Displaying items by tag: ISO 13485
Quality Management System Auditor / Lead Auditor Training Course (demonstrating compliance with ISO 13485:2016)
ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry.
ISO 13485 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.