A new world tendency is revolutionizing the excellence pattern of services and products offered to the population.
Each time more the national institutions have to update and modernize their installations, if they want to keep up with the speed of the transformations, which are happening on the market. In the diagnostic segment, the situation isn’t different. After all, each day technologies and last-generation resources come up to make the routine of the clinical laboratories more dynamic. However, the implantation of advanced systems is only one of the points to grant quality. Another very important aspect is the staff training, standardization of all processes and utilization of reliable materials.
For a better management of this group of actions it was created, on September 18, 1998, ABNT/CB-36 – Brazilian Committee of Clinical Analyses and in vitro Diagnosis, official and exclusive representative of ISO in Brazil, including ISO/TC 212. According to the former president of the Brazilian Society of Clinical Analyses (SBAC) and former superintendent of ABNT/CB-36, Dr. Humberto Marques Tibúrcio, certification is the only way for the continuous improvement of the quality of the clinical laboratories and manufacturers of products for in vitro diagnosis. This conquest permits that community has access to more efficient and precise services.
To elaborate the Technical Norms of the sector, the committee has an efficient organizational structure. The Executive Secretariat is responsibility of SBAC which, after fulfilling the demands of ABNT (Brazilian Association of Technical Norms ), signed the contract to provide the conditions of personnel, installations and infrastructure necessary to its functioning. Concerning this, SBAC has been adopting a series of measures to increase the level of the services in the country. In the Quality Control project, it is introducing new materials and adapting its software to implement personalization and adoption of bar codes, as a tool to make reliability better and faster. Continuous education is another incentive item. Because of this, the regionals and Delegacies are giving courses in order to keep its members and other interested people updated.
Quality diffusion is made through the National Program of Quality Control (PNCQ), the courses and the Brazilian Congress of Clinical Analyses (CBAC), in which a course of the Quality Control is given, free to all participating laboratories of PNCQ, besides a conference and a round table giving emphasis to the same subject.
Besides the decisive role of SBAC, a Work Group (WG) and three Sub-Committees (SC) were constituted, fulfilling the aim of ISO/TC 212. Each one of them has a coordinator, appointed by the present superintendent of ABNT/CB-36, Dr. Luiz Fernando Barcelos.
The SC.36.01 – Quality Management in the Clinical Laboratory – is coordinated by Dr. José Abol Corrêa, representing PNCQ and answering for the sectorial normalization for the quality management.
The SC.36.02 – Reference Systems – is being coordinated by Dr. Cristóvão Luis P. Mangueira, representing Hospital Albert Einstein and acting with the normalization of reference systems for the clinical laboratory.
The SC.36.03 – In vitro Diagnosis – is coordinated by Prof. Mateus Mandu de Souza, also representing PNCQ and working with the normalization for the products of in vitro diagnosis. With the purpose of giving support to ABNT/CB-36 it was created a Work Group (WG), WG.36.01, Glossary of ABNT/CB-36, under the responsibility of Prof. João Ciribelli Guimarães, representing SBAC. Its function is to elaborate, keep and spread the terminology used for the preparation of the Quality Norms, Technical Norms and Technical Reports.
People interested in participating in one or more committees should get in touch with the Executive Secretariat soliciting the sending of the registration card.
NBR 14500:2000
QUALITY MANAGEMENT IN THE CLINICAL LABORATORY .NBR 14501:2001GLOSSARY OF TERMS TO BE USED IN THE CLINICAL LABORATORY AND IN THE IN VITRO DIAGNOSIS. (CANCELLED AND REPLACED BY NBR NM 305:2006)
NBR 14711:2001
IN VITRO DIAGNOSIS – RECOMMENDATIONS AND CRITERIA FOR ACQUISITION, RECEIVING, TRANSPORTATION AND STORAGE OF PRODUCTS.
NBR 14785:2001
CLINICAL LABORATORY – SAFETY REQUIREMENTS.
NBR 14864:2002
IN VITRO DIAGNOSIS – PROCEDURES FOR REAGENT VALIDATION OR DIAGNOSIS SYSTEMS.
NBR 14866:2002
CLINICAL LABORATORY – QUANTITY MEASUREMENT IN SAMPLE OF BIOLOGICAL ORIGIN – VALUE METROLOGICAL TRACEABILITY FOR ENZYME CATALYTIC CONCENTRATION REFERRED TO CALIBRATORS AND CONTROL MATERIALS.
NBR 15051:2004
CLINICAL LABORATORY – RESIDUE MANAGEMENT.
NBR 15268:2005
CLINICAL LABORATORY – REQUIREMENTS AND RECOMMENDATIONS FOR URINE TEST
NBR 15340:2006
CLINICAL LABORATORY – PARASITOLOGIC FECES TESTS
Get in touch with the secretariat of the Brazilian Committee of Clinical Analyses and In Vitro Diagnosis and find out how to get them.
