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QUALITY MANAGEMENT SYSTEM

Master Diagnóstica is a company focused on research, development, production and, marketing of research and diagnostic products for public and private clinical laboratories. There is also a Clinical Laboratory of Pathology (Laboratory).

 

The Management is committed to continuously improve the quality prioritizing the needs and expectations of its clients and to share this responsibility with all employees. This results in the implementation and maintenance of a Quality Management System according to prestigious international standards.


Policy on wich our management system is based, as well as the R+D Vision and Strategy of the Company, is available to all interested parties who request it.

ACCREDITATIONS / CERTIFICATIONS

 

ACCREDITATION ENAC ISO 15189

The Clinical Laboratory of Pathology in Master Diagnóstica has the ACCREDITATION 1112/LE2161 by the Spanish accreditation service ENAC (Entidad Nacional de Acreditación) in compliance with the requirements of the standard ISO 15189 (Medical Laboratories. Requirements for quality and competence) for carrying out the assays included in the TECHNICAL ANNEX. This accreditation confirms our technical competence to issue reliable results and reinforce our commitment to quality. Our target is to continue working to expand the scope of the obtained accreditation.

 

CERTIFICATION ISO 13485  - MEDICAL DEVICES

Scope: Design, development, production, and commercialization of antibodies, detection kits for immunohistochemistry and in situ hibridization, molecular diagnostic systems, staining solutions, and auxiliary products for clinical and research laboratories. Download Certificate.


CERTIFICATION ISO 9001 – QUALITY MANAGEMENT SYSTEM

Scope: Design, development, production and commercialization of antibodies, detection kits for immunohistochemistry and In Situ hibridization, molecular diagnostic systems, staining solutions and auxiliary products for clinical and research laboratories. Download Certificate.

 

CERTIFICATION UNE 166002 – R&D MANAGEMENT

Scope: R&D in Molecular Diagnostic Systems.

Download Certificate