Quality assurance should prepare the agreement with manufacturing and laboratory staff on both sides. The functions of the SQ of both parties should review and approve the quality agreement. Nothing should be taken for granted. Each party must review the quality agreement to ensure that its requirements are taken into account. 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. A quality agreement must not include trade or liability conditions that should be dealt with exclusively in a supply contract. 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 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.