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ISO 13485
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Table of Contents

Scope General Application Normative References Terms and Definitions Requirements 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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