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    Management Review

    Top-management evaluation of QMS performance at planned intervals.

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

    Definition

    ISO 13485 clause 5.6 and 21 CFR 820.20 require top management to review the QMS at defined intervals, evaluating audit results, customer feedback, process performance, CAPA, and the need for resources or improvement.

    What this means in practice

    Management reviews should produce documented decisions and actions. Inspectors often request meeting minutes and follow-up evidence.

    Cross-references

    Follows

    Comes after in a typical workflow or lifecycle.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    ISO·1AAMI·1MDIC·1
    1. 1
      ISO 13485:2016
      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.