Accreditation and Quality Assurance

, Volume 22, Issue 1, pp 45–49 | Cite as

Self-Diagnosis of quality based on ISO 15189

  • Marouane Nasser
  • M’hamed Tijane
  • Omaima El Bouazzi
Practitioner's Report


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.


Self-Diagnosis Quality ISO 15189 Accreditation 


  1. 1.
    Syll NN, Adje S, Coupe S, Sebayang A, Veux V (2013) Aide à la mise en place de la norme ISO 15189 dans les laboratoires de biologie médicale N 251. Accessed 16 May 2016
  2. 2.
    International Organization for Standardization, Geneva ISO 15189, Third edition 2012-11-01 Medical laboratories—Requirements for quality and competenceGoogle Scholar
  3. 3.
    Laboratory Assessment Tool (2012)-world health organization. Accessed 30 June 2016
  4. 4.
    De Frondat F, Delahaye V, Gomez P-J, Podlunsek C, Farges G, Caliste J-P (2010) Laboratoires d’analyses de biologie médicale: un outil d’autodiagnostic basé sur la norme NF EN ISO 15189. IRBM News 31(3):3–6CrossRefGoogle Scholar
  5. 5.
    Adjeb S, Coupeb S, Sebayanga A, Syllb N, Veuxa V, Fargesa G, Calisteb JP (2013) Outil d’autodiagnostic pour aider à la mise en place de la norme ISO 15189 dans les laboratoires de biologie médicale (LBM). IRBM News 34(3):80–82CrossRefGoogle Scholar
  6. 6.
    Zheng Y, Maritins Floris L, Khedhiri MR (2015) Outil d’autodiagnostic pour le projet de la norme ISO/DIS 9001:2015. Accessed 30 May 2016
  7. 7.
    Burnett D (2006) ISO 15189:2003 Quality management, evaluation and continual improvement. Clin Chem Lab Med 44:733–739CrossRefGoogle Scholar
  8. 8.
    Libeer JC (1999) Effect of accreditation schemed on the setting of quality specifications by laboratories. Scand J Clin Lab Invest 59:575–578CrossRefGoogle Scholar
  9. 9.
    Müller MM (2010) Quality and diagnostic perspectives in laboratory diagnostics. Accessed 10 June 2016

Copyright information

© Springer-Verlag Berlin Heidelberg 2017

Authors and Affiliations

  1. 1.Laboratory of Biochemistry and Immunology of Faculty of SciencesUniversity Mohammed-VRabatMorocco
  2. 2.Laboratory of Toxicology and PharmacologyCenter of Poison Control and Pharmacovigilance of MoroccoRabatMorocco

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