What is ISO 15189?
A practical introduction to the international standard for quality and competence in medical laboratories — what it covers, who needs it, and what the accreditation process actually looks like.
ISO 15189 is the international standard that defines requirements for quality and competence in medical laboratories. Published by the International Organization for Standardization, it provides a framework allowing clinical laboratories to demonstrate they operate consistently, produce reliable diagnostic results, and manage quality in a way that protects patient safety.
The two pillars of ISO 15189
The standard is structured around management requirements and technical requirements. Management requirements cover organizational policies, document control, internal audit programs, and the continuous improvement processes that govern how a laboratory is run as an institution. Technical requirements cover the scientific work itself — personnel competency, equipment calibration, sample handling, result verification, and the quality controls that validate test performance day to day.
Who needs ISO 15189 accreditation?
Any clinical or medical laboratory seeking independent verification of its quality and competence can pursue ISO 15189. In many jurisdictions and healthcare networks, accreditation is increasingly required rather than optional. Laboratories performing diagnostic testing for patient care — including clinical chemistry, microbiology, haematology, anatomical pathology, and molecular diagnostics — commonly hold ISO 15189 accreditation.
What the accreditation process involves
Achieving ISO 15189 requires implementing a documented quality management system, demonstrating personnel competency through training and assessment records, maintaining calibrated equipment with traceable documentation, and participating in external quality assessment programs. An accreditation body then conducts an onsite assessment — reviewing documents, interviewing staff, and observing laboratory processes. Non-conformances identified during assessment must be addressed before accreditation is granted or renewed.
- Document all quality system policies, procedures, and work instructions in controlled formats
- Define personnel roles and maintain competency assessment records for every technical staff member
- Validate and verify all measurement procedures before patient use
- Participate in proficiency testing and act on any unsatisfactory results
- Complete internal audits and management reviews on a defined cycle
- Address non-conformances through a formal corrective action process
ISO 15189 vs ISO 17025
ISO 15189 is sometimes compared to ISO 17025, the standard for testing and calibration laboratories more broadly. The two share structural similarities but ISO 15189 is written specifically for medical laboratories and includes additional requirements reflecting patient safety obligations, clinical interpretation responsibilities, and the ethical dimensions of diagnostic testing.
Maintaining accreditation over time
ISO 15189 accreditation is not a one-time event. Accreditation bodies conduct surveillance assessments annually and full reassessments on a multi-year cycle. Laboratories that treat accreditation as a continuous operational state — rather than a point-in-time inspection — find the process significantly less disruptive and maintain a consistently stronger quality position.
SHELF's accreditation module organizes requirements by standard, assigns owners, and tracks readiness across assessment cycles. Every piece of compliance evidence — controlled documents, training records, PT results, audit findings — is linked and inspection-ready at all times.
See how this applies to your lab
Our team works directly with accredited laboratories on quality systems, technology platforms, and accreditation readiness.