The QMS is your number one tool to reduce risk and ultimately apply your agreement. The increased visibility associated with a strong agreement is what guides you to a successful relationship. And at the end of the day, it`s much more efficient to invest in long-term supplier relationships than to have to rebuild new ones from there. You should also be sure that your agreement specifies what comes with the materials they provide, to what degree of purity, to what extent and in the delivery framework. What kind of process validation do you need? Do you need information about the process or just a certificate of analysis for the final product they provide? It is important that you specify what should be in the certificate of analysis in order to demonstrate the identity, quality and purity of the product. The first step is to understand the unique differences in each document and then understand how they together form a basis for all aspects of a business relationship with a supplier. The Physical Operations Group (NBOG) is an organisation that provides instructions to European notified bodies to review a specific requirement, in this case the supplier`s requirement for ISO 13485. This means that if you need a European notified body to check your ISO 13485 implementation, that`s what they`ll be looking for. Therefore, medical device manufacturers should use both documents in the design of their vendor management program. In this article, special attention will be paid to quality agreements, one of the concerns of these guidelines. Quality agreements can show a long way to demonstrate the type of control that manufacturers have over their suppliers and can also be very useful for manufacturers.
A good supplier quality agreement can take the guesses of the process of deciding who is responsible (either the manufacturer or the supplier), for what and how communication between the two should work. 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. The supplier quality agreement is a comprehensive written agreement (usually supplemented by a checklist) that defines and defines the quality and good manufacturing obligations (GMP) of the design owner and supplier. A quality agreement is an essential part of a supplier qualification program, but it does not replace the supplier`s qualification processes (including audits when needed) or the supplier`s understanding of its processes and skills.