Templates and records · ISO 15189 · Clause 8.8.2

ISO 15189 medical laboratory quality indicators

The figures that show whether the laboratory works for the patient: rejected samples, turnaround times, critical values notified in time, amended reports.

In one sentence

The medical laboratory quality indicators record defines, for each phase — pre-examination, examination and post-examination — the indicator, its formula, data source, target and frequency, and records its results and the actions taken when the target is missed, because clause 8.8.2 of ISO 15189:2022 requires planned monitoring of quality indicators that evaluate the performance of the laboratory's critical processes.

Content reviewed on 17 October 2026

Where the standard requires it: ISO 15189 · Clause 8.8.2 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 Indicators to be established and monitored in a planned way (8.8.2)
Who fills it in: Quality manager With each section consultant for the indicators of their phase
When: At each indicator's frequency Usually monthly, with an annual review of the whole panel
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 quality indicators to be established to monitor critical aspects of pre-examination, examination and post-examination processes, with their planning: objectives, methodology, interpretation, limits, action plan and duration of measurement.

They must be reviewed periodically to check that they remain appropriate, and their results feed management review.

The most useful indicators arise from records that already exist — pre-examination incidents, critical result communication, amended reports — so it is worth designing them together.

Read it in context: Management system requirements, in the ISO 15189 Academy

Structure

Fields the template should include

Phase and process measured
Indicator name and formula
Data source
Target and acceptance limit
Frequency and owner
Result for each period
Analysis and action when the target is missed
Review of the indicator's suitability

Example

Example: indicator panel for April 2026

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

Field	Content
Pre-examination	Haemolysed samples: 1.9% · target ≤ 1.5% · not met
Pre-examination	Identification errors: 0.04% · target ≤ 0.05% · met
Examination	Acceptable EQA distributions: 98% · target ≥ 95% · met
Post-examination	Urgent troponin within 60 minutes: 92% · target ≥ 90% · met
Post-examination	Critical values communicated within 30 minutes: 96% · target ≥ 95% · met
Post-examination	Reports amended after issue: 0.08% · target ≤ 0.1% · met
Action	Phlebotomy training at the centre with most haemolysis · review in June

At the audit

Mistakes auditors commonly flag

All indicators are analytical and none measures the pre-examination phase.
Indicators with no target, so there is no way to tell when to act.
Targets missed for months with no recorded action.
Formulas that change from one period to the next, making comparison impossible.
Indicators never reach management review.

In Kimobox

How this record is kept in Kimobox

1Indicators are configured on the dashboard, and the system calculates the monitoring.
2A missed target can open an action with an owner, a date and a delay warning.
3Management review is prepared with the laboratory's data already aggregated.

Frequently asked questions

What people ask us before getting started

How many indicators should we have?

The standard does not say. There must be indicators for the critical aspects of all three phases. A panel of ten to fifteen well-chosen indicators is usually more useful than fifty that nobody reviews.

Are there reference indicators?

Laboratory medicine societies have proposed harmonised lists of indicators and specifications, useful for benchmarking. ISO 15189 does not impose any.

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