What is ISO and how does it work?

ISO, “International Organization for Standardization”, is a worldwide federation of national standards bodies, representing more than 130 countries. The object of ISO is to promote common standards between nations.

ISO 13485 is an International Quality Management Standard for medical devices. 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.

Total Scope, Inc. is “ISO 13485” certified. Our company is audited by an accredited certified body annually. These yearly assessments are to assure that Total Scope, Inc. continues to implement all the requirements of ISO 13485.