Propuesta para la implementación de la Norma ISO/IEC 17025:2018, para el laboratorio de la Asociación Nacional de Curtidores del Ecuador

Abstract

The objective of this project was to prepare the proposal for the implementation of the NTE INEN - ISO / IEC 17025: 2018 according to documents, procedures, records, existing instructions in the laboratory, for the possible resolution of non-conformities that the Ecuadorian Accreditation Service determined. in the Laboratory of the National Association of Tanners of Ecuador and that prevented the Designation as a certified laboratory. For which it was necessary through the use of the Deming cycle; root cause analysis (with the use of brainstorming); and, the identification, review and verification of the documents, as well as the conditions that must be considered as evidence of compliance. When diagnosing the current situation of the Laboratory, through the analysis of the technical report DS L 19-001-D, it is identified that the conformity is related to the lack of evidence. Likewise, the current version of the regulations is not being used in the Quality Management System. To promote the Designation, the fifteen Action Request Records were prepared, where the actions to be taken to resolve nonconformities are described, such as: evidence formats; increase and updating of protocols in each of the procedures, in accordance with current regulations. Thus, the Laboratory has the appropriate mechanisms for a new evaluation by the Directorate of Laboratories of the Ecuadorian Accreditation Service. However, to achieve the Designation of the Laboratory, the implementation of each and every one of the strategies proposed in the Quality Management System and in the development of laboratory activities is recommended.