Validation of standardized methods and estimation of measurement uncertainty according to ISO 21748

Validation of standardized methods and estimation of measurement uncertainty according to ISO 21748

305,00 €

Course introduction:

We provide you with the necessary knowledge to design, perform, and evaluate verifications and calculate the uncertainty of standardized methods.

This method is intended for personnel with some prior knowledge of other validation approaches, such as the global black box method.

The course explains the requirements set by ISO 21748 to verify that the applied method complies with the requirements of the reference test standard, using either reference materials or pairs of values.

It includes practical examples that will allow you to understand how to verify the laboratory method and how to estimate the measurement uncertainty of the test method based on ISO 21748, in order to meet the requirements of the UNE-EN ISO/IEC 17025:2017 standard.

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  1. INTRODUCTION.
    • 1.1. Introduction
    • 1.2. Concept of validation
    • 1.3. Validation requirements of ISO 17025
    • 1.4. Types of methods and validation
  2. VALIDATION DESIGN AND OBTAINED RECORDS
    • 2.1. Introduction
    • 2.2. Planning
    • 2.3. Execution
    • 2.4. Control
    • 2.5. Documentation and records
    • 2.6. Validation and standardized methods. Additional considerations
      • 2.6.1. Definition of the test method
      • 2.6.2. Checks to be performed
  3. VALIDATION PARAMETERS
    • 3.1. Introduction
    • 3.2. Parameter definition
      • 3.2.1. Accuracy
      • 3.2.2. Precision
      • 3.2.3. Working range
      • 3.2.4. Linearity range
      • 3.2.5. Limit of detection (LOD) and limit of quantification (LOQ)
      • 3.2.6. Selectivity and specificity
      • 3.2.7. Robustness
      • 3.2.8. Uncertainty
  4. STATISTICAL CONCEPTS
    • 4.1. Introduction
    • 4.2. Distribution models
      • 4.2.1. Measures of central tendency (central parameter µ)
      • 4.2.2. Measures of dispersion (σ)
    • 4.3. Normal distribution
    • 4.4. Estimators of the distribution model
  5. ISO 21748:2017 STANDARD
    • 5.1. Introduction
    • 5.2. Application model
    • 5.3. Evaluation of uncertainty using estimates of repeatability, reproducibility, and trueness
      • 5.3.1. Procedure for evaluating measurement uncertainty
    • 5.4. Assessment of laboratory bias
      • 5.4.1. Introduction
      • 5.4.2. Methods to demonstrate method bias control
    • 5.5. VERIFICATION OF REPEATABILITY
    • 5.6. CONTINUOUS PERFORMANCE VERIFICATION
    • 5.7. ADDITIONAL FACTORS
      • 5.7.1. Variability of routine samples
      • 5.7.2. Sampling
      • 5.7.3. Sample preparation and pre-treatment
      • 5.7.4. Types of samples
      • 5.7.5. Variation of reproducibility and uncertainty with concentration level
      • 5.7.6. Additional factors
    • 5.8. COMPARISON OF UNCERTAINTIES
    • 5.9. SUMMARY OF THE APPLICATION OF ISO 21748
      • 5.9.1. With reference value
      • 5.9.2. With pairs of values
  6. PRACTICAL EXAMPLES
    • 6.1. EXAMPLE 1: With pairs of values
    • 6.2. EXAMPLE 2: With reference value
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