Nbog Quality Agreement

Betty is the founder and president of Be Quality Associates, LLC, a consulting firm that helps medical technology companies implement and improve their quality systems to improve their businesses and comply with legislation. Other services include training, audits, vendor management and software validation validation for medical devices. 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 [1]. 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. 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.

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