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Standards
What ISO 15189 actually requires from your logistics chain.
Swiftline Editorial · January 2026 · 5 min read
ISO 15189 is the international standard for medical laboratory quality and competence. Most laboratory directors know this. Fewer know that the standard’s requirements for the pre-analytical phase — the period before a specimen reaches the laboratory — extend explicitly to specimen transport.
What the standard covers
ISO 15189 defines the pre-analytical phase as beginning at the point of the clinician’s request and ending when analytical examination begins. Specimen transport is squarely within this phase. The standard requires that laboratories have documented procedures for specimen collection and transport that protect specimen integrity.
Specifically, the standard requires:
• Documented transportation requirements including temperature range, time limits, and special handling instructions
• A system for monitoring that specimens are received in a condition suitable for examination
• Records of specimen receipt, including condition on arrival
• Procedures for handling specimens that do not meet acceptance criteria
The implication: If a specimen arrives at your laboratory in a compromised condition and you have no documentation of what happened during transport, you cannot demonstrate compliance with the pre-analytical requirements of ISO 15189. The gap in the transport documentation is a gap in your accreditation.
What assessors look for
ISO 15189 assessors reviewing pre-analytical processes will ask to see the laboratory’s transportation procedures and the records that demonstrate they are being followed. For laboratories using external transport providers, this means the transport provider’s documentation becomes part of the laboratory’s compliance evidence.
An assessor who asks to see temperature logs for a sample of recent external transfers and receives a verbal assurance that “the courier handles all that” has found a non-conformance. The standard requires documented evidence, not a description of an arrangement.
The practical requirements
Meeting ISO 15189 requirements for specimen transport means having, for every external transfer: a documented procedure specifying the transport conditions required, a logistics provider that operates to those conditions and produces documentation demonstrating compliance, and a record of specimen condition on receipt that can be linked to the transport documentation.
None of this is onerous. It is standard practice for a logistics provider designed for healthcare. The question is whether the provider a laboratory is currently using produces this documentation as a matter of course, or whether achieving it requires special arrangements every time.
ISO 15189 accreditation is only as strong as the weakest link in the pre-analytical chain. For facilities using external transport, that link is the logistics provider’s documentation standards.
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