MEDICON Hellas’ policy is established by the CEO of the company and consists in providing immediate and high-quality service to its customers and respect for the environment.
The purpose of the company is the continuous development of its capabilities and the continuous improvement of its organizational structure, in order to identify and provide with stability and consistency products and services that meet the constantly evolving needs and expectations of quality and cost of its customers, as well as the expectations of other stakeholders (personnel, external providers, shareholders and society), establishing it as an organization that achieves a competitive advantage in the market area in which it operates.
In order to achieve the above policy, all members of the company participate responsibly, starting with the CEO of MEDICON, who has the authority to implement it throughout the company.
The implementation of this policy presupposes the achievement of certain objectives, such as:
- Design, development, production, representation and distribution of in-vitro diagnostic products and devices, which fully meet the requirements of performance, reliability, safety, cost and quality of its customers, as well as recognized clinical standards.
- Providing a high level of support services to its customers.
- Creating a safe, functional and pleasant workplace, with respect for people and the environment.
- Understanding the needs and increase the awareness of personnel towards the quality and environmental objectives of the company.
- Protection of the environment.
- Identification, evaluation and control of the environmental impacts resulting from its activities.
- Minimization and rational management of the generated waste, and increase of the materials to be recycled, compared to those that are disposed of for disposal.
- Training of personnel in terms of quality and environment, for continuous improvement of their skills.
- Providing the necessary resources and optimizing their management.
The QMS is designed according to the standards ISO 9001:2015, ISO 13485:2016, ISO 14001:2015, the Greek Ministerial Order ΔΥ8/1348/04 and Regulation EU 2017/746. The various individual policies, processes, procedures and work instructions that constitute the operating framework of Medicon are described in documents such as the Procedures and Instruction Manuals.
The management of the company aims to make widely known at all levels the policy pursued, the relevant procedures and work instructions, in order to actively involve employees in the process of improving the system and the company.
The ultimate objective is the continuous improvement of the service provided through the operation of the company in controlled conditions, ensuring continuity and consistency in this operation. Adherence to the various manuals of the quality system and environment is mandatory for all users in order to achieve quality assurance. Any non-conformities must be adequately explained and documented.
The Management of the company is committed to the continuous improvement of the quality of the provided products / services, as well as its environmental imprint. The basic principles, as expressed through the company's QMS procedures, are:
- Compliance with laws and regulations
- Environmental performance
- Compliance with the requirements of ISO 9001:2015, ISO 13485:2016 και ISO 14001:2015
- The recognition of the requirements and needs of the Stakeholders
- The identification of risks and opportunities
- After-sales customer support
- The continuous training of the personnel and the enrichment of the business knowledge
- Investigating causes of non-conformities and customer complaints and determining correction and corrective action.
- The identification and evaluation of environmental aspects and their impact
- The provision of the necessary resources to achieve the above.
- The Management of the company is committed to the implementation of the quality & environmental policy.
- EU Quality Management System Certificate (IVDR)
- EN ISO 9001:2015
- EN ISO 13485:2016
- EN ISO 14001:2015
- ELOT ISO 37001:2017
- Good Manufacturing Practice (GMP) Certificate by National Organization for Medicines (EOF)
- Greek Ministerial Order 1348
- CE according to the Directive 98/79 / EC
- License for production by National Organization for Medicines (EOF)
- 510 (K) approval from the FDA for a range of products.