Your supplier contract or any work procedures or instructions associated with it should clearly specify which suppliers must have SAQ agreements and which suppliers should be considered for these agreements. The procedure should also indicate the content of the SQ agreements and specify who is responsible for the development, approval and modification of these agreements. At least quality and related services (usually companies or manufacturing companies) should approve these agreements. The number of admissions should be maintained at a high enough level that agreements are flexible enough to remain up to date, as required by experience and events. While your procedure should define the areas that should be covered by an SAQ agreement with a supplier, the SAQ agreements should always be developed jointly between you and the supplier. None of the parties should take anything for granted. These agreements are a working tool that helps you and the supplier understand your roles and responsibilities and promote good communication between the two of you. The manufacturer should agree with the supplier on individual responsibilities and performance. Although you, the manufacturer, are ultimately responsible for the medical device, the supplier also has certain obligations. Below is a list of things to include in an SAQ agreement with a supplier, as they apply to the specific task of the supplier. The SAQ agreements should specify who is responsible for any type of activity or document. This includes who makes or creates it, who authorizes it, what indications are needed and when.
In Figure 5, you will find an example of how this can be clear and brief. Agreements should define methods and points of contact. Will there be a single person in each organization responsible for all communications or multiple authorized contact points? The agreement should contain contact information, including the names, business titles, phone numbers and email addresses of each contact. This part of the agreement often has its own amending provision, so it can be kept up to date without re-signing the entire agreement. In particular, where there is only one contact at the source on each site, an alternative must be provided for periods when the main contact is not available. 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.