ISO 15189 & UKAS Validation Support
Practical validation, verification and implementation support for clinical laboratories working towards ISO 15189 accreditation or maintaining an existing scope.
Get your laboratory validation ready for UKAS assessment.
Is your laboratory facing any of these challenges?
“We're not sure whether this requires verification or validation.”
A new examination method does not always require the same level of evaluation.
The appropriate approach depends on factors such as the method, manufacturer's claims, intended use, modifications and how the examination will be performed within your laboratory.
We can help you determine the appropriate approach and develop a proportionate study plan.
“We've completed the validation, but we're not confident the evidence is sufficient.”
We can review:
- Study design
- Acceptance criteria
- Sample selection
- Performance data
- Statistical analysis
- Conclusions
- Supporting documentation
Our aim is to identify gaps before they are identified during assessment.
“We're introducing a new analyser or examination method.”
Implementation of a new platform or method requires more than simply demonstrating that the analyser works.
Your laboratory needs evidence that the examination procedure is suitable for its intended clinical application within your own environment.
ISOCHECKS can support method verification, comparison studies, performance evaluation and implementation documentation.
“We've modified the manufacturer's method.”
Changes to an established method can alter its performance characteristics.
Examples include:
Different specimen types
Modified sample preparation
Different extraction procedures
Changes to analytical parameters
Different instrumentation
Use outside the manufacturer's intended purpose
We can help assess the impact of the modification and determine an appropriate validation strategy.