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. Your supplier or contract manufacturer is your partner, which is why you want to let them know in advance what it takes to succeed and win your future business. Supplier Quality Assurance Agreements (QS) can play a crucial role in helping companies show regulators not only that they control their suppliers properly, but also that they are informed and know what their suppliers are doing. Manufacturers of all types of medical devices are responsible for the product they manufacture and sell. However, more and more companies are relocating some or all of their production or other activities.

Regulators and certification bodies are therefore interested in companies that sell the product in order to have sufficient knowledge and control of their suppliers to ensure that the products are safe and meet the requirements imposed on them. This article explains why supplier agreements are desirable and sometimes even necessary, which suppliers should have agreements on supplier quality and what should be included in these agreements. Because it`s not only your suppliers that can damage your reputation, but also your suppliers` suppliers. To achieve these benefits while reducing risk, many companies are turning to supplier quality agreements to ensure compliance with internal and regulatory standards. Further changes to ISO 13485 are intended to further reduce supplier risk and improve quality. Purchasing information has been reformulated and specified in the standard to ensure that purchase requirements are met, including specifications, product acceptance, supplier qualifications and quality system requirements. Like the FDA Quality System (QSR) Regulation, a written agreement must be reached to indicate that changes to the purchased product must be notified prior to the implementation of the amendments.