Hazard Identification Under ISO 13485

Hazard identification in an ISO 13485 system

Under ISO 13485, hazard identification for a medical-device quality management system requires the organisation to analyse and list the likely hazards associated with the device, whether it is being manufactured, sold, or serviced.

Hazard identification scope in an ISO 13485 system is generally grouped as follows:

• Hazards related to the energy the medical device emits
• Chemical hazard potential of the medical device
• Biological hazard dimension of the medical device
• Hazards that may arise during use of the medical device
• Environmental hazard dimension of the medical device
• Hazards related to user error and hazards that may arise from actual use of the medical device

The severity of the hazards listed above needs to be assessed and documented. Different methods can be used in the risk determination exercise.

Other sources can also be used to identify medical-device risks. These include:

• Published relevant standards
• Academic papers
• Relevant case studies
• Data gathered in clinical settings
• Research findings

Information and data can be obtained from, for example:

• Applicable standards,
• Scientific data,
• Data from similar devices and from the relevant field, including published and recorded cases,
• Clinical findings,
• Results of appropriate research.