Book of the Week
How to Establish a Document Control System for Compliance with ISO 9001:2015, ISO 13485:2016, and FDA Requirements
Skipper, Stephanie L., October 2015
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.
Member Price: $30.00
List Price: $50.00
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