The Proficiency Testing Programs require accredited and applicant calibration laboratories to participate. The participating lab must prepare a program outline and select a reference laboratory, either a Pilot laboratory in India or another accredited lab with better CMC. The artifacts must have excellent repeatability, stability, and resolution. After program approval, the lab must calibrate, analyze, and calculate the En ratio.
• Standard procedures utilized outside of their scope, laboratory-developed methods, and non-standard methods must all be validated. • The sampling, handling, and transportation of test or calibration materials are all part of the validation process. • Method validation techniques include interlaboratory comparisons, calibration, systematic evaluation, verifying the robustness of the method, and assessing measurement uncertainty.
En=
Where,
x is the participating laboratory’s result
X is the Reference Laboratory’s result
Ulab is the expanded uncertainty of the participant’s result
Uref is the expanded uncertainty of the reference laboratory's assigned value.
• If modifications are made to a validated method that impact the initial validation, a new method validation must be carried out. • The performance characteristics of validated techniques should be in line with the specifications and pertinent to the needs of the customers. • All validation records, including the validation process, requirements, results, and a statement on method validity, must be kept by the laboratory. In order to be accredited to ISO/IEC 17025, validation and verification are necessary.
The Proficiency Testing Programs require accredited and applicant calibration laboratories to participate. The participating lab must prepare a program outline and select a reference laboratory, either a Pilot laboratory or another accredited lab with better CMC. The artifacts must have excellent repeatability, stability, and resolution. After program approval, the lab must calibrate, analyze, and calculate the En ratio.
• Standard procedures utilized outside of their scope, laboratory-developed methods, and non-standard methods must all be validated. • The sampling, handling, and transportation of test or calibration materials are all part of the validation process. • Method validation techniques include interlaboratory comparisons, calibration, systematic evaluation, verifying the robustness of the method, and assessing measurement uncertainty.
En=
Where,
x is the participating laboratory’s result
X is the Reference Laboratory’s result
Ulab is the expanded uncertainty of the participant’s result
Uref is the expanded uncertainty of the reference laboratory's assigned value.
• If modifications are made to a validated method that impact the initial validation, a new method validation must be carried out. • The performance characteristics of validated techniques should be in line with the specifications and pertinent to the needs of the customers. • All validation records, including the validation process, requirements, results, and a statement on method validity, must be kept by the laboratory. In order to be accredited to ISO/IEC 17025, validation and verification are necessary.
