content
The seminar shows the effects of DIN EN ISO 13485 and VO 2017/745 MDR on supplier qualification in medical technology for manufacturers / distributors. The seminar will show how medical devices can be classified. Based on practical examples, the criticality of the suppliers is determined, the risk assessment is carried out and the classification of the suppliers according to risk classes is determined. Furthermore, the quality assurance agreement is examined in an example with regard to the criticality of the medical devices. The impact of the criticality on the technical documentation and on supplier audits is shown.
topic overview
- Criticality of suppliers according to DIN EN ISO 13485, chap. 4.1.2 and 4.1.3, the control of quality management processes and the associated process results
- Risk assessment of purchasing processes / assessment criteria
- Classification of suppliers according to risk classes of medical devices
- Effects on out-of-house processes
- Influence on the quality assurance agreement and the technical documentation
- Impact on supplier audits
target group
Employees from the areas of purchasing, QM and management, supplier auditors.
previous knowledge
DIN EN ISO 13485, VO 2017/745 MDR.
KONTAKT:
Max-Planck-Straße 17, TuttlingenBeruflichen Bildungsstätte Tuttlingen
