A Practical Field Guide for ISO 13485:2016 , livre ebook

ASQ Quality Press - Brandon L. Myhrberg , Joseph Raciti , Erik V. Myhrberg

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130 pages

English

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Description

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

Sujets

Business

Qualité, hygiène, sécurité, environnement

Instruments

Supplies

Medical

Médecine

ISO 13485

Informations

Publié par	ASQ Quality Press
Date de parution	06 novembre 2019
Nombre de lectures	1
EAN13	9781951058210
Langue	English

Informations légales : prix de location à la page 0,3000€. Cette information est donnée uniquement à titre indicatif conformément à la législation en vigueur.

Extrait

A Practical Field Guide for ISO 13485:2016

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A Practical Field Guide for ISO 13485:2016
Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes
• Leadership Guidance
• Implementation Support
• Documentation Assistance
• Auditing Technique
• Revisions/Updates
• Senior Management Briefs
Erik V. Myhrberg and Joseph Raciti with Brandon L. Myhrberg

Quality Press
Milwaukee, Wisconsin

American Society for Quality, Quality Press, Milwaukee 53203
© 2019 by Erik V. Myhrberg
All rights reserved. Published 2019
Publisher’s Cataloging-in-Publication Data

Names: Myhrberg, Erik V., author. | Raciti, Joseph, author. | Myhrberg, Brandon L., author.
Title: A Practical field guide for ISO 13485:2016 : medical devices—quality management systems—requirements for regulatory purposes / Erik V. Myhrberg and Joseph Raciti ; with Brandon Myhrberg.
Description: Includes bibliographical references. | Milwaukee, WI: Quality Press, 2019.
Identifiers: LCCN 2019951103 | ISBN 978-0-87389-990-1 (spiral) | 978-1-951058-21-0 (epub) | 978-1-951058-22-7 (pdf)
Subjects: LCSH Equipment Design—standards—United States. | Equipment and Supplies—standards—United States. | Industry—standards—United States. | Quality Control—United States. | BISAC MEDICAL / Instruments & Supplies
Classification: LCC R856.A2 M95 2019 | DDC 610.28—dc23
R856.15.M94 2012
610.28’4—dc23 2012039034
ISBN: 978-0-87389-990-1 (Spiralbound)
ISBN: 978-1-951058-21-0 (EPUB)
ISBN: 978-1-951058-22-7 (PDF)
No part of this book may be reproduced in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written permission of the publisher.
Publisher: Seiche Sanders
Managing Editor: Sharon Woodhouse
Sr. Creative Services Specialist: Randy L. Benson
ASQ Mission: The American Society for Quality advances individual, organizational, and community excellence worldwide through learning, quality improvement, and knowledge exchange.
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To our families, colleagues, and fellow professionals.

Introduction
Almost 30 years have passed (and over 150 international projects) since we first became aware of, and started using, the ISO standards. So much has changed and evolved during this time, including the advent of the ISO 14000 series of environmental management standards, the addition and deletion of standards within the ISO 9000 series, and the creation of a host of industrial and sector-specific standards and reports based on ISO 13485. In addition, a natural extension of the standard has been prepared for the management of quality systems for the medical and medical device sector.
Even with all this progress, the fundamental use of the ISO 9000 series (up to and including ISO 13485) for the medical and medical device sector has not changed. Companies, teams, and individuals are still trying to meet customer expectations. Worldwide competition still drives the need for innovation. And internal process pressures still demand continual improvement in order to remain functional and vital as an organization.
This field guide has been created in order to foster an inter-reliance between senior management, middle management, functional teams, and the individual. Users of the field guide will find practical tools, tips, and techniques useful for developing, implementing, and maintaining a quality management system.
It is our hope that the readers and users of this field guide will benefit from our years of extensive field and classroom experience in the application of any ISO 9000 quality management system series standard for the medical and medical device sector.
As we forge into the twenty-first century, companies and organizations of all sizes are being pushed to the limit of their resources. At one time it was sufficient to meet most of our customers’ requirements. Today, on a global scale, we are being asked to do more with less, for less, without compromising quality or delivery. At some point soon, the current internal systems will not be able to hold back the deluge, and companies will be faced with a stark decision—consistently improve or perish.
One of the best and most widely accepted ways in which companies can face these challenges is to implement an effective and efficient quality management system, which not only adds value to the organization but also satisfies the customer. Indeed, this is already the century of international standards. The ISO 13485:2016 series of standards is both useful to the organization and here to stay.
Use this guide diligently as you work through your ongoing ISO efforts!
Erik Myhrberg, Joe Raciti, and Brandon Myhrberg
http://www.moorhill.com

How to Use This Field Guide
The purpose of this field guide is to assist organizations, step by step, in implementing a quality management system (QMS) for the medical and medical device sector 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,” we have identified the requirements and inherent characteristics, or distinguishing features, for this field guide. Within the guide, each subclause containing requirements is the focus of a two-page spread that consistently highlights features that fulfill the requirements listed below.
What the Field Guide Will Do for You
• Provide a user-friendly guide to ISO 13485:2016 requirements for implementation purposes.
• Identify the documents/documentation required, along with recommendations about what to retain or add to a QMS during ISO 13485:2016 implementation.
• Guide internal auditor(s) regarding questions that verify a conforming and effective QMS exists and is being maintained.
• Direct management on ways to satisfy ISO 13485:2016 enhanced requirements, as well as responsibilities for top management.
• Depict step-by-step what must occur to create an effective, conforming QMS.
Inherent Characteristics, or What the Field Guide Provides
• The standard . A paraphrase of what a subclause of ISO 13485:2016 requires in easy-to-understand language, with references to information in ISO 9000:2015 and guidance in ISO 9004:2015 to enhance the user’s understanding of what ISO 13485:2016 requires and what possible added steps the user can take to improve performance.
• Document requirements . A list of the documentation/documents required by the subclause, with ideas to consider for satisfying those requirements that will go beyond meeting them and move toward continual improvement.
• Internal audit questions . What every internal audit team needs to ask, at a minimum, when assessing the QMS for conformance with the subclause.
• Management summary . A concise description of what management must do and/or is responsible for in order to achieve conformance to the subclause, along with some guidance on additional steps management can take to enhance the overall QMS.
• Subclause flowchart . A depiction of the necessary steps during an implementation/transition effort to effectively and efficiently satisfy the requirements of the subclause of ISO 13485:2016, along with a tip box providing guidance on use of the flowchart.
This medical device field guide is designed to provide you with a consistent approach to implementing an ISO 13485:2016–conforming QMS, which is appropriate since ISO 13485:2016 continues to view quality as the ability of an organization to consistently deliver product that meets customer requirements.
The field guide examines each subclause of S