Computer System Risk Evaluation for Determining Risk Mitigations, Validation Activities, and the Extent of Testing (RiskVal)

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  • This procedure defines a method for determining the system risk level and the risk levels associated with failures of a computer system to meet requirements.
  • This procedure adapts the risk management standard (ISO 14971) to computer systems. A methodology for a high-level risk analysis is used to determine the risk level of a computer system.
  • This procedure also includes a method for managing the risks associated with computer system failure by adapting and extending the 13 step risk management process described in ISO 134845.
  • The risk evaluation and mitigation steps are included, as well the assessment and mitigation of residual risk.

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