The Policy of the Management on the quality and risk management of medical devices provides a framework for meeting the following main objectives:
- maintaining and continuously improving the quality of the offered products and services through effective management of the company processes;
- meeting the needs and expectations of our customers and other stakeholders;
- fulfilling established criteria for acceptable risk, based on the applicable standards, legislation, and generally acknowledged state of the art, as well as available information on scientific advances in the field.
- achieving compliance with all applicable local, national, international and other quality requirements.
- initial and ongoing Analysis of the risks throughout the life-cycle of the devices;
- Acceptable risk to consumer safety and the environment.
The Management considers acceptable the risk that does not endanger the life and health of the consumer, as well as the one that does not lead to environmental pollution.
Any risk that may adversely affect consumer health and the environment is considered unacceptable by Management.
To achieve these goals, the Management will work in the following areas:
- Risk management, opportunities by setting reasonable, achievable, and economically secure goals, aimed at each of these areas;
- Striving to keep updated and oriented to new customers.
- Determining the scope of the system suitable for our products, activities, and impacts on product users;
- Improving the quality of products/services based on mutually beneficial relationships with suppliers and customers and maintaining an effective partnership in the process of joint work;
- Creating an effective organization of the company management, based on the assessed risks and the open opportunities through which to implement a flexible and rapid response to the changing market conditions;
- Compliance with applicable regulatory and other requirements regarding quality, risk management, and other specific commitments related to the context of the organization;
- Optimizing the prices of products/services, providing the necessary resources for technological renewal;
- Creating trust among stakeholders in the reliability of the organization by strictly complying with the relevant requirements for products and services;
- Continuous improvement of the quality system and the risk management system by conducting regular reviews by the Management at planned intervals;
- Actively involving the Top management and each staff member and adopting the principles of this Policy, by providing training and qualifications.
- Risk management by reducing it to the lowest possible level, without adversely affecting the benefit/risk ratio.
- Evaluating the effectiveness and suitability of the Policy through periodic reviews by the Management and updating depending on any changes in and evaluation of our activities.
With the implementation of this Policy, Labex Trade Ltd. meets the high-quality requirements in accordance with the international standard BDS EN ISO 9001: 2015 and applicable national and European standards and legislation in the field of medical devices manufactured by the Company.