{"id":382,"date":"2026-05-19T20:41:15","date_gmt":"2026-05-19T20:41:15","guid":{"rendered":"https:\/\/www.saadenerji.com.tr\/quality\/"},"modified":"2026-05-19T20:41:15","modified_gmt":"2026-05-19T20:41:15","slug":"quality","status":"publish","type":"page","link":"https:\/\/www.saadenerji.com.tr\/en\/quality\/","title":{"rendered":"Quality"},"content":{"rendered":"

QUALITY<\/span><\/strong><\/h2>\n

All KYERON implants carry the CE mark and a Class III quality certificate. It is our responsibility to provide safe and effective biomaterials. Therefore, our products are manufactured in compliance with ISO 13485:2016 and under a Full Quality Assurance System in accordance with the Medical Devices Directive 93\/42\/EEC, Annex II (excluding Section 4). <\/p>\n<\/div><\/div><\/div><\/div><\/div>

KYERON Quality Management System<\/strong><\/p>\n

KYERON operates an approved Quality Management System in compliance with EN ISO 13485:2016 requirements for the design, manufacturing, and distribution of sterile ceramic bone graft substitutes, sterile absorbable collagen, and biopolymers. This ISO 13485 certification has been issued by our authorized Notified Body. <\/p>\n

General Requirements<\/strong><\/p>\n

KYERON has established, documented, implemented, and maintains a quality management system in compliance with ISO 13485:2016, and is committed to continuously improving its effectiveness.<\/p>\n

KYERON;<\/p>\n

    \n
  1. \n

    It has defined the processes required for the quality management system and their application across the organization.<\/p>\n<\/li>\n

  2. \n

    It has defined the sequence of these processes and their interaction with one another.<\/p>\n<\/li>\n

  3. \n

    It has defined the criteria and methods necessary for the effective operation and control of these processes.<\/p>\n<\/li>\n

  4. \n

    It has ensured the availability of the resources and information necessary for the operation of these processes.<\/p>\n<\/li>\n

  5. \n

    It monitors, measures, and analyzes the processes.<\/p>\n<\/li>\n

  6. \n

    It implements the necessary actions to achieve the planned results and to ensure the continuous improvement of the processes.<\/p>\n<\/li>\n<\/ol>\n<\/div><\/div><\/div>

    These processes are managed by KYERON in compliance with the requirements of ISO 13485:2016.<\/strong><\/p>\n

    Management Commitment<\/strong><\/p>\n

    KYERON management demonstrates its commitment to the development and implementation of the quality management system defined in the Quality Assurance Manual, as well as to the continuous improvement of its effectiveness.<\/p>\n

    Quality Policy<\/strong><\/p>\n

    KYERON management ensures that the quality policy meets the following elements:<\/p>\n

      \n
    1. \n

      Ensuring that medical products, including after-sales services, are fit for their intended purpose and comply with the specified requirements.<\/p>\n<\/li>\n

    2. \n

      Including a commitment to compliance with requirements and to the continuous improvement of the effectiveness of the quality management system.<\/p>\n<\/li>\n

    3. \n

      Providing a framework for the establishment and review of quality objectives.<\/p>\n<\/li>\n

    4. \n

      Being reviewed regularly to ensure continued suitability.<\/p>\n<\/li>\n<\/ol>\n

      The quality policy is part of the Quality Assurance Manual and is signed by the KYERON Director.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-382","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.saadenerji.com.tr\/en\/wp-json\/wp\/v2\/pages\/382","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.saadenerji.com.tr\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.saadenerji.com.tr\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.saadenerji.com.tr\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.saadenerji.com.tr\/en\/wp-json\/wp\/v2\/comments?post=382"}],"version-history":[{"count":0,"href":"https:\/\/www.saadenerji.com.tr\/en\/wp-json\/wp\/v2\/pages\/382\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.saadenerji.com.tr\/en\/wp-json\/wp\/v2\/media?parent=382"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}