NF EN ISO 15195

NF EN ISO 15195

February 2019
Standard Current mandatory application standard
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Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures

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. The relationship between clauses in this document and ISO/IEC 17025:2017 are summarized in Annex A. Examinations of properties with results reported on a nominal or ordinal scale are not included. This document is not applicable to medical laboratories. NOTE Requirements for medical laboratories are specified in ISO 15189[1].

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Main informations

Collections

National standards and national normative documents

Publication date

February 2019

Number of pages

18 p.

Reference

NF EN ISO 15195

ICS Codes

03.120.20   Product and company certification. Conformity assessment
11.100.01   Laboratory medicine in general

Classification index

S92-062

Print number

1

International kinship

ISO 15195:2018

European kinship

EN ISO 15195:2019
Sumary
Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures

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.

The relationship between clauses in this document and ISO/IEC 17025:2017 are summarized in Annex A.

Examinations of properties with results reported on a nominal or ordinal scale are not included.

This document is not applicable to medical laboratories.

NOTE Requirements for medical laboratories are specified in ISO 15189[1].

Replaced standards (1)
NF EN ISO 15195
September 2004
Standard Cancelled
Laboratory medicine - Requirements for reference measurement laboratories

<p>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.</p> <p>ISO 15195:2003 is not applicable to routine medical laboratories.</p> <p>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".</p> <p>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. </p>

Table of contents
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  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Exigences générales
  • 5 Exigences structurelles
  • 6 Exigences relatives aux ressources
  • 7 Exigences relatives aux processus
  • 8 Exigences relatives au management
  • Annexe A Relation avec l'ISO/IEC 17025:2017
  • Bibliographie
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