High Criticality Region – the risk associated to these suppliers is high Supplier selection is performed through vendor assessment questionnaire.Īt least an yearly audit shall be performed in the framework of supplier evaluation Medium Criticality Region – the risk associated to these suppliers is medium Supplier selection is performed based mainly on price and other practical reasons. Low Criticality Region – the risk associated to these suppliers is low Method for Supplier Evaluation and Selection ![]() As a consequence, different actions shall be performed according to the risk profile associated to the vendor.įor example, it is possible to identify three different regions: Criticality Region One of the most simple one is to give a score to each supplier based on different parameters and then identified the risk profile associated to the supplier based on the given score. Obviously there are a lot of different methodologies for the implementation of this requirements. One of the key requirements associated to Supplier Management according to ISO 13485:2016 is the risk-based approach for supplier evaluation and selection. Implementation of a Risk-Based Approach for Supplier Management Supplier monitoring may include 2nd party audits for the most critical suppliers. The supplier re-evaluation is typically performed on an yearly base and it is related to the overall performance of the supplier. Two other very important processes in the framework of supplier managements are supplier monitoring and supplier re-evaluation. The monitoring of the supplier is the evaluation of the performance on a continuous and proactive basis to ensure to take actions immediately if any issue occurs. ![]() the risk associated with the medical device.the effect of the purchased product on the quality of the medical device.the supplier’s ability to provide product that meets the organization’s requirements.The standards properly defined the criteria that shall be used for supplier specifically the criteria shall be decided by the organization according to : Regarding the Purchasing Process, the requirements of this section are mainly related to the so-called supplier selection and supplier evaluation.
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