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

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

Hardcover, 156 pages, Published 2015
Dimensions: 7 x 10
ISBN: 9780873899178
Item Number: H1491

Member Price: $35.00

List Price: $50.00
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Keywords

  • Document Control System
  • Compliance
  • ISO 9001:2015
  • ISO 13485:2016
  • FDA Requirements

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.