Quality Policy is a core  part of  Lucomed Company Policy strategies and represents how Lucomed Management address the development of  the Organization, toward a constant improvement of results.

Within the quality targets chosen  by Lucomed Management aiming at the Customers satisfaction and expectations there are:

• commitment to meet requirements of the supplied products;
• commitment to grant the compliance with Customer's requirements and satisfaction;
• commitment to maintain and improve the achieved quality level;
• personnel  involvement in the constant Improvement;
• commitment to carefully address environmental and personnel safety and health;
• commitment to grant constant quality level throughout production;
• review of the Company Quality Policy and Targets for the improvement, in terms of efficiency, prices, reliability, performance and image as key to Company continuity and growth.

To achieve the above mentioned objectives, Lucomed

• promotes
• develops
• supports

within every Company process, all those activities that, starting from the promotion and diffusion of the continue  improvement concepts among its own staff and vendors, and going  through the implementation  of educational training and communication system inside and outside the company, lead to the assurance that the manufactured products are in compliance with the quality requirements imposed by their intended use.

To grant safety, risk prevention  and health safeguard of production personnel, as fundamentals for the growth  of the Company, Lucomed S.P.A. management has committed with:

• dispose means and human resources for defined targets achievement.
• Periodically review the safety and health policy  and verify the defined targets achievement.
• Prioritize preventive actions as far as  personnel safety and health is concerned.
• Purse  the continuous improvement achievement.

The Health and Safety Working system enforced in the Company together with policy and  defined targets in every production process, aim to achieve such targets under an effective costs- benefits perspective.

Principles  and strategic targets of the system are:

• Compliance with current laws and organization capability to comply with laws, regulations and applicable standards evolutions.
• Effective handling of  safety and proper actions planning.
• Personnel and representatives participation.
• Circulation within personnel of objectives, targets to achieve and relevant  enforcement  plans, as well as responsibilities and motivations acceptance.
• Evaluation of all parties requirements.

Responsibility of  the Safety and Health system handling is up to the entire Lucomed organization, Management and individual operators each one based on own assignments and expertise:

• Managers and Supervisors are committed to enforce in their activities all actions aiming to satisfy Safety Policy requirements and risks prevention.
• Personnel is requested to continuously and carefully enforce such Policy following dispositions received, caring own and others physical integrity and participating with improvements suggestions.

A proper handling of Safety and Health  system calls for  the support and commitment of each individual as the final goal can only  be reached by every  people commitment  together.

THE RISK POLICY ENFORCED BY LUCOMED IS STRICTLY LINKED TO ITS QUALITY POLICY AND IS CONSISTENT WITH THE QUALITY SYSTEM HANDLING. IT AIMS TO GRANT SAFETY AND RELIABILITY OF MEDICAL DEVICES AND ACCESSORIES MANUFACTURED AND DISTRIBUTED ON THE MARKET.

To this purpose Lucomed Management made available human resources, financials and infrastructures and established the Risk Management Team, in order to grant by means of a Process for Risk Handling, a risk level which is widely acceptable for all Medical Devices and accessories.

PROCESS FOR RISK HANDLING

This process, DOCUMENTED, ENFORCED, MANAGED and MANTAINED by the Risk Management Team, concentrates on determining the risks associated to all Medical Devices manufactured by Lucomed, estimates and evaluates the hazards of these risks, controls them and monitors the effectiveness of such control.

It consists of:

• Risk Analysis  aiming to determine the intended use of a medical device, to identify its hazards, and estimate the risk. 
• Risk evaluation  represented by decisions on acceptable risks 
• Risk control  procedure including analysis identification, its accomplishment and the complete acceptance of the risk.
• Post production information  comprehending after-market experiences, collection of Vigilance and Surveillance after sale reports and relevant Revision of Risk Handling.