QMS is your most important tool for reducing risk and ultimately enforcing your agreement. Increasing visibility combined with a strong match is the one that prepares you for a successful relationship. And at the end of the day, investing in long-term supplier relationships is much more effective than having to rebuild new ones from bottom to account. 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. A good supplier quality agreement can remove the guesswork from the decision-making process who (either the manufacturer or the supplier) is responsible for what and how the communication between the two should work. Laura Meyer is head of procurement at StarFish Medical.
As a lean facilitator, Laura helps optimize supply chains for customer prototypes and manufacturing. She is happy to share her know-how with her colleagues and clients. No quality or supply agreement exempts the label owner from its product quality requirements in accordance with 21 CFR Part 111 or other regulatory obligations. The biggest mistake that is made is that the brand owner/distributor of brand labels is trying to deflect these important quality obligations to the CMO. Since they always assume the final responsibility for the quality of the product, the owner of the own trademark /distributor is always the party responsible for introducing the product into the trade. While quality agreements are not necessary at present, the FDA has proposed on its website a guidance document for establishing a quality agreement. A careful reading of the warning letters issued by the FDA shows that quality agreements are becoming a fundamental requirement throughout the industry. . .