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Supplier Quality Agreements

October 10th, 2021

What does all this mean for life sciences organizations? This means that quality management systems must involve suppliers and outsourced people by informing them of product specifications and requirements and ensuring that they cooperate and communicate relevant changes. This means that the quality management system must be fully integrated with properly structured data, to ensure that all supplier activities, initial material inspection results, supplier deviations, supplier corrective actions and audit results are continuously integrated into the process of monitoring and reassessing supplier performance. This is the key to achieving the preventive and predictive signals that significantly improve the quality of your business and the achievement of customer expectations. Further changes to ISO 13485 aim to further reduce supplier risks and improve quality. Procurement information has been reformulated and specified in the standard to ensure compliance with purchasing requirements, including specifications, product acceptance, qualification of supplier personnel and quality system requirements. Like the FDA Quality System Regulation (QSR), a written agreement must be reached stating that any changes to the purchased product must be notified prior to the implementation of the changes. Iso has strengthened the wording relating to the verification of purchased products to ensure that it is appropriate on the basis of the supplier`s assessment and proportionate to the risks associated with the purchased part. Communication with your suppliers is key. Your nearby and remote suppliers need to know that the changes they`ve made affect the products you make. Written agreements help with understanding between your organizations. The Notified Body Operations Group (NBOG) is an organisation that provides European notified bodies with guidelines on how to audit a specific requirement, in this case the requirement to inspect suppliers according to ISO 13485. In other words, if you need a European notified body to audit your ISO 13485 implementation, it will look for it. Therefore, medical device manufacturers should use these two documents in the design of their supplier control program.

This article specifically addresses quality agreements, one of the concerns of these guidance documents. Quality agreements can go a long way in demonstrating the type of control manufacturers have over their suppliers and can also be extremely useful for manufacturers…


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