Quality Policy

 

The commitment of Aragogamma S.L. is the treatment by Cobalt-60 ionizing radiation, in accordance with ISO 11137 standard, of medical, pharmaceutical, cosmetic, and food products under the highest quality standards that satisfy our customers' requirements, as well as applicable legal and regulatory requirements, through continuous improvement of the effectiveness of the implemented Quality Management System.

Furthermore, Aragogamma S.L. is committed to environmental protection, minimizing the environmental impact of its activities through sustainable use of the organization's resources.

Aragogamma S.L. is certified in accordance with international standards.

  • UNE EN ISO 13485:2018 Medical Devices. Quality Management Systems

  • NCF (GMP's): Good Manufacturing Practices for medicinal products for human and veterinary use.

Likewise, it complies with the guidelines of the Nuclear Safety Council (CSN), holds authorization for irradiation of condiments and plant spices in accordance with the authorization of RSIPAC "Health Registry of Food Industries and Products of Catalonia" and is registered with the FDA for Medical Devices and Medicines.

The commitment of Aragogamma S.L. goes beyond adherence to internationally recognized standards and extends throughout the entire company, as it has highly trained personnel who are aware at all times of the importance and impact of the process on treated products.

It is the responsibility of the Senior Management of Aragogamma S.L. to achieve the following objectives, only possible through the commitment and participation of the organization's personnel at all levels.

  • The protection of workers' health and well-being for the prevention of accidents and occupational diseases.

  • The dissemination of Occupational Risk Prevention at all levels and activities of the organization.

  • Cooperation with public entities, administrations, and other interested parties in environmental and safety actions.

  • The selection and control of quality suppliers.

  • Process management of the company's activities.

  • Continuous monitoring of customer feedback as a fundamental tool for improving our service.

  • Maintain proper data management within the Quality Management System and good documentation practices, ensuring their integrity throughout their lifecycle, regardless of the format and medium in which they were generated.

  • A continuous training program for all company personnel, and ensure that this policy is understood, implemented, and maintained.

All personnel of the organization maintain conduct that is respectful of both the standards and ethical values defined in the Criminal Compliance Policy.

The company's Management establishes measurable quality objectives consistent with the quality policy, including those necessary to comply with product treatment requirements, which, together with this policy, are periodically reviewed and analyzed in the Quality Management System Review.

Barcelona, December 18, 2025

Xavier Aragó Fonts
General Manager Aragogamma S.L.