engleski

Does the supervision of the Croatian Accreditation Agency (CAA) lead to more effective reporting of nonconformities in the laboratory?

Introduction: Nonconformity is any deviation from the requirements of the ISO 15189. Accredited laboratories commit to develop the most appropriate way to manage nonconformities. The aim of this study was to assess the impact of conformity assessment bodies first audit on the raise of awareness about the importance of reporting nonconformities in the medical laboratories. Materials and Methods: Using Clinical Department for Laboratory Diagnostics network where the documentation of the QMS is distributed, the data on nonconformities before and after supervision of the CAA was retrospectively obtained. Nonconformities are then further categorized according to the grounds for their registration. Conclusion: Considering that the first CAA audit the number of reported nonconformities was noticeably increased in all categories, we are convinced that external supervision particularly stimulates the development of awareness about the importance of reporting nonconformities.

Croatian Accreditation Agency ; nonconformities

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