Easy Iso 13485

Author : Ilkka Juuso
Publisher : CRC Press
Page : 331 pages
File Size : 50,9 Mb
Release : 2022-03-20
Category : Business & Economics
ISBN : 9781000550689

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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 : Jahangir Asadi
Publisher : Silosa Consulting Group (Scg)
Page : 50 pages
File Size : 53,6 Mb
Release : 2021-10-17
Category : Electronic
ISBN : 1990451071

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Easy ISO 13485 by Jahangir Asadi Pdf

If your document can answer these 6 questions, then you have developed a completely effective document; no matter that it is a quality manual, procedure, SOP, work instruction... see page 34 for more details.

Author : Itay Abuhav
Publisher : CRC Press
Page : 735 pages
File Size : 52,6 Mb
Release : 2018-05-11
Category : Medical
ISBN : 9781351000772

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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 : Itay Abuhav
Publisher : CRC Press
Page : 376 pages
File Size : 50,6 Mb
Release : 2011-10-20
Category : Medical
ISBN : 9781439866115

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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 : 364 pages
File Size : 54,6 Mb
Release : 2011-10-20
Category : Medical
ISBN : 9781439866122

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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 : Erik V. Myhrberg,Joseph Raciti,Brandon L. Myhrberg
Publisher : Quality Press
Page : 252 pages
File Size : 41,8 Mb
Release : 2019-11-06
Category : Business & Economics
ISBN : 9781951058210

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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 : Amiram Daniel
Publisher : Quality Press
Page : 355 pages
File Size : 46,8 Mb
Release : 2008-01-01
Category : Medical
ISBN : 9780873897402

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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 : Ministry of Health & Welfare,Korea Medical Devices Industrial Coop. Association,Korea Health Industry Development Institute
Publisher : 메디칼디바이스
Page : 174 pages
File Size : 54,6 Mb
Release : 2024-07-01
Category : Electronic
ISBN : 8210379456XXX

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Medical Device Companies Directory Book 2015 by Ministry of Health & Welfare,Korea Medical Devices Industrial Coop. Association,Korea Health Industry Development Institute Pdf

This brochure illustrates a project promoted by Korean medical device companies wanting to develop a presence in global market with support from Korean government. Inside you will find how korean medical device companies are reliable partners for global collaboration.

Author : Ilkka Juuso,Ilpo Pöyhönen
Publisher : CRC Press
Page : 256 pages
File Size : 54,7 Mb
Release : 2023-11-13
Category : Business & Economics
ISBN : 9781000987904

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Medical-Grade Software Development by Ilkka Juuso,Ilpo Pöyhönen Pdf

This book is a practical guide to meeting IEC 62304 software-development requirements within the context of an ISO 13485 quality management system (QMS). The book proves this can be done with a minimum amount of friction, overlap, and back-and-forth between development stages. It essentially shows you how you should shape your medical-software development processes to fit in with the QMS processes in the smartest and leanest way possible. By following the advice in this book, you can reuse processes from your QMS, ensure your product-realization processes meet the requirements for medical-software development, and marry all the requirements together using tried and tested solutions into one efficient system. The expertise of the authors here goes beyond just the experiences of one real-world project as they tap into over 30 years of experience and countless software and software-assessment projects to distill their advice. The book takes a hands-on approach by first teaching you the top 25 lessons to know before starting to develop a process for medical-software development. It then walks you through the expectations placed on the key aspects of such a process by the key standards. The book progresses from an overview of both standards and the general requirements involved to a detailed discussion of the expected stages from software development and maintenance to risk management, configuration management, and problem resolution. The book provides insightful advice on how the requirements of the IEC 62304 software-development life cycle can be married with an ISO 13485 QMS, how the development of the technical file should be organized, and how to address conformity assessment, the daily after-approval, and the recent trends that will affect the industry in the coming years. The book is modeled after the IEC 62304 standard and adopts its clause structure in the numbering of sections for easy reference. The book does not attempt to replicate either standard. For the ISO 13485 standard, it recites the necessary requirements succinctly. For IEC 62304, the discussion is in-depth and also addresses the impact of ISO 13485 on the requirements discussed. In this way, the book drills into both standards to expose the core of each requirement and shape these into a practical, cohesive workflow for developing, maintaining, and improving a Lean software development pipeline.

Author : National Research Council,Division on Earth and Life Studies,Commission on Life Sciences,Committee on the Institutional Means for Assessment of Risks to Public Health
Publisher : National Academies Press
Page : 206 pages
File Size : 42,5 Mb
Release : 1983-02-01
Category : Medical
ISBN : 9780309033497

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Risk Assessment in the Federal Government by National Research Council,Division on Earth and Life Studies,Commission on Life Sciences,Committee on the Institutional Means for Assessment of Risks to Public Health Pdf

The regulation of potentially hazardous substances has become a controversial issue. This volume evaluates past efforts to develop and use risk assessment guidelines, reviews the experience of regulatory agencies with different administrative arrangements for risk assessment, and evaluates various proposals to modify procedures. The book's conclusions and recommendations can be applied across the entire field of environmental health.

Author : Seeram Ramakrishna,Lingling Tian,Charlene Wang,Susan Liao,Wee Eong Teo
Publisher : Woodhead Publishing
Page : 256 pages
File Size : 48,5 Mb
Release : 2015-08-18
Category : Medical
ISBN : 9780081002919

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Medical Devices by Seeram Ramakrishna,Lingling Tian,Charlene Wang,Susan Liao,Wee Eong Teo Pdf

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

Author : Jose Justiniano,Venky Gopalaswamy
Publisher : CRC Press
Page : 152 pages
File Size : 52,7 Mb
Release : 2004-11-15
Category : Science
ISBN : 9780203485743

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Six Sigma for Medical Device Design by Jose Justiniano,Venky Gopalaswamy Pdf

For designers of medical devices, the FDA and ISO requirements are extremely stringent. Designers and researchers feel pressure from management to quickly develop new devices, while they are simultaneously hampered by strict guidelines. The Six Sigma philosophy has solved this dichotomous paradigm for organizations in other fields, and seeks to do

Author : David Kong
Publisher : David Kong
Page : 108 pages
File Size : 48,8 Mb
Release : 2014-07-13
Category : Electronic
ISBN : 8210379456XXX

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Organization Excellence: Productivity and Improvement (A Simple Approach) by David Kong Pdf

Throughout my years of productivity and IT consultancy with implementation, I have encountered numerous challenges faced by organization to implement an efficient and effective system that works for them. When such challenges are not handled properly, it resulted in implementations which are not optimized to the organization business requirement. I would like to provide some useful information, which can help organizations to implement productivity and improvement activities into their daily operations. There are many factors that can affect productivity of an organization. As it is not possible for me to cover every tool which can help to improve productivity, I have decided to concentrate on some of the key ones here. I will be touching on plant layouts, proper quality frameworks and management system for the discussion in this book. An organization with an optimized system in place, can contribute to good output performance. It increases the efficiency and effectiveness of an organization. Internal controls should be installed to ensure that products at every stage of the process are being checked for conformance. Enforcement of the compliance to the procedures and internal controls that were implemented should also be available to ensure that the defined goals and objectives are met. A good organization should stress on training for staff. Such training should be structured in a way that it is geared towards equipping staff with the relevant skill sets and knowledge to perform their job. Job skill matrix table could be put up to develop staff further and also serve as a tool for resource planning. I cannot stress enough the importance of how a good proper strategic planning and implementation can contribute greatly to the success of an organization performance. Due to this, I have also included Business Continuity Planning as one of the criteria for organization excellence. With the occurrence of natural disaster, haze, pandemic flu episode and any unexpected happening, it warrants some form of planning to prepare the organization to systematically react in the event such occurrence is to happen. As a value added service, I have included a few Excel templates for some of the tools cover in this book in the website: http://pqi.dscloud.biz. You will need to be a registered user in order to gain access to them. They are listed as follows: - Fish Bone Diagram using Excel - Moving Average using Excel - Correlation using Excel - Covariance using Excel - Percentile using Excel - Pareto Chart using Excel - Solver using Excel - Goal Seek using Excel

Author : R. Timothy Stein
Publisher : Paton Professional
Page : 610 pages
File Size : 40,5 Mb
Release : 2006
Category : Business & Economics
ISBN : 1932828095

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The Computer System Risk Management and Validation Life Cycle by R. Timothy Stein Pdf

Author : Charles A. Cianfrani,John E. (Jack) West
Publisher : Quality Press
Page : 296 pages
File Size : 44,9 Mb
Release : 2016-09-08
Category : Business & Economics
ISBN : 9780873899086

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Cracking the Case of ISO 9001:2015 for Service, Third Edition by Charles A. Cianfrani,John E. (Jack) West Pdf

This guide is intended to help everyone in a service organization participate in creating and sustaining a foundation of integrity, meet requirements and customer expectations, and support robust processes, to the advantage of everyone in the organization and to each of its customers. It provides a simplified explanation of the clauses of ISO 9001:2015, including: - What’s required - Why to do it - Implementation tips - Questions to ask to assess conformity Also included is a chapter that answers the question “Why do ISO 9001:2015?” and a chapter that summarizes the key differences with past editions of ISO 9001. To assist the user in implementation of QMS processes, this guide also includes a chapter that describes 12 quality tools. For each tool, the authors describe (1) what it is, (2) where it’s used, (3) how it’s done, and (4) cautions to be considered when using the tool. The contents of this book can help organizations save time in achieving compliance with the ISO 9001 requirements and also facilitate effective implementation. This has the potential to lower internal costs and to improve customer satisfaction.