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Part-1 : Risk Management Definition

Title

Part-1 : Risk Management Definition

Category

Risk Management - ISO 14971

Reference

ISO 14971:2019

Part-1 : Risk Management Definition
  1. Risk  is the combination of the probability of occurrence of harm and the severity of the harm.

  2. Harm: Injury or damage to the health of people, or damage to property or the environment.

  3. Hazard: Potential source of harm.

  4. Severity: Measure of the possible consequences of a hazard.

  5. Hazardous situation: Circumstances in which people, property or environment is/are exposed to one or more hazards.


  1. Risk Analysis: Systematic use of available information to identify hazards and estimate the risk.

  2. Risk Assessment: Overall process containing risk analysis and a risk evaluation.

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