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Module 5 of 5 · ISO 15189 · Section 5

Management system requirements

The final module holds up the whole system: documentation, nonconformities, internal audits and periodic review.

Content reviewed on

Nonconformity control

Handling nonconforming work, evaluating whether the requesting clinician needs informing and the impact on prior results.

Internal audit

An internal audit programme covering the clinical lab's technical and management aspects.

Management review

A periodic review with specific inputs: patient and clinician complaints, external assessment results and resource adequacy.

What an auditor usually asks for

  • A nonconforming work procedure with clinical impact assessment
  • A technical and management internal audit programme
  • Management review minutes with the standard's inputs
  • Evidence of continual laboratory improvement

How to cover the management system in Kimobox

  1. 1Log every nonconforming work item with its impact assessment on prior results.
  2. 2Plan technical and management internal audits from the audit module.
  3. 3Prepare management review with the lab's data already aggregated.

Nonconforming work stays linked to the prior results it could affect, no manual searching required.

See Kimobox's 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
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