Management System According to ISO/IEC 17025: Method Validation

Abstract

The current study presents a non-random, quantitative experimental investigation detailing the steps required to accredit a non-regulated test method (referred to as its own) under the ISO/IEC 17025:2017 standard and the criteria set by the Mexican Accreditation Entity (EMA). The focus is on the methodology employed to validate the test method, particularly emphasizing the precision of the measurement system, along with the total variation in and tolerance of its components. For the measurement analysis, repeatability and reproducibility (r&R) studies were conducted using a variance analysis method variant (ANOVA). This variant is highlighted for its ability to estimate deviations more accurately. Furthermore, the chosen model incorporates random effect measurements for all factors or components of system variation (operators, parts, interaction, and instrument). This approach demonstrates the reliability, accuracy, and precision of the proposed measurement system within the test method, leading to its subsequent accreditation under ISO/IEC 17025:2017 as a conformity assessment body.

Keywords

• ANOVA
• ISO 17025
• r&R studies
• test
• validation