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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.

            empresa nos somos controllab
            empresa nos somos controllab solucoes 1

            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 calibration laboratory by Inmetro’s Cgcre; 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 Inmetro's 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 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).

            Vinicius

            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.

            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

            years of history
            and expertise

            +3500 tests

            tests for your laboratory's
            quality control

            04 internationally

            recognized
            accreditations

            +20 years

            accredited by
            Inmetro’s Cgcre

            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

            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

            ISO 9001 BUREAU VERITAS Certification

            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

            Controllab Branding Guidelines

            CAPA Manual de Identidade e Uso da Marca Controllab EXTERNO EN 1

            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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            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

                      Acreditação Cgcre/Inmetro - Provedor de Ensaio de Proficiência

                      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.

                      visualizar certificado
                      acessar escopo acreditado
                      Ensaio de Proficiência - PEP 0003 - ABNT NBR ISO/IEC 17043 - Controllab

                      A Cgcre é signatária dos Acordos de Reconhecimento Mútuo da International Laboratory Accreditation Cooperation (ILAC) e da Interamerican Accreditation Cooperation (IAAC)

                      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.

                      visualizar certificado
                      acessar escopo acreditado
                      Ensaios - CRL 0586 - NBR ISO/IEC 17025 - Controllab

                      A Cgcre é signatária dos Acordos de Reconhecimento Mútuo da International Laboratory Accreditation Cooperation (ILAC) e da Interamerican Accreditation Cooperation (IAAC)

                      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.

                      visualizar certificado
                      acessar escopo acreditado - RBC/Cgcre/Inmetro - Físico-Químico
                      acessar escopo acreditado - RBC/Cgcre/Inmetro – Massa
                      acessar escopo acreditado - RBC/Cgcre/Inmetro - Volume e Massa Específica
                      acessar escopo acreditado - RBC/Cgcre/Inmetro – Pressão
                      acessar escopo acreditado - RBC/Cgcre/Inmetro – Temperatura
                      Calibração de Instrumentos - CAL 0214 - ABNT NBR ISO/IEC 17025 - Controllab

                      A Cgcre é signatária dos Acordos de Reconhecimento Mútuo da International Laboratory Accreditation Cooperation (ILAC) e da Interamerican Accreditation Cooperation (IAAC)

                      PMR 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.

                      visualizar certificado
                      acessar escopo acreditado
                      Materiais de Referência Certificados - PMR 0009 - ABNT NBR ISO 17034-Controllab

                      A Cgcre é signatária dos Acordos de Reconhecimento Mútuo da International Laboratory Accreditation Cooperation (ILAC) e da Interamerican Accreditation Cooperation (IAAC)

                      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 2012 esta habilitação se renovou, dentro de uma nova política da agência, sob o registro nº REBLAS 23.

                      Esse processo de habilitação voluntário é conduzido conforme requisitos da ABNT NBR ISO/IEC 17043, de portarias vigentes, Critérios da ANVISA, critérios da Cgcre/INMETRO e outros protocolos internacionais. Seu objetivo é garantir a confiabilidade técnica do provedor, cujos serviços são amplamente usados em processos de avaliação e comprovação de qualidade de laboratórios clínicos.

                      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.

                      acessar habilitação - doc. 01
                      acessar habilitação - doc. 02
                      REBLAS - Nº23 - Controllab - Laboratório Habilitado 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.

                      acessar certificado Bereau Veritas/ukas
                      acessar certificado Bereau Veritas/inmetro

                      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, concedida pela Anvisa. Essa certificação é relativa à produção de produtos para saúde para fins de controle de qualidade de laboratórios.

                      O processo de certificação é voluntário e conduzido conforme requisitos da Resolução RDC n.º 665 de 30 de março de 2022 (BPF para produtos para diagnóstico para uso in vitro). Durante o processo, 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.

                      acessar certificação

                      PEP 0003

                      Accreditation Cgcre/Inmetro - Proficiency Test Provider

                      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.

                      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

                      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.
                      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

                      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.

                      view certificate
                      access accredited scope - RBC/Cgcre/Inmetro - Physical-Chemical
                      access accredited scope - RBC/Cgcre/Inmetro - Massa
                      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

                      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.
                      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).

                      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.
                      access qualification (doc. 01)
                      access qualification (doc. 02)
                      REBLAS - Nº23 - Controllab - Laboratório Habilitado ANVISA
                      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.
                      access Bureau Veritas/ukas certificate
                      access Bureau Veritas/inmetro certificate

                      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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