Biocross offers its customers high quality products, services and information. Biocross is certified as meeting the requirements of ISO 9001: 2015 and ISO 13485: 2016 for the activities of design, development and production of in vitro diagnostic (IVD) medical devices. These certifications assure that Biocross has established effective and reliable processes for the development, manufacturing, distribution and customer service of IVD medical devices. With these certifications, we establish a commitment with our clients, with our business and with all those who depend on and benefit from the use of Biocross´ products.

Likewise, Biocross has the installation license that allow us to manufacture IVD medical devices with CE marking. This certification mark guarantees that the products meets the essential requirements of European legislation on health, safety and environmental protection, as per European Directive 98/79/EC and its and RD 1662/2000, its Spanish equivalent.

Quality policy

BIOCROSS is dedicated to improving healthcare by providing high quality, safe, effective diagnostic products and ensuring compliance.

The Quality Policy is achieved through a commitment to quality and the continuing effectiveness of the Quality System to meet customer and regulatory requirements.

Management demonstrates its commitment to the Quality Policy and legal requirements by ensuring that Quality Policy is understood, implemented, communicated, and maintained at all levels of the organization.

The Quality Policy is deployed throughout the organization via the Quality System, operating procedures, quality system training, and management’s reinforcement of quality principles and practices.

Employees support the Quality Policy through compliant execution of quality system requirements; and as part of every employee’s responsibility is the continual improvement of quality systems and product quality to increase customer satisfaction.

ISO 9001:2015 and ISO 13485:2016 certification