The Quality for CURASEPT S.p.A. is an essential condition to put itself successfully on the market, considering its characteristics and evolution.

The development of the Company and its profit are insured by the continuous search for quality towards excellence through the continuous improvement of its processes.

The Company aims to increase the customer satisfaction through the application of its Quality Management System, including the processes to improve the system and to ensure the compliance with the customer and applicable regulatory requirements.

For this purpose, the Company performs specific risks and opportunities assessment activities, connected to the context, stakeholders and related objectives, in order to identify the areas of system improvements and to define the appropriate actions for the risk control and mitigation and strengthening of its Quality System.

The starting point for the implementation of this policy is the pursuit of the following objectives:

  • Define and implement a Quality Management System according to UNI EN ISO 9001:2015 and UNI EN ISO 13485:2016 regulation, as Manufacturer of Medical Devices;
  • Define and implement a system of procedures and operating instructions in harmony with the European Directive 93/42/CEE and subsequent changes and integrations, which satisfy the essential requirements set out in Annex I;
  • Define and implement in collaboration with our Outsourcer a system of procedures in harmony with the Directive 2010/84, the Regulation 1235/2010, the Implementation Regulation n. 520/2012 and in accordance with the objectives of “module I - “Good Vigilance Practices” (GVP).
  • Establish and formalize the business organizational structure with the subdivision into areas of competences;
  • Clarify roles and responsibilities of business functions;
  • Define strategies and objectives and assign human and material resources for their achievement;
  • Define accurately business processes and related performance factors;
  • Ensure compliance with qualitative, quantitative and temporal requirements;
  • Constantly monitor the level of adequacy of the system with reference to regulations and laws;
  • Promote initiatives in order to improve the process of motivational and professional growth of human resources, considered as critical resources for future business developments;
  • Ensure the commitment to the satisfaction of requirements and the maintenance of effectiveness of the Quality Management System.

These objectives can be realized thanks to the involvement of the whole Company personnel. In particular, the Managers of each Function provide their contribution so that the suggested improvements can be proposed to the General Direction, so that the Quality Policy can be a priority
element in the choice of business qualitative and organizational strategies.

The involvement of the whole personnel in the improvement of internal and external processes should be aimed at reducing non-compliance and internal and external costs of non-quality; for this reason all
employees should feel themselves committed in pursuing this policy.

Training courses, for all business levels, are promoted and planned by the General Direction in order to keep the personnel constantly up to date on the improvements performed for the processes.

The Quality Manual, which has been delivered in copy to each Manager by the General Direction, should
represent a work tool for all Managers and their personnel for the implementation of the Quality Policy.

05 March 2020

General Direction