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Self-Diagnosis of quality based on ISO 15189

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Abstract

The accreditation of medical laboratories in accordance with ISO 15189 is becoming more and more a primary requirement to ensure work and laboratory results. The laboratory of toxicology and pharmacology of the Center of Poison Control and Pharmacovigilance of Morocco (LAB-CAPM) is committed to put in place an adequate quality management system based on ISO 15189. This article has the objective to highlight the weaknesses of the LAB-CAPM quality management system in relation to the standard ISO 15189. For this, we performed self-evaluation in the LAB-CAPM using a self-diagnosis grid. This work has allowed us to identify a number of discrepancies between the work done in LAB-CAPM and the work described in the standard. Therefore, we are proposing a remediation to those discrepancies, with a focus on the analytical process, which is the most important process.

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Authors and Affiliations

  1. Laboratory of Biochemistry and Immunology of Faculty of Sciences, University Mohammed-V, Av. Ibn Batouta, B. P. 1014, Rabat, Morocco

    Marouane Nasser & M’hamed Tijane

  2. Laboratory of Toxicology and Pharmacology, Center of Poison Control and Pharmacovigilance of Morocco, Lamfadel cherkaoui Street, Madinat al Irfane, Rabat, Morocco

    Omaima El Bouazzi

Authors
  1. Marouane Nasser
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  2. M’hamed Tijane
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  3. Omaima El Bouazzi
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Correspondence to Marouane Nasser.

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Nasser, M., Tijane, M. & Bouazzi, O.E. Self-Diagnosis of quality based on ISO 15189. Accred Qual Assur 22, 45–49 (2017). https://doi.org/10.1007/s00769-016-1243-7

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  • DOI: https://doi.org/10.1007/s00769-016-1243-7

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