Be recognized for the quality of your analyses

For over 48 years, Controllab has been supporting healthcare services in achieving excellence and credibility in their results

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Featured programs

Solutions that promote quality

Periodic external evaluation to
ensure result accuracy.

Continuous monitoring to identify
and correct routine errors.

Comparative management of indicators for precise strategic decisions.

NCTC® culture collection with
technical equivalence to ATCC®.
(according to wdcm.org)

Traceability and accuracy aligned with international standards.

International quality recognition based on a standard accredited by ISQua.

Partnerships to promote quality and safety in in vitro diagnostic products.

Training resources to enhance
laboratory practices.

Get to know Controllab

Pioneering, trusted, and innovative solutions that transform analytical results.
Access our institutional brochure and see how we make a difference.

Institutional Brochure

Accreditations, Certifications and Qualifications​

Controllab, with over 48 years of experience, stands out for its recognitions.

PEP 0003 - ABNT NBR ISO-IEC 17043 - Controllab
CRL 0586 - NBR ISO-IEC 17025 - Controllab
Calibração de Instrumentos - CAL 0214 - ABNT NBR ISO/IEC 17025 - Controllab
Materiais de Referência Certificados - PMR 0009 - ABNT NBR ISO 17034-Controllab

According to the scope published on www.gov.br/inmetro

According to the scope published on www.anvisa.gov.br

Good Manufacturing Practices.

BPF - Boas Práticas de Fabricação

Our numbers

48

years of history and operation

+20

thousand users in more than 40 countries

+3500

tests analyzed periodically

04

internationally recognized accreditations

+20

years accredited by the Coordenação-Geral de Acreditação do Inmetro

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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.

view certificate
access accredited scope
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).

CRL 0586

Control Laboratory

Accredited by Coordenação-Geral de Acreditação do Inmetro

In December 2012, the Control Laboratory, responsible for process control and quality control analyses of the materials prepared by Controllab to support the Proficiency Testing and Internal Control programs, was accredited by Cgcre, becoming part of the Brazilian network of accredited laboratories, under number 0586.

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

view certificate
access accredited scope
CRL 0586 - 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).

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.

view certificate
access accredited scope - RBC/Cgcre/Inmetro - Physical-Chemical
access accredited scope - RBC/Cgcre/Inmetro - Mass
access accredited scope - RBC/Cgcre/Inmetro - Volume and Specific Mass
access accredited scope - RBC/Cgcre/Inmetro - Pressure
access accredited scope - RBC/Cgcre/Inmetro - Temperature
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).

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.

view certificate
access accredited scope
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).

ISO 9001 Certified

In June 2003, Controllab had its quality management system certified in ABNT NBR ISO 9001 by Bureau Veritas/Inmetro (national scope) and Bureau Veritas/UKAS (international scope), as “proficiency test provider in clinical tests, physical-chemical and microbiological”. Since then, it has been periodically evaluated for maintenance and/or revalidation of certification.
access Bureau Veritas/ukas certificate
access Bureau Veritas/inmetro certificate

ANVISA/REBLAS Qualification

In August 2001, Controllab was qualified by ANVISA/REBLAS as a Proficiency Testing Provider for clinical, hemotherapy, and breast milk testing, under registration number PROFI 001. In 2012, this qualification was renewed under the agency’s new policy, receiving registration number REBLAS 23.

This voluntary qualification process is conducted in accordance with the requirements of ABNT NBR ISO/IEC 17043, current regulations, ANVISA criteria, Coordenação-Geral de Acreditação do Inmetro criteria, and other international protocols.

Its objective is to guarantee the technical reliability of the provider, whose services are widely used in the quality assessment and assurance processes of clinical laboratories.

access qualification (doc. 01)
access qualification (doc. 02)
According to the scope published in www.anvisa.gov.br

BPF/ANVISA Certificate

Quality control materials

In October 2012, Controllab received the certification of Good Manufacturing Practices for health products, granted by Anvisa. This certification relates to the production of health products for laboratory quality control purposes.

The certification process is voluntary and conducted in accordance with the requirements of Resolution RDC No. 665 of March 30, 2022 (GMP for diagnostic products for in vitro use). During the process, Controllab is periodically inspected (as related) by the Sanitary Surveillance to verify good manufacturing practices.

Anvisa is a regulatory agency linked to the Ministry of Health of Brazil, whose mission is to protect and promote health, ensuring the health safety of products and services. Although registration with Anvisa does not apply to Controllab materials (RDC No. 36/2015, Article 2, Sole Paragraph, I), GMP certification is open.

access certification

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.

view certificate
access accredited scope
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).

CRL 0586

Control Laboratory

Accredited by Coordenação-Geral de Acreditação do Inmetro

In December 2012, the Control Laboratory, responsible for process control and quality control analyses of the materials prepared by Controllab to support the Proficiency Testing and Internal Control programs, was accredited by Cgcre, becoming part of the Brazilian network of accredited laboratories, under number 0586.

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

view certificate
access accredited scope
CRL 0586 - 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).

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.

view certificate
access accredited scope - RBC/Cgcre/Inmetro - Physical-Chemical
access accredited scope - RBC/Cgcre/Inmetro - Mass
access accredited scope - RBC/Cgcre/Inmetro - Volume and Specific Mass
access accredited scope - RBC/Cgcre/Inmetro - Pressure
access accredited scope - RBC/Cgcre/Inmetro - Temperature
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).

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.

view certificate
access accredited scope
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).

ISO 9001 Certified

In June 2003, Controllab had its quality management system certified in ABNT NBR ISO 9001 by Bureau Veritas/Inmetro (national scope) and Bureau Veritas/UKAS (international scope), as “proficiency test provider in clinical tests, physical-chemical and microbiological”. Since then, it has been periodically evaluated for maintenance and/or revalidation of certification.
access Bureau Veritas/ukas certificate
access Bureau Veritas/inmetro certificate

ANVISA/REBLAS Qualification

In August 2001, Controllab was qualified by ANVISA/REBLAS as a Proficiency Testing Provider for clinical, hemotherapy, and breast milk testing, under registration number PROFI 001. In 2012, this qualification was renewed under the agency’s new policy, receiving registration number REBLAS 23.

This voluntary qualification process is conducted in accordance with the requirements of ABNT NBR ISO/IEC 17043, current regulations, ANVISA criteria, Coordenação-Geral de Acreditação do Inmetro criteria, and other international protocols.

Its objective is to guarantee the technical reliability of the provider, whose services are widely used in the quality assessment and assurance processes of clinical laboratories.

access qualification (doc. 01)
access qualification (doc. 02)
According to the scope published in www.anvisa.gov.br

BPF/ANVISA Certificate

Quality control materials

In October 2012, Controllab received the certification of Good Manufacturing Practices for health products, granted by Anvisa. This certification relates to the production of health products for laboratory quality control purposes.

The certification process is voluntary and conducted in accordance with the requirements of Resolution RDC No. 665 of March 30, 2022 (GMP for diagnostic products for in vitro use). During the process, Controllab is periodically inspected (as related) by the Sanitary Surveillance to verify good manufacturing practices.

Anvisa is a regulatory agency linked to the Ministry of Health of Brazil, whose mission is to protect and promote health, ensuring the health safety of products and services. Although registration with Anvisa does not apply to Controllab materials (RDC No. 36/2015, Article 2, Sole Paragraph, I), GMP certification is open.

access certification
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