In 2006 Intrauma S.p.A. obtained ISO 13485:2004 certification for the quality system concerning the design, production and sale of its medical devices: the O’nil products are CE marked by the Notifier body Certiquality (No. 0546).
The Company Management, aware of its function of primary responsibility in the development and improvement of the QMS, makes clear its commitment to fully respond to the regulations in force, both concerning the management of ISO 13485 CE, and concerning the CE marking of its products:
- By communicating to all members of the organisation the importance of guiding all activities towards customer satisfaction and the compliance with the standards and laws;
- By defining the objectives, and spreading them at all corporate levels, ensuring they are properly implemented;
- By defining the organizational structure and responsibilities and the authority of personnel operating within the QMS;
- Carrying on periodic reviews of the QMS, in order to assess its adequacy and effectiveness and to record the results;
- Providing the necessary equipment resources;
The General Management will undertake:
- To provide maximum support in the form of information, training, tools and resources so that the undertaken initiative is successfully maintained;
- To promote and spread its quality policy through organizational arrangements, internal communications, etc.. that will always refer to measurable and achievable objectives, determined from time to time, which are monitored over time, allowing the company strategies to be constantly up-to-dated and evolved;
- To constantly supervise the proper distribution of its products and their use, and about issues that could possibly arise, in order to give accurate information to its customers and, if necessary, to take all those measures which protect the safety and health of users.
The aims of the company quality are:
- Customer satisfaction: assuring that the company has a dynamic capability that can ensure the quality of its service to the highest standards, study and experimentation of new variants and their constant adaptation to the market requirements, as those of legislation on health, safety and biocompatibility;
- On-time deliveries: INTRAUMA products must be delivered by the date of delivery provided by the supply contract / order agreed with the customer;
- The ability to establish a customer relationship based on transparency, trust, competence and professionality
- Optimization and improvement of company processes with the consequent involvement of personnel, pursued through the clear definition of responsibilities and roles;
This Quality Policy and its objectives will be reviewed annually during the Management Review to determine their continuing eligibility and the continued suitability to the purposes of the company.