Quality Management Systems for Assisted Reproductive Technology: ISO 9001:2000, 1st Edition (Paperback) book cover

Quality Management Systems for Assisted Reproductive Technology

ISO 9001:2000, 1st Edition

By Bryce E. Carson, Michael M. Alper, Christoph Keck

CRC Press

180 pages

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Paperback: 9781841844190
pub: 2004-06-29
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More than just another certification listed on your business stationary, ISO 9001:2000 can be used to help you improve your practice, regulate repeatedly performed procedures, define responsibilities, and form and integrate tests to validate the quality of work performed. The certification elements, although quite technical, are valuable tools that enable you to deliver a high-quality IVF service. The theory behind implementing an ISO 9001:2000 quality management system is quite simple: a well-organized workflow will guarantee good quality work.

Quality Management Systems for Assisted Reproductive Technology: ISO 9001:2000 introduces you to the philosophy of quality management, its function, and its resulting benefits. The guidance provided is based on the hands-on experience of the authors. They draw on their extensive expertise to elucidate how to apply the ISO 9001:2000 standard to IVF programs. Examples demonstrate the many ways of achieving the intent of the standard. An interpretive guide to an internationally accepted system for quality management philosophy, this book will help you define efficiency and competence, pass on management information, and solve problems effectively.


"This thoughtfully assembled book will guide, assist, and provide foundation and reference to both the neophyte and the seasoned ARTisan."


"If ART is your field, then anything you may want to look up or simply browse through, you will find in this very comprehensive and competent volume."

"…a formidable compilation of contributions from the leading lights of the reproductive sciences. …a new textbook, the future of which appears secure. …will undoubtedly be of great usefulness for physicians in other fields who are in need of dependable information. Medical students, residents in training, and graduate students will all find this resource worthwhile. …occupies an important place niche in the pantheon of comparable publications. Indeed, the current version can be viewed as a marked improvement over the first edition, and I recommend it highly."

--Eli Y. Adashi, M.D., University of Utah School of Medicine, Salt Lake City, USA

Table of Contents

Eight Factors to Creating a Sustainable Quality Management System

Introduction to ISO 9001:2000

ISO 9001:2000 Clause 4 - Quality Management System

ISO 9001:2000 Clause 5 - Management Responsibility

ISO 9001:2000 Clause 6 - Resource Management

ISO 9001:2000 Clause 7 - Product and Service Realization

ISO 9001:2000 Clause 8 - Measurement, Analysis and Improvement


Comparison Between ISO 9001:2000 and MBNQA

ISO 9001:2000 Self-Assessment Instrument

Sample ISO 9001:2000 Duality Systems Manual and Procedures

Sample Process Flow Charts

Subject Categories

BISAC Subject Codes/Headings:
MEDICAL / Reproductive Medicine & Technology