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

Stephanie L. Skipper

Quality Press, Oct 14, 2015 - Business & Economics - 156 pages

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, and a full set of formatted procedures and document templates are available for download to get you off to an even faster start.

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.

About the author

Stephanie L. Skipper is the owner and principal consultant at Ticalion Quality Management Services, LLC. As a senior-level quality management practitioner, she has over a decade of hands-on experience engineering and directing the remediation and commissioning of FDA-regulated and ISO quality systems, including GMP, GCP, ISO 13485, and ISO 9001, in a wide spectrum of organizational types. Skipper has experience implementing and remediating global business environments for compliance to the ISO 27000, ISO 20000, and ISO 31000 standards, as well as integrating compliance with these supporting standards within the primary quality system. She has a master of science in pharmaceutical quality assurance and regulatory affairs from the Temple University School of Pharmacy and has attained professional certifications in quality auditing (ASQ-CQA), quality operational management (ASQ-CMQ/OE), project management (PMI-PMP), and IT service delivery (ITIL Foundations v3).

Bibliographic information

• 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
• Edition: illustrated
• Publisher: Quality Press, 2015
• ISBN: 0873899172, 9780873899178
• Length: 156 pages
• Subjects: Business & Economics / Industries / Service; Business & Economics / Total Quality Management