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    Nonconformance (NCR)

    Failure of a product, process, or system to meet specified requirements.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed September 19, 2026

    Definition

    A nonconformance is documented evidence that a product, process, or system did not conform to specified requirements. Investigation may lead to disposition (use as is, rework, scrap) and/or a CAPA. Nonconforming product must be identified, documented, segregated and evaluated so it cannot be used by mistake, as required by ISO 13485 clause 8.3. The evaluation decides whether an investigation is needed and who can approve the disposition. 'Use as is' and concession decisions need justification and records. When product is found nonconforming after delivery, the manufacturer must act on the effects, which can lead to a field action or recall.
    What the regulation says
    Regulators view nonconformances as critical indicators of quality system effectiveness and product safety. For example, FDA 21 CFR Part 820.90 requires manufacturers to establish procedures for controlling nonconforming product, including identification, documentation, evaluation, segregation, and disposition. Similarly, EU MDR (Regulation (EU) 2017/745) Annex I, General Safety and Performance Requirements, implicitly demands robust handling of nonconformities to ensure devices meet safety and performance objectives throughout their lifecycle. ISO 13485:2016, clause 8.3, specifically details requirements for the control of nonconforming product, emphasizing documentation and appropriate action commensurate with the nonconformity.

    What this means in practice

    Trend analysis of NCRs is a key feedback loop into design and process improvements.

    Examples

    • During final inspection, a batch of sterilization pouches is found to have seals outside the specified width, leading to the generation of a nonconformance report.
    • A software validation test fails to produce the expected output for a critical function, initiating a nonconformance process to investigate the code defect.
    • Customer feedback indicates that a specific MedTech device is intermittently freezing, prompting a nonconformance investigation into potential underlying hardware or software issues.
    Common pitfalls
    • •Confusing a nonconformance with a deviation; a nonconformance indicates failure to meet a requirement, while a deviation is a departure from an approved procedure without necessarily failing a requirement.
    • •Failing to adequately investigate the root cause of nonconformances, which can lead to recurrence and persistent quality issues.
    • •Treating all nonconformances with the same level of urgency rather than prioritizing based on risk to patient safety or product quality.
    • •Not integrating nonconformance data into broader quality system processes like management review, risk management, and CAPA.
    • •Failing to ensure that disposition actions for nonconforming product are properly implemented and verified.

    Frequently asked questions

    Documenting a nonconformance ensures that deviations from specified requirements are formally recorded, investigated, and addressed, providing a clear audit trail for quality assurance and regulatory compliance.

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    Sources

    3 sources

    Every citation below opens the original document. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.

    Tier 1Binding law and standards· 2Tier 2Regulator guidance and consensus· 1
    Link health: 3 verified· last checked 2026-06-20
    eCFR·1FDA·1ISO·1
    1. 1
      21 CFR 820.90
      Tier 1 Verified
      eCFRecfr.gov
    2. 2
      FDA - Quality Systems
      Tier 2 Verified
      FDAfda.gov
    3. 3
      ISO 13485 Standard Page
      Tier 1 Verified
      ISOiso.org

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