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

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 ...