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

Stephanie L. Skipper

Description

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.

Sujets

• Business
• Qualité, hygiène, sécurité, environnement
• Techniques
• Automatisation et Contrôle
• Contrôle des processus
• Automatisation
• Automate
• Food and Drug Administration
• QMS
• Engineering
• International Organization for Standardization
• Technology
• FDA
• Sciences et techniques
• Quality Control

Informations

• Publié par: ASQ Quality Press
• Date de parution: 12 octobre 2015
• Nombre de lectures: 0
• EAN13: 9781953079497
• Langue: English
• Poids de l'ouvrage: 4 Mo

Extrait

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

Also available from ASQ Quality Press:

ISO 9001:2015 Explained, Fourth Edition Charles A. Cianfrani, John E. “Jack” West, and Joseph Tsiakals

ISO 9001:2015 Internal Audits Made Easy, Fourth Edition Ann W. Phillips

ISO Lesson Guide 2015, Fourth Edition J.P. Russell and Dennis R. Arter

ISO 9001:2015 for Small and Medium Sized Businesses, Third Edition Denise Robitalle

A Practical Field Guide to ISO 13485 Erik V. Myhrberg and Joseph Raciti

The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, Second Edition Amiram Daniel and Ed Kimmelman

Implementing ISO/IEC 17025:2005 Bhavan “Bob” Mehta

The Biomedical Quality Auditor Handbook, Second Edition Biomedical Division and Bruce Haggar, editor

The Quality Toolbox, Second Edition Nancy R. Tague

Root Cause Analysis: Simplified Tools and Techniques, Second Edition Bjørn Andersen and Tom Fagerhaug

The Certified Six Sigma Green Belt Handbook, Second Edition Roderick A. Munro, Govindarajan Ramu, and Daniel J. Zrymiak

The Certified Manager of Quality/Organizational Excellence Handbook, Fourth Edition Russell T. Westcott, editor

The ASQ Auditing Handbook, Fourth Edition J.P. Russell, editor

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 Printed in the United States of America 21 20 19 18 17 16 15 5 4 3 2 1

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.

 Printed on acidfree paper

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.

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Table of Contents

List of Figures and Tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Applicability to ISO 9001:2015 and ISO 13485:2016 Updates. . . . . . . . . . . . . . . Acknowledgments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 1: Document Control in the Quality Management System . . . . . . . Chapter 2: Document Management versus Document Control . . . . . . . . . . . 2.1 ISO and US FDA Regulatory Document Control Requirements . . . . . . . Chapter 3: Manual Document Control Systems versus Electronic Document Control Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 4: Foundational Concepts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Foundational Concept: Controlled . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Foundational Concept: Controlled Document . . . . . . . . . . . . . . . . . . . . . . . . Foundational Concept: Proactively Managed . . . . . . . . . . . . . . . . . . . . . . . . . Foundational Concept: Document Life Cycle . . . . . . . . . . . . . . . . . . . . . . . . Foundational Concept: Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Foundational Concept: Process Steps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Foundational Concept: Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Foundational Concept: Document Control . . . . . . . . . . . . . . . . . . . . . . . . . . . Foundational Concept: Standard Operating Procedure . . . . . . . . . . . . . . . . . Chapter 5: ProcessBased Approach . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 6: The Document Life Cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.1 Scope of Document Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 7: Organization of Controlled Documents . . . . . . . . . . . . . . . . . . . . . 7.1 Document Levels and Families: Basic Organization Model . . . . . . . . . . . 7.2 Document Family Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.3 Purpose and Scope of Controlled Documents by Controlled Document Level . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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7.3.1 Purpose and Scope of Level 1 Policies (Top Level— Directives) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.3.2 Purpose and Scope of Level 2 Manuals and Master Plans (High Level—Informative) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.3.3 Purpose and Scope of Level 3 Standard Operating Procedures (Mid Level—Process) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.3.4 Purpose and Scope of Level 4 Work Instruction/Procedures (Low Level—Detailed Instructional) . . . . . . . . . . . . . . . . . . . . . . . . . 7.3.5 Purpose and Scope of Level 5 Supporting Documents (Specific, Detailed, Functional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 8: Document Identification: Numbering, Versioning, and Naming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8.1 Numbering . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Example #1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Example #2: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8.2 Versioning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8.3 Naming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 9: Incorporating Document Control Objectives and Requirements into the Document Control Procedural Set . . . . . . . . . . . . . Chapter 10: Structure, Format, and Content of Controlled Documents . . . . 10.1 The Minimum Content Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10.1.1 Document Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10.1.2 Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10.1.3 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10.1.4 Roles and Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10.1.5 Related Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10.1.6 Supporting Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10.1.7 Document/Version History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10.1.8 Process Steps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10.1.9 Quality Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10.2 The Minimum Content Standards for External Documents and Other Documented Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 11: Writing the Document Control Policy, SOPs, and Work Instructions/Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 12: Writing the Document Control Policy (POL) . . . . . . . . . . . . . . . 12.1 Document Identification Information . . . . . . . . . . . . . . . . . . . . . . . . . . . 12.1.1 Header . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12.1.2 Footer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12.2 Document Sections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12.2.1 Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12.2.2 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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12.2.3 Roles and Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12.2.4 References and Related Documents . . . . . . . . . . . . . . . . . . . . . . . 12.2.5 Supporting Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12.2.6 Requirements Section . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12.2.7 Exceptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12.2.8 Quality Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12.2.9 Document/Version History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 13: Writing the Document Control Standard Operating Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13.1 Document Identification Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13.1.1 Header . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13.1.2 Footer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13.2 Document Sections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13.2.1 Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13.2.2 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13.2.3 Roles and Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13.2.4 References and Related Documents . . . . . . . . . . . . . . . . . . . . . . . 13.2.5 Supporting Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13.2.6 Definitions and Acronyms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13.2.7 Prerequisites Section . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13.2.8 Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13.2.9 Exceptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13.2.10 Quality Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13.2.11 Document/Version History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 14: Writing the Document Control Work Instructions . . . . . . . . . . 14.1 Document Identification Information . . . . . . . . . . . . . . . . . . . . . . . . . . . 14.1.1 Header . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14.1.2 Footer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14.2 Document Sections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14.2.1 Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14.2.2 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14.2.3 Roles and Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14.2.4 References and Related Documents . . . . . . . . . . . . . . . . . . . . . . . 14.2.5 Supporting Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14.2.6 Definitions and Acronyms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14.2.7 Prerequisites Section . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14.2.8 When Is This Work Instruction Used Section . . . . . . . . . . . . . . . 14.2.9 Work Instruction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14.2.10 Exceptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14.2.11 Quality Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14.2.12 Document/Version History . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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