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WELCOME, WE ARE CONTROLLAB

We are the largest Brazilian laboratory quality control company

Since 1977 we have been working with the objective of sowing quality and we are committed to taking care of life. The 48-year history of the company is based on the commitment to offer complete and integrated solutions in quality and assertiveness of laboratory results.

The services provided by Controllab facilitate routine for laboratory accreditation processes and regulatory bodies in the broadest portfolio on the market: there are more than 3,500 tests.

We are a full solution company in several segments: clinical, blood bank, veterinary, microbiology and physical-chemical tests for medicines, food, sanitizers, water and effluents, fuels and others, among services that serve hospitals and industries.

With a focus on developing the best user experience, we help clients to provide accurate, indisputable services and that stand out in the national and international markets. We have unique know-how in quality control solutions. We have the exclusive support of important scientific societies and the recognition of the main standards related to our performance: ISO 9001, 17025, 17034 and 17043.

Our story

Vanguard, leadership, quality and professionalism: Controllab is represented by the trajectory of Mr. Marcio Biasoli,
son of a pharmacist, from where he inherited the deep respect and concern for the health of the population.

Marcio Biasoli

Controllab President

1976

Marcio Biasoli creates the biochemistry internal and external control program for 20 laboratories.

1977

On July 12, 1977, Controllab was founded.

1980-1999

Inclusion of educational materials, courses, advice and calibration services. The services were updated, following international protocols.

2000-2003

ANVISA recognition as a Proficiency Testing provider; Accreditation as a calibration laboratory by Coordenação-Geral de Acreditação do Inmetro; ISO 9001 certification; Online System Software.

2004-2006

Laboratory Indicators Program; Blood Bank/Hemotherapy Program

2007-2010

Start of the L'Avenir project; Partnership with the Brazilian Society of Veterinary Medicine (SBMV) and the Oswaldo Cruz Foundation (Fiocruz); Launch of the books "Management of the analytical phase for laboratories".

2011-2012

Accreditation as a provider of Proficiency Testing and testing laboratory by Coordenação-Geral de Acreditação do Inmetro; Good Manufacturing Practices Certification.

2013-2014

Availability of digitalized tests; Quality control for testing laboratories.

2015-2016

Accreditation as a CRM producer by Coordenação-Geral de Acreditação do Inmetro; Expansion and internationalization of the Benchmarking and Laboratory Indicators Program.

2017-2019

International Expansion; Partnership with the UK Health Security Agency (UKHSA); Partnership with LIS companies; Launch of CI ONLINE and Analytical Quality Management Software;

2020-2021

Pioneering in laboratory quality control actions for Covid-19, receiving recognition as the first globally accredited provider for all virus detection methodologies.

2022

In another pioneering initiative, Controllab launched quality control for Monkeypox; The company structured the Education Sector, reinforcing its commitment to education since its foundation, aiming to expand the offering of materials and activities for the improvement of professionals in the laboratory quality field.

2023

Adherence to important International Scientific Societies: International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and European Organisation for External Quality Assurance Providers in Laboratory Medicine (EQALM).

Vinícius Biasoli

Executive Director Controllab

Structure

The Controllab team consists of more than 400 direct employees, along with approximately 100 technical-scientific advisors who are committed to updating, innovation, and the quality of services. Located in Rio de Janeiro, with approximately 10,000 m² of built area, Controllab is divided into two structures:

Preparation of Materials

Proyectada para atender las Buenas Prácticas de Fabricación de muestras para los Ensayos de Aptitud, Control Interno, Materiales de Referencia y Cepa de Referencia. Posee áreas de producción química y bilógica, laboratorio de control da calidad, áreas de esterilización, cámaras frías y liofilizadores.

Services

It encompasses all sectors involved in the management process of Proficiency Testing, Calibration, Advisory, Training and Business Administration. Among them, Research & Development, Customer Management, Quality Assurance, Service and Project Management, Information Technology, Marketing and New Business.

What's behind Controllab's controls?

Watch the video to learn more.

All processes

are conducted according to Good Manufacturing Practices of the Ministry of Health, AOAC/ISO/IUPAC International Protocol (homogeneity and stability of items), ABNT NBR ISO/IEC 17043: 2011 (Conformity Assessment - General Requirements for Proficiency Tests ) and ANVISA/GGLAS 02/43 procedure.

Solid Principles

Our values and principles are solid and we want to spread them even more, as we are sure that they are what unite us with our partners and customers.

Mission

To provide efficient services, guaranteeing indisputable performance and accurate results for our customers.

Vision

To be reference in the Americas in offering services and technologies for quality control, providing reliability for laboratories and safety for citizens.

Values

Competence, experience, confidence and innovation.

Our numbers

48

years of history and operation

+20

thousand users in more than 40 countries

+3500

tests analyzed periodically

04

years of internationally recognized accreditations

+20

years accredited by the General Coordination of Accreditation of Inmetro

QUALITY POLICY

Offer services that meet the real needs of our customers through the search for new opportunities and constant technological updating, keeping our quality management system in a continuous process of improvement, with total involvement and commitment of our employees, attending

Note: all Controllab services are supported by procedures for handling doubts, suggestions or complaints. These procedures are available for consultation by the interested parties.

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

Good Manufacturing Practices.

BPF - Boas Práticas de Fabricação
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

REBLAS - Nº23 - Controllab - Laboratório Habilitado ANVISA

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

Good Manufacturing Practices.

BPF - Boas Práticas de Fabricação

Partnerships

With the challenge of seeking new paths and expand scientific knowledge to offer better solutions to its customers, Controllab establishes partnerships with scientific societies and universities.
SBPC/ML - Sociedade Brasileira de Patologia Clínica e Medicina Laboratorial
SBMV - Sociedade Brasileira de Medicina Veterinária
Fiocruz - Fundação Oswaldo Cruz
UKHSA
NCTC logo
NCPV logo
NCPF logo
Member
IFCC
EQALM
Associate
CBDL
ABIMO

Controllab Branding Guidelines

In January 2021, Controllab announced the evolution of its brand. Following the company’s trajectory, the new branding reflects the zeal for quality and care for life.

Note: Controllab grants the laboratories registered and active in the Proficiency Test the authorization to use the Quality Control Seal (CQ Seal) in their media. The QC Seal is evidence of active and continuous participation in External Quality Control.

Download Controllab Brand Identity and Use Manual

How can we help you?

SUPPORT
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Institutional

About
Our Story
Structure
Solid Principles
Our Numbers
Quality Policy
Accreditations, Certifications and Qualifications
Partnerships
Identity Manual

Solutions

Proficiency Testing
Internal Control
Metricare
Reference Strains
Certified Reference Materials
Calibration of Instruments
Segments

Segments

Clinical
Hemotherapy
Veterinary
Microbiology
Physicochemical

Support

Central de AjudaHelp Center

Phone+55 21 3891-9900
+55 21 3613-5200

WhatsApp+55 21 98258-0074

Emailcontact@controllab.com

Emergency PhoneControllab Emergency

+55 21 98036-1592

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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.

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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.

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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.

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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.

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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.
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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.

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ANVISA/REBLAS Qualification

Proficiency Test Provider
In August 2001, Controllab was qualified by ANVISA/REBLAS as a Proficiency Test Provider for clinical tests, hemotherapy and human milk, under registration number PROFI 001. In 2012 this qualification was renewed, within a new policy of agency, under registration nº REBLAS 23.
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REBLAS - Nº23 - Controllab - Laboratório Habilitado ANVISA
According to the scope published in www.anvisa.gov.br
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