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 7.5: Nonconforming work

What does 7.5 require?

A process shall govern what happens when any part of the laboratory's activities or results departs from its procedures, quality specifications or user requirements. The process shall make sure that: responsibilities and authorities are defined; immediate and longer-term actions follow from the laboratory's risk analysis; examinations are stopped and reports held back where harm could result; the clinical significance is assessed, including the effect on results already issued; a decision is taken on whether the work is acceptable; results are corrected and users told where needed; and it is defined who may authorize work to restart. Corrective action shall be proportionate to the risk of recurrence, and records of nonconforming work and of the actions taken shall be kept.

Maintained by Gerard BlokdykControl text last updated

What else in your programme already covers this

This control maps to 2 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

  • 1234 Identify and document problems arising from breakdowns in communication between the laboratory and the authorised persons who order or receive test results
  • 1282 Maintain and follow corrective action procedures, and document every corrective action taken when test systems fall outside established performance specifications, when calibration or control results fail (with evaluation of all patient results since the last acceptable run), or when reagent and specimen storage criteria are not met

Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.

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

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The graph holds this control, the 2 it maps to, and the evidence behind each claim, over MCP and REST.