ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
Clause 4: General requirements – ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence

ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence 4.1: Impartiality

What does 4.1 require?

Laboratory work shall be carried out impartially, and the laboratory's structure and management shall protect that impartiality. Management shall commit to impartiality and the laboratory is accountable for it, letting no commercial, financial or other pressure weaken it. The laboratory shall keep watch on its activities and relationships, and those of its staff, for anything that threatens impartiality (for example ownership, governance, staffing, shared resources, finances, contracts, marketing and incentives for referrals). When a threat is found, the laboratory shall remove it or reduce its effect and be able to show how it did so.

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