Quality

GENOMICA satisfies the requirements of its customers, employees and other interested parties, maintaining quality standards and complying with the legal requirements established both in the European Union Directive 98/79/EC and in the applicable Royal Decrees in force.

At international level, GENOMICA complies with the legal requirements demanded in the countries where it distributes its products, which has allowed it to obtain the GMP certifications issued by ANVISA and KFDA.

Currently, GENOMICA is immersed in the process of adaptation to Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices of the European Union, which will come into force in 2022.

In addition, the company has ISO 9001:2015 certifications for all its activities and ISO 13485:2016, specific for in vitro diagnostic medical devices, so the diagnostic kits marketed by GENOMICA offer an additional quality guarantee that affects both their design and development and their manufacture, distribution and marketing.

As for the genetic identification service, GENOMICA has since 2005 the ENAC (National Accreditation Entity) accreditation according to the ISO/IEC 17025:2017 standard which guarantees the quality of all the services provided.

Compliance with legislation

GENOMICA has adapted all its processes to achieve compliance with the legislation applicable to the activity developed by the company both in the field of in vitro diagnostic medical devices and genetic identification services.

In terms of data protection, GENOMICA has defined the control and security measures that guarantee the rights and freedoms of data subjects in accordance with Regulation (EU) 2016/679 (GDPR), with the aim that the processing of data respects the privacy requirements associated with the level of risk to which it is exposed. All this, allows the establishment of a data protection management system that guarantees the safeguarding of the rights and freedoms of data subjects.

Independence, integrity and impartiality

GENOMICA establishes competences independent from the rest of the organization in all matters concerning technical direction, management, administration, purchasing, marketing and experimental techniques.

All personnel, whether internal or external, are committed to impartiality in the judgments made during the services rendered, which allows the company’s activities to be managed ethically and responsibly.

All GENOMICA employees must be aware of the influence of their personal work on the quality of products and services. The Management must be exemplary and it is its obligation to provide the necessary means and training so that both individual and team work ensures continuous improvement. It is also responsible for providing and maintaining the working environment necessary for the proper functioning of the processes in accordance with the Law on Prevention of Occupational Hazards.

GENOMICA employs a process risk assessment methodology whose main purpose is to prevent possible deviations of the quality management system, as well as fairness and integrity. Management is responsible for ensuring the alignment of the company’s context with the risk management objectives.

The Quality Management System defines the tools and processes necessary for its own review and improvement. Clear and achievable quality objectives are formulated annually and communicated in conjunction with the company’s strategy.

The Quality Manager and the General Manager are primarily responsible for fostering GENOMICA’s quality culture, as well as for the continuous improvement of products and services and customer satisfaction.