OEM Contract new由刀豆文库小编整理，希望给你工作、学习、生活带来方便，猜你可能喜欢“contractbreach”。
OEM Agreement
(between OBL and OEM)
OBL / PLM :
OEM / Supplier:
(The following items should be covered in agreement:)
Scope of the agreement(devices / device groups concerned)范围
Period of agreement’s validity有效时间
Detailed specifications for the respective devices自由设备的详细描述
Conformation and proof(if poible OEM / supplier’s audit documents), that the products
purchased are identical to the certified ones.资质证明，产品的采购一样需要认证
Production site information including the place of production and labeling.Responsibilities for all activities relating to the production of the final product including validation, execution of packaging and affixing of labels.最终产品过程包括验证、包装、张贴标签
Regulations governing who is responsible for which changes to the device and in the
manufacturing proce are initiated, released, implemented and documented
Regulations governing who is responsible for which documentation(technical
documentation, DHR(Device History Record)etc.)incl.retention periods
Traceability information(Traceability of raw material / components)between OBL / PLM
and OEM / supplier. Agreement of OEM manufacturer that Intertek have the acce to critical production of OEM manufacturer. Obligation to provide information where there are changes to the status of the certificates
of the OEM
Right for the notify body and competent authorities of the PLM to examine the Technical
documentation for all devices supplied. The ability of both parties to transfer information as appropriate(e.g.as a result of production, customer complaints or post problems market surveillance). Agreement of OEM manufacturer to inform PLM about product changes and Intertek. Agreement both parties about Annex VII, section 4(Post-marketing clinical follow up and
vigilance system)
