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

 156 Pages    2015
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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.

Sample Chapter

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Customer Reviews:     Please log in or register to comment.    FAQ

This book is for implementing/establishing a new system but has nothing to do with the NEW 9001:2015 and 13485:2016 standards; rather, it glosses over terminology and vocabulary, which is only helpful if you are new to ISO/Quality. It starts by stating that a gap analysis should be conducted to the new standards, but never addresses any of the new standards or how to mesh the two systems since they are no longer as similar. If you are looking for help in the standard changes for 9001 and 13485 and how to continue with both systems, this is not the book.
--Jennifer, 08-31-2016

(1) Customer Reviews

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