Evidence that every result can be trusted
ISO 15189:2022 requires a laboratory to show that each examination method performs as intended before it is used for patient results. Commercial methods used as the manufacturer intended need verification. Laboratory-developed tests, modified methods and methods used outside their intended scope need full validation.
We help you decide which applies to each test, design studies of the right size, work through the statistics and write reports an assessor can follow from raw data to conclusion. That covers precision, trueness and accuracy, linearity and reportable range, measurement uncertainty and reference intervals.
The result is a verification or validation file for each method, ready for your quality records and your next assessment.
How it works
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Validation protocol design
We confirm whether each method needs verification or full validation, then set the studies, sample numbers and acceptance criteria before any testing starts.
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Accuracy, precision and linearity studies
Studies run on your own analysers, with guidance on sample selection, run order and data capture so the results stand up.
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Measurement uncertainty calculations
Uncertainty estimated from your internal quality control and proficiency testing data, and compared with performance goals.
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Method verification reports
Each study written up with its data, statistics and a clear statement of whether the method meets its acceptance criteria.
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Reference range establishment
Reference intervals established or verified for your patient population, with the evidence behind each decision.
What you receive
Validation protocol
Study design, sample requirements and acceptance criteria, agreed before testing begins.
Statistical analysis
Worked calculations for every study, so results can be checked and reproduced.
Verification or validation report
A report for each method stating whether it is fit for patient testing, ready for sign-off by your laboratory director.
Uncertainty and reference interval records
Documented estimates and intervals for each measurand, ready to share with users on request.
Common questions
What is the difference between verification and validation?
Verification confirms that an unmodified, already validated method performs as the manufacturer claims in your laboratory. Validation is needed when you develop a method yourself, modify one or use it outside its intended scope, and establishes its performance from the ground up.
Do we need to verify methods that are already CE-marked or FDA-cleared?
Yes. Regulatory clearance shows the method can perform. Verification shows it performs in your laboratory, on your analysers, with your staff, and ISO 15189:2022 expects that evidence before patient testing.
Can you help when we install a new analyser?
Yes. A new analyser or platform change is a common point to verify methods, and we can plan the studies alongside installation so verification is complete before the analyser goes into service.
How is measurement uncertainty estimated?
Usually from internal quality control data for imprecision, combined with bias estimates from proficiency testing or reference materials where they are available. We document the approach and the result for each measurand.