Simple Quality Agreement

The supplier quality agreement is a comprehensive written agreement (usually supplemented by a checklist) that defines and defines the quality and good manufacturing obligations (GMP) of the design owner and supplier. A quality agreement is an essential part of a supplier qualification program, but it does not replace the supplier`s qualification processes (including audits when needed) or the supplier`s understanding of its processes and skills. A quality agreement must not include trade or liability conditions that should be dealt with exclusively in a supply contract. I recommend that a supplier quality contract be put in place at the beginning of the development process. Maintaining quality in your supply chain at the beginning of the game certainly can`t hurt. If you start educating your suppliers and working productively with them at this point, avoid surprises later in the development cycle – if it may be too late to change a key component or supplier. Conversely, a delivery contract explains how the supplier promises to provide all goods or services reported over a period of time and at what cost. It also includes the buyer`s obligations as to when and how the goods are purchased. The delivery agreement helps to facilitate the management of companies working together, eliminates ambiguities and establishes the framework for ordering and delivering goods and services. Normally, the question of the duration of a SQA between two parties depends or depends on the changes of one of the two parties.

Knowing the differences can help us move towards the document to use, but when? Which one should support and when to use it? The first step is to understand the unique differences in each document and then understand how they together form a basis for all aspects of a business relationship with a supplier. Laura Meyer is supply chain manager at StarFish Medical. As a lean moderator, Laura helps optimize supply chains for customer models and manufacturing. She willingly shares her know-how with her colleagues and clients. While it is important to secure long-term care and maintain the current configuration of a component crucial to the design of your medical device, the process can become a little more complex. Typical components that can be checked are those that are exclusively intended for the performance or safety of your medical device. A supplier quality contract or delivery contract may be required.

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