ASQ Quality Medical Devices Publications

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ASQ BOOKS & STANDARDS - QUALITY MEDICAL DEVICES

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H0965	The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices	1996
H1033	Mastering and Managing the FDA Maze: Medical Device Overview	1999
H1198	Development of FDA-Regulated Medical Products: Prescription Drugs, Biologics and Medical Devices	2004
H1221	Measurement Matters: How Effective Assessment Drives Business and Safety Performance	2004
H1230	Simplified Project Management for the Quality Professional: Managing Small & Medium-size Projects	2004
H1236	Applied Statistics for the Six Sigma Green Belt	2005
H1240	The Path to Profitable Measures: 10 Steps to Feedback That Fuels Performance	2005
H1245	Six Sigma for the Next Millennium: A CSSBB Guidebook	2006
H1259	Get It Right: A Guide to Strategic Quality Systems	2006
H1262	Safe and Sound Software: Creating an Efficient and Effective Quality System for Software Medical Device Organizations	2006
H1267	The Management System Auditor's Handbook	2006
H1285	Managing Contract Quality Requirements	2006
H1293	The Quality Calibration Handbook: Developing and Managing a Calibration Program	2007
H1294	Project Portfolio Selection for Six Sigma	2007
H1300	The Internal Auditing Pocket Guide: Preparing, Performing, Reporting and Follow-up, Second Edition	2007
H1301	The Certified HACCP Auditor Handbook	2007
H1303	The Executive Guide to Understanding and Implementing Lean Six Sigma: The Financial Impact	2007
H1332	The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, Second Edition	2008
H1340	The Certified Quality Engineer Handbook, Third Edition	2009
H1365	HALT, HASS, and HASA Explained: Accelerated Reliability Techniques, Revised Edition	2009
P1246	Beyond Governance: Creating Corporate Value through Performance, Conformance, and Responsibility	2005
P1248	Six Sigma Quality Improvement with MINITAB	2006
P1263	Master of All You Survey: How to Use Surveys to Improve Organizations, Teams, & Leaders	2006
P1297	The Analysis of Means: A Graphical Method for Comparing Means, Rates, and Proportions	2005
P1351	Combination Products: Regulatory Challenges and Successful Product Development	2008
T810	ANSI/ISO/ASQ Q10012-2003: Measurement management systems — Requirements for measurement processes and measuring equipment	2006

About the American Society for Quality

The American Society for Quality (ASQ), formerly known as the American Society for Quality Control (ASQC), is a knowledge-based global community of quality control experts, dedicated to the promotion and advancement of quality tools, principles, and practices in ther workplaces and in their communities.


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