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 - Couverture souple

Skipper, Stephanie L

 
9781636941400: 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
Couverture souple
ISBN 10 : 1636941400 ISBN 13 : 9781636941400
Editeur : ASQ Quality Press, 2015

Synopsis

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 data Sample 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.

Les informations fournies dans la section « Synopsis » peuvent faire référence à une autre édition de ce titre.

Éditeur
ASQ Quality Press
Date d'édition
2015
Langue
anglais
ISBN 10 
1636941400
ISBN 13 
9781636941400
Reliure
Broché
Nombre de pages
156
Coordonnées du fabricant
non disponible
Personne responsable
gpsr@libri.de
gpsr@libri.de

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Hamburg
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Allemagne

Autres éditions populaires du même titre

9780873899178: 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

Edition présentée

ISBN 10 :  0873899172 ISBN 13 :  9780873899178
Editeur : ASQ Quality Press, 2015
Couverture rigide