ISO 13485:2016 is an international standard that establishes the requirements for a quality management system specific to the medical devices industry. It specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.
Every member of your workforce who participates in planning, leading, and conducting your company’s internal QMS audit activities and managing its quality program will benefit from taking ISO 13485 training. Estimated to take up to four-hours to complete, this ISO 13485 overview is particularly adapted for training top management on the high level requirements of this standard.
By participating in this online course, you will understand:
This course is for you if you want to:
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