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QUALITY POLICY 

MEDICARE HELLAS S.A. applies the Quality Management Systems, environmental management and Quality Management for Medical Devices in accordance with the international standards ISO 9001: 2015, ISO 14001:2015, ISO 13485:2016 and the Ministerial Decision ΔΥ8δ / ΓΠ / οικ. 1348/04 (Government Gazette 32 Β / 16-1-2004): Principles and guidelines of good practice in the distribution of medical-devices products.

The main goal of the Company’s Quality Management System is to create a basis for the continuous improvement of the efficiency of its processes, always guided by the continuous satisfaction of the needs and expectations of its customers as much as possible.

For the implementation of the above, the Management Team continuously supports and applies the basic principles and rules that govern the Company’s Unified Management System, establishing objective goals for quality, based on the undivided and constructive cooperation of both its employees and its associates.

The basic principles, as they are expressed in the Company System’s procedures, are:

  • The observance of the legislative and regulatory framework that governs the Company’s operation. Special emphasis is given to the management of patients' personal data which the Company adheres to. Compliance with specified customer requirements as agreed through written contracts / agreements in order to increase their satisfaction
  • The compliance with the requirements of the Ministerial Decision ΔΥ8 / 1348/2004 concerning the "Definition of Quality System of Medical Devices’ Distribution Companies" as well as with the requirements of the standards EN ISO 9001: 2015, EN ISO 13485: 2016 as well as the Community directives- regulations governing medical devices
  • Ongoing customer after-sales support as well as constructive cooperation with all suppliers
  • The continuous information and training of the staff
  • Investigation of the causes of non-compliances or complaints and further examination of corrective actions
  • Operating with environmentally friendly practices and in accordance with legal and regulatory requirements related to climate change.

The principles of the system, as well as the objective goals for quality, are reviewed regularly by the Company’s Management Team in order to adapt to the new needs and developments in the business field, the legal requirements but also to the achievements of the goal of continuous improvement of the Company's operations.

Through the continuous reviews of the above, the Management Team is in a constant search to identify new needs. The Management Team is committed to providing the necessary resources to meet the needs, as they arise and are shaped by the existing situations, to the maximum of its capabilities.

All the Company’s departments have the responsibility to respond, assimilate and implement the procedures required by the Unified Management System through their daily activities.

It is also the responsibility of the Company’s Management Team to ensure that the Quality Policy is communicated, understood and apllied by all the human resources of the Company, with the ultimate goal of continuous, stable development of its business activity with unwavering commitment to its principles and continuous offering of high quality products and services.

 

Chairman & CEO

Markopoulos Athanasios

 

 

ENVIRONMENTAL MANAGEMENT POLICY

The Management of MEDICARE HELLAS S.A. is aware of the effects that burden the environment during the implementation of its business activities.

For this reason, MEDICARE HELLAS S.A. records, analyzes and implements environmental programs aimed at reducing its impact on the environment and is constantly working to expand and continuously improve its environmental footprint. This environmental policy is an integral part of the Company's corporate and product strategy.

The Management of MEDICARE HELLAS S.A. is committed to continuously improve the environmental footprint of the Company through:

  • the identification of the environmental aspects & effects of the Company per process / activity as well as the evaluation of their criticality,
  • the recording and analysis of environmental data related to the Company's performance and specifically:
    1. The consumption of natural resources,
    2. Recycling of materials (eg electrical / electronic equipment, batteries)
    3. The production of solid and liquid waste,
    4. The production of hazardous waste (eg batteries, non-recyclable products),
    5. The CO2 emissions into the atmosphere from the implementation of transport.
  • the implementation of environmental mitigation programs that are considered critical,
  • the definition of measurable targets & corresponding indicators (KPIs) for the environment,
  • the Identification and Evaluation of potential risks and opportunities related to the environment, per process / activity, and taking measures to prevent and address them,
  • maintaining a high level of environmental awareness of executives through continuous training and information,
  • the periodic evaluation of all the suppliers, partners and subcontractors of the Company with quality and environmental criteria,
  • the implementation of contingency plans to ensure the protection of the health and safety of staff and third parties as well as the protection of the environment,
  • the implementation of the Management System application according to the International Standard ISO 14001: 2015.
  • Operating with environmentally friendly practices and in accordance with legal and regulatory requirements related to climate change.

For this purpose, MEDICARE HELLAS S.A. continuously and systematically controls the applicable legal instructions and requirements, resulting from these relevant works which are then documented and included in the Company’s Management System.

The Company's Unified Management System is inspected by an independent certification body, ensuring that MEDICARE HELLAS S.A.'s commitment in the field of environmental management can be compared to domestic and international terms of reference.

 

Chairman & CEO

Markopoulos Athanasios

 

 

ANTI-BRIBERY POLICY

The Company declares zero tolerance for all forms of Active and Passive Bribery and "Prohibits bribery in all its forms and any financial or other payment, direct or indirect (providing business opportunities, jobs, favorable contracts, donations, trips, gifts, and hospitality) aimed at obtaining, maintaining, or securing an (improper) advantage for the Company."

Within this context, it has integrated the requirements of the ISO 37001:2016 "Anti-Bribery Management System" into its Quality System and is committed to its adherence.

The anti-bribery prevention measures are expressed within the procedures of the Company's Quality System and include:

  • Identification of Bribery risks.
  • Compliance with the relevant Legislative and Regulatory framework related to Bribery.
  • Implementation of policies and rules to ensure Ethical Transactions.
  • Regular review of Policy suitability for the Company's Purpose.
  • Establishment of objective anti-Bribery goals.
  • Conducting Due Diligence checks on involved personnel and business partners.
  • Continuous training of personnel to prevent Bribery and encourage incident reporting.
  • Provision of whistleblower protection.
  • Ensuring the Independence and Impartiality of the Anti-Bribery Structure.
  • Providing an anonymous reporting mechanism.
  • Impartial investigation of Bribery incidents and imposition of consequences on those involved.

The principles of the system as well as the quality objectives are reviewed at regular intervals by the Management Team to ensure continuous improvement.

The Company's Management is committed to providing the necessary resources for the maintenance and implementation of the Anti-Bribery System.

All departments of the Company are responsible for responding to, assimilating, and implementing the procedures required by the Anti-Bribery System in their daily activities.

It is also the responsibility of the Company's Management to ensure that the Anti-Bribery Policy is communicated, understood, and applicable by all the Company's human resources.

Chairman  & CEO
Markopoulos Athanasios

 

INFORMATION SECURITY MANAGEMENT SYSTEM

MEDICARE HELLAS S.A., responding to the requirements of the modern business environment and aiming to protect its information systems, always seeking uninterrupted and exemplary service to its customers, has decided to design and implement an Information Security Management System (ISMS) in accordance with the requirements of the International Standard ISO/IEC 27001:2022, in order to:

  1. Ensure the confidentiality, availability, and integrity of the information managed by the Company.
  2. Be able to promptly address any incident that is reported or detected and may indicate a breach of confidentiality, integrity, or availability.
  3. Minimize the impact that information security incidents may have on the Company’s reliability and reputation with its customers.

 

The Company’s Information Security Management System covers the following scope:

 

  1. Trading and Distribution of Sterile and Non-Sterile Medical Devices for Hospital Use (Laparoscopic, Endoscopic, Sutures and other Surgical Materials, Gynecological Products, Anesthesiology Materials and other Medical Consumables, Interventional Cardiology and Electrophysiology Materials, and Surgical Sets).
  2. Trading and Distribution of Surgical, Endoscopic, Laparoscopic Equipment and Instruments, as well as Sterilization Systems.

The ISMS has been designed in accordance with the Company’s needs and objectives, the Legal and Regulatory Requirements of applicable Greek and European legislation, contractual obligations, and the requirements of the standard related to information security.

The main objectives, as expressed through the procedures of the Company’s Information Security Management System, are:

 

  1. The establishment of a foundation for the continuous improvement of the effectiveness of its processes, with a focus on continuously meeting customer needs and expectations to the maximum possible extent.
  2. The reduction of the impact of events that may affect the Company’s business continuity.
  3. The Company’s compliance with applicable laws and regulations.
  4. The management of information maintained and transmitted in any manner through its electronic and non-electronic systems—information that is of critical importance to its operation and market position—in a way that protects its security in terms of confidentiality, integrity, and availability.
  5. The continuous improvement of the ISMS.

Information security objectives are aligned with the Company’s strategic objectives, and the Company ensures that the resources required for the ISMS are available.

The Management’s objective regarding the protection of personal data is to adhere to the following principles:

 

  1. Processing personal data in a fair and lawful manner.
  2. Personal data is maintained in a lawful and fair manner.
  3. Personal data shall be limited strictly to what is absolutely necessary for the achievement of the relevant purposes.
  4. Protection of personal data through appropriate security measures.
  5. Retention of personal data for a specified period of time (depending on the purposes).

The Company’s system is reviewed at regular intervals by Management in order to adapt to new needs and market developments, legislative requirements, and the achievement of the Company’s information security objectives. On an annual basis, information security objectives are also reviewed and revised where necessary.

Management is committed to providing the necessary resources for the implementation, operation, and continuous improvement of the ISMS.

Each employee is responsible for responding to, understanding, and applying the procedures required by the Information Security Management System in the context of their daily activities.

For this reason, all employees, depending on their responsibilities, are informed about the system and demonstrably act in accordance with the established security and confidentiality rules.

The Information Security Policy is available, understandable, and applicable to all human resources, with the aim of ensuring the continuous and stable development of the Company’s business activities, with unwavering commitment to its principles and the ongoing provision of services of excellent quality and maximum security to its customers.

It is reviewed at regular intervals to ensure continuous alignment with market conditions, technological developments, and applicable legislation.

Chairman  & CEO
Markopoulos Athanasios

 

 

 

 

CERTIFICATION

MEDICARE HELLAS S.A. has successfully completed its certification process for the entire range of its activities, ensuring the quality of its products and services for their end user.