Training requirements, training records, and role-based assignment of quality-affecting tasks — 820.25 personnel training fundamentals persist.
Competency replaces attendance: organizations must define competency criteria per role, deliver training to achieve them, and evaluate effectiveness — read-and-sign is insufficient.
Competency criteria definitions and effectiveness evaluation records — training matrices listing SOP reads without demonstrated competency are a major gap.
Maps to
QMSR / ISO 13485: §820.25 Personnel.
ISO 13485: §6.2 Human resources
Requirement text
Personnel performing work affecting product quality shall be competent on the basis of education, training, skills, and experience.
Why this clause exists
Competence requirements exist because a quality system implemented by inadequately qualified personnel does not function as designed, regardless of how well the procedures are written. The gap between documented procedure and actual practice narrows when the people executing the procedure have the education, training, skills, and experience necessary to understand what the procedure requires and why. The requirement to define competency criteria for each role — rather than relying on general credentials — reflects the recognition that quality-affecting work spans highly specialized activities: a sterilization validation technician, a complaint intake coordinator, and a design verification engineer each require distinct demonstrated competencies, and a credential that qualifies one role may not satisfy another. Training effectiveness evaluation is the mechanism that distinguishes training from attendance: presenting material to personnel accomplishes nothing if the content does not result in changed behavior or demonstrated capability. The proportionality principle in ISO 13485:2016 § 6.2 — requiring that effectiveness assessment rigor scale with the risk associated with the work — reflects the regulatory audience's understanding that a post-training quiz for office file-handling is not analogous to a supervised practical for aseptic technique or critical measurement operations. Awareness of how individual roles contribute to quality objectives addresses the motivational dimension of competence: personnel who understand the downstream consequences of their activities are more likely to recognize and escalate quality events than those who treat their role as procedurally isolated.
What changed
§820.25 — Part 820 (legacy)
"Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed. Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented. (1) As part of their training, personnel shall be made aware of device defects which may occur from the improper performance of their specific jobs. (2) Personnel who perform verification and validation activities shall be made aware of defects and errors that may be encountered as part of their job functions."
§6.2 — ISO 13485:2016 (current)
"Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience. The organization shall document the process(es) for establishing competence, providing needed training, and ensuring awareness of personnel. The organization shall: a) determine the necessary competence for personnel performing work affecting product quality; b) provide training or take other actions to achieve or maintain the necessary competence; c) evaluate the effectiveness of the actions taken; d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives; e) maintain appropriate records of education, training, skills and experience (see 4.2.5). NOTE The methodology used to check effectiveness is proportionate to the risk associated with the work for which the training or other action is being provided."
Δ Adds a requirement to evaluate the effectiveness of training actions; competence is now the standard (not just sufficiency), and records must cover skills and experience in addition to training.
Common gaps (what we see in audits)
- Read-and-Sign as Sole Training Evidence — Training records consist exclusively of signatures confirming that personnel read SOPs or watched training videos. There is no assessment of whether the person understood the content or can apply it. This satisfies Part 820's training record requirement but fails ISO 13485's competency demonstration requirement.
- Competency Requirements Not Defined Per Role — There is no documented definition of what competencies are required for each quality-affecting role. Training is assigned based on departmental tradition or manager judgment rather than a formal competency analysis linked to job descriptions and quality system requirements.
- No Training Effectiveness Evaluation — After training is delivered, there is no systematic evaluation of whether it was effective. Training records show completion dates but there is no follow-up assessment, no error rate monitoring, and no mechanism to identify when retraining is needed.
- Undefined competence criteria — Job descriptions exist but lack specific 'Competence Requirements' (e.g., 'Must have 3 years experience in sterile packaging'). ISO 13485 §6.2 requires documented criteria.
- Quality Awareness Not Addressed — Personnel perform their tasks correctly but cannot articulate how their work contributes to product quality and patient safety. There is no training or communication program addressing quality awareness and the relevance of individual activities to quality objectives.