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

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.