Proficiency Testing
EXCELLENCE IN CLINICAL ANALYSIS

Demonstrate the reliability of your results​

The Proficiency Testing (EP), also known as External Quality Control (EQC), is an effective quality control tool for determining the analytical performance of the laboratory and a necessary requirement for laboratory accreditation processes (ISO 15189, ISO 17025, PALC-SBPC/ML, DICQ-SBAC, etc.) and regulatory bodies.

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Standardize the analytical stage against the market

Assess the efficiency of internal control and ensure its suitability for specific methods

Evaluate and monitor the performance of laboratories in specific tests

Identify hits and compliance

Determine the performance characteristics of already established methods and/or new methods and technologies

Provide corrective/preventive actions

In summary, in addition to assessing technical quality, the Proficiency Testing is:

Mandatory by regulatory bodies

Accreditation process and bidding prerequisites

Requirements for accreditation with the main health insurers

Differential against to the competition

ACCREDITATIONS AND
RECOGNITIONS

Continuous improvement, based on quality and reliability, has given Controllab some recognition for the Proficiency Testing:

According to the scopes
published in www.inmetro.com.br

How can Proficiency Testing
help in your laboratory?

ASSIST THE LABORATORY ROUTINE

Assessments are continuous, with regular intervals, annual targets and multiple items in varying concentrations. These assessments are the result of statistical studies and analysis by experts, whose reports commonly point out errors, possible causes and considerations on the overall performance of the participants. These actions take place so that each one can compare their performance with the others, at the moment and over time.

MANAGE ANALYTICAL PERFORMANCE

Management information is dynamic and optimized, with indicators and graphs that facilitate the identification of the laboratory’s analytical performance and provide an agile and objective analysis of the tests that need immediate action.

SIMPLIFIES THE AUDIT PROCESSES

Controllab’s Proficiency Testing keeps track of performance on results. It provides a list with possible causes of non-conforming results and centralizes the information in the same environment, for management evolution and evidence in audits.

How it works?

Learn more about how Controllab Proficiency Testing works by clicking on the steps below.

How it works?

Learn more about how Controllab Proficiency Testing works by clicking on the steps below.

Service

Proficiency Testing with rounds at regular and continuous intervals, annual targets and multiple items with unknown results for analysis. Structured in ABNT NBR ISO/IEC 17043.

Participants

Organizations of different sizes compare their analysis with consolidated laboratories in analytical excellence.

Rounds

Sending samples that simulate routine testing. The laboratory reports the results online together with information from the analytical system for Controllab to perform the comparison and evaluation.

Evaluation

Comparison based on the most specific groups and limits applied according to statistical studies based on ABNT NBR 13528.

Reports

Individuals with the performance of the round and graphs of the Deviation Index and Z Index; global market with technical and marketing information and continuous performance over the period.

Management

Management center with summary of analytical performance and indicators to achieve the goals of excellence in analysis.

Promotion

Continuous participation is an investment in quality and can be disclosed through the registration certificate, disclosure seal and certificates of proficiency and participation.

 

Annually, the participating laboratory will receive the participation certificate and the Proficiency certificate for the tests that obtained continuous participation and that reached the minimum performance level.

The Clinical Proficiency Testing has the seal of the Brazilian Society of Clinical Pathology/Laboratory Medicine (SBPC/ML).

The veterinary program is supported by the Brazilian Society of Veterinary Medicine (SBMV).

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Solicite o Ensaio de Proficiência da Controllab e ganhe confiabilidade, qualidade e aprimore o desempenho analítico para o laboratório.

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.

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.

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.

Request Controllab's Proficiency Testing (EP) and gain reliability, quality and improve analytical performance for the laboratory.

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.

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.

This voluntary qualification process is conducted in accordance with the requirements of ABNT NBR ISO/IEC 17043, of current ordinances, ANVISA criteria, criteria of Cgcre/INMETRO and other international protocols. Its objective is to guarantee the technical reliability of the provider, whose services are widely used in the evaluation and quality assurance processes of clinical laboratories.

ANVISA is a regulatory agency linked to the Ministry of Health, whose mission is to protect and promote health, guaranteeing the health security of products and services. REBLAS – Brazilian Network of Health Analytical Laboratories is within the ANVISA structure.

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.

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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.