The Notified Body Operations Group (NBOG) is an organisation that provides European notified bodies with guidelines on how to audit a specific requirement, in this case the requirement to inspect suppliers according to ISO 13485. In other words, if you need a European notified body to audit your ISO 13485 implementation, it will look for it. Therefore, medical device manufacturers should use these two documents in the design of their supplier control program. This article specifically addresses quality agreements, one of the concerns of these guidance documents. Quality agreements can go a long way in demonstrating the type of control manufacturers have over their suppliers and can also be extremely useful for manufacturers. A good supplier quality agreement can remove the guesswork from the decision-making process who (either the manufacturer or the supplier) is responsible for what and how the communication between the two should work. Companies often have written agreements with their main suppliers, but these are often delivery agreements that focus on financial and legal agreements between the two. Quality or quality assurance agreements (QAAs) are best kept separate from supplier agreements, although they are usually included in the main contract by reference. Supplier and quality agreements should be at least somewhat separated, since agreements with suppliers often require legal review, the authorisation of a company manager and the relationship between the manufacturer and the supplier can exist for many years. On the other hand, quality agreements, such as annexes such as annual prices and quantities, must be flexible, based on daily operation and easy to amend if necessary without legal verification. In Figure 2, you will find the main points of the supplier agreements and the SAQ. Conversely, a delivery contract describes how the supplier promises to deliver all the goods or services indicated over a specified period of time and at what cost. It also includes the buyer`s obligations as to when and how the goods are purchased.
The supply agreement facilitates the management of cooperation between companies, removes ambiguities and provides the framework for how goods and services are ordered and delivered. Betty Lane has over 20 years of experience in medical device quality assurance and regulatory affairs….