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

Language: English

Published by ASQ Quality Press, 2015

0873899172 / 9780873899178

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Seller: AHA-BUCH GmbH, Einbeck, GermanyAHA-BUCH GmbH

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nach der Bestellung gedruckt Neuware - Printed after ordering - 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 business units Improving access to knowledge-based information Improving employee performance by providing standardized processes and communicating clear expectations Improving customer communication and satisfaction by providing documented information from which common understanding can be achieved Providing traceability of activities and documentation throughout the organization Improving organization of and access to documents and dataSample documents are included in the appendixes of this book to help clarify explanations.This book provides a process-based approach that can be used for controlling all forms of documented information that are required to be managed under the quality management system.…

Seller Inventory # 9780873899178

Title
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
Publisher
ASQ Quality Press
Publication year
2015
Condition
Neu
Binding
Buch
Language
English
ISBN 10
0873899172
ISBN 13
9780873899178
Item weight
505 grams
Dimensions
260x183x13 mm

AHA-BUCH GmbH

Einbeck, Germany

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