Certificate in ISO 13485 for Quality Managers
-- ViewingNowThe Certificate in ISO 13485 for Quality Managers course is a comprehensive program designed to equip learners with the essential skills needed to excel in the medical device industry. This course focuses on ISO 13485, an international standard for quality management systems specific to this industry.
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Here are the essential units for a Certificate in ISO 13485 for Quality Managers:
โข ISO 13485:2016 Overview
โข Understanding Quality Management Systems (QMS)
โข ISO 13485:2016 Requirements and Implementation
โข Risk Management in Medical Devices
โข Documentation Control and Record Keeping
โข Management Responsibilities and Management Review
โข Resource Management and Training
โข Product Realization and Design Control
โข Measurement, Analysis, and Improvement of the QMS
โข Internal and External Audits for ISO 13485 Certification
These units cover the critical aspects of ISO 13485 and provide a comprehensive understanding of the Quality Management System for medical devices. By mastering these units, Quality Managers can effectively implement and maintain a QMS compliant with ISO 13485:2016.
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