Quality Policy
AENDUO S.r.l., which is a manufacturer of medical devices pursuant to Directive 93/42/EEC and subsequent amendments and additions, and EU Regulation 2017/745, is particularly sensitive to the needs of the market and considers feedback information to be of fundamental importance through the adoption of a correct Quality Assurance and Control Policy in accordance with ISO 9001 standards. ISO 27001 and ISO 13485. In particular, the objectives that the Management has set itself are:
• meet the requirements indicated in Legislative Decree no. 46 of 24/02/97, as amended. and EU Regulation 2017/745;
• comply with the mandatory and current regulations, in particular those relating to the safety of the worker and those relating to the safety of medical devices, common specifications and MDCG (Medical Device Coordination Group);
• functionality and continuous improvement of the product;
• obtain and maintain the certification of the Quality Management System according to ISO 9001:2015, ISO 27001 and ISO 13485 over time;
• quality and safety of the marketed product;
• prevention rather than subsequent elimination of defects;
• responsibility for one's work;
• commitment aimed at meeting the requirements and maintaining the effectiveness of the Quality Management System;
• improvements necessary to maintain the effectiveness of the Quality Management System and its processes;
• evaluate the customer's return information for the product/service provided;
• periodically assess new customer needs;
• periodically assess the risks and opportunities for improvement related to business processes;
• change planning and continuous verification of system integrity;
• guarantee the security of information with the constant supply of fundamental supports for the Company's Core Business through the most technologically advanced means and tools kept in perfect working order; with the periodic and systematic analysis and identification of threats to the information managed, assessing the real exposures to risks and implementing the appropriate countermeasures to cancel their effects.
To achieve these objectives, the company is engaged in continuous market research for the updating and improvement of products together with a careful evaluation and selection of suppliers.
This policy will contribute decisively to ensuring the seriousness, professionalism and efficiency that have always characterized the company's activity: to this end, it will be the commitment of the Management and the QA to assist all staff to correctly perform the procedures of the Quality System, training them appropriately and stimulating them to the required quality improvement.
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