RESUMO
The control of the measuring equipment (balances, mass standards, micropipettes, dilutors, volumetric glassware, thermometers...) is essential to obtain reliable analytical results. This control requires knowledge and use of the main standards, instructions for use, metrological verifications and confirmations as well as creation of checking and standardizing certificates ensuring metrological traceability. These items should help to control the quality of the analytical performances (fidelity and trueness in particular).
Assuntos
Equipamentos e Provisões/normas , Laboratórios/normas , Controle de Qualidade , Técnicas de Laboratório Clínico/normas , Análise de Falha de Equipamento/normas , Humanos , Garantia da Qualidade dos Cuidados de Saúde/normas , Valores de Referência , Reprodutibilidade dos Testes , Sensibilidade e Especificidade , IncertezaRESUMO
In order to ensure the quality of analytical results, clinical laboratories shall have a perfect control of process and equipments of measurement. Therefore is recommended individualisation of metrological function, generally entrusted the quality manager. This quality manager will draw up a metrological traceability, verifications and confirmations, control of non conformities, follow-up and evaluation of metrological function.
Assuntos
Testes de Química Clínica/normas , Técnicas de Laboratório Clínico/normas , Documentação/normas , Garantia da Qualidade dos Cuidados de Saúde/organização & administração , Testes de Química Clínica/instrumentação , Técnicas de Laboratório Clínico/instrumentação , Falha de Equipamento , Humanos , Manutenção/normas , Padrões de Referência , Sistema de Registros/normas , Pesos e Medidas/normasRESUMO
Clinical laboratories shall have a perfect control of "in vitro diagnostic medical devices" to ensure the quality of their analytical results. This introductory presentation to a serie of documents of recommendations tackles the different standards of metrology concerning the requirements to reference materials, metrological traceability, metrological confirmation, management of measurement as well as uncertainty of measurement. The standards concerning clinical laboratories are then succinctly described.