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ISO 13485

Although complex and lengthy, the process of certification for the ISO 13485 can be easily mastered using the simple method outlined in ISO 13485: A Complete Guide to Quality Management in the Medical Device Industry. Written by an experienced industry professional, this practical book provides a complete guide to the ISO 13485 Standard certification for medical device manufacturing. Filled with examples drawn from the author's experience and spanning different sectors and fields of the medical device industry, the book translates the extra ordinary requirements and objectives of the standard into feasible activities and tasks. The book provides a full analysis of each clause and sub clause through quality perspectives: the implications on an organization, its processes, management, human resources, infrastructures, work environment, control and effectiveness, documentations and records. The book is organized like the standard itself -- the table of contents is identical to the ISO 13485 Standard's table of contents -- making it user friendly, familiar, and unintimidating. You can use the book as a consulting session -- read it, explore it ,extract ideas -- and draw on the information and knowledge that suits you and your organization, and then apply it effectively to your quality management system and processes.
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Table of Contents

Scope General Application Normative References Terms and Definitions Requirementsã Quality Management System General Requirements Documentation Requirements Management Responsibility Management Commitment Requirements Customer Focus Quality Policy Planning Responsibility, Authority, and Communication Management Review Resource Management Provision of Resources Human Resource Requirements Infrastructure Requirements Work Environment Requirements Product Realization Planning of Product Realization Customer-Related Processes Design and Development Purchasing Production and Service Provision Control of Monitoring and Measuring Device Requirements Measurement, Analysis, and Improvement Measurement, Analysis, and Improvement-General Requirements Monitoring and Measurement Control of Nonconforming Products Analysis of Data Improvement

About the Author

Eng. Itay Abuhav, based in Switzerland, 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.

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