Nonconformities Analysis According to ISO/IEC 17025 in Brazil

Abstract

This paper presents the analysis of nonconformities found in auditing of testing and calibration laboratories in accordance with ISO/IEC 17025. This International Standard specifies the general requirements for the competence to carry out tests and/or calibrations. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods. The auditing was conducted by auditors from Rede Metrológica RS (RMRS). The RMRS is a nonprofit association of technical and scientific nature that acts as an articulator in metrology and quality in Brazil. The main objective of this research was to identify the ISO/IEC 17025 requirements that have a higher number of non-conformities. We collected data on laboratory auditing performed in 2008, 2009, 2010, 2011 and 2012 years that represent about 500 laboratories audits. The data analyses were conducted clustering the laboratories by calibration and test area, by ISO/IEC 17025 requirements and by year. The areas of calibration laboratories were: acoustic; length, electricity, force, torque and hardness, mass, optical, pressure, flow and level, temperature and humidity, time and frequency, viscosity, volume. The areas of testing laboratories were: chemistry and physical chemistry, microbiological, biological and toxicological, mechanical and biochemistry. In the analysis were considered separately the percentages of non-conformities in technical and management requirements and also joint. Among the technical requirements with the highest number of non-conformities are Test and calibration methods and method validation (5.4) and Measurement traceability (5.6). Among the management requirements are Document control (4.3) and Control of records (4.13). Was also possible to identify which area of calibration or test showed a higher number of non-conformities. The calibration areas that had the highest number of non-conformities were pressure, flow and level, temperature and humidity and length. The testing areas that had the highest number of non-conformities were chemistry and physical chemistry and microbiological. Finally, one can see the trend of nonconformities in assessments of laboratories in accordance with the ISO/IEC 17025 requirements using the result of five years.