Medical device manufacturers are ultimately responsible for the products they make and sell, even if they outsource some or all of their manufacturing or other operations. To ensure that products are safe and meet the claims made for them, the U.S. Food and Drug Administration (FDA) and other regulatory bodies are looking to the companies that sell the product to have sufficient control over their suppliers.
Quality agreements with suppliers can go a long way to demonstrating the kinds of control that medical device manufacturers have over their suppliers.
A good supplier quality agreement takes the guesswork out of the process of deciding who – the manufacturer or the supplier – is responsible for what and how communication should work between the two. It specifies what is expected of both parties and spells out the roles for each type of activity or document.
Supplier quality agreements may vary from company to company, but all generally include:
Note that quality agreements are not supply agreements. The FDA recommends that the quality agreement be a separate document from the supply agreement, though it may be included by reference in the main supplier agreement.
Critical and key suppliers should have quality agreements, as should outsourced processes related to the manufacture of your product:
Outsourced processes are a part of the manufacturing process that the manufacturer doesn’t control directly. Quality agreements are one working tool, in addition to process validation, that can be used to maintain control over outsourced processes.
While the FDA doesn’t require medical device manufacturers to have a quality agreement, FDA 21 CFR 820.50 requires that companies control all their suppliers, including providers of materials, services, consultants, and contractors, if they could have an effect on product quality or the quality system. ISO 13485 section 7.4.1 includes purchasing control requirements that would be best achieved with the use of a quality agreement as a tool.
Although it is in a supplier’s best interest to maintain a high standard of quality, the regulatory burden ultimately rests on the company receiving the supplier’s product or service. Quality agreements can play a crucial role in helping companies demonstrate to regulatory agencies that they are properly controlling their suppliers.
Quality agreements are an essential part of the relationship between a manufacturer and its suppliers and contractors. These documents help both the manufacturer and the supplier understand their roles, responsibilities, and expectations. In addition to demonstrating proper control of contract manufacturers and critical and key suppliers, quality agreements can also provide clarity, foster good communication, and facilitate smoother operations for both the manufacturer and the supplier.
Enjoying this blog? Learn More.
How to Successfully Manage Your Suppliers and Ensure Product Safety and ComplianceDownload Now