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Module 3 of 5 · ISO 15189 · Section 3

Process requirements

The clinical process splits into three critical phases: before, during and after the test, each with its own risks.

Content reviewed on

Pre-examination phase

Test request, patient preparation, sample collection and transport through to receipt at the lab.

Examination phase

Selecting and validating analytical methods, with performance verification before clinical use.

Post-examination phase

Reviewing results, authorizing the report and communicating critical values to the responsible clinician.

What an auditor usually asks for

  • A sample collection and transport procedure
  • Documented validation of analytical methods
  • A critical value communication procedure
  • Sample traceability across all three phases

How to cover process in Kimobox

  1. 1Log sample traceability from collection through to the final report in Kimobox.
  2. 2Document the validation of each analytical method as a controlled record.
  3. 3Set up an automatic alert for critical value communication.

A critical value triggers an automatic alert, not dependent on someone reviewing the list in time.

See batch traceability and certificates in Kimobox

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
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