Competence evaluation and improvement of internal audits in ISO 15189

Abstract

[Introduction] For ISO 15189-accredited laboratories, “high-quality” internal audits are very important. The competence of the personnel conducting the internal audits is an important factor; however, declining competence has become a problem. This report describes an analysis of the current status of internal audits and an evaluation of competence after the implementation of countermeasures. [Methods] From FY2019 onward internal audit committee members have played a leading role in auditing. To understand the current level of competence, we performed a statistical analysis that compared evaluations of lead auditors whose competence had been certified in FY2018 to committee members certified from FY2019 onward. We conducted the same evaluation in the first half and the second half of the two audits for the committee members. [Results] We found that the average score of the lead auditors was 41.4 and CV% was about 26%. In the evaluation of the first half of the internal audit, the committee members had improved average score (49.1) and CV% (about 13%). Moreover, one member (11.1%) had a high score. In the second half, the average score was 55.7, and five committee members (about 56.6%) had a high score. The results showed a significant difference. [Conclusion] By analyzing the results of competence and taking countermeasures, we were able to improve the competence of committee members. We will continue to carry out internal audits and improve quality consistently through continuous practice by updating evaluation criteria.