Templates and records · ISO 15189 · Clause 7.3.2

ISO 15189 examination method verification

Before using an analyser or commercial reagent on patients, the laboratory checks that in its hands it delivers what the manufacturer promises and what the clinic needs.

In one sentence

Examination method verification records the performance specifications the method must meet, the studies carried out — imprecision, trueness, measuring interval, comparison with the previous method — their results and the statement of whether the requirements are met, because clause 7.3.2 of ISO 15189:2022 requires the laboratory to verify, before use, that it applies correctly the validated methods it uses unmodified, while 7.3.3 reserves full validation for in-house or modified methods.

Content reviewed on 17 October 2026

Where the standard requires it: ISO 15189 · Clause 7.3.2 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 Verification records: specifications, results and statement (7.3.2)
Who fills it in: Consultant responsible for the section With authorised technical staff; release for use is approved by the laboratory director or their delegate
When: Before the method is used on patients And again after significant changes: new analyser, change of reagent or relocation
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

Most methods in a European medical laboratory are CE-marked devices under Regulation (EU) 2017/746, already validated by their manufacturer. Used unmodified, ISO 15189 requires them to be verified: confirming with objective evidence that the laboratory achieves the declared performance and that it is fit for the intended clinical use.

The laboratory decides the extent of verification, but it must cover the characteristics relevant to the intended use and be recorded: the specifications sought, the results obtained and a statement of whether they are met. Specifications should ideally come from clinical requirements or biological variation, not just the package insert.

If the method is developed in-house, modified or used outside its intended use — another sample type, another interval — the requirement rises to validation (7.3.3). It is the same logic as in ISO/IEC 17025, where validation is the rule rather than the exception.

Read it in context: Process requirements, in the ISO 15189 Academy

Structure

Fields the template should include

Measurand, method, analyser and reagent with its CE marking
Intended use and sample type
Required performance specifications and their source
Imprecision study: levels, days and replicates
Trueness or bias study: material or comparison
Comparison with the previous method or another analyser
Measuring interval and carry-over, if applicable
Results against specifications
Statement of conformity and approval for use

Example

Example: verification of enzymatic creatinine on a new analyser

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

Field	Content
Method	Enzymatic creatinine in serum · new analyser at Riverside clinical laboratory (fictitious)
Specifications	Imprecision ≤ 3.0% · bias ≤ 4.0%, from biological variation criteria
Imprecision	2 levels × 5 replicates × 5 days: 1.9% and 1.4%
Trueness	Traceable reference material: bias of 1.8%
Comparison	60 patient samples against the previous analyser · mean difference 2.1%, no proportional effect
Interval	Verified from 0.15 to 25 mg/dL
Statement	Meets specifications · fit for clinical use
Approval	Clinical biochemistry consultant · 12 February 2026

At the audit

Mistakes auditors commonly flag

Specifications copied from the manufacturer's insert without asking whether they serve the clinic.
Verification started after patient results were already being reported.
No comparison with the previous method, so patient results shift from one day to the next.
Changes of intended use (another sample type) treated as verification instead of validation.
Reference intervals not reviewed when the method changes.

In Kimobox

How this record is kept in Kimobox

1Validation and verification of each examination method are documented as a controlled record.
2Each method keeps its version, and a change of analyser leaves a trace in the history.
3The competence and authorisation of technical staff appear in the employee portal.

Frequently asked questions

What people ask us before getting started

Does a CE-marked reagent have to be validated?

No, if it is used unmodified and within its intended use: it is verified. If the laboratory modifies it or uses it outside what the manufacturer declares, ISO 15189 requires it to be validated.

How does it differ from validation under ISO/IEC 17025?

In a testing laboratory, most methods are standards to be verified or in-house methods to be validated. In the medical laboratory closed commercial systems predominate, and the usual record is verification against clinically based specifications.

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