target group
Medical device manufacturers and suppliers, QM managers, complaints processing, change managers, purchasing and supplier support as well as internal auditors.
content
Purchasing processes are central elements of a quality management system in the medical device industry. In addition to the procurement of materials, components and auxiliary materials, they also include the processes for controlling the outsourced manufacturing processes and services. The seminar gives an overview of the legal and normative requirements that have to be implemented in these processes. It shows how the purchasing processes are integrated into the product life cycle and what connections there are to risk management. In particular, methods and criteria for supplier qualification, the content of quality assurance agreements and specifications are explained. Finally, methods for continuous supplier evaluation including the regular auditing of suppliers are shown.
topic overview
- Basics of supplier management - corporate philosophy, goals
- Integration of supplier management processes into the phases of the product life cycle
- Legal and normative requirements for manufacturers of medical devices
- Groups of supplier evaluation criteria for qualification, initial evaluation
- Purchasing specifications, contract requirements (quality assurance agreements)
- Supplier monitoring and development
- Supplier audits as a method for initial and follow-up assessment, based on ISO 19011
previous knowledge
Prior knowledge of quality management and the manufacture of medical devices is recommended, but not mandatory.
KONTAKT:
Max-Planck-Straße 17, TuttlingenBeruflichen Bildungsstätte Tuttlingen & Online
