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. 2 The manufacturer may not waive (contractually or otherwise) responsibility for one or all of the functions of the quality management system of a particular device. These include things such as customer vigilance and vigilance. This means that responsibility for meeting QMS`s requirements cannot be delegated to a supplier of a product and/or a service. 2 Definitions Suppliers Organization or person who provides a product, service or information and who is outside the manufacturer`s MQ . Conversely, a delivery contract explains how the supplier promises to provide all goods or services reported over a period of time and at what cost. It also includes the buyer`s obligations as to when and how the goods are purchased. The delivery agreement helps to facilitate the management of companies working together, eliminates ambiguities and establishes the framework for ordering and delivering goods and services. 5 They apply at all stages, from design to final control.
In its assessment, the notified body takes all necessary measures to design and/or manufacture a medical device implemented by the supplier. These include the supply of raw materials, components and services. Appendix II, point b), Of Directive 93/42/EEC, (b) Of Directive 93/42/EEC states that the design, manufacture and/or final control of products or items are carried out by a third party, that methods of monitoring the effective operation of the quality system and, in particular, the nature and scope of the control applicable to the third party must be included in the manufacturer`s examination of the notified body for evaluation. 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. I recommend that a supplier quality contract be put in place at the beginning of the development process. Maintaining quality in your supply chain at the beginning of the game certainly can`t hurt.
If you start educating your suppliers and working productively with them at this point, avoid surprises later in the development cycle – if it may be too late to change a key component or supplier. 6 suppliers are examples of a third party. The guidelines, in Appendix II of Directive 93/42/EEC, state that the evaluation team must have at least one member with previous experience in the evaluations of the technology concerned.