ISO 15195:2018
ISO 15195:2018

ISO 15195:2018

December 2018
International standard Current

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

International ISO standards

Publication date

December 2018

Number of pages

8 p.

Reference

ISO 15195:2018

ICS Codes

11.100.99   Other standards related to laboratory medicine

Print number

1
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)
ISO 15195:2003
ISO 15195:2003
October 2003
International 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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