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19 Palaiologou Street
Τ.Κ. 15232 Chalandri

+30 210 4820408
kalteq@kalteq.gr

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    Certifications

    HomeCompanyCertifications

    Certifications

    At Kalteq, we rigorously adhere to EU and international regulations and standards, holding certifications for every facet of our operations from recognized bodies in quality management, processes, and business ethics. Our steadfast dedication to quality and transparency is underscored by the certifications and awards we have garnered, reflecting our commitment to upholding the highest standards in all aspects of our business. These accolades not only validate our operational excellence but also reinforce our pledge to ethical practices and continuous improvement.

    Certifications

    iso 9001
    iso 13485
    ya ΔΥ8δ Γ.Π.ΟΙΚ.1348 2004

    Distinctions and Awards

    Code of Conduct and Business Ethics

    Submission Policy & Management of Reports & Complaints (Whistleblowing)

    Adopting measures & regulations on harassment and violence at work

    Code of Business Conduct Violation Report

    EN ISO 13485:2016

    The quality management system for medical devices in accordance with the requirements for regulatory purposes. This certification ensures the safety and effectiveness of our products, covering all aspects of medical device manufacturing and distribution, from initial conception and design to production, maintenance and storage. In particular, it includes the marketing and distribution of medical devices and equipment (general surgery, laparoscopic, neurosurgery, cardiology, orthopaedics), as well as equipment for washing and sterilization.

    EN ISO 9001:2015

    The quality management system that sets the foundation for continuous improvement of our processes and services, with emphasis on customer satisfaction. The ISO 9001:2015 certification by TÜV HELLAS (TÜV NORD) S.A. confirms that Kalteq implements the best quality management practices and that our services and products consistently meet the expectations and requirements of customers and regulatory authorities. The certification covers the marketing and distribution of medical devices, consumable healthcare equipment, as well as the technical support of equipment.

    ISO 37001:2016

    Our anti-bribery management system, which supports our commitment to ethical and transparent business practice. With ISO 37001:2016 certification, Kalteq adopts measures and practices that prevent and detect incidents of corruption and bribery, ensuring integrity in all our business activities.