ISO 15189 medical laboratories
We support lab review with specimen tracking, result ranges and authorised verification, helping your team inspect the recorded steps behind the results it releases.
Set by ISO
Subject type: standard. ISO 15189 sets requirements for quality and competence in medical laboratories, and an accreditation body assesses a laboratory against it. This page describes laboratory workflow records, not a quality system or an accreditation assessment.
What is built
- Care Laboratory records barcode-based specimen collection and receipt.
- Entered abnormal and critical ranges support result review.
- A second authorised verifier supports the described verification process.
Edition and requirement context
ISO 15189 has editions. Name the edition your accreditation body applies and the requirement you want to review before using any record shown here. This page maps records to no clause and no edition.
Illustrative example: a specimen trail
This example uses synthetic data. A specimen is collected for a synthetic patient, Yusuf Ali, and its barcode is scanned at collection and again at receipt. The result is entered against the abnormal and critical ranges your laboratory has set, then a second authorised person verifies it. A reviewer can follow the specimen through collection, receipt, result entry and verification, with the people and times recorded.
What your reviewer sees
These records support a review of how a sample moved through the configured workflow. They do not establish laboratory competence, measurement validity or the full set of evidence needed for accreditation. Evaluate equipment, methods, personnel and quality processes alongside the application record. No automatic result verification or complete requirements mapping is claimed.
Official source
ISO 15189. ISO publishes the standard. The application supports laboratory evidence. It does not confer accreditation or replace the laboratory’s own competence and method assessments.
What we claim, precisely
The system holds the evidence; the facility's accountable person attests. Nothing here asserts that a facility is compliant.
Common questions
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No automatic verification is claimed. The confirmed workflow includes a second authorised verifier, and your laboratory remains responsible for its configured process, result review and release decisions.
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None is named on this page. Confirm the edition your accreditation body applies and the requirement you want to review. We will show which laboratory records relate to it and which do not.
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It supports the evidence a laboratory keeps about specimens and results. Accreditation concerns the laboratory’s competence, methods and quality system, and is decided by an accreditation body, not by software.
Not answered here? Contact the team
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