MATERIAL DE REFERÊNCIA CERTIFICADO (MRC)
Certified Reference Material (CRM) ISO 17034
A Certified Reference Material (CRM) is a material that possesses one or more homogeneous and well-defined properties, which are certified by a laboratory that complies with the ISO 17034 standard. Certification guarantees that the material was rigorously produced and characterized, and that its property values (such as concentration, purity, etc.) are reliable and traceable to international standards.
The ISO 17034 standard (“General requirements for the competence of producers of reference materials”) is the international standard that establishes the requirements for producers of CRMs. It ensures competence and consistency in the production, certification, and issuance of certificates for reference materials.
What is the importance of an CRM?
The main function of an CRM is metrological traceability. This means that measurements performed in laboratories can be related to a globally known and accepted reference, such as the International System of Units (SI).
They are essential in various areas, including:
• Validation of testing methods: Ensuring that the method used in a laboratory is functioning correctly.
• Calibration of equipment: Ensuring that measuring instruments are providing accurate results.
• Quality control: Monitoring the consistency and accuracy of routine results in a laboratory.
• Interlaboratory comparison: The use of certified reference materials (RMs) compliant with ISO 17034 is a crucial step for laboratories seeking to guarantee the quality and reliability of their analytical results.
The PNCQ RM is a stabilized, lyophilized human-derived reference material with known concentrations and purity, accompanied by a certificate. The measurement standards with certified values were determined using internationally traceable standards.
Below is the link to INMETRO’s information on the PNCQ Reference Material: https://www.gov.br/inmetro/pt-br/assuntos/acreditacao-reconhecimento-bpl/organismos-acreditados/produtores-de-materiais-de-referencia
The demand for new, higher-quality reference materials is growing, both as a result of improved precision in measuring equipment and the need for more accurate and reliable data in the area of analytical procedures for Clinical Laboratory Accreditation processes and in vitro diagnostic reaction validations.
A Reference Material Producer must demonstrate its technical and scientific competence to ensure adequate quality in the production of a Reference Material.
The PNCQ was evaluated by a team of specialists from INMETRO’s General Coordination of Accreditation (Cgcre), who granted the PNCQ the competence to operate Reference Material Production.
The PNCQ is a pioneer in the production of a CRM in this segment of Clinical Chemistry.
New parameters are currently being characterized to expand the scope of laboratory analysis.