KMC Systems Documents Sample Clauses

KMC Systems Documents. 5.7.1.1 781-02003: Control of Assembly Work Instructions
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KMC Systems Documents. 5.9.1.1 781-06001: Supplier Section, Approval Quality Rating 5.9.1.2 781-06003: Purchase Orders
KMC Systems Documents. 5.10.1.1 781-03015: Controlled Release of Material
KMC Systems Documents. 781-03017: Control and Maintenance of Inspection, Measuring, and Test Equipment and Tool Control 781-03007 will be used as required for any equipment not controlled by NxStage.
KMC Systems Documents. 781-03017: Control and Maintenance of Inspection, Measuring, and Test Equipment and Tool Control 781-03007 will be used as required for any equipment not controlled by NxStage. 5.19 Return Material Procedure 5.19.1 KMC Systems Documents: 781 -02008: Control of Returned Item/Product will be used to control and document returns to KMC. Warranty information will be defined in the contract between KMC and NxStage. The Manufacturing Team Leader will supply a RMA number at NxStages's request for a return. 5.20 Product Release Procedure 5.20.1 KMC Systems Documents: 781-03013: Product Audit/Release for Shipment. 5.20.2 After the successful completion of testing, accepted units will be submitted to Quality for Product Audit. 5.20.3 The Quality acceptance for the "release for shipment" (acceptance of unit to be moved to packaging/shipping) of each NxStage System One Cycler will be based upon successful completion of processing, testing, and labeling per the Device Master Record. This will include but is not limited to passing the latest revision of the Acceptance Test Procedures (ATP), XxXxxxx Xxxxxxxx # XX0000 along with Quality acceptance after completion of the Product Audit, procedure 921-00004ACR. 5.20.4 Spares may be supplied to NxStage as requested. For value added spare assemblies KMC Quality inspection is required as defined in 781-03013, Product Audit/Release for Shipment. Non-value added spares, parts Page 14 0f 16 <PAGE> KMC Systems, Inc. Document # 920-00102ACR Rev C XXXXXXXXX, XX 00000, X.X.X MANUFACTURING PROGRAM/QUALITY PLAN KMC PROPRIETAR supplied as received by KMC with no alteration after inspection and acceptance by the receiving inspection, will be shipped, no additional Quality inspection required. Non-value added spares will be defined as part of the Release for Shipment database under routing exceptions. 5.21 Device Master Record Index 5.21.1 KMC Systems Documents: 781-03005: Device Master Record Index. 5.21.2 The Device Master Record is a compilation of records containing the procedures and specifications for the finished device (from FDA, Quality System Regulation (QSR), 21 CFR Part 820.3). 5.21.3 A Device Master Record Index (DMRI) will list the location of the specifications and procedures required in the manufacture of the device. The DMRI for the NxStage System One Cycler, Document 800-00041ACR, will be maintained at KMC Systems. 5.21.4 A copy will be provided to NxStage Medical. 5.21.5 The Device Master Record Index will require the a...

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