Metrology in an ISO 15189 accredited medical biology laboratory
All French medical biology laboratories must be accredited according to ISO 15189 for all tests conducted. Metrology is therefore critical and covers a wide variety of areas. This presentation will focus on the metrology manager’s role which is tailored to the medical b...
| Main Authors: | , |
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| Format: | Article |
| Language: | English |
| Published: |
EDP Sciences
2014-01-01
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| Series: | International Journal of Metrology and Quality Engineering |
| Subjects: | |
| Online Access: | https://doi.org/10.1051/ijmqe/2014016 |
| Summary: | All French medical biology laboratories must be accredited according to ISO 15189 for all
tests conducted. Metrology is therefore critical and covers a wide variety of areas. This
presentation will focus on the metrology manager’s role which is tailored to the medical
biology laboratory: human resources in place, methods used, parameters followed, equipment
used and strategies implemented when using equipment which is not connected to the
International System of Units. It will be illustrated by examples of in vitro
and in vivo clinical biochemistry, biological haematology, human
toxicology and radiotoxicology. The presentation will cover the exploitation of results of
internal controls and interlaboratory comparisons in order to calculate uncertainties and
provide doctors with a result along with an interpretation or opinion to ensure optimum
patient care. The conclusion will present the steps carried out at the Laboratoire
National d’Essai (French National Testing Laboratory) to provide medical
biology laboratories with certified clinical biology standards. |
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| ISSN: | 2107-6839 2107-6847 |