XXXX有限公司 （中德合资）
质 量 管 理 手 册
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目录
第一章 总则···························································3 1、1 目的··················································3 第二章 质量标准及检验标准··································3 2、1 质量标准及检验规范的范围规范···························3
2、2 质量标准及检验标准的制订···························3 2、3 质量标准及检验标准的修订···························4
第三章 仪器管理············································4
3、1 仪器校正、维护计·····································4 3、2 校正计划的实施·····································4 3、3 仪器使用与保养···································5
第四章 原材料质量管理··········································6
4、1 原料质量检验·······································6
第五章 制造前质量条件复查···································6
5、1 制造通知单的审核································6 5、2 生产前制造及质量标准复核····························6
第六章 制程质量管理···················································7
6、1 制程质量检验········································7 6、2 制程自动检查········································8
第七章 产品质量管理················································9
7、1 产品质量检验···················································9
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7、2 出货检验····················································9
第八章 质量异常反应及处理·······································9
8、1 原料质量异常及反应·····································9 8、2 半成品与成品质量异常反应及处理························10 8、3 制程间质量异常反应·····································10
第九章 产成品出厂前的质量检查····································11
9、1 产成品缴库管理··········································11 9、2 检验报告申请工作·········································11
第十章 产品质量确认························································12
10、1 质量确认·················································12 10、2 确认样品的生产、取样与制作······························13 10、3 质量确认书················································13 10、4 质量确认处理期限及追踪····································14
第十一章 质量异常分析改善·········································15
11、1 制程质量异常改善··················································15 11、2 质量异常统计分析·················································15 11、3 实施与修订···············································16
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第一章 总则
第一条 目的
为保证质量管理工作的顺利开展，及时发现问题，并能迅速处理，确保和提高产品质量，使之符合管理及市场的需要，特制订本制度。
第二章 质量标准及检验标准
第二条 质量标准及检验规范的范围规范包括： 1.原料质量标准及检验标准； 2.半成品质量标准及检验标准； 3.产品质量标准及检验标准。 第三条 质量标准及检验标准的制订 1.质量标准
生产管理部会同质量管理部、生产部、营销部、研发部及有关人 员依据“操作规范”，并参考国家标准、行业标准、国际标准、客户需求、本身制造能力以及原料供应商水准，分材料、半成品、产品填制“质量标准检验及规范制(修)订表”一式二份，报总经理批准后，质量管理部一份，研发部一份，并交有关单位凭此执行。
2.质量检验标准
生产管理部会同质量管理部、生产部、营销部、研发部及有关人员，分原料、半成品、产品将检查项目规格、质量标准、检验频率、检验方法及使用仪器设备等填注于“质量标准及检验规范制(修)订表”内，交有关部门主管核签并且经总经理核准后分发有关部门。
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第四条 质量标准及检验标准的修订
1.各项质量标准、检验规范若因设备更新、技术改进、制造过程改善、市场需要以及加工条件变更等因素变化时，可予以修订。
2.生产管理部每年年底前至少重新校正一次，并参照以往质量实绩会同有关部门检查各规格的标准及规范的合理性，予以修订。
3.质量标准及检验标准修订时，生产管理部应填“质量标准及检验标准制(修)订表”，说明修订原因，并交有关部门主管核签，报总经理批示后，方可凭此执行。
第三章 仪器管理
第五条 仪器校正、维护计划 1.周期设订
仪器使用部门应依仪器购入时的设备资料、操作说明书等资料，填制“仪器校正、维护基准表”设定定期校正维护周期，作为仪器年度校正、维护计划的拟订及执行的依据。
2.年度校正计划及维护计划
仪器使用部门应于每年年底依据所设订的校正、维护周期，填制“仪器校正计划实施表”、“仪器维护计划实施表”作为年度校正及维护计划实施的依据。
第六条 校正计划的实施
1.仪器校正人员应依据“年度校正计划”执行日常校正、精度校正作业，并将校正结果记录于“仪器校正卡”内，一式一份存于使用部门。
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XX公司质量管理手册
