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Part-1 : Risk Management Definition
Title
Part-1 : Risk Management Definition
Category
Risk Management - ISO 14971
Reference
ISO 14971:2019

Risk is the combination of the probability of occurrence of harm and the severity of the harm.
Harm: Injury or damage to the health of people, or damage to property or the environment.
Hazard: Potential source of harm.
Severity: Measure of the possible consequences of a hazard.
Hazardous situation: Circumstances in which people, property or environment is/are exposed to one or more hazards.
Risk Analysis: Systematic use of available information to identify hazards and estimate the risk.
Risk Assessment: Overall process containing risk analysis and a risk evaluation.
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