for medical device specific requirements. This book examines the possibility of a unified approach whilst investigating the relevance of the CMMI® SPI model to the medical device regulatory requirements.

GMP ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers Volume 2 Regulations Standards and Guidelines

Author: Leonard Steinborn
Publisher: CRC Press
ISBN: 0203026659
Release Date: 2004-12-30
Genre: Medical

This well-known QA manual has been updated to provide the guidance readers need to assess their compliance with standard regulations. This Volume 2 of a three-part package contains the full text on: * FDA regulations * EC and IPEC guidelines * ISO/BSI standards referenced in the checklists furnished in volume 1 Easy-to-read and organized to provide fast access to guidelines and regulations, this is an essential reference for those working in the field.

The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices

Author: Amiram Daniel
Publisher: ASQ Quality Press
ISBN: 9780873897402
Release Date: 2008-01-01
Genre: Medical

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.

Design Controls for the Medical Device Industry Second Edition

Author: Marie B. Teixeira
Publisher: CRC Press
ISBN: 9781466503557
Release Date: 2013-11-12
Genre: Medical

The second edition of a bestseller, Design Controls for the Medical Device Industry provides a comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure your company’s design control program evolves in accordance with current industry practice. The text assists in the development of an effective design control program that not only satisfies the US FDA Quality System Regulation (QSR) and ISO 9001 and 13485 standards, but also meets today’s third-party auditor/investigator expectations and saves you valuable time and money. The author’s continual participation in FDA QSR inspections and Notified Body ISO audits is reflected in updates to all chapters and appendices of the book, now bursting at the seams with: New coverage of ISO 9001 and 13485 design control requirements More real-world examples from the medical device industry Additional detail for greater understanding and clarity Fresh templates for practical implementation Extensive references for further study The book addresses design control elements such as design planning, input, output, review, verification, validation, change, transfer, and history, as well as risk management inclusive of human factors and usability, biocompatibility, the FDA Quality System Inspection Technique (QSIT) for design controls, and medical device regulations and classes in the US, Canada, and Europe.