Companies that supply a manufacturer with components are a critical part of your manufacturing process. If you manufacture medical devices, there are numerous requirements for control of these suppliers. The FDA essentially considers a supplier an extension of the manufacturer, meaning that the service/material supplied must meet pre-established specifications. According to 21 CFR 820, “Each manufacturer shall establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants.”
The manufacturer’s role requires them to perform a balancing act between risk, cost and quality while maintaining compliance with all regulations. The best approach of this is to think of your suppliers as if they were a part of the in-house production process. This essentially requires you to determine what shall be required of your quality systems, focusing on change control and CAPAs. Manufacturers are expected to work with their suppliers to establish critical controls, limits and periodic reviews of the process controls. There is a minimum requirement to have these quality controls in place: change control for design and processes, process controls, and supplier quality assurance for your critical suppliers.
ISO 9001 also addresses supplier management. This standard expects you to evaluate and select your suppliers based on their ability to meet your production or design needs. Once you define what requirements your company needs to have met, you can start the process to select your suppliers. From there, you will compile a list of your approved suppliers, known as an Approved Supplier List. This list will be part of your quality management system.
There must be a clear definition of what criteria is being used to evaluate suppliers. This isn’t defined by any regulation, but has to be determined per company needs and resources.
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