All KYERON implants carry the CE-mark and a certificate of quality (Class III). Our products are certified by our notified body BSI Global; It's our responsibility to offer safe and effective biomaterials. Therefore our products are manufactured in accordance with ISO 13485:2003.
KYERON has developed an approved quality management system and has
been ISO 9001 certified. This ISO 9001 certificate was awarded by our notified body BSI Global.
General Requirements
KYERON has established, documented, implemented and maintained a quality management system and shall continually improve its effectiveness in accordance with ISO 9001:2000.
KYERON has:
| 1) | Identified the processes needed for the quality management system and their application throughout KYERON |
| 2) | Determined the sequence and interaction of these processes |
| 3) | Determined criteria and methods needed to ensure that both operatiion and control of these processes are effective |
| 4) | Ensured the availability of resources and information necesarry to support the operation of these operations |
| 5) | Monitored, measured and analyzed these processes |
| 6) | Implemented actions necessary to achieve planned results and continual improvement of these processes |
Management Commitment
The management of KYERON provides evidence of its commitment to the development and implementation of the quality management system described in the quality assurance manual and continually improving its effectiveness.
Quality Policy
The management of KYERON ensures that the quality policy:
| 1) | Is appropriate to the purpose and delivery of medical products to specified requirements including after sales services |
| 2) | Includes a commitment to comply with the requirements and continually improve the effectiveness of the quality management system |
| 3) | Provides a framework tor establishing and reviewing quality objectives |
| 4) | Reviewing for continuing suitability |
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