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Stephanie L. Skipper

Total Book : 1

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
Author: Stephanie L. Skipper
ISBN: 0873899172 / 9780873899178
Year: 2016
Availability: Out of Stock

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...