A Complete Guide to Quality Management in the Medical Device Industry
What is risk based thinking? Do you know how to address risks and opportunities? Did you ever analyzed risks? Are you sure it is that what the ISO 9001 expects? What do you really know about knowledge management? Can you identify the types of know...
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.
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