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SRPS EN ISO 15195:2019

Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures (ISO 15195:2018)

Jul 31, 2020
Jul 31, 2020

General information

60.60     Jul 31, 2020

ISS

Z076

European Norm

03.120.20     11.100     11.100.99  

Serbian  

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Scope

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].

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

765/2008

REGULATION (EC) No 765/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93

Harmonized
Directive 765/2008

Life cycle

PREVIOUSLY

WITHDRAWN
SRPS EN ISO 15195:2008

NOW

PUBLISHED
SRPS EN ISO 15195:2019
60.60 Standard published
Jul 31, 2020

Related project

Adopted from EN ISO 15195:2019

Adopted from ISO 15195:2018 IDENTICAL