Integrated Management System
OMNILOY operates an Integrated Management System that brings together the following management systems:
- Quality Management System, covering the following activities:
- Development of Artificial Intelligence software
- Environmental Management System, covering the following activities:
- Development of Artificial Intelligence software
- Medical Device Quality Management System, covering the following activities:
- Development of Artificial Intelligence software for clinical environments
- Artificial Intelligence Management System, covering the following activities:
- Development, deployment and responsible use of Artificial Intelligence systems
Business Scope
Our business development focuses on the national and international markets, primarily Latin America and emerging markets.
Our Policy serves as a reference framework for the entire Organisation in order to satisfy customer needs, improve the Environment, increase information security, support legal compliance, and all of this by establishing improvement objectives within the Integrated Management System aligned with our organisation's strategic direction.
Organisation and Management Commitments
The organisation and its management commit to:
- Ensure that the development of our activity takes into account:
- Both the context of the Organisation and its stakeholders.
- The nature, scale and environmental impact of our activities, for both products and services.
- The protection and security of information in order to preserve its Confidentiality, Integrity, Traceability, Authenticity and Availability.
- Comply with legal requirements and other requirements in all areas of our activity: Quality of products and services, Environmental responsibility, Information Security and, with special attention, the protection of personal data within the limits set by the applicable legislation and, specifically, by the requirements of Regulation (EU) 2016/679 of the European Parliament.
- The legal and regulatory requirements for medical devices, including Regulation (EU) 2017/745 and current standards, minimising risks and ensuring the safety of users and patients.
- The responsible management of artificial intelligence ensuring transparency, ethics, safety and risk mitigation in the development and use of AI systems.
- Protect the Environment, including the prevention of pollution, taking into account other commitments adopted.
- Ensure the effectiveness of the Integrated Management System through review and continuous improvement, in order to optimise the performance, security and regulatory compliance of processes.
- Develop, deploy and maintain the Integrated Management System in accordance with the reference standards ISO 9001:2015, ISO 14001:2015, ISO/IEC 27001:2022, ISO 13485:2018 and ISO 42001:2023 in order to ensure:
- That agreements reached with customers are clear, transparent and well-documented.
- That the projects carried out comply with the agreements reached.
- That the products or services supplied by providers that affect the Integrated Management System are compliant.
- Integration of risk management throughout the lifecycle of products and services, guaranteeing the safety of the end user.
- Foster a culture of quality, responsibility and continuous improvement at all levels of the organisation.
- The competence of the people who participate in the various processes.
- That processes are controlled, standardised, properly documented and compliant.
- That, in the event of any non-conformity, it will be controlled and resolved as quickly and effectively as possible.
- That the services supplied by providers and external collaborators that affect the system are efficient and compliant with our requirements and those of the customer.
Commitment to Our Teams
The Organisation considers its teams to be its most relevant asset, and therefore aims for them to:
- Participate proactively in the processes of the Integrated Management System.
- Be able to develop their activity in the best work environment and with equal opportunities.
- Minimise errors and environmental impact in the development of their processes.
- Exceed customer expectations by offering excellent, timely, friendly and professional service, ensuring product and service quality, patient safety in medical devices, the preservation of information security, environmental protection and the responsible management of Artificial Intelligence.