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ISO 15189:2022 Medical Laboratories

Quality and competence for medical laboratories — accurate results that clinicians and patients can trust.

ISO15189Medical Labs
Focus
Medical Lab Quality
Ideal For
Medical & diagnostic labs
Framework
Quality + competence
Validity
Accreditation cycle
Medical laboratory testing
15189
Medical Lab Quality
Accreditation Support

What is ISO 15189?

ISO 15189 specifies the requirements for quality and competence in medical laboratories. It covers the entire testing process — pre-examination, examination and post-examination — as well as laboratory management.

Accreditation assures clinicians and patients that diagnostic results are accurate, reliable and delivered to recognized standards. IQS supports medical and diagnostic laboratories on the path to accreditation.

  • Patient focus — reliable results that support clinical decisions.
  • Full testing cycle — control pre-, intra- and post-examination phases.
  • Competence — qualified staff and validated diagnostic methods.
Why It Matters

Benefits of ISO 15189

Accreditation that assures accurate, reliable diagnostic results across the full testing cycle.

ACCURACY

Reliable diagnostics

Assure clinicians of accurate, dependable laboratory results.

PATIENTS

Patient safety

Reduce diagnostic error and improve patient outcomes.

RECOGNITION

Trusted standard

Meet the internationally recognized medical-lab benchmark.

QUALITY

Controlled processes

Manage the entire testing cycle to consistent standards.

CONFIDENCE

Clinician trust

Strengthen confidence among referring clinicians and hospitals.

IMPROVE

Continual quality

Continually improve diagnostic quality and competence.

Key Requirements

What ISO 15189 involves

The core areas your organization will address with IQS support.

  • 1Pre-examination controlManage sample collection, handling and identification.
  • 2Examination processesValidate methods and ensure measurement quality.
  • 3Post-examinationControl result reporting, interpretation and records.
  • 4Competent staffQualify and train laboratory personnel.
  • 5Equipment & reagentsCalibrate equipment and control reagents.
  • 6Quality assuranceRun internal QC and external quality assessment.
Who Needs It

Who benefits from ISO 15189

Hospital Laboratories
Diagnostic Centres
Pathology Labs
Reference Laboratories
Blood Banks
Clinical Research
The Pathway

How IQS supports your ISO 15189 accreditation

A transparent, impartial route from first contact through to ongoing support.

01

Gap Assessment

We assess your laboratory or body against the accreditation standard and identify gaps.

02

System Development

We help build the management system, procedures, methods and competence records.

03

Internal Audit & Review

Internal audits and a management review confirm readiness before the assessment.

04

Accreditation & Surveillance

Support through the accreditation body assessment and ongoing surveillance.

Related Services

Explore related services

Ready to accredit your medical laboratory?

Talk to our team for a free, no-obligation discussion about ISO 15189 — usually within one business day.