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

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, and a full set of formatted procedures and document templates are available for download to get you off to an even faster start.

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.

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
Chpater 3 : Manual Document Control Systems versus Electronic Document Control Systems
Chapter 4 : Foundational Concepts
Chapter 5 : Process-Based Approach
Chapter 6 : The Document Life Cycle
Chapter 7 : Organization of Controlled Documents
Chapter 8 : Document Identification : Numbering, Versioning, and Naming
Chapter 9 : Incorporating Document Control Objectives and Requirements into the Document Control Procedural Set
Chapter 10 : Structure, Format, and Content of Controlled Documents
Chapter 11 : Writing the Document Control Policy, SOPs, and Work Instructions/Procedures
Chapter 12 : Writing the Document Control Policy (POL)
Chapter 13 : Writing the Document Control Standard Operating Procedure
Chapter 14 : Writing the Document Control Work Instructions
Chapter 15 : Conclusion

Appendix A : FLW-DOC-01-00-01 Document Control Process Flowchart
Appendix B : POL-DOC-01 Controlled Document Policy
Appendix C : SOP-DOC-01 Document Control Process
Appendix D : WI-DOC-01-01 Controlled Document Content, Format, and Style Requirements
About the Author
Index