Content
Value creation and core competence – driving factors for outsourced processes. The decision to outsource processes is often made quickly - but as recent audits have shown, the consequences are not taken into account. The external provision of processes, services or products does not relieve responsibility for the final medical product - over the entire life cycle.
So how does an organization ensure that requirements are identified and met, quality is ensured and the safety and performance of the medical device is guaranteed at all times?
ISO 9001 summarizes the following requirement in Section 8.4: “Criteria for selection, assessment, performance monitoring and (continuous) re-evaluation”. DIN EN ISO 13485 describes right from the start that it can also be applied to outsourced processes - this means that external and internal processes can be controlled. The requirements are then described specifically in Section 7.4. In particular, clear communication is also mentioned. The EU MDR initially only requires a general QM system - however, it allows the notified body to carry out unannounced/unannounced inspections on the premises of economic operators as well as suppliers and/or subcontractors. Mostly applicable here for critical suppliers.
Topic overview
- Requirements and methods for the selection and classification, control, clear communication and evaluation of outsourced processes
- Terms and examples
- Types of outsourced processes
- Requirements for the resources, processes, methods and infrastructure of the outsourced processes as well as obligations of the legal manufacturer
- Dealing with changes, non-conformities (SCAR), obligations and escalations
- Implementation, communication and control (strategic and operational) of outsourced processes
target group
People from procurement, development, supplier management, product management and quality management.
Prior knowledge
Not required.
Funding opportunity
ESF funding is possible. Further information can be viewed here .
Early bird discount
If you register up to 3 weeks before the start of the seminar, you will receive an early bird discount of 10 percent.
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