How to Establish a Document Control System for Compliance with ISO 9001:2015, ISO 13485:2016, and FDA Requirements: A Comprehensive Guide to Designing a Process-Based Document Control System

By Stephanie L. Skipper

This book explains the requirements for compliance with FDA regulations and ISO standards (9001/13485) for documented information controls, and presents a methodology for compliance.

The document control system (DCS), or documented information control system (DICS), is the foundation of a quality management system. It is the first quality system element that must be implemented because the establishment and control of documented processes and information in a quality-controlled environment is dependent on the ability to proactively manage access to documents and the movement of documents through the document life cycle.
A well-developed document control system benefits business by: Improving knowledge retention and knowledge transfer within and across business units

Improving access to knowledge-based information
Improving employee performance by providing standardized processes and communicating clear expectations

Improving customer communication and satisfaction by providing documented information from which common understanding can be achieved

Providing traceability of activities and documentation throughout the organization

Improving organization of and access to documents and data

Sample documents are included in the appendixes of this book to help clarify explanations.
This book provides a process-based approach that can be used for controlling all forms of documented information that are required to be managed under the quality management system.

• Language: English
• Publisher: ASQ Quality Press
• Release date: Oct 12, 2015
• ISBN: 9781953079503

Book preview

How to Establish a Document Control System for Compliance with ISO 9001:2015, ISO 13485:2016, and FDA Requirements

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To request a complimentary catalog of ASQ Quality Press publications, call 800-248-1946, or visit our website at http://www.asq.org/quality-press.

How to Establish a Document Control System for Compliance with ISO 9001:2015, ISO 13485:2016, and FDA Requirements

A Comprehensive Guide to Designing a Process-Based Document Control System

Stephanie L. Skipper

ASQ Quality Press

Milwaukee, Wisconsin

American Society for Quality, Quality Press, Milwaukee 53203

© 2016 by ASQ

All rights reserved. Published 2015

Library of Congress Cataloging-in-Publication Data

Skipper, Stephanie L., author.

How to establish a document control system for compliance with ISO 9001:2015, ISO 13485:2016, and FDA requirements : a comprehensive guide to designing a process-based document control system / Stephanie L. Skipper.

pages cm

Includes index.

ISBN 978-0-87389-917-8 (hard cover : alk. paper)

1. Records—Management—Data processing. 2. Electronic records—Management. 3. Information storage and retrieval systems. 4. Database management. 5. Quality control. I. Title.

HF5738.S55 2015

651.50285—dc23 2015030766

ISBN: 978-0-87389-917-8

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: Lynelle Korte

Acquisitions Editor: Matt T. Meinholz

Project Editor: Paul Daniel O’Mara

Production Administrator: Randall 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 place orders or to request ASQ membership information, call 800-248-1946. Visit our website at http://www.asq.org/quality-press.

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This book is dedicated to:

My parents—thank you for instilling in me the value of lifelong learning.

My husband—thank you for encouraging me to be all that I can be and do all that I can do.

My children—realize that you can do anything.

My clients—thank you for allowing me the opportunity to work with you and learn about your needs, hopes, and challenges.

List of Figures and Tables

Figure 5.1 Process.

Figure 5.2 Process definition diagram.

Figure 6.1 Document life cycle.

Figure 6.2 ISO and FDA objectives met by the document life cycle.

Figure 6.3 Example of operational activities that are in scope for controlled documents.

Figure 7.1 Controlled document levels.

Figure 8.1 Library to document control comparison

Figure 8.2 Efficient document control numbering structure.

Figure 8.3 Company ABC global operations organizational chart.

Figure 8.4 Company XYZ organizational chart.

Table 9.1 Document control objectives and requirements checklist.

Figure 10.1 User information needs to document structure comparison.

Figure 13.1 Document life cycle.

Figure 13.2 Sample version 2.0 document change history.

Figure 14.1 Document life cycle.

Figure C.1 Controlled document levels.

Figure C.2 Document life cycle.

Figure C.3 Controlled document life cycle—level 5 highly specific support documents.

Foreword

Throughout my experiences as a student of quality system methodologies and practitioner of quality system deployment and management, there have been many pearls of wisdom passed on to me by professors and colleagues. I have never forgotten my food and drug law instructor stating that the FDA regulations are the floor, not the ceiling . . . and some of us need to get out of the basement! At the time, I thought that his statement was insensitive to the students in the room who were employees of an organization with a highly publicized consent decree in effect. However, over time I began to understand the wisdom of his statement and how it succinctly made the same point that FDA makes in the preambles to the GMP regulations. The point is that the regulations provide the minimum requirements by law, but an organization that is quality focused will usually end up with a system that includes many elements that are not required by law but instead are just good business practice in a quality-focused organization.

In writing this book, I have explained the requirements for compliance with FDA regulations and ISO standards (9001/13485) for documented information controls, and I have presented a methodology for compliance. However, as you embark on this journey, I would like to pass on my own pearl of wisdom to you:

Usually, there is more than one way to do something right.

Establishing quality procedures is about finding one right way to do something, teaching employees how to do it that way, and then doing it that same way until an authorized change is made. A quality system or any element of a quality system will vary between one organization and another due to differences in geography, available business tools, budget to purchase and implement software, and other factors. One organization may have a paper-based document control system while another uses a software-based document control system. I have even seen electronic signatures implemented in a quasi-­paper-based document control system. Different is OK as long as the requirements are met. As you develop and implement the procedures that will form the foundation of your process-based document control system, the most important thing that you can do is to make sure that the process that you sign into effect meets the requirements of standards and regulations that are applicable to your organization and accurately states how work is performed. Afterward, you must manage and continually improve the process. ­Continuous improvement does not mean that the quality system is in a constant state of flux. Continuous improvement means that the organization makes planned changes to systems and processes for the purpose of increasing the effectiveness and efficiency of the system or process. A quality management system impacts the economy of the business, a function known as cost of quality. The theory behind cost of quality is that it is less expensive to build a product right the first time than to fix problems. Therefore, it stands that any organization should examine their quality system annually and identify ways to improve quality. This is the rationale behind management review and quality system review.

So, get started. Sample