Company

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 40-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.

empresa nos somos controllab solucoes 1
empresa nos somos controllab

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

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 test provider; Accreditation as a Cgcre/Inmetro calibration laboratory; 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

Availability of digitalized tests; Quality control for testing laboratories.

2013-2014

Accreditation as a CRM producer by Cgcre/Inmetro; Expansion and internationalization of the Benchmarking and Laboratory Indicators Program.

2015-2016

Accreditation as a CRM producer by Cgcre/Inmetro; Expansion and internationalization of the Benchmarking and Laboratory Indicators Program.

2017-2019

International Expansion; Partnership with the British Ministry of Health (PHE); Partnership with LIS companies; Launch of CI ONLINE and Analytical Quality Management Software;

Vinicius

Vinícius Biasoli

Controllab Executive Director

Structure

The Controllab team is formed by a team with more than 300 direct employees, allied to an extensive scope of technical-scientific advisors who maintain their commitment to updating, innovation and the quality of services. Installed in Rio de Janeiro, in approximately 10,000 m2 of built area, Controllab is divided into two structures:

Preparation of Materials

Designed to comply with Good Manufacturing Practices for items for Proficiency Test, Internal Control, Reference Materials and Control Strains. It has areas of chemical and biological production, quality control laboratory, sterilization areas, cold chambers and freeze dryers.

Services

It encompasses all sectors involved in the proficiency test, calibration, advisory, training and business administration management process. Among them, Customer Management, Quality Assurance, Service and Project Management, Information Technology, Marketing and New Business.

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 references 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

+40 years

of history
and performance

+3500 tests

analyzed
periodically

04 accreditations

recognized
internationally

+15 years

of accreditations
Cgcre/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

Continuous improvement, based on quality and reliability, provides Controllab with the following recognitions:

click on each of the stamps to view the scopes and get more details

According to the scopes published in www.gov.br/inmetro

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

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.

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.

A Controllab não é avaliadora e nem acreditadora da Garantia da Qualidade do laboratório. O Ensaio de Proficiência, também conhecido como Controle Externo da Qualidade, se aplicado e seguido corretamente, insere qualidade nos processos de análises.

How can we help you?

LOG IN

PEP 0003

Acreditação Cgcre/Inmetro - Laboratório de Controle

Em setembro de 2011, a Controllab foi acreditada pela Coordenação Geral de Acreditação (CGCRE) do Inmetro como provedor de ensaio de proficiência, sob o nºPEP0003. Inicialmente dentro de um projeto piloto do Inmetro, esta acreditação baseou-se na ILAC G13: 2007 e incluiu diversos ensaios clínicos e de hemoterapia. Nas avaliações periódicas desta acreditação novos segmentos e ensaios são incluídos e a avaliação passa a ser conduzida segundo a ABNT NBR ISO/IEC 17043.

Esta acreditação atesta a competência técnica da Controllab em desenvolver e conduzir ensaios de proficiência conforme requisitos internacionais e a habilita reconhecida em outros países, conforme acordos de reconhecimento mútuo firmados pelo Brasil no Mercosul, Américas e Europa.

CRL 0586

Acreditação Cgcre/Inmetro - Laboratório de Controle

Em dezembro de 2012, o Laboratório de Controle, responsável pelas análises de controle de processo e controle de qualidade dos materiais preparados pela Controllab para atender ao Ensaio de Proficiência e Controle Interno foi acreditado pela Coordenação Geral de Acreditação (CGCRE) do Inmetro, tornando-se parte integrante da rede brasileira de laboratórios acreditados, sob o nº 0586.

O selo do Inmetro atesta competência técnica, credibilidade e capacidade operacional da Controllab para a realização de ensaios, conforme requisitos da ABNT NBR ISO/IEC 17025.

CAL 0214

Acreditação Cgcre/Inmetro - Laboratório de Calibração

Em dezembro de 2002, o Laboratório de Calibração foi acreditado pela Coordenação Geral de Acreditação (CGCRE) do Inmetro. Com esse reconhecimento, tornou-se parte integrante da rede brasileira de laboratórios acreditados, sob o nº214. Desde então, é avaliado periodicamente para a manutenção e/ou extensão da acreditação.

O selo do Inmetro atesta competência técnica, credibilidade e capacidade operacional da Controllab para os serviços de calibração, conforme requisitos da ABNT NBR ISO/IEC 17025.

PRM 0009

Acreditação Cgcre/Inmetro - Produtor de Material de Referência Certificado

A Controllab é acreditada como Produtor de Material de Referência Certificado (MRC) desde 2016 pela Coordenação Geral de Acreditação (CGCRE), do Inmetro, sob o n.º PMR 0009. A avaliação dessa conformidade é realizada conforme os requisitos estabelecidos nas normas ABNT NBR ISO 17034 e Inmetro, garantindo assim a competência para a produção dos MRC, conforme Escopo de Acreditação.

Esta acreditação atesta a competência técnica da Controllab em produzir MRC, conforme requisitos internacionais e a habilita para ser reconhecida em outros países, conforme acordos de reconhecimento mútuo, estreitando as barreiras técnicas entre o Brasil e os outros países dos Continentes.

Habilitação ANVISA/REBLAS

Provedor de Ensaio de Proficiência

Em agosto de 2001, a Controllab foi habilitada pela ANVISA/REBLAS como Provedor de Ensaio de Proficiência para ensaios clínicos, de hemoterapia e de leite humano, sob o registro nº PROFI 001. Em 2021 esta habilitação se renovou, dentro de uma nova política da agência, sob o registro nº REBLAS 23.

A Controllab foi novamente reconhecido pelo Ministério da Saúde, por meio do processo de Habilitação da Rede Brasileira de Laboratórios Analíticos em Saúde, como Laboratório Analítico para Controle de Qualidade em análises de Hemoderivados, sob o registro REBLAS 023, conforme disposto na RDC nº 390 de 26 de maio de 2020.

A ANVISA é uma agência regulamentadora vinculada ao Ministério da Saúde, que tem a missão de proteger e promover a saúde, garantindo a segurança sanitária de produtos e serviços. A REBLAS – Rede Brasileira de Laboratórios Analíticos em Saúde está dentro da estrutura ANVISA.

De acordo com o escopo publicado em www.anvisa.gov.br

Certificado ISO 9001

Em junho de 2003, a Controllab teve seu sistema de gestão da qualidade certificado na ABNT NBR ISO 9001 pela Bureau Veritas/Inmetro (âmbito nacional) e Bureau Veritas/UKAS (âmbito internacional), como “provedor de ensaio de proficiência em ensaios clínicos, fisico-químicos e microbiológicos”. Desde então, é avaliada periodicamente para manutenção e/ou revalidação da certificação.

Certificado BPF/ANVISA

Materiais para controle de qualidade

Em outubro de 2012, a Controllab recebeu a certificação de Boas Práticas de Fabricação de produtos para saúde, para as classes de risco I e II, concedida pela Anvisa, e em novembro de 2018 para as classes de risco III e IV, mediante a Resolução RE n.º 4.023, publicada no DOU de 06/10/2020, suplemento, relativa à produção de produtos para saúde para fins de controle de qualidade de laboratórios.

Esse processo de certificação é voluntário e conduzido conforme requisitos da Resolução RDC n.º 16, de 28 de março de 2013 (BPF para produtos para diagnóstico para uso in vitro), frente a qual a Controllab é inspecionada periodicamente (como correlata), pela Vigilância Sanitária para verificação das boas práticas de fabricação.

A ANVISA é uma agência regulamentadora vinculada ao Ministério da Saúde do Brasil, que tem a missão de proteger e promover a saúde, garantindo a segurança sanitária de produtos e serviços. Embora o registro junto a Anvisa não se aplique aos materiais da Controllab (RDC n.º 36/2015, Artigo 2º, Parágrafo Único, I), a certificação em BPF é aberta.

PEP 0003

Accreditation Cgcre/Inmetro - Control Laboratory

In September 2011, Controllab was accredited by Inmetro’s General Coordination for Accreditation (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.

CRL 0586

Accreditation Cgcre/Inmetro - Control Laboratory

In December 2012, the Control Laboratory, responsible for the analysis of process control and quality control of the materials prepared by Controllab to meet the Proficiency Test and Internal Control, was accredited by Inmetro’s General Coordination for Accreditation (CGCRE), becoming if part of the Brazilian network of accredited laboratories, under Nº 0586.

CAL 0214

Accreditation Cgcre/Inmetro - Calibration Laboratory

In December 2002, the Calibration Laboratory was accredited by Inmetro’s General Coordination for Accreditation (CGCRE). With this recognition, it became an integral part of the Brazilian network of accredited laboratories, under nº214. Since then, it is periodically evaluated for the maintenance and/or extension of accreditation.

PRM 0009

Accreditation Cgcre/Inmetro - Certified Reference Material Producer

Controllab has been accredited as a Certified Reference Material Producer (MRC) since 2016 by Inmetro’s General Coordination for Accreditation (CGCRE), under the PMR 0009 number. The assessment of this conformity is carried out according to the requirements established in ABNT NBR standards ISO 17034 and Inmetro, thus ensuring competence for the production of MRCs, according to the Scope of Accreditation.

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.

Controllab was once again recognized by the Ministry of Health, through the Qualification process of the Brazilian Network of Analytical Laboratories in Health, as an Analytical Laboratory for Quality Control in Blood Derivatives analysis, under registration REBLAS 023, as provided for in RDC No. 390 of May 26th, 2020.

ANVISA is a regulatory agency linked to the Ministry of Health, whose mission is to protect and promote health, ensuring the sanitary safety of products and services. REBLAS – Brazilian Network of Analytical Laboratories in Health is part of the ANVISA structure.

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

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.

BPF/ANVISA Certificate

Quality control materials

In October 2012, Controllab received the certification of Good Manufacturing Practices for health products, for risk classes I and II, granted by Anvisa, and in November, 2018 for risk classes III and IV, through Resolution RE n.º 4,023, published in the DOU of 06/10/2020, supplement, related to the production of health products for the purpose of laboratory quality control.

This certification process is voluntary and conducted according to the requirements of Resolution RDC n.º 16, of March 28, 2013 (GMP for diagnostic products for in vitro use), against which Controllab is periodically inspected (as a correlate), by Health 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, guaranteeing 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.

acesso ao sitema

Estamos enfrentando alguns problemas de acesso ao sistema, pedimos a compreensão de todos. Tente novamente em alguns minutos.

COOKIES NOTICE

We use cookies and other similar technologies to improve your experience, enabling a more personalized navigation, according to the characteristics and your interest.

For more information see our Privacy and Security Policy.