Supplier Quality Requirements

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The Supplier identified on the purchase order (“Seller”) agrees to incorporate the quality requirements outlined below and implement where appropriate in accordance with the Supplier’s business and the Products and Services being provided to Saunders Instruments as identified in the purchase order. 

The Supplier agrees to ensure that Products/Services meet Saunders Instruments requirements and specifications.

The Supplier agrees to notify Saunders Instruments of any changes in the product, service, processes, or manufacturing location(s) so that Saunders Instruments may determine whether the changes will affect the quality of a finished device. 

The Supplier shall notify the buyer of any change in design and obtain Saunders Instruments approval prior to delivery of any product which includes the changed design.

The Supplier agrees to maintain a documented quality management system.

The Supplier agrees to notify Saunders Instruments of any changes to the quality management system including certification, recertification, or withdrawals.

Raw Materials Suppliers shall ONLY use the material specified on the drawing or purchase order to fabricate components.

Material Certifications shall be maintained on file at the supplier’s facility and made available upon request to Saunders Instruments.

All raw materials shall be identified and directly traceable to the certifications that demonstrate the material's conformance to stated requirements.

Raw materials shall be stored and handled in such a way that it will not degrade or become contaminated. Storage and handling shall not result in the raw material no longer conforming to material certifications, material standards, or acceptance specifications.

Surplus materials, including remnants, coverage, and scrap, that cannot be traced directly to its certification shall not be used.

Alternate forms of raw materials (e.g. plate, bar, sheet, etc.) that are not specified on the drawing shall not be substituted.

Saunders Instruments reserves the right to test raw material or require that a supplier test raw material at a Saunders Instruments approved independent lab to confirm that the material is conforming to stated standards, acceptance specifications, or material certifications.

Special process certifications shall be maintained on file at supplier's facility and made available upon request to Saunders Instruments.

Special processing requirements that are required by the specified requirements (e.g. heat treatment, chemical treatment, painting, cleaning, etc.) must be certified by the supplier.

If the Supplier receives any complaints related to the product, or any similar product or becomes aware of potential deficiencies or defects the Supplier will promptly notify Saunders Instruments. If Saunders Instruments receives a complaint related to the Supplier’s product, Supplier will fully co-operate with the investigation, inspection, or inquiry regarding the Products.

Saunders Instruments shall have the sole authority to declare a recall of any Products if Saunders Instruments believes there is or may be a potential significant health hazard or non-compliance with applicable government regulations.