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Cookie akzeptierenStephanie L. Skipper
How to Establish a Document Control System for Compliance with ISO 9001
- ASQ Quality Press
- 2015
- Taschenbuch
- 156 Seiten
- ISBN 9781636941400
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
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