Abstract

ETCHEGOYEN, María Cecilia; PREVOO, María Marta  and  GIRARDI, Raúl Héctor. Programa de Evaluación Externa de la Calidad "Prof. Dr. Daniel Mazziotta": una nueva etapa asegurando la mejora continua de la calidad. Acta bioquím. clín. latinoam. [online]. 2019, vol.53, n.4, pp.499-504. ISSN 0325-2957.

Clinical laboratory determinations have a very important role in the evaluation, diagnosis, treatment and evolution of the health status of people. The reliability of their results is achieved through quality assurance and continuous improvement. The External Quality Assessment Programme Prof. Dr. Daniel Mazziotta has been accompanying clinical analysis laboratories for 31 years offering different tools to ensure analytical quality. It provides the services of external quality assessment, supply of material for internal quality control for determinations in Clinical Chemistry and solutions for instrumental control and sufficiency tests. Since the creation of the program, strategic objectives have been established to be developed in three stages: establishment, consolidation and support for quality management. A new stage is now being generated, whose final objective is accreditation. As a first step of this cycle, a quality management system (QMS) was implemented according to the requirements established in the IRAM Argentina standard-ISO 9001:2015. In August 2019, the Argentine Institute for Standardization and Certification (IRAM), representative in Argentina of the International Organization for Standardization (ISO), certified that the Programme's QMS complies with the provisions of said standard. Its application aims to ensure that the services offered meet the needs of clinical laboratories by fulfilling the legal requirements and ensuring continuous improvement. The objective of this work is to describe the actions carried out in the implementation of the QMS and the subsequent IRAM-ISO 9001: 2015 certification by the IRAM.

Keywords : External quality assessment; Continuous improvement; IRAM-ISO 9001:2015.

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