ISO 15189 Accreditation Support
15189 accreditation applies to laboratories that have been accredited by CAP / UCAS/ DAkkS / COFRAC /ACCREDIA or other organization, according to ISO 15189 standard. A fundamental principle required by accreditation is that the recipient of the result must be able to identify clearly and without doubt which tests are included within the accredited scope and which are not.
The use of the accreditation mark and references to accreditation are governed by regulations and requirements of ISO 15189.
To ensure that readers of test results report from the MediLab LIS can distinguish between accredited and non-accredited tests, the following method is applied:
- The accreditation logo, together with the laboratory’s certificate number, appears at the top of the page.
- The special symbol * is used next to each accredited test.
- A footnote is printed at the bottom of the report explaining: “Tests marked with the symbol * are included within the laboratory’s accreditation scope according to ISO 15189 by the National Accreditation System.”
ISO 15189 Accreditation Support
The software managing the accredited laboratory process under 15189 accreditation must:
- Distinguish Accredited Tests
The report must clearly separate which of the displayed tests are accredited and which are not.
It must not create the impression that the entire report is accredited when only a portion of the tests falls within the accreditation scope.
- Perform Automatic Marking on Results
When printing or generating a PDF:
- Automatically place the accreditation symbol next to the relevant test.
- Display the appropriate footnote.
- Manage Versions of the Accreditation
The system must maintain accreditation start dates, expiration or suspension dates, and accreditation version information for each test.
In this way, historical results remain marked according to the accreditation status that was valid when they were issued.
- Record Changes – Audit Trail
Any change in the accreditation status of a test must be recorded in accordance with the traceability requirements of the ISO 15189 quality system.
- Manage Accreditation Suspensions
If a test is temporarily removed from the accreditation scope, the system must:
- Automatically remove the relevant accreditation marking.
- Require no manual intervention for each individual result.
- Monitoring – Automatic Management of Accreditation Changes
Accreditation changes are implemented automatically by specifying the effective date and change status for tests whose accreditation status has been modified.
All other management functions, as well as report marking, are performed automatically by the LIS software, eliminating the need for manual user intervention. This constitutes the safest and most controlled approach for complying with accreditation requirements.
More information about the“MediLab LIS” Laboratory Information System can be found here.
