ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
Clause 6: Resource requirements – ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence

ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence 6.2.2: 6.2.2 Competence requirements

For every function that can affect results, the laboratory shall define the competence needed in terms of education, qualifications, technical knowledge, skills, experience, training and retraining. It shall make sure every member of staff is competent for the activities assigned to them, run a process for managing competence that sets how often it is assessed, and keep documented information that shows competence (for example assessment by direct observation, monitoring of results, review of records, problem-solving exercises and specially prepared samples).

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