Advance Supplier Management Coming up with MDR

As having the new regulations, supplier quality management has come to be seen as the most important subheading of the Quality Management System and functions as a cyclical process linked to other parts of the Quality Management System .

The new requirements have made the supplier management process and supplier evaluations much more important than before. After determining what you will buy and what kind of supplier you need, when it comes time to find qualified partners, the first goal will be to plan and implement a consistent, risk-based approach to connecting with new suppliers.

According to the requirements of ISO 13485 Quality Management System, manufacturers should evaluate and select suppliers according to clear criteria, quality and safety impact.

It has been defined as an important part of the process to document the procedures described in the Quality Management System, the supplier evaluation and selection criteria, which will be mandatory, and then a record of the supplier evaluations that you have performed in addition to these documents.

Supplier evaluation is not designed as a one-time process. It is very important to

ensure that its performance is constantly monitored to ensure that it continues to meet the requirements defined after the supplier selection criteria have been approved and accepted as an approved supplier after the process. If it is observed that it does not meet the established quality requirements, the problem should be addressed and the necessary corrections should be made. It is necessary to carry out this approval process for suppliers, to conduct frequent and continuous monitoring, as well as to show the documents kept to show that the suppliers can meet the requirements of corrections when necessary, with records.

In particular, supplier validation has become one of the important processes to be considered in order to ensure sustainability, as well as supplier selection.