Due to the importance of the sector in which it operates, PENTAFERTE ITALIA s.r.l. is aware that the quality of its devices is the fundamental basis for customer safety. To this end, it establishes, maintains and improves its quality management system in order to meet customer requirements, while respecting the principles of ISO 13485:2016 and in accordance with the legislation regulating the medical sector.

This is summarised in the COMPANY MISSION as set out below:

All PENTAFERTE ITALIA personnel work every day, in a dedicated, flexible and dynamic manner, to offer safe devices useful for safeguarding human health.

The Quality Manual, of which this document is an integral part, give a detailed description of all actions and checks that are carried out in order to achieve the objectives that the company sets itself in a satisfactory manner.

In particular, the achievement of these objectives requires the implementation of strategies aimed at ensuring:

• improved customer service, paying the utmost attention to present and future needs and aiming to exceed customer expectations,
• the development of human resources, promoting the unity of purpose and direction by company managers, who are responsible for creating and maintaining an internal environment which is motivated and fully involved in the pursuit of the quality objectives,
• improved product quality, planning and implementing interventions that can help reduce the percentage of non-conforming products,
• the continuous improvement of overall performance, through the identification, analysis and systematic management of all those processes that are interconnected to achieve a specific objective,
• socially responsible business management by joining the UN GLOBAL COMPACT, the largest international network for the dissemination of the Ten Principles for Sustainable Development.

The Executive Board has defined this quality policy and ensures that it is understood, implemented and supported at all levels of the organisation. Each employee is obliged to transpose it and transfer it to their own activities.

The Executive Board also undertakes to adapt its human, economic/financial and infrastructural resources to the needs that will arise in the course of management.

In order to put these commitments into practice, every year, within the scope of the relevant activities, the General Management establishes specific objectives for the company’s Management related to the responsibilities held and the contribution of each in relation to the company’s strategic objectives.

The data resulting from the application of the Quality Management System is analysed by the General Management during the annual review, in order to verify its implementation, effectiveness and promote its continuous improvement.