ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
Clause 7: Process requirements – ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence

ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence 7.1: 7.1 Process requirements: general

Across pre-examination, examination and post-examination work, the laboratory shall identify possible risks to patient care, assess them and reduce them as far as it can, tell users about any remaining risk where appropriate, and monitor and evaluate those risks and how well the mitigations work in proportion to the harm a patient could suffer. It shall also find ways to improve care for patients and set up a framework for managing those opportunities.

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