Controllab’s Excellence Standard certified by ISQua, a global reference in healthcare

Controllab’s Excellence Standard certified by ISQua, a global reference in healthcare

Controllab’s Excellence Standard certified by ISQua, a global reference in healthcare

Norma de Excelência da Controllab é certificada pela ISQua, referência mundial em acreditação em saúde

International recognition highlights the company’s commitment to quality in accordance with the highest standards.

Controllab, the leader in laboratory quality control in Latin America, celebrates the international recognition by the world’s leading accreditation organization for healthcare services, ISQua – International Society for Quality in Health Care.

The excellence standard of Controllab’s International Clinical Laboratories Accreditation Program (ICLAP) has been accredited by ISQua’s External Evaluation Association (ISQuaEEA).

ISQua is a non-profit organization working to improve the quality of healthcare worldwide. Operating in over 70 countries across six continents, ISQua conducts rigorous and independent evaluations of accreditation programs, ensuring they meet the highest international standards.

Achieving this recognition in a record time of 12 months and being among the leading Brazilian institutions to have its standard accredited by ISQuaEEA is a victory not only for Controllab but for the entire healthcare ecosystem. This accreditation validates how our commitment to excellence in quality, safety, and innovation in healthcare services aligns with the best international practices, says Fernando Berlitz, accreditation and indicators manager at Controllab.

ISQua recognition and Controllab excellence

With several accreditations in its portfolio, including ISO 9001, 17025, 17034, and 17043, Controllab demonstrates its continuous commitment to quality and excellence. The accreditation of ICLAP’s normative standard by ISQuaEAA not only validates the excellence and robustness of its accreditation program but also enables Controllab to extend its expertise, certifying other healthcare establishments and raising global quality standards in clinical laboratories.

For laboratories certified by Controllab’s accreditation program, this means their management system is evaluated and accredited by a normative standard recognized by the world’s leading authority in patient safety and healthcare quality.

Understanding Laboratory Accreditation

Laboratory accreditation is a process that evaluates and certifies a laboratory’s technical competence and compliance with quality standards. This process is essential to ensure that laboratories have management aligned with international best practices and contribute to the excellence of services offered to patients and physicians. The endorsement of a healthcare organization through ISQua’s accreditation seal is recognition that the accrediting institution meets rigorous internationally required standards.

About Controllab’s Accreditation Program

The International Clinical Laboratories Accreditation Program (ICLAP) is an innovative initiative that establishes a streamlined yet robust and effective accreditation standard for clinical laboratories. Developed based on international best practices in Laboratory Medicine and utilizing objective evidence through performance indicators, ICLAP comprehensively addresses all relevant aspects of quality in laboratories.

The ICLAP’s excellence level standard, known as the “Clinical Laboratories Excellence Standards” (CLES), adopts ISQua’s standard guidelines as the prevailing model and covers the essential requirements for clinical laboratories to demonstrate a quality management system focused on continuous improvement and patient safety.

The CLES standard aims to promote excellence holistically in healthcare, contributing to clinical laboratories offering high-quality services with a continuous focus on process improvement and patient-centered care, emphasizes Berlitz.

International presence

The ICLAP program has an international presence, promoting Controllab’s commitment to spreading quality globally. In Brazil, the company supports the Brazilian Society of Clinical Pathology and Laboratory Medicine – SBPC/ML, in the Clinical Laboratories Accreditation Program (PALC).

The accreditation of ICLAP’s normative standard by ISQua is a milestone that strengthens Controllab as a reference in quality within the segment, driving excellence standards for the benefit of the population and global health.

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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.

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).

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.

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).

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.

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).