QUALITY POLICY
The culture of quality is a tradition deeply rooted in the history of our Company.
One of the guiding principles, which has always been practiced and shared by all, is that:
“The Company’s success and customer satisfaction depend on the quality of the products and services offered”.
To this initial conception of quality, of a purely technical nature and limited to products and services in the strict sense, it is progressively associated with the concept that “quality” means:
- understand the expressed or implicit needs of Customers to provide them with adequate products and services and safe and effective medical devices;
- understand the expressed or implicit needs of stakeholders;
- create new products and services and improve those already offered to anticipate future customer requests;
- provide qualified support to customers to enable them to use the products and services with full advantage and satisfaction.
These quality objectives are pursued at all levels through constant efforts to ensure that in daily operations:
- Each activity is properly planned
- All activities are carried out in accordance with the standards set by the Quality System, committing themselves to meeting the requirements and maintaining effectiveness
- Risk management is kept under control during all life stages of medical devices
- Each customer activity produces the expected result
- Each activity is completed on established time
- Any complaints are resolved
- The post-sales surveillance phase of all medical devices is managed in order to maintain their efficacy and safety, guarantee the reliability of the products over time and the continuous improvement of technical capabilities and production standards.
- Improve the Company’s image on the market through an efficient structure and through greater transparency towards the outside
- Continuous improvement is pursued, based on the analysis of company performance
- meet specific product performance supervisory commitments to medical industry regulatory requirements.
To achieve the Quality objectives and customer satisfaction, the Quality values must also be reported within the organization:
- The value of a person is a value for the company;
- It is important to document or motivate company choices;
- In the company you can grow by merit.
DISCLOSURE OF POLITICS TO ALL LEVELS OF ORGANIZATION
The General Management undertakes, through training meetings, to disseminate the quality and safety policy and improvement objectives to all levels of the organization.
Furthermore, the policy as expressed in this manual is disclosed within the structure through the special notice boards hanging in strategic points.
Making all personnel involved in the objectives and the policy represents the fundamental commitment of the General Management, in order to achieve the continuous improvement of the Quality Management System and Company Safety.
PLANNING
The General Management has planned the quality of the Organization by defining the processes necessary to effectively achieve the objectives for quality, based on the general requirements of the Quality Management System, the historical experiences of the Company, the Company strategies, the customer needs, opportunities identified for improvement. It also documented this planning, through the manual, procedures, instructions and records.
The General Management has established:
- the skills and knowledge necessary for the Organization, defining the activities and responsibilities of each Company Function;
- the responsibilities and authorities for the implementation of the improvement objectives;
- the necessary financial resources and resources in terms of infrastructure;
- the indicators to measure the effectiveness and improvement of processes and the methods to implement the improvements.
The General Management, in order to ensure the integrity of the Quality Management System when changes to the System itself are planned and implemented, provides for the updating or integration of the documents of the Quality System, in order to guarantee its effectiveness also in the face of unforeseen needs or in any case not properly covered by the tools made available.
Vallefoglia, 10/10/2020