Are the POCT certificates already part of your analytical routine?

Are the POCT certificates already part of your analytical routine?

Discover how Lot-by-Lot Certification is transforming the diagnostic field and boosting the reliability of analyses.

The Lot-by-Lot Certification Program is the evidence your laboratory needs to enhance safety in the analytical routine of POCTs.

With certified lots, your establishment already has a prior evaluation of the lot integrated into the routine, highlighting the consistency compared to the previous lot and the reliability of the analyses.

The certificate from the Lot-by-Lot Program, issued by Controllab, ensures that the POCT lots are consistent with previous ones from the same manufacturer, promoting efficiency and cost savings for laboratories and other clinical analysis establishments.

What are the benefits of using lots certified by the Program?

This certification brings efficiency and cost savings to your establishment, promoting:

  • Quality and reliability: prevents potential issues or deviations that could affect the performance of the devices;
  • Simplification of routine: with certification, the introduction of a new lot into analytical processes becomes simpler and faster;
  • Reduction of costs and resources: saves reagents, time, and effort required for performance testing and analyses between lots, optimizing the frequency of Internal Quality Control.

Which manufacturers have already certified their quality?

Abbott, Biosys, Eco Diagnóstica, and MedLevensohn have already secured certification for a selection of their products:

To view the updated list of certified lots, please visit this link.

These manufacturers meet the needs of your audience, helping to reduce costs and efforts in monitoring the transition to new reagent lots in the analytical routine. Talk to your manufacturer and bring this benefit to your routine!

For more information about the Lot-by-Lot Certification Program, visit this exclusive channel and speak directly with the specialist for this solution.

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PRM 0009

Certified Reference Material Producer

Accredited by Coordenação-Geral de Acreditação do Inmetro

Controllab has been accredited as a Certified Reference Material (CRM) Producer since 2016 by Cgcre, under number PMR 0009. The conformity assessment is carried out in accordance with the requirements established in ABNT NBR ISO 17034 and Inmetro standards, ensuring competence for the production of CRMs, as defined in the Scope of Accreditation.

This accreditation attests to Controllab’s technical competence in producing CRMs according to international requirements and enables it to be recognized in other countries, under mutual recognition agreements, thereby reducing technical barriers between Brazil and other countries across continents.

Materiais de Referência Certificados - PMR 0009 - ABNT NBR ISO 17034-Controllab
Cgcre is signatory to the Mutual Recognition Arrangements of the International Laboratory Accreditation Cooperation (ILAC) and Interamerican Accreditation Cooperation (IAAC).

CAL 0214

Calibration Laboratory

Accredited by Coordenação-Geral de Acreditação do Inmetro

In December 2002, the Calibration Laboratory was accredited by Cgcre. With this recognition, it became part of the Brazilian network of accredited laboratories, under number 214. Since then, it has been periodically evaluated for the maintenance and/or extension of its accreditation.

The Inmetro seal attests to Controllab’s technical competence, credibility, and operational capability for calibration services, in accordance with the requirements of ABNT NBR ISO/IEC 17025.

Calibração de Instrumentos - CAL 0214 - ABNT NBR ISO/IEC 17025 - Controllab
Cgcre is signatory to the Mutual Recognition Arrangements of the International Laboratory Accreditation Cooperation (ILAC) and Interamerican Accreditation Cooperation (IAAC).

PEP 0003

Proficiency Test Provider

Accredited by Coordenação-Geral de Acreditação do Inmetro

In September 2011, Controllab was accredited by Cgcre as a proficiency test provider, under nº PEP0003. Initially as part of a pilot project by Inmetro, this accreditation was based on ILAC G13: 2007 and included several clinical and hemotherapy tests. In the periodic evaluations of this accreditation, new segments and tests are included and the evaluation is now conducted according to ABNT NBR ISO/IEC 17043.

This accreditation attests to Controllab’s technical competence to develop and conduct proficiency tests in accordance with international requirements and enables it to be recognized in other countries, in accordance with mutual recognition agreements signed by Brazil in Mercosur, the Americas and Europe.

PEP 0003 - ABNT NBR ISO-IEC 17043 - Controllab

Cgcre is signatory to the Mutual Recognition Arrangements of the International Laboratory Accreditation Cooperation (ILAC) and Interamerican Accreditation Cooperation (IAAC).