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    ISO 31000

    Generic enterprise risk management standard; complements ISO 14971's product risk focus.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    ISO 31000 provides high-level principles and a framework for risk management across an organization - strategy, projects, supply chain, IT - rather than the patient-safety focus of ISO 14971.

    What this means in practice

    Useful for quality leaders building enterprise-level risk programs that cover product, business continuity, and cyber risk in one structure.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    ISO·1AAMI·1MDIC·1
    1. 1
      ISO 31000
      Verified
      ISOiso.org
    2. 2
      AAMI - Quality Systems Resources
      Verified
      AAMIaami.org
    3. 3
      MDIC Case for Quality
      Verified
      MDICmdic.org

    Inline markers like [1] jump to the matching reference above.