MedTech Terms
    The authoritative reference
    All terms
    Quality & RiskQuality System

    Training Records

    Documented evidence personnel have the education, training, and experience for assigned tasks.

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

    Definition

    21 CFR 820.25 and ISO 13485 clause 6.2 require establishing competency needs, providing training, and maintaining records that demonstrate personnel are qualified for their roles.
    What the regulation says
    Training records are essential for demonstrating that personnel are qualified for their assigned duties, a requirement explicitly stated in regulations such as 21 CFR 820.25 for the United States and ISO 13485:2016 clause 6.2 internationally. These records serve as objective evidence during audits that MedTech manufacturers have established competency needs, provided necessary training, and evaluated training effectiveness, especially for roles impacting product quality and patient safety, as further detailed in guidance from bodies like the IMDRF.

    What this means in practice

    Common audit gaps include missing read-and-understood records for new SOP versions and lack of effectiveness evaluation for safety-critical training.

    Examples

    • A medical device company implements a new software for automated testing, and all engineers involved in testing complete a mandatory training course, with their completion certificates and competency assessments filed as training records.
    • During an FDA inspection, an auditor requests training records for production line operators demonstrating their proficiency in assembling a high-risk surgical instrument, reviewing documentation of initial training and annual refreshers.
    • A MedTech firm updates its cybersecurity policy for connected devices, and all relevant R&D and post-market surveillance personnel attend a workshop, with attendance logs and acknowledgments of understanding recorded.
    Common pitfalls
    • •A common pitfall is failing to document that personnel have read and understood new or revised Standard Operating Procedures (SOPs), particularly in electronic Quality Management Systems.
    • •Another frequent mistake is neglecting to evaluate the effectiveness of training, especially for critical roles or tasks that directly impact product quality or patient safety.
    • •Manufacturers often err by not conducting periodic refresher training or assessing ongoing competency, leading to skill degradation over time.
    • •Inadequate training record retention, or records that do not clearly link training to specific job functions, can be a significant audit finding.
    • •Failing to include specific cybersecurity training for personnel involved in the design, development, or maintenance of connected medical devices is a growing compliance issue.

    Frequently asked questions

    The primary purpose is to provide objective evidence that all personnel are adequately trained and competent to perform their assigned responsibilities, thereby ensuring product quality, safety, and regulatory compliance.

    Cross-references

    Part of

    A larger framework or document this term belongs to.

    Grouped by theme

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-06-20
    eCFR·1MDIC·1FDA·1
    1. 1
      21 CFR 820.25
      Verified
      eCFRecfr.gov
    2. 2
      MDIC Case for Quality
      Verified
      MDICmdic.org
    3. 3
      FDA - Quality Systems
      Verified
      FDAfda.gov

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