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 is dependent on the ability to ...
Read More
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.
Read Less
Add this copy of How to Establish a Document Control System for to cart. $34.36, new condition, Sold by Ingram Customer Returns Center rated 5.0 out of 5 stars, ships from NV, USA, published 2015 by ASQ Quality Press.
Add this copy of How to Establish a Document Control System for to cart. $42.84, new condition, Sold by GreatBookPrices rated 4.0 out of 5 stars, ships from Columbia, MD, UNITED STATES, published 2015 by ASQ Quality Press.
Choose your shipping method in Checkout. Costs may vary based on destination.
Seller's Description:
New. Trade paperback (US). Glued binding. 156 p. In Stock. 100% Money Back Guarantee. Brand New, Perfect Condition, allow 4-14 business days for standard shipping. To Alaska, Hawaii, U.S. protectorate, P.O. box, and APO/FPO addresses allow 4-28 business days for Standard shipping. No expedited shipping. All orders placed with expedited shipping will be cancelled. Over 3, 000, 000 happy customers.
Add this copy of How to Establish a Document Control System for to cart. $42.85, new condition, Sold by BargainBookStores rated 4.0 out of 5 stars, ships from Grand Rapids, MI, UNITED STATES, published 2015 by ASQ Quality Press.
Choose your shipping method in Checkout. Costs may vary based on destination.
Seller's Description:
New in New jacket. How to Establish a Document Control System for Compliance with ISO 9001: 2015, ISO 13485: 2016, and FDA Requirements: A Comprehensive Guide to Designin (Paperback or Softback)
Add this copy of How to Establish a Document Control System for to cart. $51.00, new condition, Sold by Russell Books rated 4.0 out of 5 stars, ships from Victoria, BC, CANADA, published 2015 by ASQ Quality Press.
Add this copy of How to Establish a Document Control System for to cart. $54.30, new condition, Sold by Ria Christie Books rated 5.0 out of 5 stars, ships from Uxbridge, MIDDLESEX, UNITED KINGDOM, published 2015 by ASQ Quality Press.
Add this copy of How to Establish a Document Control System for to cart. $65.48, good condition, Sold by Bonita rated 4.0 out of 5 stars, ships from Newport Coast, CA, UNITED STATES, published 2015 by ASQ Quality Press.
Add this copy of How to Establish a Document Control System for to cart. $100.56, new condition, Sold by Bonita rated 4.0 out of 5 stars, ships from Newport Coast, CA, UNITED STATES, published 2015 by ASQ Quality Press.
All Editions of 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
