Quality Policy of Genomcore

Mission and Objectives

The mission of Genomcore S.L. (hereinafter, the "Company") is to develop and provide advanced personalized health services and bio-health data management, guaranteeing the protection and confidentiality of our clients' personal and genetic data. The Company is committed to continuous innovation and the implementation of cutting-edge technologies to ensure the quality and safety of its services. In addition the Company is committed to designing, manufacturing, and delivering in vitro medical devices that improve the health and well-being of patients worldwide. Our dedication to excellence is driven by a commitment to quality, safety, and efficacy in all aspects of our operations, from initial design through to post-market surveillance.

Quality Commitments

Compliance with Regulations and Standards

We adhere to the highest industry standards and regulatory requirements to ensure the safety and reliability of our solutions and medical devices. This commitment is underscored by our strict compliance with, but not limited to:

• International Standards: UNE ISO/IEC 27001:2023, UNE-EN ISO/IEC 27017:2021, UNE-EN ISO/IEC 27018:2020; UNE-EN ISO 13485:2018 + A11: 2022; UNE-EN ISO 9001:2015 + A1:2024.
• National Regulations: Royal Decree 311/2022 - National Security Scheme.
• Data Protection and Information Services Legislation: General Data Protection Regulation (GDPR) - Regulation (EU) 2016/679; Organic Law on Data Protection and Guarantee of Digital Rights (LOPDGDD) - Organic Law 3/2018; LSSI - Law 34/2002 on information society services and electronic commerce.
• In vitro Medical Devices Regulation (IVDR): Regulation (EU) 2017/746.
• Artificial Intelligence Act: Regulation (EU) 2024/1689.
• Other Relevant Regulations: Specific health sector regulations and any other regulatory framework applicable to the management of personal and genetic data, including digital environments; Law 14/2007 on Biomedical Research; Law 41/2002 which regulates patient autonomy and the rights and obligations regarding clinical information and documentation.

Although these are the main applicable regulations, the complete register of reference regulations is available to interested parties upon specific request.

Leadership Commitment:

The leadership team at the Company is fully committed to maintain this Quality Policy, providing the resources necessary for its implementation, and ensuring that it is communicated, understood, implemented, and maintained at all levels of the organization.

In addition to the above mentioned, the Company will:

• Establish a Quality Committee to oversee, coordinate, and support the development, implementation, maintenance, and continual improvement of Genomcore's Integrated Quality Management System.
• Work with suppliers and subcontractors committed to the constant improvement of their product or service, ensuring both quality and competitive pricing.
• Have qualified employees who, along with appropriate technological resources, ensure the consistent quality of our services.
• Have the necessary tools to evaluate and understand the expectations of our customers and stakeholders, taking appropriate measures to achieve their full satisfaction with our work.
• Consider the evolution of the context applicable to the organization as input for system improvement.
• Ensure the protection of confidential information and the rights of customers.

The management will provide the necessary means for this Quality Policy to be understood, implemented, and kept up-to-date throughout the organization and stakeholders.

Customer Focus

The Company is also committed to understanding and meeting the expectations of customers, partners, and regulatory bodies, and ensuring the security, reliability, and usability of our health data solutions and in vitro medical devices (IVDs).

Continuous Improvement

Continuous improvement is a fundamental pillar of our quality policy. We are committed to continuously enhancing our Quality Management System, products, and processes through systematic reviews, employee development, customer insights, and performance analysis. Our objective is to not only meet but surpass customer expectations and regulatory requirements, driving innovation and excellence by:

• Implementing a risk-based approach to decision-making and operational planning.
• Encouraging innovation and technological advancements to improve efficiency and security.
• Regularly reviewing and enhancing our Quality and Information Security Management Systems.

Risk Management and Information Security

Risk management is at the core of our Quality Management System. We proactively identify, assess, and mitigate risks related to quality, security, and regulatory compliance, and throughout the manufactured in vitro medical devices' lifecycle. This approach allows us to:

• Ensure confidentiality, integrity, and availability of sensitive health data.
• Protect customer information and preventing unauthorized access or data breaches.
• Manufacture health solutions and IVDs safe for their intended use (our comprehensive approach to risk management related with IVDs is aligned with the principles of ISO 14971, integrating risk analysis into product design, development, and post-market activities).

Employee Engagement and Training

Our employees are the driving force behind our quality objectives. We cultivate a culture of excellence, integrity, and accountability, where every team member is encouraged and empowered to actively contribute to our quality goals. Through ongoing training and professional development, we ensure our team stays ahead of industry standards and best practices, reinforcing our commitment to continuous improvement.

Implementation and Review

This Quality Policy is communicated, implemented, and maintained at all levels of the organization. It is reviewed annually during management review meetings to ensure its relevance and effectiveness. In addition, compliance with this policy is monitored through internal audits, performance evaluations, and regulatory inspections.

Approval and Ownership

This policy is approved by the Company's CEO and is the responsibility of the QARA Lead and Quality Committee to oversee its implementation.