NF EN ISO 15195

NF EN ISO 15195

September 2004
Standard Cancelled

Laboratory medicine - Requirements for reference measurement laboratories

ISO 15195:2003 gives the specific requirements for reference measurement laboratories in laboratory medicine. Examinations of properties with results reported on a nominal or ordinal scale are not included. ISO 15195:2003 is not applicable to routine medical laboratories. The general requirements for the competence of calibration laboratories are laid down in ISO/IEC 17025 for testing and calibration laboratories. ISO 15195:2003 refers to the specific aspects of calibration laboratories in the field of laboratory medicine where such "calibration laboratories" are usually denoted as "reference measurement laboratories". ISO 15195:2003 may form a basis for the accreditation of a reference measurement laboratory that applies for official recognition of the performance of a reference measurement procedure. Reference measurement laboratories are usually accredited by national metrology institutes or national accrediting bodies.

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Main informations

Collections

National standards and national normative documents

Publication date

September 2004

Number of pages

22 p.

Reference

NF EN ISO 15195

ICS Codes

11.100.01   Laboratory medicine in general

Classification index

S92-062

Print number

1 - 09/09/2004

International kinship

ISO 15195:2003

European kinship

EN ISO 15195:2003
Sumary
Laboratory medicine - Requirements for reference measurement laboratories

ISO 15195:2003 gives the specific requirements for reference measurement laboratories in laboratory medicine. Examinations of properties with results reported on a nominal or ordinal scale are not included.

ISO 15195:2003 is not applicable to routine medical laboratories.

The general requirements for the competence of calibration laboratories are laid down in ISO/IEC 17025 for testing and calibration laboratories. ISO 15195:2003 refers to the specific aspects of calibration laboratories in the field of laboratory medicine where such "calibration laboratories" are usually denoted as "reference measurement laboratories".

ISO 15195:2003 may form a basis for the accreditation of a reference measurement laboratory that applies for official recognition of the performance of a reference measurement procedure. Reference measurement laboratories are usually accredited by national metrology institutes or national accrediting bodies.

Standard replaced by (1)
NF EN ISO 15195
February 2019
Standard Current
Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures

<p>This document specifies the requirements for competence to carry out reference measurement procedures in laboratory medicine, using the requirements of ISO/IEC 17025:2017 as a normative reference and listing additional requirements for calibration laboratories to perform their tasks adequately.</p> <p>The relationship between clauses in this document and ISO/IEC 17025:2017 are summarized in Annex A.</p> <p>Examinations of properties with results reported on a nominal or ordinal scale are not included.</p> <p>This document is not applicable to medical laboratories.</p> <p>NOTE Requirements for medical laboratories are specified in ISO 15189<sup>[1]</sup>.</p>

Table of contents
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  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    2
  • 4 Exigences relatives au système de management
    4
  • 4.1 Organisation et management
    4
  • 4.2 Système de management de la qualité
    5
  • 4.3 Personnel
    6
  • 4.4 Documentation et enregistrements relatifs aux mesures
    6
  • 4.5 Contractualisation
    6
  • 5 Exigences techniques
    7
  • 5.1 Locaux et conditions environnementales
    7
  • 5.2 Traitement des échantillons
    7
  • 5.3 Équipement
    7
  • 5.4 Matériaux de référence
    8
  • 5.5 Modes opératoires de mesure de référence
    8
  • 5.6 Traçabilité métrologique - Incertitude de mesure
    9
  • 5.7 Assurance qualité
    9
  • 5.8 Compte rendu des résultats
    9
  • Annexe A (informative) Références croisées avec l'ISO/IEC 17025:1999
    11
  • Bibliographie
    12
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