Legal

Organisation Policy

Last updated: 21 October 2026 · Revision 2.2

Integrated Management System

OMNILOY has an Integrated Management System that integrateds the following management systems:

  • Quality Management System.
  • Environmental Management System.
  • Medical Device Quality Management System.
  • Artificial Intelligence Management System.
  • National Security Framework (ENS).
  • Compliance with the EMAS Regulation.

Business Scope

Our business development focuses on both national and international markets, primarily Latin America and emerging markets.

Our Policy serves as a reference framework for the entire organization with the aim of meeting customer needs, improving environmental performance, enhancing Information Security, managing Artificial Intelligence responsibly, ensuring legal compliance, and establishing continuous improvement objectives within the Integrated Management System aligned with our organization’s strategic direction.

Organisation and Management Commitments

The organization and its management are committed to:

  • Ensuring that the following aspects are considered in the development of its activities:
    • Both the organizational context and the needs and expectations of interested parties.
    • The nature, scale, and environmental impacts of its activities, products, and services.
    • The protection and security of information in order to preserve its Confidentiality, Integrity, Traceability, Authenticity, and Availability.
  • Complying with legal and other applicable requirements in all areas of its activities, including:
    • The quality of products and services.
    • Environmental protection and respect.
    • Information Security and the protection of personal data in accordance with Regulation (EU) 2016/679 (GDPR).
    • Legal and regulatory requirements for medical devices, including Regulation (EU) 2017/745 and applicable standards, minimizing risks and ensuring the safety of users and patients.
    • The responsible management of Artificial Intelligence, ensuring transparency, ethics, security, and risk mitigation in the development and use of AI systems.
  • Protecting the environment, including the prevention of pollution, taking into account other commitments undertaken.
  • Continuously improving our environmental performance beyond legal compliance by reducing the impact of our activities.
  • Ensuring the effectiveness of the Integrated Management System through ongoing review and continuous improvement, optimizing process performance, security, and regulatory compliance.
  • Developing, implementing, and maintaining the Integrated Management System in accordance with the requirements of ISO 9001:2015, ISO 14001:2015, ISO/IEC 27001:2022, ISO 13485:2016, ISO/IEC 42001:2023, and Regulation (EC) No. 1221/2009 (EMAS), ensuring:
    • Clarity, transparency, and documentation of agreements with customers.
    • Compliance of projects with agreed requirements.
    • Conformity of products and services supplied by providers may affect the Integrated Management System.
    • Integration of risk management throughout the lifecycle of products and services, ensuring end-user safety.
    • Competence of personnel involved in various processes.
    • Control, standardization, and documentation of processes to ensure compliance with the Integrated Management System.
    • Rapid and effective management of any potential nonconformity.
    • Effectiveness and compliance of services provided by suppliers and external collaborators.
  • Promoting a culture of quality, responsibility, and continuous improvement at all levels of the organization.
  • Communicating our environmental performance openly and transparently to interested parties, particularly through the Environmental Statement verified in accordance with EMAS.

Commitment to Our Teams

The Organization considers its people to be its most asset and therefore seeks to ensure:

  • Proactive participation in the processes of the Integrated Management System and in improving the organization’s environmental performance.
  • A safe and equitable working environment.
  • The minimization of errors and environmental impacts within processes.
  • The achievement and surpassing of customer expectations by delivering excellent, timely, courteous, professional service, while ensuring the quality of products and services, patient safety in medical devices, the preservation of Information Security, environmental protection, and the responsible management of Artificial Intelligence.