Maps to
QMSR / ISO 13485: §820.25
ISO 13485: §6.2
Requirement text
Personnel performing work affecting product quality shall be competent on the basis of education, training, skills, and experience.
What changed
This transition represents one of the most commonly misunderstood changes in the QMSR. Part 820 section 820.25 focused primarily on training — ensuring that personnel were trained to perform their assigned tasks and that training records were maintained. The emphasis was procedural: did the person attend the training? Is there a record of it? Many Part 820-era training programs consisted of read-and-sign acknowledgments where employees signed that they had read an SOP, and this was considered sufficient evidence of training.
ISO 13485 section 6.2 shifts the focus from training attendance to demonstrated competency. The standard requires that personnel performing work affecting product quality be competent on the basis of appropriate education, training, skills, and experience. Critically, it also requires that the organization: (a) determine the necessary competence for each role, (b) provide training or take other actions to achieve competency, (c) evaluate the effectiveness of the actions taken, and (d) ensure personnel are aware of the relevance and importance of their activities and how they contribute to quality objectives.
The word 'competence' is the key differentiator. Under ISO 13485, reading an SOP and signing a training record is not sufficient — the organization must demonstrate that the person can actually perform the task competently. This means defining what competent performance looks like for each role (competency criteria), providing training designed to achieve that competency (not just awareness), evaluating whether the training was effective (not just completed), and documenting the evidence.
This has significant practical implications. A training matrix under Part 820 might list SOPs each person needs to read. A competency-based training matrix under ISO 13485 must define the competencies required for each role, the training or experience that satisfies each competency, the method for evaluating competency (quiz, practical demonstration, supervised performance, peer review), and the evidence of competency achievement. For roles like incoming inspectors, process technicians, or internal auditors, practical demonstration of competency is expected, not just SOP read-and-sign.
Atomic constraints
- •Competency requirements must be defined for each role
- •Training records must be maintained
- •Training effectiveness must be evaluated
- •Training matrix must exist
- •The organization must determine the necessary competence for each role that affects product quality, including education, training, skills, and experience requirements.
- •The organization must provide training or take other actions to achieve and maintain the required competence for each role.
- •The effectiveness of training or other competency actions must be evaluated and the results must be recorded.
- •Personnel must be made aware of the relevance and importance of their activities and how they contribute to achieving quality objectives.
- •Records of education, training, skills, and experience must be maintained for all personnel performing work affecting product quality.
- •Personnel performing verification activities must have demonstrated competence appropriate for the verification tasks being performed, which may include technical training beyond general QMS training.
Common gaps
Read-and-Sign as Sole Training Evidence
majorTraining 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
moderateThere 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
moderateAfter 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
moderateJob 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
minorPersonnel 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.
Evidence signals
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FILE_EXISTS
(Training.*Matrix|Competency|Training.*Record|Training.*SOP|Qualification)
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CONTENT_MATCH
Does this document describe training requirements, competency assessment, or training records for quality-affecting personnel?
Audit defense
Personnel competency for [your product] manufacturing and quality activities is managed through [your document ID]. Competency requirements are defined for each quality-affecting role, with training records and effectiveness evaluations maintained per QMSR 820.25.