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Genomcore

Quality Policy of Genomcore

Last updated: 6 October 2026

Mission and Objectives

This Quality Policy applies to Genomcore S.L. and Made of Genes (hereinafter, jointly, the "Company"), the organisations covered by the Integrated Quality Management System (IQMS).

The mission of the Company is to develop and provide advanced personalised health services and bio-health data management solutions, guaranteeing the protection and confidentiality of our clients' personal and genetic data. The Company is committed to continuous innovation and to the use 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 diagnostic medical devices (IVDs) that improve the health and well-being of patients in the markets where it operates.

Our dedication to excellence is driven by a commitment to quality, safety and performance in all aspects of our operations, from initial design through to post-market surveillance.

Quality Commitments

Compliance with Regulations and Standards

We are committed to meeting applicable customer, statutory and regulatory requirements and the requirements of the standards we adopt, to ensuring the safety and reliability of our solutions and IVDs, and to maintaining the effectiveness of our quality management system. This includes, but is not limited to:

  • Management system standards: ISO 9001, ISO 13485, ISO/IEC 27001, ISO/IEC 27017 and ISO/IEC 27018.
  • Medical device standards: ISO 14971 (application of risk management to medical devices) and IEC 62304 (medical device software lifecycle processes).
  • National regulations:
    • Royal Decree 311/2022, regulating the National Security Scheme (ENS).
    • Royal Decree 942/2025, regulating in vitro diagnostic medical devices.
  • Data Protection and Information Services Legislation:
    • General Data Protection Regulation (GDPR) - Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016.
    • Organic Law on Data Protection and Guarantee of Digital Rights (LOPDGDD) - Organic Law 3/2018, of December 5.
    • LSSI - Law 34/2002, of July 11, 2002, on information society services and electronic commerce.
  • In Vitro Diagnostic Medical Devices Regulation (IVDR): Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices.
  • Artificial Intelligence Act: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence.
  • 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, of July 3, 2007, on Biomedical Research.
    • Law 41/2002, of November 14, 2002, which regulates patient autonomy and the rights and obligations regarding clinical information and documentation.
  • The editions in force of these standards, and the complete register of applicable standards and regulations, are maintained in the applicable standards register (R_003_002_Standards), which is available to interested parties upon request.

Framework for Quality Objectives

This policy provides the framework for establishing and reviewing quality objectives. Top management sets measurable objectives consistent with this policy at relevant functions and levels, and reviews their progress periodically and at each management review.

Leadership Commitment

Top management is fully committed to this Quality Policy: it provides the resources needed to implement it and ensures that it is communicated, understood, applied and kept up to date at all levels of the organisation.

In particular, the Company:

  • Has a Security and Quality Committee (Annex_QM_004) that oversees, coordinates and supports the development, implementation, maintenance and continual improvement of the IQMS.
  • Works with suppliers and subcontractors committed to the continual improvement of their products and services, evaluated for their ability to meet our quality and security requirements.
  • Has qualified employees who, together with appropriate technological resources, ensure the consistent quality of our services and products.
  • Has the tools needed to understand the needs and expectations of customers and other interested parties, and takes appropriate measures to meet them.
  • Considers the evolution of its internal and external context, including climate change where relevant, as an input for improving the system.
  • Ensures the protection of confidential information and the rights of customers and data subjects.

Customer Focus

The Company is committed to understanding and meeting the expectations of customers, partners and regulatory bodies, and to ensuring the security, reliability and usability of our health data solutions and 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 not only to meet but to 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 lifecycle of the IVDs we manufacture. This approach allows us to:

  • Ensure the confidentiality, integrity and availability of sensitive health data.
  • Protect customer information and prevent unauthorised access and data breaches.
  • Place on the market health solutions and IVDs that are safe and perform as intended, applying risk management in accordance with ISO 14971 throughout design, development, production and post-market activities.

Information security is governed in detail by the Company's information security policies.

Artificial Intelligence

Where the Company acts as provider of high-risk AI systems, in particular AI embedded in IVDs, it is committed to meeting the obligations of Regulation (EU) 2024/1689 throughout their lifecycle, including risk management, data governance, technical documentation, transparency, human oversight, accuracy, robustness and cybersecurity, integrated with the requirements of the IVDR. The governance of AI is set out in POL_IS_023 Artificial Intelligence Governance and POL_006 Policy on Fundamental Rights and AI Systems.

Employee Engagement and Training

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

Implementation and Review

This Quality Policy is communicated, understood and applied at all levels of the organisation, and is available to relevant interested parties.

It is reviewed annually during management review meetings to ensure its continuing suitability 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. The QARA Lead and the Security and Quality Committee are responsible for overseeing its implementation.