Our Quality System

S.I.T. – Sordina IORT Technologies SPA has the primary objective of full customer satisfaction and compliance with regulatory and legal requirements in the activity of:

Design, manufacture and technical assistance of particle accelerators for medical use and related accessories (applicators, discs, radiation protection barriers, software and treatment planning systems).

In carrying out its business, SIT undertakes to “make quality" by differentiating the features of its products/services through a constant research activity aimed at improving and optimizing the processes.

SIT undertakes itself to respect the regulatory and legal requirements of the applicable destination markets.

SIT applies to its devices a risk management policy based on:

– the compliance to national or regional applicable law and international standards;

– the information related to state of the art and stakeholders interests.

SIT and the whole staff maximise their efforts to carefully manage quality issues. The whole staff has therefore a strong responsibility to ensure the quality of their work. In particular, this must be pursued in relation to the following strategic objectives:

–      identify the Customer’s needs and expectations and the mandatory requirements on the products and comply with them;

–      improve process efficiency;

–      activate an adequate self-control system of the Quality Management System that allows to measure the activities, neutralize the problems and provide the Management with suitable elements to carry out the reviews;

–      activate communication tools inside and outside SIT to organize an effective information flow between staff and customers to ensure that their needs are known and understood by all those who contribute to the realization of products / services of SIT;

–      prevent non-conformities instead of acting for their subsequent elimination;

–      maintain the safety and comfort of the workplace and the implementation of accident prevention measures;

–      pursue the maintenance / continuous improvement of the QMS effectiveness.

Therefore, SIT Management undertakes to take an active role in promoting awareness of the customer’s requirements and the mandatory requirements on the products in order to meet them and increase customer satisfaction.

The Management is directly responsible for raising awareness, organization and coordination of the corporate functions that contribute to the development, maintenance and continuous improvement of quality.

The Management undertakes to ensure the availability of the resources necessary for the maintenance and continuous improvement of the effectiveness of the Quality Management System and the satisfaction of the Customer’s requirements.

These objectives led the Company to define a Quality System compliant with the UNI EN ISO 9001 and UNI CEI EN ISO 13485 standards,
of which the Quality Manual is documented evidence.

In order to pursue the aforementioned objectives, SIT Management takes the responsibility of preparing a Management System capable of pursuing the strategic objectives defined in this policy, of keeping it under control in order to verify the pursuit of the objectives themselves and to promote the appropriate improvement actions.

SIT Management delegates:

–      to the Quality System Manager the responsibility and authority to draw up company procedures, perform internal audits, report to the Management annually on the progress of Quality, verify the correct implementation of all the remaining tools of the self-control system (including proposals for improvement);

–      to each Area manager, the responsibility and authority of the application of the Quality Management System, as far as it is competent, with the obligation to report annually to the Management on the Quality trend in the area / process of its relevance (including improvement proposals).

These objectives and commitments undertaken by the company are suitably and constantly spread out through personal communications addressed to collaborators or through formal notices posted on the company notice board.

The measurable quality objectives will be established from time to time as part of the periodic quality reviews by the Company Management and communicated to the staff.

Vicenza, 15th May 2021