Templates and records · ISO 15189 · Clause 7.3.7.3

ISO 15189 external quality assessment record

Schemes in which the medical laboratory tests unknown samples and compares its result with other laboratories', handled exactly as if they came from a patient.

In one sentence

The external quality assessment record captures the schemes the medical laboratory takes part in for each measurand, how samples are processed — like patient samples and by the usual staff — the results and their assessment, actions after an unacceptable result and alternatives where no scheme exists, because clause 7.3.7.3 of ISO 15189:2022 requires participation in schemes appropriate to its examinations, point-of-care testing included, and monitoring of performance.

Content reviewed on 17 October 2026

Where the standard requires it: ISO 15189 · Clause 7.3.7.3 Clauses are cited using the numbering of ISO 15189:2022, the edition in force since the transition ended in December 2025 and the same one the Academy uses.
Type of information: Mandatory record Monitoring of EQA performance and actions (7.3.7.3)
Who fills it in: Consultant responsible for each section Quality keeps the calendar and the overall follow-up
When: According to each scheme's calendar Assessment of each report on receipt and annual review of coverage
How long it is kept: Set by the laboratory ISO 15189 asks for the retention time of each record to be defined, taking into account legal and user requirements (8.4). Those forming part of the medical record also follow the applicable health regulations.

What the standard requires

What ISO 15189 demands and what it leaves to your judgement

The standard requires participation in external quality assessment schemes appropriate to the examinations and the interpretation of results, including point-of-care testing. Samples are processed like patient samples, by the staff who routinely carry out the examinations.

The laboratory does not discuss samples with other participants before the closing date, nor send them to another laboratory for confirmation. It monitors its performance and, when it does not meet the criteria, investigates and acts.

If no scheme exists for a measurand, the laboratory must use alternatives — sample exchange with other laboratories, reference materials, patient samples tested at another centre — and justify its choice.

Read it in context: Ensuring the validity of results, in the ISO 15189 Academy

Structure

Fields the template should include

Measurand and scheme taken part in
Scheme provider and frequency of distributions
Distribution, date tested and technician
Laboratory result and consensus or reference value
Acceptance criterion and assessment
Investigation of unacceptable results
Effect on patient results
Alternative used where no scheme exists

Example

Example: unacceptable sodium result

Company, people and figures are fictitious: the example only shows what a properly completed record looks like.

Field	Content
Scheme	General clinical chemistry · 12 distributions a year
Distribution	March 2026 · tested in the morning routine by the usual technician
Sodium	Result 146 mmol/L · consensus 140 · outside the ±4 mmol/L acceptance limit
Investigation	Sodium electrode calibration shifted after the change of calibrator lot
Effect	Positive bias in internal QC undetected for 4 days · review of 37 patients with sodium > 145
Action	Recalibration, clinicians of 3 patients notified and a new control rule for sustained bias
No scheme	Faecal calprotectin: six-monthly exchange of 10 samples with a reference hospital

At the audit

Mistakes auditors commonly flag

Scheme samples tested in duplicate or by the best technician.
Unacceptable results with no review of their effect on patients.
Measurands with no scheme and no justified alternative.
Point-of-care tests that take part in no external assessment.
Scheme reports filed without a signed assessment.

In Kimobox

How this record is kept in Kimobox

1Participation in EQA schemes and the results are documented in the system.
2An unacceptable result opens a nonconformity with a mandatory root cause and verification of effectiveness.
3The internal QC trend is shown on the same dashboard, so both sources can be cross-checked.

Frequently asked questions

What people ask us before getting started

Is it the same as proficiency testing?

It is the same concept under the name used in the clinical field. ISO 15189 adds requirements such as including point-of-care testing and processing samples exactly like patient samples.

What if there is no scheme for a test?

Use a documented alternative: sample exchange with other laboratories, certified reference materials or testing of patient samples at another laboratory, with defined acceptance criteria.

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