QUALITY POLICY-CERTIFICATES

All HELLABIO products are used in assisting medical diagnosis.

Policy of "Dimitriadis Ioannis and Son PC(HELLABIO)" and each of its executives, is to comply with the relevant legislative and regulatory requirements regarding its products and providing them to its customers to fully cover their requirements.The quality policy is achieved through the goals set and monitored by the company such as:

▪Commitment of the management to comply with the regulatory requirements regarding the products that manufacture

▪Implementation of a Quality Management System and application of the appropriate actions to continuously improve its effectiveness.

▪Providing capable products to meet customer requirements in accordance with the procedures defined in the Quality Management System that is implemented.

▪Review and continuous improvement of the Quality Management System procedures in order to produce high quality products, so that to meet the demands of their customers to the maximum extent possible.

▪Maintaining and improving the working environment so that it is friendly to every employee, giving each one freedom of expression and active participation in the Quality Management System that is implemented

▪Provision of all of the necessary resources for the smooth, efficient and effective operation of the Quality

Management System

In order to achieve the above objectives, the company implements a Quality Management System in accordance with the requirements of the international standards and ISO13485:2016 with scope as follows:

DESIGN, PRODUCTION OF IN VITRO DIAGNOSTICS IN THE FIELD OF ELECTROPHORESIS (ISO 13485:2016)

The Management is committed to providing all the required means and resources to achieve the goals it has set for the appropriate training of its employees, the improvement and continuous flow of expertise and continuous coverage of the necessary needs that arise.