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 8.8.2: Quality indicators

What does 8.8.2 require?

Monitoring of quality indicators shall be planned, setting out for each indicator its objective, method, how it is interpreted, its limits, the action plan and how long monitoring lasts; the indicators shall be reviewed from time to time to confirm they remain appropriate.

Maintained by Gerard BlokdykControl text last updated

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This control maps to 1 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.

Australia National Pathology Standards (First Edition 2027) · 1 control

  • 2.07 Quality management systems: collect and interpret safety and quality data on specimen collection, integrity, traceability and testing, equipment testing, result interpretation and reporting, incident and error rates and turnaround times; monitor and report performance and improvement activities; give the governing body, designated person and workforce access to the data; involve the workforce in improvement reviews; and audit the system's effectiveness

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

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