Method Validation, QC & Measurement Uncertainty
Method Validation, Quality Control & Measurement Uncertainty
Practical technical support to demonstrate method fitness for purpose, establish effective quality control and evaluate measurement uncertainty.
ISO4LAB supports laboratories in the planning, evaluation and improvement of method validation and verification studies, internal quality control systems and measurement uncertainty estimates.
Our approach connects these activities rather than treating them as separate exercises, helping laboratories use their analytical data effectively to demonstrate method performance, monitor ongoing quality and understand the uncertainty associated with reported results.
How We Can Support Your Laboratory
Method Validation & Verification
Planning, review and evaluation of validation and verification studies. Support with selecting appropriate performance characteristics, experimental design, acceptance criteria, statistical evaluation and validation reporting.
Internal & External Quality Control
Development and improvement of practical quality control systems, including QC materials, control charts, acceptance criteria, monitoring frequency, proficiency testing participation and ongoing evaluation of laboratory performance.
Measurement Uncertainty
Development and review of practical measurement uncertainty estimates using appropriate bottom-up, top-down or laboratory-data-based approaches.
Method Validation & Verification
Method validation should provide objective evidence that a method is suitable for its intended application. The extent of validation or verification therefore depends on the method, its intended use and the performance requirements that need to be demonstrated.
ISO4LAB can support the planning, statistical evaluation and reporting of studies covering relevant performance characteristics such as:
- Selectivity and specificity
- Working range and linearity
- Precision
- Bias, trueness and recovery
- Limit of detection and quantification
- Robustness
- Comparison of methods
- Other method-specific performance requirements
Quality Control That Works in Practice
Internal quality control should provide meaningful evidence that a method continues to perform as expected after validation.
ISO4LAB supports laboratories in developing practical QC systems appropriate to their methods, risks and available control materials, together with effective use of proficiency testing and other interlaboratory comparisons for independent performance evaluation.
Practical Measurement Uncertainty
Measurement uncertainty should reflect the actual performance of the measurement process and provide useful information about the reliability of reported results.
ISO4LAB supports laboratories with the development, review and improvement of uncertainty estimates using approaches appropriate to the method and available data.
Support may include:
An Integrated Approach
Define Requirements
Understand the method, measurand, intended use and required analytical performance.
Plan the Study
Select appropriate performance characteristics, experimental design and acceptance criteria.
Evaluate Method Performance
Analyse validation or verification data and determine whether the method is fit for purpose.
Establish Quality Control
Design ongoing QC activities to demonstrate that method performance remains under control.
Evaluate Measurement Uncertainty
Use available method-performance, validation, QC and other relevant data to estimate uncertainty.
Monitor & Improve
Review accumulated data, investigate changes and update validation, QC or uncertainty estimates when necessary.
Need Support with Method Performance?
Whether you are validating a new method, verifying an existing procedure, improving your quality control program or reviewing measurement uncertainty, ISO4LAB can provide practical technical support tailored to your laboratory and method.
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