--- title: "Training Records, Definition | MedTech Terms" description: "Documented evidence personnel have the education, training, and experience for assigned tasks. 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ISO 13485:2016 clause 4.2.4 requires records to be maintained for a period at least equivalent to the lifetime of the medical device as defined by the organization, or as specified by applicable regulatory requirements, whichever is longer." } }, { "@type": "Question", "name": "What kind of information should be included in a training record?", "acceptedAnswer": { "@type": "Answer", "text": "A comprehensive training record should include the trainee's name, the date of training, the topic or procedure covered, identification of the trainer, methods used for training, and evidence of successful completion or demonstrated understanding, such as a signature or quiz results." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Quality & Risk](/terms?cat=Quality%20%26%20Risk) 6. / 7. Training Records [All terms](/terms) Quality & Risk [Quality System](/ecosystems/quality-system) # Training Records Documented evidence personnel have the education, training, and experience for assigned tasks. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition 21 CFR 820.25 and [ISO 13485](/terms/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](/terms/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](/terms/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 What is the primary purpose of maintaining training records in MedTech? 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. How long should training records be retained? What kind of information should be included in a training record? ## Cross-references ### Part of A larger framework or document this term belongs to. - [ ISO 13485 ](/terms/iso-13485) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Quality & Risk Quality System Regulation(QSR / 21 CFR 820) FDA's current good manufacturing practice (cGMP) requirements for medical devices. ](/terms/qsr)[ Standards ISO 13485 International standard for medical device quality management systems. ](/terms/iso-13485) ### More in Quality & Risk · Same category [ Quality & Risk Biocompatibility Ability of a material to perform with an appropriate host response in a specific application. ](/terms/biocompatibility)[ Quality & Risk CAPA Effectiveness Check Verification step confirming a corrective or preventive action actually fixed the problem. ](/terms/capa-effectiveness)[ Quality & Risk Change Control Formal QMS process for evaluating, approving, and implementing changes that could affect product quality or compliance. ](/terms/change-control)[ Quality & Risk Complaint Handling Process for receiving, evaluating, and responding to device complaints. ](/terms/complaint-handling) Cited by Where this term appears across MedTech Terms. Ecosystems (1) - [Quality System](/ecosystems/quality-system) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 eCFR· 1 MDIC· 1 FDA· 1 1. [1 21 CFR 820.25 Verified eCFR · ecfr.gov ](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820) 2. [2 MDIC Case for Quality Verified MDIC · mdic.org ](https://mdic.org/program/case-for-quality/) 3. [3 FDA - Quality Systems Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Tying cybersecurity into your QMS? We help align cybersecurity activities with ISO 13485 design controls and ISO 14971 risk management. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Quality & Risk Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=training-records) Learn in 60 seconds Card Lesson Quiz Documented evidence personnel have the education, training, and experience for assigned tasks. - · Common audit gaps include missing read-and-understood records for new SOP versions and lack of effectiveness evaluation for safety-critical training. Remember this Watch out: 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. Related terms - [Quality System Regulation(QSR / 21 CFR 820) ](/terms/qsr) - [ISO 13485 ](/terms/iso-13485) You may also need Auto-suggested from Quality & Risk and shared keywords. - [Management Review ](/terms/management-review) - [Production and Process Controls ](/terms/production-process-controls) - [Quality Manual ](/terms/quality-manual) - [Process Validation ](/terms/process-validation) - [Quality Management System Regulation(QMSR) ](/terms/qmsr) - [Risk Management File(RMF) ](/terms/risk-management-file) [All Quality & Risk terms](/terms?cat=Quality%20%26%20Risk) From the Blue Goat network Related resources and services on this topic. - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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