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.

ASQ 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

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