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Simple Quality Agreement

The supplier`s quality agreement is a comprehensive written agreement (usually supplemented by a checklist) that defines and defines the quality and GMP (Good Manufacturing Practice) obligations of the design owner and the supplier. A quality agreement is an important part of a supplier qualification program, but it does not replace supplier qualification processes (including audits if necessary) or understanding of the supplier, its processes and competencies. A quality agreement should not contain commercial or liability terms that should only be addressed in a supply agreement. I recommend launching a supplier quality agreement from the beginning of development. Maintaining quality in your supply chain at the beginning of the game certainly can`t hurt. If you educate your suppliers at an early stage and work productively with them at this stage, surprises will be avoided later in the development cycle – if it`s too late to change a key component or supplier. Conversely, a delivery contract describes how the supplier promises to deliver all the goods or services indicated over a specified period of time and at what cost. It also includes the buyer`s obligations as to when and how the goods are purchased. The supply agreement facilitates the management of cooperation between companies, removes ambiguities and provides the framework for how goods and services are ordered and delivered. 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.

The duration of the SQA between two parties or whether it would take time normally depends on the changes made by both parties. Knowing the differences can help us know which document to use, but when? So, which one should you use and when to use it? The first step is to understand the unique differences in each document and then recognize how together they form a foundation for all aspects of a business relationship with a supplier. While it`s important to secure long-term care and maintain the current configuration of a component crucial to the design of your medical device, the process may require a little more complexity. Typical components that can be subject to controls are those that are exclusively purchased or that are essential for the performance or safety of your medical device. A supplier quality agreement or delivery agreement may be required….

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