The General Management of Resintex Industriale S.r.l. is committed to comply with the Quality System according to UNI CEI EN ISO 13485 regulation.
The main targets are:
• The fulfillment, maintaining and improvement of the regulatory requirements, either for product and system.
• the customer satisfaction and its requirements
• the creation of a company culture aimed to the continuous improvement
• the continuous improvement of performances and their efficacy
• the full achievement of the customer satisfaction and of other involved parties (owners, employers, suppliers, company).
• the respect and protection of patient health, by providing medical devices and materials that bring benefits, by using up-to-date technologies and following the most advanced scientific research indications
• the respect of the Essential Requirements according to Annex I of the Law N. 46 of 224/02/1997, implementation of Directive 93/42/CEE and EU 2017/745 Regulation (MDR) and subsequent amendments and additions
• the compliance of its products with CE Declaration of Conformity, by the fulfillment of its Quality System
• the correct communication about the quality of its products and consequently about the positive image of Resintex Industriale.
The General Direction is then committed to:
• divulge and promote the Quality Policy inside its organization
• increase the prevention activity for decreasing the costs of “non-quality”, by means of customer reports and corrective and preventing actions
• optimize the management processes for increasing the company competitiveness
• optimize the decision-making processes for making them faster and supportive to preset targets
• monitor the conformity of the product through the tools and indicators provided in the Direction Review
• make use of competent and aware staff.
For this purpose a Quality Plan is issued every year to define the targets of Resintex Industriale s.r.l. (Quality Plan – Objectives).
The General Management is committed to ensure the full respect of that what described in its Quality Manual by all involved sectors of the company and that its actions will be aimed to maintain in every moment the control of processes, the product performances in compliance with its commitments.
Issued on January 9th, 2018
Resintex Industriale S.r.l.
The General Management