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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].
Author | ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems |
---|---|
Editor | ISO |
Document type | Standard |
Format | Paper |
Edition | 2 |
ICS | 11.100.99 : Other standards related to laboratory medicine
|
Number of pages | 8 |
Replace | ISO 15195:2003 |
Weight(kg.) | 0.1136 |
Year | 2018 |
Country | Switzerland |