Distributor Quality Agreement

Posted by on April 9, 2021

In summary, the SAQ agreements are not only the expected control method for high-risk suppliers, but can also ensure clarity and fluidity of procedures for both the manufacturer and the supplier. Distributors should have SAQ agreements because they are directly linked to the customer and the extent of their responsibilities can have an impact on both quality and regulatory. For example, when action on the ground is required, it is important that a trader is cooperative and has the necessary information. In addition, devices that require installation and/or service and are often the responsibility of a distributor can seriously affect the safety and operation of a device. Outsourced processes are again part of the manufacturing process that you do not directly control as a manufacturer. There are often processes that you can`t just check have been done properly. SAQ agreements are one way to keep control of outsourced processes in addition to validating processes that you can use. As requested in the above guidelines, the risk should be taken into account when deciding on the nature of supplier control. High-risk outsourced processes and high-risk outsourced processes, such as contract sterilization, design and development, are examples of processes that are generally considered key or critical and therefore expect quality agreements. Companies often have written agreements with their main suppliers, but these are often supply agreements that focus on financial and legal agreements between the two.

Quality or quality assurance (QS) agreements are best held separately from supplier agreements, although they are generally included in the main reference delivery contract. Supplier and quality agreements should at least remain somewhat separate, as supplier agreements often require legal review, approval from a business leader and can endure for many years the relationship between manufacturer and supplier. On the other hand, quality agreements, such as prices. B annuals and annual quantities, must be flexible, based on daily operation and, if necessary, easily modified without legal verification.

Last modified on April 9, 2021

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