A Practical Field Guide for ISO 13485:2016

Joseph Raciti, Erik V. Myhrberg

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: 0
• EAN13: 9781951058227
• Langue: English
• Poids de l'ouvrage: 4 Mo

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 Printed in the United States of America 25 24 23 22 21 20 19 5 4 3 2 1

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)

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TABLE OF CONTENTS

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

How to Use This Field Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

ISO 13485 Strategic Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Section 4: Quality Management System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.1 General Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.2 Documentation Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Section 5: Management Responsibility. . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . 5.1 Management Commitment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.2 Customer Focus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.3 Quality Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.4 Planning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.5 Responsibility, Authority and Communication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.6 Management Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Section 6: Resource Management. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.1 Provision of Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.2 Human Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.3 Infrastructure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.4 Work Environment and Contamination Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Section 7: Product Realization. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . 7.1 Planning of Product Realization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.2 Customer-Related Processes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.3 Design and Development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.4 Purchasing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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13 14 16 18 20 24 30

39 40 42 46 48

53 54 56 62 76

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7.5 Production and Service Provision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.6 Control of Monitoring and Measuring Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Section 8: Measurement, Analysis and Improvement. . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . 8.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8.2 Monitoring and Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8.3 Control of Nonconforming Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8.4 Analysis of Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8.5 Improvement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

ISO 13485:2016 Documented Requirements from Most Strategic to Most Tactical . . . . . . . . . . . .

Sources of Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

82 94

103 104 106 116 118 120

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INTRODUCTION

lmost 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, includ- dele A tion of standards within the ISO 9000 series, and the creation of a host of industrial and sector-specific ing the advent of the ISO 14000 series of environmental management standards, the addition and standards and reports based on ISO 13485. In addition, a natural extension of the standard has been pre- pared 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.

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