Reference materials are one of the fundamental pillars in the industry and support sectors. Having certainty in the characteristics and properties of these materials provides a solid and accurate basis for the development of tests and monitors, otherwise, their lack of knowledge would compromise the quality and confidence in the results.
The demand for new quality reference materials is increasing as a consequence of both the improvement in the precision of measuring equipment and the need for more accurate and reliable data in scientific and technological disciplines.
Different standards such as ISO/IEC 17025, ISO 15189 or ISO/IEC 17043 require organizations to verify or validate their methods or procedures and confirm that they are fit for purpose. Such processes require the use of appropriate reference materials as they play a key role in ensuring the validity of the results and the metrological traceability of the measurements made. Thus, these bodies require an extended supply of reference materials that meet the highest quality standards, for which they make use of materials from Reference Material Producers that demonstrate their technical competence through accreditation under the international standard ISO 17034.
Chemistry of the National University of Colombia
Specialist in Applied Statistics of the Fundacion Los Libertadores University
Expert in physicochemical, microbiological and microbiological laboratory analysis and microbiological potency of drugs and raw materials.
Validation of analytical methodologies, process validation and pharmaceutical stability.
Linked to ONAC since March 2021 as Sectoral Coordinator of Testing Laboratories.
The accreditation in ISO 17034 evaluates the compliance with the competence and quality requirements of the Material Producers – RMP for the production of materials, substances or items that are the basis for the performance of different laboratory tests that support different sectors and support the confidence in goods produced in the market.
Accredited RMPs have the ability to produce certified reference materials, which are reference materials characterized by a metrological procedure valid for one or more specified properties, accompanied by a reference material certificate that provides the value of the specified property, its associated uncertainty and a statement of metrological traceability.
This accreditation scheme covers reference materials or items produced by RMP under specific characterization strategies for each of the materials produced following the international standard ISO 17034.
At ONAC we have the technical capacity to attend evaluations for various categories of reference materials and we constantly receive new needs to expand our portfolio of services and thus strengthen the quality infrastructure and competitiveness of the country.
Verify the status of an accreditation by typing the accreditation code below:
Documentos adicionales o complementarios de la norma de acreditación, para algunos alcances específicos, que el solicitante debe cumplir y son objeto de evaluación por parte de ONAC para determinar su competencia como Organismo Evaluador de la conformidad.
Conoce las reglas y los requisitos para acreditarte como Productor de Materiales de Referencia:
Requisitos que debe cumplir el solicitante que desea acreditarse de acuerdo con el esquema de evaluación de la conformidad y que son objeto de evaluación para determinar la competencia del organismo. ejemplo ISO 17034 requisitos para Productores de materiales de referencia.
Los documentos ILAC suministran información que puede apoyar la implementación de los requisitos establecidos en la norma ISO 17034. Los documentos R (Reglas) y P (Políticas) de ILAC contienen requisitos mandatorios para los OEC que buscan la acreditación con ONAC. Los documentos G (guías) son de carácter informativo, aunque una vez son acogidas por los OEC, se tornan obligatorias.
Aplican para todos los esquemas de acreditación y definen condiciones desde la presentación de la solicitud hasta el mantenimiento y renovación de la acreditación, forman parte de la relación contractual con ONAC.
