An Introduction to ISO 13485 - The Quality Management System for Medical Devices

The international standard ISO 13485:2016 specifies the requirements for a quality management system that can be used by an organization in one or more stages of the life-cycle. ISO 13485 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations. This course is the first of a two part series. Topics in this course include: ISO 13485:2016, Process Approach, Clauses 4-6, Clauses 7 and 8, and Preparation. This course also addresses specific aspects of ISO 13485 as it relates to the European Union (EU). After completing this course, learners will be able to recognize the requirements of ISO 13485.

Recognize the difference between ISO 13485 and ISO 9001. Recognize the process approach of ISO 13485. Identify management’s role in implementation and maintenance of ISO 13485 and recognize the requirements for quality management system Clauses 4-8 of ISO 13485:2016. Recognize how to ensure compliance with ISO 13485:2016.