Yes, I am well verse in ISO 13485 and its requirements. The ISO 13485 is a quality management system for medical devices. The quality system is centered upon risk-based approach and it calls for the controls and management of "Facility & Equipment Controls", "Design Controls", "Production & Process Controls, "Material Controls", Records/Documents Change Controls", and "CAPAs".
The failure that I encountered was missed out a critical QC check (drug acting acronym e.g.: ER) during incoming inspection. I raised an investigation report to resolve this incident, one of the CAPA was to get training on drug acronyms description and function so that I aware about the drug impact to the patient. I felt that I had significance improvement after this investigation and made me more particular when performing checking.