Distributors should have SAQ agreements, given that they are directly linked to the customer and that the extent of their responsibilities can have an impact both qualitatively and regulatoryly. For example, when action on the ground is necessary, 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 dealer can have a significant impact on the safety and operation of a device. Outsourced processes are in turn part of the manufacturing process that you don`t directly control as a manufacturer. There are often processes where you can`t easily check if they have been executed correctly. In addition to process validation, SAQ agreements are a way to allow you to keep control of outsourced processes. As required by the above-mentioned guidelines, risk must be taken into account in the decision on the type of control for suppliers. High-risk suppliers and high-risk outsourced processes, such as sterilization, contract design and development, are examples of processes that are normally considered key or critical and would therefore expect quality agreements. The FDA in 21 CFR 820.50 requires companies to control all of their suppliers, including suppliers of materials, services, consultants, and subcontractors, whether they may impact product quality or the quality system. ISO 13485, section 7.4.1, requires device manufacturers to have a process that includes the following requirements: Betty Lane has over 20 years of experience in quality assurance of medical devices and regulatory matters.
It has set up or updated quality systems for many small and medium-sized medical device and diagnostic companies. Their work allows companies to manage their operations in accordance with fda and ISO 13485 requirements and thus enable the global sale of their products. His background in the digital system allowed him to facilitate software design controls and validation as it became FDA and industry requirements. In summary, SAQ agreements are not only the expected control method for high-risk suppliers, but can also offer clarity and smoother procedures for both the manufacturer and the supplier. Betty is the founder and president of Be Quality Associates, LLC, a consulting firm that helps medical device companies implement and improve their quality systems both to improve their business and comply with legislation. Other services include training, auditing, supplier management and software validation for the medical device quality system. . . .