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QUALITÄTSRICHTLINIE

ELITE BAGS, S.L. is a highly specialised Company designing, manufacturing and selling, bags, vests, organisers and accessories for professionals of emergencies; EMS, firefighters, home visit GP’s, physiotherapists for sport therapy, clinical analysis, diabetic people, first aid and military rescue teams with uniforms, vests, clogs and medical instrumentation.

Our catalogue has been implemented by the introduction of medical products, as the following:

  • ELITE BAGS S.L., we carry out the distribution, importation and exportation of medical products and related. We manage, the design, the development, the manufacture and the production processes of our own product as well as Taylor made for our customs.

To reach excellence of our goods and services, we have introduced a Quality Management System bases in the guidelines of Standards UNE-EN-ISO 13485:2016, UNE-EN-ISO 9001:2015 y UNE-EN-ISO 14001:2015, which includes regulatory measures form the law. For Medical devices, we specifically follow the requirement of Directive93/42/CEE until its abrogation and Regulation MDR 2017/745, depending which may correspond to each product, establishing the following principles:

 

  • Selling compromise, only medical devices in compliance with the standards of current legislation, as well as develop our activities in compliances to this framework.
  • Satisfaction of customers’ needs’, always recognising quality and environmental questions, as a part of a responsibility and a compromise from all the employees.
  • Ensure environmental protection, working with respect, preventing pollution and minimizing the impact of our activity upon Nature.
  • Objective establishment, focusing on increasing the customer satisfaction.
  • Fulfilled the legal and regulatory requirements applicable, the agreements with the customer, to our products and services.
  • Identifying and analysing the environmental impacts of our activities.
  • Permanent training to capacitate our employees, to be qualified, in order to fulfilled with their responsibilities and continuously participate in processes improvement.
  • Analysing the context, and the significant process of the organization to define improvement opportunities and necessary initiatives to meets the customer requirements.
  • Risks assessments’ of the processes, to prevent possible deflection of the system, as well as opportunities.
  • The continuous improvement of methods and/or processes, are parts of the Quality Management performance introduced in ELITE GROUP. To offer the highest efficiency, we use the data from our system, thank to information gathering and analysing from our system.
  • Waste disposal generated during the development of our activity, minimizing negative impacts on environment.
  • Committing with products’ traceability, complying with current regulation for the commercialization and distribution of medical devices.
  • Carrying out the continuous, follow up and monitoring of the life cycle, in accordance with the requirement of AEMPS, even if the product is already launch on the market.
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