Improving Performance of Testing Laboratories – A Statistical Review and Evaluation

Abstract

This paper outlines the most common quality challenges testing laboratories are facing during their accreditation process. Accreditation is the independent evaluation of conformity assessment bodies (i.e. Testing laboratories) against recognized standards to carry out specific activities to ensure their impartiality and competence. Through the application of national and international standards, government, procurers and consumers can have confidence in the quality of test results, inspection reports and certifications provided.

This study has been performed based on data collected by more than 300 testing laboratories, from 41 countries worldwide, accredited against the requirements of the international standard ISO/IEC 17025-2005 “General requirements for the competence of testing and calibration laboratories.”

The Non-Conformities were issued during the accreditation process of various testing laboratories specializing in different testing categories (Civil, Geotechnical, Mechanical, Electrical, Chemical, Microbiological, etc.). Findings vary from commonly reported quality management system issues to the most demanding technical challenges faced by testing laboratories.

The identified Non-Conformities were categorized and statistically processed. The trends are identified and analyzed per quality management system or technical category. Under the accreditation process, laboratories are required to respond to any significant findings with a submittal of a corrective action plan containing an analysis of the root cause, details of actions taken to resolve the issue and strategies to prevent reoccurrence. Various responses were analyzed and some suggestions and good practices were gleaned from these submittals. Opportunities for improvement are presented for each corresponding category of findings.

ISO/IEC 17025:2005 specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods. It is applicable to all organizations performing tests and/or calibrations. These include, for example, first-, second- and third-party laboratories, and laboratories where testing and/or calibration forms part of inspection and product certification. The standard is applicable to all laboratories regardless of the number of personnel or the extent of the scope of testing and/or calibration activities.

Appendix

See Appendix Table 1.

Table 1. Relating the clauses of ISO/IEC 17025:2005 to ISO/IEC 17025:2017