Medical Laboratory Accreditation
Acronym
LCL
Normative Reference
ISO 15189
Accredited Organizations
0
Medical Laboratory Accreditation

Medical Laboratory Accreditation.

If you are a laboratory that provides testing services such as neonatal screening, hemogram, uroanalysis, coproanalysis, immunoassays, DNA sequencing, blood analysis, glucose, PCR, among others, this accreditation service is for you. It will give you the possibility to raise your service to a high level of reliability and accuracy to your customers, with the support of the international recognition of ONAC. It also gives you the advantage that the results delivered by your laboratory will be accepted in the member countries of the ILAC MRA agreements.

On the other hand, if you are looking for a laboratory that performs analysis with quality and with all the technical knowledge in clinical tests, at the top of this section or in our Official Accreditation Directory organizations, you can consult the list of Medical Laboratory Accreditation.

Diana Milena
Jacome Molina
SECTORAL COORDINATOR
diana.jacome@onac.org.co

Chemist, Peoples’ Friendship University of Russia, Moscow, Russia.

Master in Agricultural Sciences, National University of Colombia at Bogota.

Specialization in applied statistics from Los Libertadores University.

Expert in physicochemical analysis of food, water and pharmaceutical laboratories. Analysis of natural contaminants and bromatological analysis for quality assurance and safety in animal feed.

Linked to ONAC since 2019 in the position of Sectoral Coordinator of Testing and Clinical Laboratories

Professor for 3 years at the College of Natural Sciences of the Central University in the areas of chemistry, analytical chemistry, biogeochemistry and environmental chemistry

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The services provided by Medical Laboratory Accreditation are essential for patient care and for any health system because their results are the main input for medical decision making. For this reason, in ONAC, we have prepared ourselves to have the technical competence to meet the accreditation requests of the laboratories that perform tests related to the sector and thus contribute to strengthening the quality infrastructure of the country.

Description

In the accreditation scheme of Medical Laboratory Accreditation, we assess the technical competence for the performance of tests under the compliance of the requirements of the ISO 15189 standard. The fulfillment of all its requirements allows us to guarantee that the Medical Laboratory Accreditation have a management system, the necessary infrastructure, competent personnel, and the necessary equipment. Thus, in the end, the patients have the security and confidence in the clinical results and the subsequent medical diagnosis derived from them. Thanks to the multilateral recognition agreements of which ONAC is part, these results are recognized in Colombia and internationally.

Scope

In ONAC we have been concerned in recent years to cover all the market needs. Today, we have the technical capacity to run assessments in several disciplines, such as clinical bacteriology, biochemistry, hemostasis, immunology, genetics, hematology, mycology, parasitology, pathology, virology, mycology and virology. Other services or disciplines such as clinical physiology, diagnostic imaging, and medical physics could also make use of this scheme.

International Recognition Agreements for LCL

  • Clinical laboratories ISO 15189
  • Clinical Laboratories ISO 15189

Laboratorios Clínicos Acreditados

Confirm accreditation status

Verify the status of an accreditation by typing the accreditation code below:

Antes de Acreditarse

Es importante que antes de aplicar al proceso de acreditación, el solicitante conozca los requisitos y documentos que debe tener en cuenta en cada una de las etapas.

Criterios de Evaluación

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:

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Criterios de Acreditación

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.

  • ISO 17034 “Requisitos generales para la competencia de los Productores de Materiales de Referencia”

Documentos Relacionados

  • ISO/IEC 17025 «Evaluación de la conformidad. Requisitos generales para la competencia de los laboratorios de ensayo y de calibración»
  • ISO Guide 30:2015 «Reference materials — Selected terms and definitions»
  • ISO 33401:2024 «Reference materials — Contents of certificates, labels and accompanying documentation»
  • ISO 33405:2024 «Reference materials — Approaches for characterization and assessment of homogeneity and stability»
  • ISO 33406:2024 «Approaches for the production of reference materials with qualitative properties»

Documentos ILAC

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.

  • ILAC P8 ILAC Mutual Recognition Arrangement (Arrangement): Supplementary Requirements for the Use of Accreditation Symbols and for Claims of Accreditation Status by Accredited Conformity Assessment Bodies
  • ILAC P9 ILAC Policy for Proficiency Testing and/or Interlaboratory comparisons other than Proficiency Testing
  • ILAC P10 ILAC Policy on Metrological Traceability of Measurement Results
  • ILAC G24 Guidelines for the determination of recalibration intervals of measuring equipment
  • ILAC R7 Rules for the Use of the ILAC MRA Mark

Instructivos y Procedimientos

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Documentos Generales

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.

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