Quality & Policies

OMNIA HOLDINGS IKE

Quality Policy

QP-IMS_v.1 · Date: 01.09.2026

OMNIA HOLDINGS IKE, engaged in the importation, storage and distribution of medical devices, implements a Quality Management System in accordance with the requirements of ISO 9001 and ISO 13485, Greek Ministerial Decision 4822/2025, as well as the applicable requirements of Regulation (EU) 2017/745 (MDR), arising from its role and obligations as an importer and distributor of medical devices.

The Company's primary objective is to supply compliant medical devices that meet established specifications, applicable regulatory requirements and customer requirements.

To achieve this objective, the Management of OMNIA HOLDINGS is committed to:

• Complying with all applicable legal, regulatory and other requirements governing the importation, storage and distribution of medical devices.
• Ensuring that imported and distributed products meet the applicable conformity requirements and are accompanied by the required documentation, labelling and information.
• Implementing appropriate controls during the receipt, storage, handling and delivery of products to preserve their quality, safety and integrity.
• Ensuring product identification and traceability throughout all stages of distribution.
• Systematically identifying, assessing and managing risks associated with the Company's activities.
• Appropriately selecting, evaluating and monitoring suppliers and other external partners.
• Ensuring suitable storage and transportation conditions in accordance with manufacturers' requirements.
• Providing appropriate training and information and maintaining the competence and capabilities of the Company's partners and external collaborators.
• Effectively managing complaints, returns, nonconforming products, recalls and corrective actions.
• Cooperating with manufacturers, authorised representatives, other economic operators and competent authorities, where required.
• Management ensures that the necessary resources are available for the implementation, maintenance and effective operation of the Quality Management System.

At OMNIA, we believe that quality goes beyond meeting specifications and following procedures. It is a daily commitment to our partners, healthcare professionals and, above all, the people who benefit from our products.

Through responsibility, consistency and a commitment to continual improvement, we strive to build relationships based on trust and make a meaningful contribution to providing safe and reliable solutions in healthcare.

For us, quality means responsibility, collaboration and trust.

COMPANY MANAGER

OMNIA HOLDINGS IKE

Anti-Bribery Policy

ABP-IMS_v.1 · Date: 01.09.2026

OMNIA HOLDINGS IKE, engaged in the importation, storage and distribution of medical devices, implements an Anti-Bribery Management System in accordance with the requirements of ISO 37001:2025, with the aim of preventing, detecting and addressing bribery within its activities and business relationships.

The Company's primary objective is to establish and maintain relationships of trust with customers, suppliers, business partners and other interested parties, based on transparency, integrity, responsibility and respect for professional ethics.

OMNIA adopts a zero-tolerance policy towards bribery and prohibits all forms of direct or indirect bribery, regardless of the person involved, the transaction concerned or any potential business benefit associated with it.

To achieve these objectives, the Management of OMNIA HOLDINGS is committed to:

• Complying with applicable anti-bribery legislation and other relevant regulatory requirements.
• Prohibiting the offering, promising, giving, requesting or accepting of any improper financial or other advantage, directly or through third parties.
• Ensuring transparency and accurate documentation of financial transactions, payments and other business activities.
• Avoiding and appropriately managing actual or potential conflicts of interest.
• Informing and raising awareness among the Company's partners and external collaborators regarding anti-bribery principles and requirements.
• Encouraging the reporting of concerns, suspicions or incidents of bribery in good faith, without fear of retaliation.
• Objectively reviewing reports and taking appropriate measures when violations are identified.
• Providing the necessary resources and supporting the anti-bribery compliance function.
• Continually improving the effectiveness of the Anti-Bribery Management System.

Reporting Concerns and Bribery Incidents

OMNIA encourages anyone working with or conducting business with the Company to openly and in good faith raise any concerns regarding suspected bribery or conduct that may be inconsistent with the principles of this Policy. Concerns, reports or information relating to suspected bribery may be submitted to the following email address: kali@omniamed.gr.

All reports are handled with discretion, objectivity and due regard for the confidentiality of the information and the individuals involved. The Company does not tolerate any form of retaliation, adverse treatment or intimidation against individuals who report concerns in good faith or cooperate in an investigation.

Our commitment is to maintain mutual trust and integrity in our professional relationships.

COMPANY MANAGER