Definition of risk management
Systematic application of management policies, procedures and practices to the tasks of analyzing, evaluating and controlling risk
[ISO 14971:2000, definition 2.18]
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Harm
Physical injury or damage to the health of people, or damage to property or the environment
[ISO/IEC Guide 51:1999, definition 3.1]
Hazard
Potential source of harm
[ISO/IEC Guide 51:1999, definition 3.5]
Residual risk
Risk remaining after protective measures have been taken.
[ISO/IEC Guide 51:1999, definition 3.9]
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Risk
Combination of the probability of occurrence of harm and the severity of that harm
[ISO/IEC Guide 51:1999, definition 3.2]
Risk analysis
Systematic use of available information to identify hazards and to estimate the risk
[ISO/IEC Guide 51:1999, definition 3.10]
Risk assessment
Overall process comprising a risk analysis and a risk evaluation
[ISO/IEC Guide 51:1999, definition 3.12]
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Risk control
Process through which decisions are reached and protective measures are implemented for reducing risks to, or maintaining risks within, specified levels
[ISO 14971:2000, definition 2.16]
Risk evaluation
Judgment, on the basis of risk analysis, of whether a risk which is acceptable has been achieved in a given context based on the current values of society
[NOTE Based on ISO/IEC Guide 51: 1999, definitions 3.11 and 3.7]
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