ISO 15189 is the international standard for medical laboratory quality and competence. You may see it referenced on a laboratory's website or on a test report, but what does it actually mean in practice? This article explains what the standard requires, how accreditation is assessed, and why it is relevant to the reliability of the results you receive.
What ISO 15189 Requires ¶
ISO 15189 sets requirements across two broad areas: technical competence and quality management. On the technical side, it covers the validation of test methods, the qualification and ongoing competency assessment of laboratory staff, the calibration and maintenance of equipment, and the management of reference materials. On the quality management side, it covers document control, internal audit, management review, handling of non-conformances, and participation in external quality assurance schemes. A laboratory cannot self-declare ISO 15189 compliance; it must be assessed by an accredited body.
How Accreditation Is Assessed ¶
Accreditation involves an initial assessment by a team of external assessors, followed by annual surveillance audits and a full re-assessment every four to five years. Assessors review documentation, observe laboratory processes, interview staff, and examine quality control data. Non-conformances are classified as major (requiring corrective action before accreditation is granted or maintained) or minor (requiring a documented corrective action plan). A laboratory with major non-conformances does not receive or retain accreditation until those issues are resolved.
The Difference Between Accreditation and Certification ¶
ISO 15189 accreditation is specific to medical laboratories and is granted by a national accreditation body. It is not the same as ISO 9001 certification, which is a general quality management standard applicable to any organisation. ISO 9001 certification can be granted by several certification bodies and does not require technical assessment of laboratory methods. When evaluating a laboratory's quality credentials, ISO 15189 accreditation from a recognised national body is the more meaningful indicator for clinical and research purposes.
What It Means for Your Results ¶
Accreditation does not guarantee that every result is correct. No quality system can make that promise. What it does mean is that the laboratory has demonstrated, to an independent external assessor, that its methods are validated, its staff are competent, its equipment is maintained, and its quality controls are working. It also means the laboratory participates in external quality assurance schemes, where its results are compared against those of other laboratories using the same or equivalent methods. Persistent poor performance in external QA would be identified and would affect accreditation status.
Pulse Path Lab Core holds ISO 15189:2022 accreditation across all six of its laboratory disciplines. A copy of the current accreditation certificate is available on request by emailing enquiries@pulsepathlabcore.com.