Common use of Quality Systems Requirements Clause in Contracts

Quality Systems Requirements. Seller will establish and maintain formal quality systems and processes that are compliant with the FDA's Quality System Regulation ("QSR") and ISO 13485, and shall use its commercially reasonable efforts to ensure that all of Seller's Suppliers are compliant therewith to the extent that compliance by such Suppliers is required thereunder. Such systems and processes will be provided and maintained at all times during the term of this Agreement by Seller and, to the extent reasonably practicable, all Suppliers to the extent required under the QSR and/or ISO 13485. Any and all special quality system requirements for the Products shall be provided by or agreed to by Buyer via the Specifications for the Product or as subsequently changed via Seller's ECO processes, in writing, at the time of Purchase Order. Seller will inform Buyer and obtain prior approval in accordance with Seller's ECO process, as described under Section 1.4, for any changes to be made, including changes with respect to Seller's Suppliers, that can affect the form, fit or function of the Products.