ISO 9001:2015 | ISO 13485:2016 | ID8d/G.P. ec. /1348

Company SANTAIR S.A. is a Medical Care company that is active in the promotion and support of medical equipment and the provision of medical care services.

The goal of SANTAIR A.E. is to provide its customers with complete solutions. The company’s main goals are focused on providing technical support, improving customer service, service time and reducing management costs. To achieve these goals, we implement in the company a Quality Management System that includes all those business processes that affect quality and ensure that the products we offer to our customers meet both their expectations and the most modern scientific techniques.

The Quality system provides for procedures to:

• Identify market needs
• Secure all resources necessary for the operation of the company and create a modern and professionally suitable working environment
• Continuous education and training of staff in new techniques
• Define objective goals and closely monitor them through reviews
• Offer innovative high level services to its customers by acting consistently, honestly and respectfully towards them.

The goal of the company is to maintain a constant open channel with involved parties (e.g. customers, suppliers, etc.) that ensures the receipt of all messages -positive and negative- about our products, as well as greater involvement of management and focus on the identification and management of risks with the ultimate goal of identifying opportunities to become more competitive in its field of activity.

Last but not least, it is considered important to emphasize that our Company always takes care to fully comply with national and Community Legislation governing the promotion and support of medical equipment and the provision of medical care services.

The Quality Management System of our company is harmonized with the requirements of the standard EN ISO 9001:2015, the standard EN ISO 13485:2016 and the Ministerial Decision ID8d / G.P. ec./1348 concerning the principles and guidelines of good practice and distribution of medical devices.

The Quality Management Manager, appointed by the Company’s Management, has the authority and power to oversee the operation and continuous improvement of the Quality Management System. He also has the power and organizational freedom to identify and investigate issues affecting the quality of products, services and the Quality Management System documented in writing.

Adherence to the policy of SANTAIR S.A. for quality is mandatory for the company’s employees and generally those who have a dependent employment relationship with it; the company is committed to continuously improving and maintaining the effectiveness of the Quality Management System.

SANTAIR S.A., always having as its guiding principle the provision of services that meet the requirements of its customers, and respect for people and the environment, has decided to install and operate a Management System in accordance with the requirements of standards ISO 9001:2015, ISO 13485:2016, ISO 14001:2015 and ISO 45001:2018.

The approach to Quality, the Environment and Health and Safety at Work are continuous and strictly defined procedures that ensure the guarantees for the company’s consistent presence in the field of promotion and support of medical equipment and the provision of medical care services, in which the Company operates.

Main Motivations:

• improving the internal operating system;
• acquiring know-how to better carry out the work and meet the needs and requirements of the customers;
• creating an external communication “channel” at all levels to ensure, on the one hand, that third party requirements are clearly identified and the company makes a clear statement of how they are met, and, on the other side, that the environment and the customer are protected;
• training and utilizing human resources;
• making prudent and rational use of natural resources, while minimizing the negative impact of the company’s activities on the environment;
• ensuring the protection of the health and safety of its employees, partners, the local community and the general public.

As part of the continuous improvement of the System, the Management of the Company sets targets for quality, overall development path, the environment and health and safety at work, which are reviewed annually in terms of the extent of their implementation, while new targets are approved and old ones are modified according to the company’s performance and the new conditions in the Company’s field of activity.

The Company Is Committed to:

• systematically monitoring and complying with regulatory and legislative requirements related to the environment, health and safety at work, as well as other legal requirements related to its operation;
• systematically identifying, assessing and controlling environmental impacts on and risks to health and safety arising from its activities;
• minimizing and rationally managing its waste, and increasing the quantities of materials to be recycled as compared to those to be disposed of;
• informing and encouraging its staff to actively participate, individually and in groups, in both improving the working environment and environmental protection actions in its field of activity;
• ensuring the protection of the environment and the health and safety of its employees, partners, the local community and the general public;
• safely and effectively managing all types of details, data and information that may become known to the Company in its dealings with the customers, as well as having the above exclusively managed by competent persons and, according to ethical principles, non-disclosing them to third parties for any reason;
• continuously marketing quality services with the ultimate aim of increasing customer satisfaction and improving competitiveness;
• systematically updating the business on developments in the sector in which it operates or on developments relating to the Company’s sector of activity;
• fostering harmonious cooperation with its customers and suppliers, as well as expanding the coverage of Greek and international markets;
• continuously improving the quality of services provided and working conditions, environmental management, as well as the Quality, Environment, Health and Safety Management System by assessing procedures and related indicators;
• promoting open dialogue and informing the parties concerned in a spirit of honest and mutual respect.

As a consequence, the Management of the Company is committed to actively participating in the implementation of the System and providing resources at all levels (human resources, materials or financial means) that will contribute to its continuous improvement.

SANTAIR S.A. has implemented a Single Management System that complies with the standards ISO 27001:2022 & ISO 27701:2019 and is committed to:

• Ensuring the confidentiality, integrity and availability of information processed, stored, electronically or physically transmitted through the company’s staff and information systems.
• Early and rapidly recognizing and responding to emergencies related to a breach (or potential breach) of the company’s information security.
• Ensuring that the information security and privacy policy as well as and information security and privacy objectives established are consistent with the company’s strategic direction.
• Protecting the company’s investment in information and communication technologies.
• Abiding by the requirements of Greek and European Legislation on the management of personal data, confidentiality of communications, copyrights, etc. in its field of activity.
• Continuously improving the Privacy Management and Information Security System.
• Defining the operational requirements for the availability of information systems.
• The definition of stakeholders and internal/external issues that concern the operational framework of the company.
• Implementing a risk assessment process to identify threats and opportunities.

SANTAIR S.A. Management has the necessary resources to support the Single Management System, provides the necessary knowledge to its staff and raises their awareness of information security and privacy issues by utilizing their skills and abilities.

SANTAIR S.A. fully recognizes the objectives of the Single Management System relating to information security and supports their implementation.

The senior management of the Company has defined the following specific principles on which the anti-bribery policy is based:

• It applies a zero-tolerance policy towards bribery and corruption and is committed to acting with professionalism, legality, and integrity in all its business dealings and relationships
• It does not tolerate any form of bribery or corruption.
• It will not provide, offer, or be offered to provide, approve, or require from any person to provide, directly or indirectly, benefits of any kind to individuals, so that such individuals act, in breach of their duties, by act or omission
• It shall never seek or accept, directly or indirectly, benefits of any kind or the promise of such, to induce or reward inappropriate behaviour in the form of acts or omissions arising out of or in conflict with one’s duties
• The policy is suitable for the aims and objectives of the Company
• It actively complies with all laws and regulations relating to anti-bribery, money laundering and terrorism and recognizes its responsibility to report any suspicious behaviour to the competent Greek Authorities
• It strives for the continuous improvement of the Anti-Bribery System
• It informs and trains the workforce as well as partners and subcontractors, regarding the anti-bribery policy
• It sets and measures specific goals and objectives to combat corruption
• It assigns the management of the System to a specific role, namely the Anti-Bribery System Manager.

The policy is available to the company’s staff and subcontractors, who are obliged to implement it.