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

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

  1. 156 pages
  2. English
  3. PDF
  4. Available on iOS & Android
eBook - PDF

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

About this book

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 dataSample 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.

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Yes, you can access How to Establish a Document Control System for Compliance with ISO 9001:2015, ISO 13485:2016, and FDA Requirements by Stephanie L. Skipper in PDF and/or ePUB format, as well as other popular books in Business & Operations. We have over one million books available in our catalogue for you to explore.

Information

Publisher
ASQ Quality Press
Year
2015
Print ISBN
9780873899178
eBook ISBN
9781953079497
Edition
1
Topic
Business
Subtopic
Operations
Index
Business

Table of contents

  1. Cover
  2. Title Page
  3. CIP data
  4. Dedication
  5. Table of Contents
  6. List of Figures and Tables
  7. Foreword
  8. Applicability to ISO 9001:2015 and ISO 13485:2016 Updates
  9. Acknowledgments
  10. Chapter 1: Document Control in the Quality Management System
  11. Chapter 2: Document Management versus Document Control
  12. Chapter 3: Manual Document Control Systems versus Electronic Document Control Systems
  13. Chapter 4: Foundational Concepts
  14. Chapter 5: Process-Based Approach
  15. Chapter 6: The Document Life Cycle
  16. Chapter 7: Organization of Controlled Documents
  17. Chapter 8: Document Identification: Numbering, Versioning, and Naming
  18. Chapter 9: Incorporating Document Control Objectives and Requirements into the Document Control Procedural Set
  19. Chapter 10: Structure, Format, and Content of Controlled Documents
  20. Chapter 11: Writing the Document Control Policy, SOPs, and Work Instructions/Procedures
  21. Chapter 12: Writing the Document Control Policy (POL)
  22. Chapter 13: Writing the Document Control Standard Operating Procedure
  23. Chapter 14: Writing the Document Control Work Instructions
  24. Chapter 15: Conclusion
  25. Appendix A: FLW-DOC-01-00-01 Document Control Process Flowchart
  26. Appendix B: POL-DOC-01 Controlled Document Policy
  27. Appendix C: SOP-DOC-01 Document Control Process
  28. Appendix D: WI-DOC-01-01 Controlled Document Content, Format, and Style Requirements
  29. About the Author
  30. Index