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 establis...