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What is iso 13485 in plain english9/27/2023 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. ![]() The document control system (DCS), or documented information control system (DICS), is the foundation of a quality management system. 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. ![]() 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
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