ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
Clause 8: Management system requirements – ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence

ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence 8.9.2: Review input

What does 8.9.2 require?

The inputs to the review shall be recorded and shall cover: progress on actions from earlier reviews; changes inside and outside the laboratory, shifts in the volume and kind of work, and whether resources are adequate; whether objectives were met and whether policies and procedures remain fit; what evaluations, monitoring of quality indicators and internal audits found, together with nonconformity analysis, corrective actions taken and external assessments; feedback and complaints from patients, users and staff; assurance that results are valid; how well improvements and actions on risk worked; how external providers performed; interlaboratory comparison outcomes; the evaluation of POCT; and further matters such as monitoring and training.

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