NF EN ISO 15189

NF EN ISO 15189

December 2012
Standard Current mandatory application standard
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Medical laboratories - Requirements for quality and competence

ISO 15189:2012 specifies requirements for quality and competence in medical laboratories.ISO 15189:2012 can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.

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Main informations

Collections

National standards and national normative documents

Thematics

Management et performance

Publication date

December 2012

Release date

décembre 2025 par NF EN ISO 15189 de 2014

Number of pages

64 p.

Reference

NF EN ISO 15189

ICS Codes

03.100.70   Management systems
03.120.10   Quality management and quality assurance
11.100.01   Laboratory medicine in general

Classification index

S92-060

Print number

2 - 01/10/2014

International kinship

ISO 15189:2012

European kinship

EN ISO 15189:2012
Sumary
Medical laboratories - Requirements for quality and competence

ISO 15189:2012 specifies requirements for quality and competence in medical laboratories.

ISO 15189:2012 can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.

Replaced standards (1)
NF EN ISO 15189
August 2007
Standard Cancelled
Medical laboratories - Particular requirements for quality and competence

ISO 15189:2007 specifies requirements for quality and competence particular to medical laboratories. ISO 15189:2007 is for use by medical laboratories in developing their quality management systems and assessing their own competence, and for use by accreditation bodies in confirming or recognising the competence of medical laboratories.

Table of contents
  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    1
  • 4 Exigences relatives au management
    6
  • 4.1 Responsabilité en matière d'organisation et de management
    6
  • 4.2 Système de management de la qualité
    9
  • 4.3 Maîtrise des documents
    10
  • 4.4 Contrats de prestations
    11
  • 4.5 Examens transmis à des laboratoires sous-traitants
    12
  • 4.6 Services externes et approvisionnement
    12
  • 4.7 Prestation de conseils
    13
  • 4.8 Traitement des réclamations
    13
  • 4.9 Identification et maîtrise des non-conformités
    13
  • 4.10 Actions correctives
    14
  • 4.11 Actions préventives
    14
  • 4.12 Amélioration continue
    14
  • 4.13 Maîtrise des enregistrements
    15
  • 4.14 Évaluation et audits
    16
  • 4.15 Revue de direction
    18
  • 5 Exigences techniques
    19
  • 5.1 Personnel
    19
  • 5.2 Locaux et conditions environnementales
    21
  • 5.3 Matériel de laboratoire, réactifs et consommables
    23
  • 5.4 Processus préanalytiques
    26
  • 5.5 Processus analytiques
    30
  • 5.6 Garantie de qualité des résultats
    33
  • 5.7 Processus post-analytiques
    35
  • 5.8 Compte rendu des résultats
    35
  • 5.9 Diffusion des résultats
    37
  • 5.10 Gestion des informations de laboratoire
    38
  • Annexe A (informative) Correspondance avec l'ISO 9001:2008 et l'ISO/IEC 17025:2005
    40
  • Annexe B (informative) Comparaison entre l'ISO 15189:2007 et l'ISO 15189:2012
    45
  • Bibliographie
    49
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