Sistemas de garantia de calidad

sistgarcal gmp transparente Biocientífica S.A. complies with the Good Manufacturing and Control Practices (GMP) quality system, which helps ensure that the industrial products and processes are safe and effective for their intended use. GMP regulation is a mandatory practice in Argentina. Biocientífica manufactures under the GMP directives of the National Administration of Medicines, Food and Medical Technology (ANMAT) since 1997, and is subject to periodical audits from this healthcare governmental body.

In October 2003 Biocientífica obtained the approval for CE marking for almost all manufactured products in accordance with quality standards of the European Community. The regulation became mandatory as of December 6, 2003. The company appointed Medical Technology Promedt Consulting GmbH (St. Ingbert, Germany) as its Authorized Representative in Europe for certification and regulatory affairs in the European Community.

9001 13485 eng bw transparente

On November 2004 Biocientifica's Quality Management System was certified to the ISO 9001:2000 standard and further updated to ISO 9001:2008 version on January 2011. In turn, the Quality Management System was certified in January 2011 to the ISO 13485:2003 standard and a few years later, on January 2014, was updated to the NS-EN ISO 13485:2012/ISO13485:2003 version.

Our Quality Management System’s scope covers the design, manufacture, dispensing and assembling of in vitro clinical diagnostics and research products, as well as the distribution and sale of products and equipment for in vitro clinical diagnosis diagnostics and research products, equipment and spare components for the laboratory and technical service.

As it was for almost thirty years, Biocientífica reaffirms once again its commitment to provide customers with quality products, complying with regulatory requirements and international standards of management, in addition to providing adequate service for technical advice and assuming a commitment to continuous quality improvement, maintaining the effectiveness of the Quality Management System.