Supplier management: Supplier qualification and monitoring
Description
Medical device manufacturers, like manufacturers in a number of other sectors, outsource a range of processes. These processes include services such as development work or maintenance of equipment and manufacturing processes, for instance component manufacture, product or component finishing, and packaging and contract sterilisation. In medical technology, however, both the applicable standards and, in particular, legal regulations stipulate that these processes must be monitored and controlled using the company's own QM system. From a regulatory perspective, the manufacturer always remains responsible for outsourced processes.
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Goals
This seminar provides an overview of the requirements and policies that govern how to handle outsourced processes, and how they can be implemented effectively in practice. It explains the requirements for efficient collaboration that complies with all regulations from the manufacturer's and supplier's perspective. In particular, it outlines the required quality assurance agreements and specifications for both parties. It then explains methods for continuous supplier assessment, including supplier auditing.
Seminar content
- Overview of the requirements and policies for dealing with outsourced processes
- Current guidelines and how they are interpreted and implemented
- Defining an "outsourced process", defining a "critical" supplier and required rules
- Methods and required processes in the QM system for guiding outsourced processes
- Final inspections at the supplier, incoming inspections at the manufacturer
- Interfaces and communication with suppliers
- Requirements for contract developers and manufacturers, as well as service providers: Organisation qualifications (certificates, accreditations)
- OEM (Original Equipment Manufacturer) and PLM (Private Label Manufacturer) special circumstances
- Supplier auditing
- Required content of quality assurance agreements and specifications: Formal requirements, contractual content, corresponding product and service specifications
- Supplier and service provider monitoring, as well as monitoring by notified bodies and third parties
Target group / seminar duration and certificate
This seminar is suitable for specialists and managers within companies working in the medical device industry; it is also suitable for employees who are involved in supplier selection and qualification, such as staff with responsibilities in purchasing, development, production, regulatory affairs, product management and quality management.
The content is presented over the course of a one-day seminar. The participants receive a certificate of attendance and, on request, materials for participants in physical or digital form.
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