ISO 15189: what it is, who needs it, and how accreditation works

What is ISO 15189?

ISO 15189:2022 is the international standard for the quality and competence of a medical laboratory, covering its management system and the examination of patient samples from the request to the reported result. A national accreditation body assesses the laboratory against it and grants accreditation, then returns on a surveillance cycle to check the laboratory still works as assessed.

The 2022 edition is the fourth, published in December 2022 and built on the structure of ISO/IEC 17025:2017. Clauses 4 and 5 set the general requirements for impartiality, confidentiality and the care of patients, and the structural and governance requirements. Clause 6 covers the resources (personnel, facilities, equipment and calibration, reagents and external services) and clause 7 the processes from pre-examination through examination, reporting, nonconforming work and complaints. Clause 8 is the management system, and point-of-care testing, formerly ISO 22870, is Annex A.

Who needs ISO 15189?

The standard becomes urgent when the initial assessment goes on the calendar, when a hospital tender or a trial sponsor asks for the accreditation number and its scope, or when a new analyser arrives and nobody can find its calibration records.

ISO 15189 IN QUALIO

Qualio maps your procedures, competence records and equipment records to every clause, so the assessor finds each one where the standard puts it

Qualio breaks ISO 15189 down clause by clause and maps your procedures, competence records, equipment and calibration records and corrective actions to the clauses they answer. It reassesses when a record changes and recommends a fix on each gap. Copilot drafts the procedure update or the corrective action, and your team approves it. Before the assessment visit, you export the audit pack by clause, with the evidence behind each one.

Procedures held as controlled documents for clause 8, with training assigned on the effective date of every revision for the personnel requirements of clause 6.2

Equipment, calibration and metrological traceability records for clauses 6.4 and 6.5 held as controlled documents, with calibration and maintenance run as workflows beside the procedures that use them

Nonconforming work and complaints raised as events for clauses 7.5 and 7.7, each traceable to the corrective action that closed it under clause 8.7

Internal audits and management review run as events for clauses 8.8 and 8.9, so the review reads the audit findings, quality indicators and open corrective actions as they stand

Standards that apply alongside ISO 15189

LaboratoriesISO/IEC 17025: The competence standard for testing and calibration laboratories, which shares its structure with ISO 15189 and is the accreditation a laboratory holds when it tests products and materials instead of patient samples
Management systemsISO 9001: The quality management system standard a laboratory can hold beside its accreditation, which clause 8.1 notes can meet the management system requirements when it also supports clauses 4 to 7
Electronic records21 CFR Part 11: The FDA's rule for electronic records and signatures, which reaches the laboratory's records where they support an FDA submission or a trial the FDA will inspect
ClinicalICH E6 (R3): Good clinical practice, which reaches the laboratory through the sponsor's oversight when its results feed a clinical trial

Ender Diagnostics

Ender Diagnostics is a Swiss developer and manufacturer of rapid molecular diagnostic kits for the detection of SARS-CoV-2.

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Guides and checklists for ISO 15189

Blog

What is ISO 15189? A complete overview

Checklist

Audit readiness checklist: Be prepared to pass your next audit

Guide

Annex SL: the core of your ISO journey

Questions about ISO 15189

What is ISO 15189?

ISO 15189:2022 is the international standard for quality and competence in medical laboratories, covering the management system and the technical work from sample request to reported result. A national accreditation body assesses the laboratory against it and grants accreditation. It is the standard hospitals, health services and trial sponsors expect a clinical laboratory to be accredited to.

Is ISO 15189 an accreditation or a certification?

An accreditation. A certification body certifies that a management system conforms to a standard such as ISO 9001. An accreditation body also assesses the laboratory's technical competence to produce the results on its scope, witnessing examinations and reviewing the staff, equipment and methods behind them. A laboratory is accredited to ISO 15189. There is no ISO 15189 certificate.

What changed in ISO 15189:2022?

The 2022 edition restructured the standard to match ISO/IEC 17025:2017, with clauses 4 to 8 covering general, structural, resource, process and management system requirements. It brought point-of-care testing in from ISO 22870 as Annex A, ran risk management through every laboratory process and wrote patient welfare into the requirements. ILAC recognition of accreditation to the 2012 edition ended in December 2025.

How does ISO 15189 accreditation work?

The laboratory applies to its national accreditation body (UKAS, INAB, DAkkS or A2LA, for example) with the scope of examinations it wants accredited. Assessors review the documentation, then visit to witness examinations and check the staff, equipment and records behind them, and findings are closed before accreditation is granted. Surveillance visits follow, and a full reassessment ends the cycle.

Can we add ISO 15189 to the standards we already run in Qualio?

Yes. Add it from the library and Qualio assesses the records you already hold against every clause, so the procedures, training records and corrective actions that answer ISO 9001, ISO/IEC 17025 or cGMP count towards ISO 15189 without being re-filed. The first assessment lists what is covered and what is new.

When is the assessment visit?

Bring the date and your procedures. We will show you ISO 15189 assessed against them clause by clause, the gaps listed and the pack exported in the order the assessor works through it.

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