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CRC Press


Book: ISO 13485

A complete guide to quality management in the medical device industry

Published: Wednesday, October 26, 2011 - 12:21

(CRC Press: Boca Raton, FL) -- Although complex and lengthy, the process of certification to the International Organization for Standardization (ISO) standard, ISO 13485—“Medical devices—Quality management systems—Requirements for regulatory purposes,” can be easily mastered using the simple method outlined in ISO 13485: A Complete Guide to Quality Management in the Medical Device Industry, by Itay Abuhav (CRC Press, 2011).

Written by an experienced industry professional, this practical book is filled with examples drawn from the author’s experience, and spanning different sectors and fields of the medical device industry, the book translates the extraordinary requirements and objectives of the standard into feasible activities and tasks. The book provides a full analysis of each clause and subclause through quality perspectives: the implications of an organization, its processes, management, human resources, infrastructures, work environment, control and effectiveness, documentation, and records.

The book is organized like the standard itself. The table of contents is identical to ISO 13485’s table of contents, making it user friendly, familiar, and unintimidating. You can use the book as a consulting session, draw on the information and knowledge that suits you and your organization, and then apply it effectively to your quality management system and processes.


• Presents from-the-trenches advice from a quality manager to quality managers and other organizational parties
• Clarifies and interprets the ISO 13485 standard requirements in detail
• Refers to the harmonization of regulatory requirements with the quality management system and the integration of risk management activities throughout the realization processes (with reference to the ISO 14791:2007)
• Provides a large number of examples of how one can implement the requirements drawn from various sectors and industries
• Puts words into actions, translating the requirements and objectives into feasible activities and tasks
• Includes a full and comprehensive reference to the interrelations between the different clauses and subclauses of the standard.
• Compares ISO 13485 requirements alongside ISO 9001 requirements using tables that present both for easy reference


Normative References
Terms and Definitions Requirements
Quality Management System
Management Responsibility
Resource Management
Product Realization
Measurement, Analysis, and Improvement

Based in Switzerland, author Itay Abuhav served for many years as a quality manager and consultant for international companies in various fields and industries, among them the medical device industry. He has certified and provided consultation to a number of medical device factories in quality management for the ISO 13485 standard.


About The Author

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CRC Press

CRC Press is a premier global publisher of science, technology, and medical resources. It offers unique, trusted content by expert authors, spreading knowledge and promoting discovery worldwide. Its aim is to broaden thinking and advance understanding in the sciences, providing researchers, academics, professionals, and students with the tools they need to share ideas and realize their potential. CRC Press is a member of Taylor & Francis Group, an informa business.