NF EN ISO 15189

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.

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Main informations

Collections

National standards and national normative documents

Thematics

Management et performance

Publication date

August 2007

Number of pages

51 p.

Reference

NF EN ISO 15189

ICS Codes

03.120.10   Quality management and quality assurance
11.100.01   Laboratory medicine in general

Classification index

S92-060

Print number

1 - 03/08/2007

International kinship

ISO 15189:2007

European kinship

EN ISO 15189:2007
Sumary
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.

Replaced standards (1)
NF EN ISO 15189
October 2003
Standard Cancelled
Medical laboratories - Particular requirements for quality and competence

Le présent document spécifie les exigences de qualité et de compétence propres aux laboratoires d'analyses de biologie médicale

Standard replaced by (1)
NF EN ISO 15189
December 2012
Standard Current
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.

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
    4
  • 4.1 Organisation et management
    4
  • 4.2 Système de management de la qualité
    5
  • 4.3 Maîtrise des documents
    7
  • 4.4 Revue de contrats
    8
  • 4.5 Analyses transmises à des laboratoires sous-traitants
    8
  • 4.6 Services externes et approvisionnement
    9
  • 4.7 Prestations de conseils
    9
  • 4.8 Traitement des réclamations
    10
  • 4.9 Identification et maîtrise des non-conformités
    10
  • 4.10 Actions correctives
    10
  • 4.11 Actions préventives
    11
  • 4.12 Amélioration continue
    11
  • 4.13 Enregistrements qualité et enregistrements techniques
    11
  • 4.14 Audits internes
    12
  • 4.15 Revue de direction
    13
  • 5 Exigences techniques
    14
  • 5.1 Personnel
    14
  • 5.2 Locaux et conditions environnementales
    16
  • 5.3 Matériel de laboratoire
    17
  • 5.4 Procédures préanalytiques
    19
  • 5.5 Procédures analytiques
    22
  • 5.6 Assurer la qualité des procédures analytiques
    23
  • 5.7 Procédures postanalytiques
    24
  • 5.8 Compte rendu des résultats
    25
  • Annexe A (informative) Correspondance entre l'ISO 9001:2000 et l'ISO/IEC 17025:2005
    28
  • Annexe B (informative) Recommandations relatives à la protection des systèmes informatiques de laboratoire (SIL)
    32
  • Annexe C (informative) Éthique et laboratoires d'analyses de biologie médicale
    36
  • Bibliographie
    40
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