Competency information

Details

Ensure device modifications are undertaken appropriately

Considerations

  • Compliance standards that ensure modifications are effectively controlled, including an assessment as to whether this has implications for the device CE marking
  • Monitoring/track modification undertaken by manufacturers, eg resulting from safety alerts

Relevant learning outcomes

# Outcome
# 1 Outcome Manage the key components of the planned maintenance and repair process
# 3 Outcome Apply quality management systems, such as ISO 9001 to the workshop environment