ISO 13485

Quality-management-system standard for organizations involved in medical devices.

Examples

01A maker of insulin pens runs its quality system to ISO 13485, including design controls and risk management.
02During the ISO 13485 audit, the auditor checks that complaint data feeds back into the risk file.
03When an ISO 13485 audit finds incomplete sterilisation records, the affected lots are held and a CAPA is opened.