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    ISO 22301

    Standard for business continuity management systems.

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

    Definition

    ISO 22301 specifies requirements to plan, establish, implement, operate, monitor, review, maintain, and continually improve a business continuity management system. Increasingly relevant for MedTech given EO supply, semiconductor, and contract-manufacturer disruptions.

    What this means in practice

    Hospital procurement teams and FDA shortage staff are both paying more attention to BCMS evidence from critical-device manufacturers.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    ISO·2IEC·1
    1. 1
      ISO 22301
      Verified
      ISOiso.org
    2. 2
      ISO Standards Catalogue - Health
      Verified
      ISOiso.org
    3. 3
      IEC Webstore - Medical Equipment
      Verified
      IECwebstore.iec.ch

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