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. Implementation of a quality written agreement can facilitate compliance with the CGMP, and in particular with 21 CFR 211.22 (d), which stipulates that the activities and procedures of the quality unit must be written down.
The FDA recommends that owners and contract organizations enter into a written quality agreement to describe their respective roles, responsibilities and activities related to the CGMP in drug manufacturing. The FDA in 21 CFR 820.50 requires companies to control all their suppliers, including suppliers of materials, services, consultants and contractors, if they can have an impact on product quality or quality system. Clause 7.4.1 of Iso 13485 provides that device manufacturers have a procedure that contains the following requirements: Which supplier should have QS agreements? It is neither expected nor desirable for all suppliers to have SAQ agreements. However, critical and important suppliers should have all SAQ agreements and all outsourced processes related to the manufacture of your product should be considered for SAQ agreements. See Figure 4 for definitions of critical suppliers. In addition to critical suppliers, major suppliers may be those that come from one hand for a key component or material, even if the component or material does not affect product safety, those with long delivery times, or those that do not have a certified quality management system. Contract manufacturers need saQ agreements because they act on behalf of the manufacturer and perform a large number of transactions that the manufacturer does not directly control. The SAQ agreements are how the manufacturer can have maximum control over the manufacturer without interfering with the actual operation of the contract manufacturer.