A Practical Field Guide for ISO 13485

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ASQ Quality Press, Oct 8, 2012 - Business & Economics - 144 pages
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The purpose of this field guide is to assist the reader, step-by-step, in implementing a Quality Management System (QMS) in conformance with ISO 13485:2003. What separates this field guide from most other books on ISO 13485:2003 and its implementation are the flow charts showing the steps to be taken in implementing a QMS to meet a sub-clause’s requirements. The flow charts can be overwhelming when you first look at them, for this reason, a box appears with each flow chart that explains pertinent facts and/or what the flow chart represents and how it is to be used.
The ISO 13485:2003 QMS your organization implements must meet the needs of its users—you and the rest of your organization’s employees, from senior management to the most junior employee. So the QMS you create using this field guide will not only satisfy ISO 13485:2003’s requirements, but will provide a set of processes that suits your organization and will foster improved use of the system and improvement in the processes of the organization as it matures.
 

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Contents

Quality Management System
1
Management Responsibility
11
Resource Management
35
Product Realization
47
Measurement Analysis and Improvement
91
2003 Documented Requirements by Section
115
Sources of Information
119
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About the author (2012)

 Erik V. Myhrberg is CEO and cofounder of Moorhill International Group, Inc., a Virginia-based firm dedicated to fostering international relations through commerce and cultural exchange. He has been involved in technical marketing and operations with such multinational firms as IBM and American Express. He has 20 years of experience within the area of international management system standards as auditor, consultant, and member of U.S. Technical Advisory Groups (TAGs) TC 207 and TC 176. Myhrberg holds a BS in international marketing from Arizona State University, an MIM in international management from Thunderbird School of Global Management, a Ph.D. in international business from Rushmore University, and an MS from Bethany in Biblical Studies that he utilizes as a USASOC Reserve Chaplain. He is also co-author of A Practical Field Guide for ISO 9001:2008 (ASQ Quality Press, 2009) and A Practical Field Guide for AS9100C (ASQ Quality Press, 2011). He is a senior member of ASQ, and enjoys martial arts and weightlifting. He resides in Virginia with his wife of 20+ years and their two wonderful children.

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