ISO13485：2016&FDA-QSR820医疗器械管理体系全套表单-中英文对照版
合格外发加工/生产商名册ApprovedSupplierList AVL 合格供应商名册ApprovedVendorList CPAR 纠正及预防措施要求书CorrectiveandPreventiveActionRequest SCAR 供应商纠正措施报告SupplierCorrectiveActionReport DCC 文控中心DocumentControlCentre DHF 完成器材的设计历史之编纂纪录 ...
ASL合格外发加工/生产商名册ApprovedSupplierList AVL合格供应商名册ApprovedVendorList CPAR纠正及预防措施要求书CorrectiveandPreventiveActionRequest SCAR供应商纠正措施报告SupplierCorrectiveActionReport DCC文控中心DocumentControlCentre 完成器材的设计历史之编纂纪录 ...
ISO13485：2016&FDA QSR820采购及外发加工控制程序-中英文对照
8.AVL:认可的供货商清单(ApprovedVendor List) 9.BOM:物料清单(Bill OfMaterial) 10.BPR:企业流程再造(BusinessProcess Reengineering) 11.BSC:平衡记分卡(BalancedScoreCard) 12.BTF:计划生产(Build ToForecast) 13.BTO:订单生产(Build To Order) 14.CPM:要...
Approved Vendor List 认可的供货商清单 QCD Quality cost delivery 品质,交期,成本 MPM Manufacturing project management 制造专案管理 KPI Key performance indicate 重要绩效指标 MVT Manufacturing Verification Test 制造验证试产 Q/R/S Quality/Reliability/Service 质量/可靠度/服务 STL ship to line 料到上线 NTF...
Redundant testing at the purchasing manufacturer may not be necessary if the testing methods at the vendor are approved by the purchasing manufacturer. Custom reagents, such as monoclonal antibodies, enzymes, other proteins, uncommon amino acids and derivatives, or glycolipids, used in purification or...
the raw material approved vendor may be specific to a customer DMF filing. Since you have not challenged the system by setting different vendor codes for the same material (or use entirely different SAP material codes), you cannot...
(采购订单) purchaserequest aql:acceptablequality level允收品质水准lql;limiting quality level最低品质水准qvl:qualified vendor list合格供应商名册avl:认可的供货商清单(approved vendor list) qcd: quality cost delivery(品质,交期,成本)mpm:manufacturing project management制造专案管理kpi:key performance indicate...
Vendor Information Files Approved Vendor List Requalification Schedule Standard Operating Procedures (SOPs) Other Programs that Feed the Vendor Qualification Program Change Control Complaint Handling CAPAs Deviation Management Sales The Question Phase - What a Potential Vendor Needs to Supply ...