Iso 13485 The Quality Management System For Medical Devices

Author : Ilkka Juuso
Publisher : CRC Press
Page : 331 pages
File Size : 55,9 Mb
Release : 2022-03-20
Category : Business & Economics
ISBN : 9781000550689

Get Book

Developing an ISO 13485-Certified Quality Management System by Ilkka Juuso Pdf

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.

Author : Itay Abuhav
Publisher : CRC Press
Page : 376 pages
File Size : 55,8 Mb
Release : 2011-10-20
Category : Medical
ISBN : 9781439866115

Get Book

ISO 13485 by Itay Abuhav Pdf

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.

Author : Itay Abuhav
Publisher : CRC Press
Page : 735 pages
File Size : 54,8 Mb
Release : 2018-05-11
Category : Medical
ISBN : 9781351000772

Get Book

ISO 13485:2016 by Itay Abuhav Pdf

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.

Author : Brendan Cooper
Publisher : Createspace Independent Publishing Platform
Page : 130 pages
File Size : 48,8 Mb
Release : 2017-04-14
Category : Electronic
ISBN : 1545382379

Get Book

ISO 13485 - The Quality Management System for Medical Devices by Brendan Cooper Pdf

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.

Author : Erik V. Myhrberg,Joseph Raciti,Brandon L. Myhrberg
Publisher : Quality Press
Page : 252 pages
File Size : 40,7 Mb
Release : 2019-11-06
Category : Business & Economics
ISBN : 9781951058210

Get Book

A Practical Field Guide for ISO 13485:2016 by Erik V. Myhrberg,Joseph Raciti,Brandon L. Myhrberg Pdf

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

Author : Erik V. Myhrberg,Joseph A Raciti
Publisher : ASQ Quality Press
Page : 0 pages
File Size : 40,5 Mb
Release : 2019-11-06
Category : Electronic
ISBN : 163694132X

Get Book

A Practical Field Guide for ISO 13485 by Erik V. Myhrberg,Joseph A Raciti Pdf

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

Author : George Dennis Green,British Standards Institute Staff
Publisher : Unknown
Page : 179 pages
File Size : 48,6 Mb
Release : 2005
Category : Medical instruments and apparatus
ISBN : 0580456447

Get Book

Medical Devices by George Dennis Green,British Standards Institute Staff Pdf

Medical equipment, Medical instruments, Medical technology, Quality management, Quality assurance systems, Quality, Acceptance (approval), Quality auditing, Management Quality and Management

Author : Amiram Daniel
Publisher : Quality Press
Page : 355 pages
File Size : 55,6 Mb
Release : 2008-01-01
Category : Medical
ISBN : 9780873897402

Get Book

The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices by Amiram Daniel Pdf

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.

Author : Ann Goodall,British Standards Institute Staff
Publisher : Unknown
Page : 196 pages
File Size : 49,6 Mb
Release : 1914-04-04
Category : Electronic
ISBN : 0580685950

Get Book

Implementing an Iso 13485 Quality Management System for Medical Devices by Ann Goodall,British Standards Institute Staff Pdf

Medical equipment, Medical instruments, Medical technology, Quality management, Quality assurance systems, Acceptance (approval), Management Quality and Management

Author : Priscilla Browne
Publisher : Independently Published
Page : 106 pages
File Size : 42,9 Mb
Release : 2021-12
Category : Electronic
ISBN : 9798778002975

Get Book

ISO 13485 for Engineers by Priscilla Browne Pdf

This book is written to provide Quality engineers, medical engineers, device engineers with a practical and insightful companion to understand ISO 13485, Quality Management system for medical devices. It provides a straight-to-the-point perspective which should assist in the interpretation of the standard and provide a benchmark for what is expected in the application of the standard and compliance for industry. ISO 13485:2016 is an international standard for the quality management of medical devices. It is of value and applicable to a number of business areas that are involved in the various stages of a medical device and its product lifecycle. It may be applied by a design company, manufacturer, raw material supplier, calibration service, sterilization services or distributer. The scope of the standard covers: design and development production, storage and distribution installation servicing (if required) decommissioning and disposal In particular, manufacturers of medical devices and typically mandated by regulatory bodies to comply with ISO 13484, and must demonstrate compliance and application of the standard subject to certification and an audit process. FDA, 21 CFR Part 820 is another example of a Quality Management system. While its official designation is a Quality System (QS) it serves a similar purpose to ISO 13485- Quality management system for medical devices. However, there is an important distinction. 21 CFR Part 820 has a regulatory standing in the United states. While many competent authorities require the application of ISO 13485, the framework of ISO 13485 is a standard opposed to a regulation. Revised in 2016, ISO 13485:2016 "specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements." The scope of the standard can apply to any organisation or company involved throughout the life-cycle of a product, including design and/or development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of technical or professional services. The 2016 revision is designed to address recent developments in quality management and other updated regulations that relate to the industry. Improvements in the new version of the standard include broadening its applicability to include all organisations involved in the life cycle of the product, from the concept stage to end of life along with greater alignment with regulatory requirements and post-market surveillance including complaint handling. Overview of Content: Introduction to ISO 13485, Directives and Standards, Competent Authorities, Notified Bodies, How ISO 13485 differs to ISO 900I ISO/TR 14969, Terms /Definitions, Process Approach, Plan-Do-Check-Act (PDCA) Quality Management System, Introduction, Regulatory Requirements, Risk Based Approach, Changes within the QMS, Documentation, Quality Manual, Control of Records Management Responsibility, Management Commitment, Customer Focus, Quality Policy, Planning, Management Review, Resource Management, Provision of resources, Human resources, Infrastructure, Work environment & contamination control, Product realization, Planning of Product Realization, Design and Development, Production and service provision, Ctrl of monitoring & measuring equipment Measurement Analysis PART 2 Good Documentation Practices, Introduction, Quality Management Systems PART 3 Validation Introduction, Equipment and Software Validation, Software Validation, Process Validation, Packaging Validation

Author : Itay Abuhav
Publisher : Unknown
Page : 877 pages
File Size : 47,9 Mb
Release : 2018
Category : BUSINESS & ECONOMICS
ISBN : 1523118105

Get Book

ISO 13485:2016 by Itay Abuhav Pdf

"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."--

Author : Canadian Standards Association,International Organization for Standardization,Standards Council of Canada
Publisher : Mississauga, Ont. : Canadian Standards Association
Page : 58 pages
File Size : 47,8 Mb
Release : 2003
Category : Medical instruments and apparatus
ISBN : 155397526X

Get Book

Medical Devices [electronic Resource] : Quality Management Systems : Requirements for Regulatory Purposes by Canadian Standards Association,International Organization for Standardization,Standards Council of Canada Pdf

Author : Anonim
Publisher : Unknown
Page : 36 pages
File Size : 41,5 Mb
Release : 2016
Category : Electronic
ISBN : OCLC:948781258

Get Book

ISO 13485-2016. Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes by Anonim Pdf

Author : Ilkka Juuso
Publisher : CRC Press
Page : 371 pages
File Size : 50,9 Mb
Release : 2022-03-20
Category : Business & Economics
ISBN : 9781000550665

Get Book

Developing an ISO 13485-Certified Quality Management System by Ilkka Juuso Pdf

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.

Author : Emmet Tobin
Publisher : Createspace Independent Publishing Platform
Page : 0 pages
File Size : 54,5 Mb
Release : 2016-06-13
Category : Electronic
ISBN : 1534675272

Get Book

ISO 13485 Starter Guide by Emmet Tobin Pdf

Revised in 2021, This short, concise book provides an introduction to ISO 13485. It is written in accessible language, providing a straight forward resource for the reader. It introduces the core themes of the standard to those who wish to work in regulated industries such as medical devices, highlighting key areas and practices. It is a perfect introduction for operators, factory workers, engineers and managers wishing to learn the fundamentals. It is also a useful pocket reference book, small enough to slip into a case or pocket. ISO 13485 is the Quality management standard of choice for manufactures of medical devices. Revised in 2016, ISO 13485:2016 "specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements." The scope of the standard can apply to any organization or company involved in throughout the life-cycle of a product, including design and/or development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of technical or professional services.(Page count pages 82) While not suitable for experienced or advanced professionals, this publication aims to provide context and a fundamental grounding in ISO 13486- Quality management system for medical devices. Second Edition, 2021