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Module 4 of 5 · ISO 15189 · Section 4

Ensuring the validity of results

The clinical lab must continually demonstrate the reliability of its results, with internal controls and external comparisons.

Content reviewed on

Internal quality control

Using control materials in every analytical run, with clearly defined acceptance and rejection rules.

External quality assessment

Participating in interlaboratory comparison programmes as objective evidence of competence.

Reporting results

Clear, complete reports with reference intervals and the clinical interpretation notes needed.

What an auditor usually asks for

  • Internal quality control with defined acceptance rules
  • Participation in external quality assessment programmes
  • A report template with reference intervals
  • An analytical nonconformity log with its action

How to cover result assurance in Kimobox

  1. 1Log internal quality control results with their trend in Kimobox.
  2. 2Document participation in external quality assessment programmes and their results.
  3. 3Generate clinical reports from a controlled system template.

The internal quality control trend stays visible on a dashboard, ready to catch a drift in time.

See audits and indicators in the quality portal

Where each figure comes from

References to the official text in force. If a standard is revised, this page is updated and the review date says so.

  1. ISO 15189:2022 — Medical laboratories. Requirements for quality and competence ISO · December 2022
  2. ISO/IEC 17025:2017 — Competence of testing and calibration laboratories ISO/IEC · November 2017
  3. Entidad Nacional de Acreditacion ENAC · Official portal