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Quality policy

KC SOLUTIONS Policy is designed to ensure that the medical devices meet the expectations of our clients and users, our contractual obligations, both general and specific legal and regulatory requirements of our business, and enable continuous improvement of the quality system, of processes and products.

To achieve this objective, the company´s line of action is based on the following principles and commitments:

  • Ensure the quality excellence of the manufactured products.
  • Understand and meet customer needs and requirements.
  • Understand and comply with our contractual obligations.
  • Maintaining a Quality management system efficiently.
  • Ensure compliance with applicable Legal and regulatory requirements.

The Management is responsible for defining, implementing and maintaining this Quality Policy, for which, the Quality Manual and Quality Management System are based in accordance with the requirements of:

  • UNE – EN- ISO 13485: 2012 rules
  • European Directive 93/42/EEC and its amendment 2007/47/EC
  • Transposition of the Directives into Spain Law RD 1591/2009

The effectiveness of KC-Solutions Quality Management System depends on the unconditional support of all our employees. The staff embraces the quality concerns, understanding the importance of the tasks they perform and that the sum of all of them makes it possible achieve the objectives.

Download the Quality Policy

Download the ISO 13485

Download the CE Mark