ISO9001:2015全套文件英文版(含质量手册及全套程序文件)

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ISO9001-2015年-全文下载-解释版

ISO9001-2015年-全文下载-解释版

■商函6.曰・ 运T3月3年4目■和4汪4肓1CD 闍征闻童见図DISR 投曹FDISM 苴秦FDIS^投福・3C2工作纽廂也 使命和战酩方蕖 •质医管犀原刖前 评审 •网鳍调査• ISO 轻则附怦SL验证和蕃认v狛关朮语冃宜与SC 1进行交盍i 与国际以E 论怎<I*IF>I羽I SO/CASCO <150^恪评逹绡却J肄训换版安排WDO —工性组苴案初稿工怙组岂秦CO —SJ 员余苴滾 sis —m 标准草童 FD IS —国I 阮标准就终IS09001 : 2015 标准针对 £09001:2008 标准的修订,由ISO/TC176/SC2 (国际标准化组织/质量管理 和质量保证技术委员会/质量体系分委员会)负责起草的征求意见稿已经发布。

原稿为英文 版,编译整理。

本编译稿便于大家了解新版标准的大体修订方向,后续正式版将会有更多 修订,一切以最终正式版为准。

ISO 9001:2015编写时间表ISO/TC 176/SC 2分技术委员会采用了 3年的标准编写时间期限,来对ISO 9001:2015 标准进行编与,拟定的编与时间表如口图 2所示。

图ISO 9001:2015编写时间表【导读】ISO9001 : 2015新版,再也见不到《质量手册》和《程序文件》这类中国人最难以理解的文件形式了,统一用 形成文件的信息”取而代之。

通篇也见不到 记录'这两个字 眼了,统一用 活动结果的证据”取而代之。

ISO9001 : 2015新版标准大量篇幅要求将 活动结果的信息(证据)形成文件”!注 意:这里是绝对不能断章取义的理解为 活动的信息(证据)形成文件”的。

如如: ISO9001 : 2015新版8.2.3条款与产品和服务有关要求的评审”仍然强调 评审结果的信息应形成文 件”、IS09001 :如1斗年11月2015-^1月2015新版842条款外部供方的控制类型和程序”仍然强调评价结果的信息应形成文件”、ISO9001 :2015新版9.3条款“管理评审”仍然强调“管理评审结果的证据”、IS09001 : 2015新版9.1.3条款“数据分析和评价”仍然强调“数据分析和评价结还要特别强调的是,同老版本一样,IS09001 : 2015新版标准几乎每个条款用的都是动词”,如评审、验证、确认 .............. 等;也就是说:IS09001 : 2015新版关注的仍然是:你是否有“动作”(即:实干兴邦)。

ISO9001-2015年-全文下载-解释版

ISO9001-2015年-全文下载-解释版

ISO9001:2015 标准针对ISO9001:2008 标准的修订,由ISO/TC176/SC2(国际标准化组织/质量管理和质量保证技术委员会/质量体系分委员会)负责起草的征求意见稿已经发布。

原稿为英文版,编译整理。

本编译稿便于大家了解新版标准的大体修订方向,后续正式版将会有更多修订,一切以最终正式版为准。

ISO 9001:2015 编写时间表ISO/TC 176/SC 2分技术委员会采用了3年的标准编写时间期限,来对ISO 9001:2015标准进行编写,拟定的编写时间表如图2所示。

图ISO 9001:2015编写时间表【导读】ISO9001:2015新版,再也见不到《质量手册》和《程序文件》这类中国人最难以理解的文件形式了,统一用“形成文件的信息”取而代之。

通篇也见不到“记录”这两个字眼了,统一用“活动结果的证据”取而代之。

ISO9001:2015新版标准大量篇幅要求将“活动结果的信息(证据)形成文件”!注意:这里是绝对不能断章取义的理解为“活动的信息(证据)形成文件”的。

如:ISO9001:2015新版8.2.3条款“与产品和服务有关要求的评审”仍然强调“评审结果的信息应形成文件”、ISO9001:2015新版8.4.2条款“外部供方的控制类型和程序”仍然强调“评价结果的信息应形成文件”、ISO9001:2015新版9.3条款“管理评审”仍然强调“管理评审结果的证据”、ISO9001:2015新版9.1.3条款“数据分析和评价”仍然强调“数据分析和评价结果”……还要特别强调的是,同老版本一样,ISO9001:2015新版标准几乎每个条款用的都是“动词”,如评审、验证、确认……等;也就是说:ISO9001:2015新版关注的仍然是:你是否有“动作”(即:实干兴邦)。

通篇见不到“记录”这两个字眼就是明证!因此,关注“动作”的存在和有效性,新版本比老版本有进一步的强化!ISO9001:2015标准目录1 范围2 规范性引用文件3 术语和定义4 组织的背景4.1 理解组织及其背景4.2 理解相关方的需求和期望4.3 质量管理体系范围的确定4.4 质量管理体系5 领导作用5.1 领导作用和承诺5.2 质量方针5.3 组织的作用、职责和权限6 策划6.1 风险和机遇的应对措施6.2 质量目标及其实施的策划6.3 变更的策划7 支持7.1 资源7.2 能力7.3 意识7.4 沟通7.5 形成文件的信息8 运行8.1 运行的策划和控制8.2 市场需求的确定和顾客沟通8.3 运行策划过程8.4 外部供应产品和服务的控制8.5 产品和服务开发8.6 产品生产和服务提供8.7 产品和服务放行8.8 不合格产品和服务9 绩效评价9.1 监视、测量、分析和评价9.2 内部审核9.3 管理评审10 持续改进10.1 不符合和纠正措施10.2 改进附录 A 质量管理原则文献ISO9001:2015标准前言(略)委员会征求意见稿说明(略)质量管理体系-要求1 范围本标准为有下列需求的组织规定了质量管理体系要求:a)需要证实其具有稳定地提供满足顾客要求和适用法律法规要求的产品和服务的能力;b)通过体系的的有效应用,包括体系持续改进的过程,以及保证符合顾客和适用的法律法规要求,旨在增强顾客满意。

全套经典ISO9001-2015版质量管理体系质量手册审核文件.doc

全套经典ISO9001-2015版质量管理体系质量手册审核文件.doc

质量体系文件
**有限公司
文件编号 OCMT-QM-01 第 5 页共 78 页 1.0
质 量 管理手册
证能力。
页次 文件版本
本手册由品管部负责组织起草,由管理者代表审核,总经理批准,其解释权 归品管部。 0.2 公司简介
0.3
颁布令 为了健全和完善我公司的质量管理体系,持续改进,规范公司在质量管理方
质 量 管理手册
目 序号 0.1 0.2 0.3 0.4 0.5 0.6 0.7 1 2 3 4 4.1 4.2 4.3 4.4 5 5.1 5.2 引言 公司简介 颁布令 管理承诺 管理代表任命书 质量方针 质量管理手册说明 目的与适用范围 引用标准 术语和定义 组织环境 理解组织用其环境 理解相关方的需求和期望 确定质量管理体系的范围 质量管理体系及其过程 领导作用 领导作用和承诺 方 针 录 内容
面的行为,促进公司质量管理的规范化、正常化,提高企业管理水平,使顾客和相 关方满意,公司依据 ISO9001:2015《质量管理体系 要求》同时结合公司在质量管 理方面的实际运作,遵照“科学、严谨”的原则编制了本手册。 本手册阐述了公司的质量方针、目标,规定了公司的组织机构设置以及各部
质量体系文件质Βιβλιοθήκη 量 管理手册页次 文件版本
2、 制订公司的质量方针、 目标, 并确保与公司在质量方面的战略方向一致 且切实可行; 3、 在体系建立的过程中, 促进过程方法和风险思维的运用; 并为体系的建 立提供必要的资源; 4、 确保体系的实施在公司内部得到有效的沟通, 指导并支持员工为体系做 出贡献; 5、 在公司内部推动体系改进,确保体系获得预期的效果;
文件编号 OCMT-QM-01 第 4 页共 78 页 1.0
质 量 管理手册

ISO9001:2015质量管理体系内审和管理评审全套资料

ISO9001:2015质量管理体系内审和管理评审全套资料

2020年度ISO9001:2015质量管理体系内部审核资料汇编编制:XXX审核:XXX批准:XXXXXX生活用品制造有限公司2020年9月目录内部审核计划表 (2)内部审核实施计划 (2)关于开展管理体系内部审核通知 (4)内审员委派通知书 (5)内部审核首次会议记录 (6)首次会议签到表 (7)内部审核检查表 (8)不符合项记录 (22)内部审核末次会议记录 (23)末次会议签到表 (24)内审报告 (25)不符合工作及纠正措施跟踪表 (26)2020年度内部审核计划表年月日年月日2020年度内部审核实施计划XXX生活用品制造有限责任公司文件XX发[2020]47号关于开展管理体系内部审核通知公司各部门:为确保本公司建立的质量、安全和职业健康安全管理体系能够持续有效的运行,经公司会议研究,总经理批准,公司决定于2020年9月1日对公司的质量管理体系开展一次年度内审活动,以便及时查找出在质量管理体系运行中的不符合工作情况。

请各部门接到通知后做好准备工作,确保通过内部审核的检查工作,争取取得良好的效果。

XXX生活用品制造有限责任公司 2020年8月17日内审员委派通知书根据公司本年度的内部审核计划,现委派XXX为内审组组长,成员XX、XXX、XXX、XX。

内审组按照GB/T 19001-2016《质量管理体系要求》(ISO 9001:2015)中要素要求对公司质量管理体系进行审核。

内审时间:2020年9月1日管理者代表:XX 2020年8月17日内部审核首次会议记录记录人:时间:年月日首次会议签到表内部审核检查表内部审核检查表内部审核检查表内部审核检查表内部审核检查表不符合项记录内部审核末次会议记录记录人:时间:年月日末次会议签到表内审报告不符合工作及纠正措施跟踪表2020年度ISO9001:2015质量管理体系管理评审资料汇编编制:XXX审核:XXX批准:XXXXXX生活用品制造有限公司2020年9月目录管理评审计划表 (2)关于开展管理评审通知 (3)评审内容报告 (4)管理评审会议记录 (11)管理评审报告 (13)管理评审签到表 (15)不符合/潜在不符合及纠正/预防措施表 (16)管理评审计划表2020年10月15日 2020 年10月16日XXX生活用品制造有限责任公司文件XX发[2020]53号关于开展管理评审通知公司各部门:为确保本公司建立的质量管理体系能够持续有效的运行,公司定于2020年11月11日在会议室展开2020年度管理评审,以便及时查找出在管理体系运行中的不符合工作情况。

ISO9001:2015版标准

ISO9001:2015版标准

ISO9001:2015新版(CD草稿)翻译稿说明质量管理体系要求(编译稿)针对ISO9001:2008 标准的修订,由ISO/TC176/SC2(国际标准化组织/质量管理和质量保证技术委员会/质量体系分委员会)负责起草的征求意见稿已经发布。

本编译稿便于大家了解新版标准的大体修订方向,后续正式版将会有更多修订,一切以最终正式版为准。

【导读】ISO9001:2015新版(CD草稿),再也见不到《质量手册》和《程序文件》这类中国人最难以理解的文件形式了,统一用“形成文件的信息”取而代之。

通篇也见不到“记录”这两个字眼了,统一用“活动结果的证据”取而代之。

ISO9001:2015新版(CD草稿)标准大量篇幅要求将“活动结果的信息(证据)形成文件”!注意:这里是绝对不能断章取义的理解为“活动的信息(证据)形成文件”的。

如:ISO9001:2015新版(CD草稿)8.2.3条款“与产品和服务有关要求的评审”仍然强调“评审结果的信息应形成文件”、ISO9001:2015新版(CD草稿)8.4.2条款“外部供应的控制类型和程序”仍然强调“评价结果的信息应形成文件”、ISO9001:2015新版(CD草稿)9.3条款“管理评审”仍然强调“管理评审结果的证据”、ISO9001:2015新版(CD草稿)9.1.3条款“数据分析和评价”仍然强调“数据分析和评价结果的证据”,还要特别强调的是,同老版本一样,ISO9001:2015新版(CD草稿)标准几乎每个条款用的都是“动词”,如评审、验证、确认¼¼等;也就是说:ISO9001:2015新版关注的仍然是:你是否有“动作”(即:实干兴邦)。

通篇见不到“记录”这两个字眼就是明证!因此,关注“动作”的存在和有效性,新版本比老版本有进一步的强化!第1页ISO9001:2015标准目录1 范围2 规范性引用文件3 术语和定义4 组织的背景4.1 理解组织及其背景4.2 理解相关方的需求和期望4.3 质量管理体系范围的确定4.4 质量管理体系5 领导作用5.1 领导作用和承诺5.2 质量方针5.3 组织的作用、职责和权限6 策划6.1 风险和机遇的应对措施6.2 质量目标及其实施的策划6.3 变更的策划7 支持7.1 资源7.2 能力7.3 意识7.4 沟通7.5 形成文件的信息8 运行8.1 运行的策划和控制8.2 市场需求的确定和顾客沟通8.3 运行策划过程8.4 外部供应产品和服务的控制8.5 产品和服务开发8.6 产品生产和服务提供8.7 产品和服务放行8.8 不合格产品和服务9 绩效评价9.1 监视、测量、分析和评价9.2 内部审核9.3 管理评审10 持续改进10.1不符合和纠正措施10.2改进附录A 质量管理原则质量管理体系-要求1 范围本标准为有下列需求的组织规定了质量管理体系要求:质量管理体系要求(编译稿)a)需要证实其具有稳定地提供满足顾客要求和适用法律法规要求的产品和服务的能力;b)通过体系的的有效应用,包括体系持续改进的过程,以及保证符合顾客和适用的法律法规要求,旨在增强顾客满意。

2017年最新ISO9001-2015质量管理体系全套文件(手册及程序文件)

2017年最新ISO9001-2015质量管理体系全套文件(手册及程序文件)

XXX有限公司XXX CO.LTD质量手册Quality Manual(符合GB/T19001-2015 idt ISO9001:2015标准)QM-01版本:A修改码:0编制:审核:批准:2017年09月01日发布2017年09月01日实施发布令为规范公司行为,保证产品质量满足顾客要求,提高公司信誉和产品竞争能力,使质量管理与国际惯例接轨,本公司建立了系统化、文件化的质量管理体系。

该体系符合GB/T19001-2015 idt ISO9001:2015标准的要求,编制了《质量手册》,规定了质量管理体系的组织结构、管理职责和质量管理体系过程的控制要求。

根据公司发展和管理提升的需要,结合2015版标准转换,经领导层决策,对现版文件换版,发布了A版《质量手册》。

《质量手册》阐述了我公司新阶段的质量方针和质量目标,是实施、保持公司质量管理体系的纲领性文件和进行质量管理的公司法规,也是向顾客提供质量保证的证实文件,并作为第三方质量管理体系认证的依据,要求全体员工必须严格贯彻执行。

从2017年9月1日起实施。

特批准发布!总经理:2017年9月1日任命书为了贯彻执行GB/T19001-2015 idt ISO9001:2015标准的要求,加强对质量管理体系的管理,特任命XXX 先生为本组织的管理者代表。

管理者代表的职责是:a)确保质量管理体系符合标准的要求;b)确保各过程获得其预期输出;c)报告质量管理体系的绩效及其改进机会,特别向最高管理者报告;d)确保在整个组织推动以顾客为关注焦点;e)确保在策划和实施质量管理体系变更时保持其完整性。

总经理:2017年9月1日我公司为保证产品质量始终得到顾客的满意,经管理者代表组织员工按总经理对方针、目标的要求,进行了讨论,形成了公司的质量方针和目标,并经过了总经理批准。

现声明如下:1.质量方针:顾客至上,信誉为本;质量为先,精益求精;以人为本,持续改进。

在质量管理中,我公司认真按照GB/T19001-2015 idt ISO9001:2015《质量管理体系要求》进行质量管理,生产中严格按照顾客要求和产品标准进行生产,诚信为本,科技创新,生产出顾客满意的高附加值的产品。

ISO9001:2015质量管理体系全套文件最新版

ISO9001:2015质量管理体系全套文件最新版

质量手册QUALITY MANUAL(依据GB/T19001-2015 idt ISO9001:2015标准)文件编号:QM01--2018受控状态:发布日期:2018年1月12日实施日期:2018年1月12日总目录0批准令0.1发布令0.2任命书1范围2引用标准和术语2.1引用标准2.2通用术语和定义2.3专用术语3概况3.1公司概况3.2手册管理4 公司的背景4.1 理解公司及其背景4.2 理解相关方的需求和期望4.3 质量管理体系范围的确定4.4 质量管理体系及其过程5 领导作用5.1 领导作用和承诺5.2 质量方针5.3 公司的角色、职责和权限6 策划6.1 风险和机遇的应对措施6.2 质量目标及其实施的策划6.3 变更的策划7 支持7.1 资源7.2 能力7.3 意识7.4 沟通7.5 形成文件的信息8 运行8.1 运行的策划和控制8.2产品和服务的要求8.3 产品和服务的设计和开发8.4 外部提供过程、产品和服务的控制8.5 生产和服务的提供8.6 产品和服务放行8.7 不合格输出的控制9 绩效评价9.1 监视、测量、分析和评价9.2 内部审核9.3 管理评审10 持续改进10.1 总则10.2不合格和纠正措施10.2 持续改进11 附录:附录1:生产工艺流程图0 批准令0.1发布令为规范公司行为,保证产品质量满足顾客和法定要求,提高公司信誉和产品竞争能力,增强顾客满意,公司建立了系统化、文件化的质量管理体系。

该体系符合GB/T19001-2015 idt ISO9001:2015标准的要求,编制了《质量手册》,规定了质量管理体系的组织结构、管理职责和质量管理体系过程的控制要求。

根据公司发展和管理提升的需要,结合2015版标准等要求,经领导层决策,发布本《质量手册》。

《质量手册》阐述了我公司新阶段的质量方针和质量目标,是实施、保持公司质量管理体系的纲领性文件和进行质量管理的公司法规,也是向顾客提供质量保证的证实文件,并作为第三方质量管理体系认证的依据,要求全体员工必须严格贯彻执行。

iso9001:2015版标准

iso9001:2015版标准

iso9001:2015版标准ISO9001:2015新版(CD草稿)翻译稿说明质量管理体系要求(编译稿)针对 ISO9001:2008 标准的修订,由 ISO/TC176/SC2(国际标准化组织/质量管理和质量保证技术委员会/质量体系分委员会)负责起草的征求意见稿已经发布。

本编译稿便于大家了解新版标准的大体修订方向,后续正式版将会有更多修订,一切以最终正式版为准。

【导读】ISO9001:2015新版(CD草稿),再也见不到《质量手册》和《程序文件》这类中国人最难以理解的文件形式了,统一用“形成文件的信息”取而代之。

通篇也见不到“记录”这两个字眼了,统一用“活动结果的证据”取而代之。

ISO9001:2015新版(CD草稿)标准大量篇幅要求将“活动结果的信息(证据)形成文件”~注意:这里是绝对不能断章取义的理解为“活动的信息(证据)形成文件”的。

如:ISO9001:2015新版(CD草稿)8.2.3条款“与产品和服务有关要求的评审”仍然强调“评审结果的信息应形成文件”、ISO9001:2015新版(CD草稿)8.4.2条款“外部供应的控制类型和程序”仍然强调“评价结果的信息应形成文件”、ISO9001:2015新版(CD草稿)9.3条款“管理评审”仍然强调“管理评审结果的证据”、ISO9001:2015新版(CD草稿) 9.1.3条款“数据分析和评价”仍然强调“数据分析和评价结果的证据”,还要特别强调的是,同老版本一样,ISO9001:2015新版(CD草稿)标准几乎每个条款用的都是“动词”,如评审、验证、确认??等;也就是说:ISO9001:2015新版关注的仍然是:你是否有“动作”(即:实干兴邦)。

通篇见不到“记录”这两个字眼就是明证~因此,关注“动作”的存在和有效性,新版本比老版本有进一步的强化~第1页ISO9001:2015标准目录1 范围2 规范性引用文件3 术语和定义4 组织的背景4.1 理解组织及其背景4.2 理解相关方的需求和期望4.3 质量管理体系范围的确定4.4 质量管理体系5 领导作用5.1 领导作用和承诺5.2 质量方针5.3 组织的作用、职责和权限6 策划6.1 风险和机遇的应对措施6.2 质量目标及其实施的策划6.3 变更的策划7 支持7.1 资源7.2 能力7.3 意识7.4 沟通7.5 形成文件的信息8 运行8.1 运行的策划和控制8.2 市场需求的确定和顾客沟通8.3 运行策划过程8.4 外部供应产品和服务的控制8.5 产品和服务开发8.6 产品生产和服务提供8.7 产品和服务放行8.8 不合格产品和服务9 绩效评价9.1 监视、测量、分析和评价9.2 内部审核9.3 管理评审10 持续改进10.1不符合和纠正措施10.2改进附录 A 质量管理原则质量管理体系-要求1 范围本标准为有下列需求的组织规定了质量管理体系要求:质量管理体系要求(编译稿)a)需要证实其具有稳定地提供满足顾客要求和适用法律法规要求的产品和服务的能力;第2页b)通过体系的的有效应用,包括体系持续改进的过程,以及保证符合顾客和适用的法律法规要求,旨在增强顾客满意。

ISO9001:2015质量手册英文版(按标准条款)

ISO9001:2015质量手册英文版(按标准条款)

ISO 9001:2015Quality ManualA quality manual is a document that states the company’s intentions for operating the processes within the quality management system. It can include policies for all areas of the business that affect your ability to make high-quality products and meet your customers’ and ISO’s requirements. These policies define how your department managers will implement procedures within the boundaries specified in the quality manual. The use of Quality Manual are as follows:1.To communicate management’s expectations to employees2.To demonstrate the company’s plan to conform to therequirements of ISO 9001:20153.To demonstrate the fulfilment of Clause 5.3, thatorganizational roles, responsibilities and authorities are assigned, communicated and understood4.To provide a starting point for auditors:1.Internal2.Customer3.ISO Certification BodyTo develop a quality manual, you might consider these steps: 1.List policies to be written (note any ISO requirements thatdo not apply).2.Draft policies based on applicable ISO requirements.3.List operating procedures or refer to them as appropriate.4.Determine the format and structure of the manual andmake the first draft.5.Circulate the draft manual for input from all departmentsand address inadequacies identified.6.Attain a formal approval and release.The contents of your quality manual are completely up to you. But, remember that everything you say you do, you must show evidence that you really do it! So be careful what you include and make sure the policies reflect actual practices. Here are some common topics included in quality manuals.the scope of QMSQuality policyExplanation of the company’s documentation structureOrganizational chartPolicy statements for each applicable ISO requirementReference to operating procedures1) The scope of the Quality Management System. This is in place to identify the limit of the system and is based on the scope agreed with the registrar to be placed on the ISO9001 certificate. This is the explanation of what your company does, be it “Design and Manufacture of the bevel Gear,” “Machining Services for Customers in the oil and service Industry,” or “Providing Fast Food for People in Kuwait city.” The second part of the scope requirement is to identify any exclusions from the standard. In many cases, the Quality Manual will identify none, but the most common exclusion is the requirement of the ISO 9001 standard for “Design & Development” for companies such as a machining shop, which works exclusively from customer drawings and does not design any products itself.2) The documented procedures established for the Quality Management System (or references): ‘Documentation’ means anything written down or captured in some form such as written procedures, policies, checklists, forms, or graphics, drawings, flowcharts, diagrams, IT systems. This is called ‘documentedinformation’ in the current version (2015) of ISO 9001. Confusingly, they have also decided to use the same term for what was formerly called ‘records’ – those things that showed what had been done, such as registers, logs, competed for forms, reports, meeting minutes and so on. ‘Documented information’ in 9001 terms means both the ‘written stuff’ that describe your quality system and say how it should operate (eg, flowcharts, procedures, policies, checklists) and the ‘written stuff’ that shows what was done. A system must be documented to achieve ISO 9001 certification because having certain documented information is required by the Standard. All the documents t needs to control how things are done, whether procedures, flowcharts, checklists, forms, IT systems or any other media or format that work in your business. But note that no mandatory procedures are prescribed. Nor a quality manual. What can confuse people is that actually, you can choose what your documents look like, what format and structure you use, and what to put in them. Provided you meet these requirements. You can use one or many formats, from checklists and flowcharts to intranets, wikis or workflow embedded into IT systems. You can use any media, hardcopy or soft, including intranet, online, internet or wiki. One often used way to do that was with a thingcalled a ‘quality manual’. And you can still do that if you choose. And it can be in hard copy (paper) or softcopy: online documents like web pages, help files or IT systems. And you can write your document in various ways, from easy and user-friendly to bureaucratic, verbose and very hard to follow. And such a manual may be the only document you have for your system, or it may be one of a number of documents. Or something in between.3) A description of the interaction of processes. This is most simply done with a flowchart that identifies all the processes in the organization with arrows showing how they connect. While an in-depth flowchart may help you to better understand the interactions between processes in your organization, a simple top-level flowchart is all that is needed for most people to understand the basics. Example of Quality Manual1.0 Company ProfileInclude your company profile1.1 The mission of the FirmOur mission is to enhance mobility through innovation, leadership and public service. Innovation by providing unparalleled value combined with flexibility and risk-taking ability, leadership by delivering exceptional performance in every domain and corporate responsibility through service to society.1.2 The vision of the FirmTo strive relentlessly with an aim to achieve excellence in all businesses that we venture into, with the objective of becoming an organization that all its employees and associates are proud of.2.0 Organization ScopeDesign, Development of Land, Construction Sales of Residential and Commercial Complexes2.1 Exclusions:NIL2.1 Quality PolicyXXX is committed to delivering quality construction work with promised amenities, in time possession, which meets and exceeds the needs & expectation of our customers. We promise our valued customer’s commitment to excellence in each activity by each employee in the organization by adopting innovative and best in class engineering and management practices with continual improvement in business and quality management system as a part of our efforts for enhancement in customer satisfaction while assuring 100% quality and quantity.2.2 Key ObjectivesTimely completion of projectsIncrease Customer satisfactionReduce Customer Complaint3.0 Glossary & Abbreviations4.0 Context of Organization4.1 Understanding the organization and its context: Shah Promoters and Developers determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system through PEST and SWOT. The external and internal issues identified throughPEST and SWOT are continuously being monitored and reviewed by CEO.PESTSWOT4.2- Understanding the needs and expectations of interested partiesxxx has determined the interested parties who are relevant to the xxx Quality management system and the requirement of the interested parties in order to prevent the potential effect on the organization’s ability to consistently provide products and services which meet the customer and applicable statutory and regulatory requirements.4.3 Determining the scope of the quality management systemThe organization had determined the scope of the Quality management system by considering external and internal issues, the requirement of relevant interested parties and Product & Service of the organization.The scope of Quality Management System isDesign, Development of Land, Construction Sales of Residential and Commercial ComplexesExclusions:NIL4.4 Quality management system and its processes4.4.1: xxx has determined the processes needed for the quality management system and their application throughout the organization in Process map & Interactions of processes.xxx has determined the inputs required and the outputs expected from each process in individual process map addressed in the documented information of each process.xxx has determined the sequence and interaction of the processes in Process map & Interactions of processes.xxx has determined and applied the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes in the documented information of each process.xxx has determined the resources needed for these processes and ensure their availability in the documented information of Support process.xxx has assigned the responsibilities and authorities for each processxxx has addressed the risks and opportunitiesxxx has been evaluating these processes and implementing any changes needed to ensure that these processes achieve their intended results and improve the processes and the quality management systemImprove the processes and the quality management system4.4.2- xxx is also maintaining documented information to support the operation of its processes and retaining documented information to have confidence that the processes are being carried out as planned.5.0 Leadership5.1 Leadership and commitmentXxx Management has demonstrated leadership and commitment with respect to the quality management system through1.Taking accountability for the effectiveness of the qualitymanagement system by periodical review of qualitymanagement system through management review meeting, Quality objectives review and providing necessary resources.2.Management has established the quality policy andquality objectives for the quality management system and is compatible with the context and strategic direction of the organization.3.Management has determined the organizationalprocesses and integrated with the quality management system requirement through process map & Interaction this can be demonstrated.4.The established procedure for promoting the use of theprocess approach and risk-based thinking.5.Ensuring that the resources needed for the qualitymanagement system are available, this is being periodically reviewed through management review meeting.municating the importance of effective qualitymanagement and of conforming to the quality management system requirements7.Ensuring that the quality management system achievesits intended results8.Engaging, directing and supporting persons to contributeto the effectiveness of the quality management system by providing training, conducting awareness programs and 9.Promoting improvement by introducing the suggestionscheme, Kaizens and conducting meetings.10.Supporting other relevant management roles todemonstrate their leadership as it applies to their areas of responsibility.5.1.2 Customer focusXxx management has demonstrated leadership and commitment with respect to customer focus by ensuring that: 1.Customer and applicable statutory and regulatoryrequirements are determined, understood and consistently met.2.The risks and opportunities that can affect conformity ofproducts and services and the ability to enhance customer satisfaction are determined and addressedc) The focus on enhancing customer satisfaction is maintained and procedure for customer satisfaction is addressed5.2 QUALITY POLICYXXX is committed to delivering quality construction work with promised amenities, in time possession, which meets and exceeds the needs & expectation of our customers. We promise our valued customer’s commitment to excellence in each activity by each employee in the organization by adopting innovative and best in class engineering and management practices with continual improvement in business and quality management system as a part of our efforts for enhancement in customer satisfaction while assuring 100% quality and quantity. We are also committed to serving society as a whole by generating through clean development mechanism (CDM) project.5.2.1 Establishing the quality policyXxx management has established, implemented and maintained a quality policy that:1.is appropriate to the purpose and context of theorganization and supports its strategic direction.2.Provides a framework for setting quality objectives3.Includes a commitment to satisfy applicable requirements4.Includes a commitment to continual improvement of thequality management system5.2.2 Communicating the quality policyThe quality policy is1. Available and be maintained as documented informationmunicated, understood and applied within theorganization through display, Training and periodical review.3.Available to relevant interested parties, as appropriate. 5.3 Organizational roles, responsibilities and authoritiesXxx management has ensured that the responsibilities and authorities for relevant roles are assigned communicated and understood within the organization. While assigning roles, responsibility and authority, top management has considered and ensured that1.The quality management system conforms to therequirements of this International Standard2.The processes are delivering their intended outputs3.Reporting on the performance of the quality managementsystem and on opportunities for improvement, in particular, to top management4.The promotion of customer focus throughout theorganization5.The integrity of the quality management system ismaintained when changes to the quality management system are planned and implemented.Roles, responsibility and authorities assigned are available in process & as per Organization chart wiseDirectorsResponsibilityOverall Responsibility for formulating and communicating Quality Policy & Quality objectives.Formulation of Strategy for continuous up gradation of Business and Quality System.Ensure periodic assessment of the performance of Quality System.Approval of Quality System Manual.Budget Approval for the organization.Overall Responsibility for Business Development & all financial issues.Provision of resources as required.Strategic decisions on developments and technical setups. To provide the leadership for efficient implementations of the system.Authorities:Approval of customers orders, P.O. and Cheque.Sanctioning leaves of all Staff.Approval of funds for Training needs.All the authorities of downline personnel.Chairing Management review meetings.Project PlanningResponsibilities:Overall coordination between client, project managers and office department.Follow up for Schedules.The entire responsibility of Quality.Monitoring Client Satisfaction.Coordination with the consultants.Disciplinary actions against the staff.Prime responsibility for the safety at the siteProvision of a suitable working environmentEnsure the quality system is established, implemented and maintained.Authorities:Appointment of the staff, engineers and tech staff.Sanctioning the Leaves to Staff.All the authorities of downline personnel.Project ManagersResponsibilities:Responsibilities for the entire Project work, i.e. Quality, Quantity and Time.Coordination with consultants and contractors.Coordination with Consultants for drawings.Coordination with the Site engineers.Coordination with the client for the ongoing changes in drawings and projects.Monitoring site engineers work on a daily basis.Reporting to the GM Projects on the above issuesResponsibilities for safety at the site. (Good working environment).Authorities:Make or force a required decision at all levels to achieve project objectives.Initiate actions on the Contractors and consultants for Quality, Quantity and Timeframe issues related to project work.To stop and initiate corrective actions on non–confirming products/services.Site SupervisorResponsibilities:Coordinating with all staff for the Quality related issues of Construction.Daily Labour Handling for Civil Work.Monitoring of Work progress and daily reporting.Preparation of work progress report / Quality Documentation.Control of non – conformities on siteSafety at site / Construction work.Coordination with the Site Contractor for the daily work requirements.Coordination with external agencies for calibration of instruments and material testing.Authorities:Initiate actions on the staff for non-fulfillments of the documentation related qualityTo stop and initiate corrective actions on non–conforming products.Site engineerResponsibilities:Monitoring of site and labour contractors.Monitoring of work progress and daily reportingPreparation of work progress report.Control of non – conformities on site.Ensuring instruments are properly used and are with the status of calibration.Track Project progress & produce regular weekly status reports.Coordinate with all labour contractors to achieve continuous progress at the site as per schedule.Follow up with the Project manager for pending decisions/drawings/building specifications.Communicate management decisions and information to Site subordinate staff.Ensuring the worker’s safety at site and usage of safety equipment.Implementation and follow up and regular monitoring of implemented ISO 9001 system at the site.Coordination with the Quality Person for Quality related issues.Coordinating Material Accountability at siteAuthorities:Initiating the corrective and preventive actions as needed on contractors and consultants.Decision making on during any emergencies at the site.In-charge Marketing:Managing & motivating the sales force towards the achievement of target.Preparation of Sales plan.Annual sales forecast.Monthly sales forecast.Implementation of sales plan.Authorities:Approval of documents as per the Master list of Quality System Document.Authorized to decide corrective & preventive action.Authorized to obtain concessional acceptance for non – conforming product from the customer.InCharge – ADMIN + ACCOUNTResponsibilities:Responsible for tendering activity.Customer order review.Handling and coordinating customersIdentification of resources, as applicable.Document & Data control system pertaining to his department.Maintain all documents related to the quality system.Coordinator for Management reviews.Promoting awareness of customer requirements throughout the Organization.Compliance & effectiveness of the training system.Suitable working environment (cleanliness, ventilation, lighting, safety etc.).Record maintaining for Sales Register, Rent Register, Sale Files, Stationery and Office equipment.Archiving and record keeping of old files.Payroll Monthly: Salary –To release monthly salary of the employees as per policy finalized.Leave – To keep the record of leave as per policy finalized.Annual Allowance – To release annual allowances as per policy finalized.Employee Record – To update employee details as per organization Policy and QMS.To prepare an appointment letter, confirmation letter, experience letter & all employee-related matter as per policy finalized with the help of the Managing Director.Authorities:Approval of customer orders.Approval of documents as per the master list of Quality System Document.Authorized to decide corrective & preventive action.In charge Purchase:Responsibilities:Overall in charge of purchase activities.Identification of resources, as applicable.Purchasing system – Evaluation, selection, purchasing, monitoring.Document & Data control system pertaining to his department.Corrective / Preventive action system (subcontractor non-conformances, in particular.)Control of recordsAuthorities:Authorized to review & approve purchasing documents.Authorized to select & discontinue sub-contractor6.0 Planning6.1 Actions to address risks and opportunities6.1.1Xxx is addressed the issues, requirements the risks and opportunities1.give assurance that the quality management system canachieve its intended result(s)2.Enhance desirable effects3.Prevent, or reduce undesired effects4.achieve improvement6.1.21.actions to address these risks and opportunities2.How to1.integrate and implement the actions into its qualitymanagement system processes2.Evaluate the effectiveness of these actions6.2.2 Quality objectives and planning to achieve them 6.2.1Xxx establish quality objectives at relevant functions, levels and processes needed for the quality management system.The quality objectives shall1.Be consistent with the quality policy2.Be measurable3.Take into account applicable requirements4.Be relevant to the conformity of products and services andto the enhancement of customer satisfaction5.Be monitored6.Be Communicated7.Be updated as appropriate6.2.2 Xxx achieve its quality objectives,1.What will be done?2.What resources will be required?3.Who will be responsible?4.When it will be completed5.How the results will be evaluatedOur Quality Objectives are as below:Timely completion of projectsEnergy Generation Per YearIncrease Customer satisfactionReduce Customer Complaint6.3 Planning of changesXxx determines the need for changes to the quality management system, the changes are carried out in a planned manner1.the purpose of the changes and their potentialconsequences2.the integrity of the quality management system3.the availability of resources4.the allocation or reallocation of responsibilities andauthoritiesXxx has determined the processes needed for the quality management system and their application throughout the organization in Process map & Interactions of processes7 Support7.1 Resources7.1.1 GeneralXxx is determined and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system. Xxx is consider1.the capabilities of, and constraints on, existing internalresources2.what needs to be obtained from external providersHR determine and provide the resources needed to implement and maintain the quality management system and continually improve its effectiveness and to enhance customer satisfaction by meeting customer requirement. The resources will be in the form ofHuman resources including qualified personnel for verification activities.Manufacturing machines, Test Equipment’s &infrastructure.Provide raw material & other inputs for the realization of the product.Providing funds.The Required resources are identified in the event of new Process Development / Business plan review, Mfg Process Flow, also based on the Organization performance review in MRM and monthly business reviews.7.1.2 PeopleXxx determine and provide the persons necessary for the effective implementation of its quality management system and for the operation and control of its processes. HR along with respective process IN CHARGE ensures that personnel performing work affecting product quality is competent and training to give on the basic operation and control of its processes.7.1.3 InfrastructureXxx is determined, provide and maintain the infrastructure necessary for the operation of its processes and to achieve conformity of products and services. Infrastructure can include1.buildings and associated utilities2.equipment, including hardware and software3.transportation resourcesrmation and communication technologyAt Xxx management determine, provide and maintain the infrastructure needed to achieve conformity to product requirements & in identifying the required resources the PARTNER play a key role based on their day to day interactions with respective IN CHARGE’s and employees 7.1.4 Environment for the operation of processesXxx is determined, provide and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services. A suitable environment can be a combination of human and physical factors1.Social (e.g. non-discriminatory, calm,non-confrontational)2.Psychological (e.g. stress-reducing, burnout prevention,emotionally protective)3.Physical (e.g. temperature, heat, humidity, light, airflow,hygiene, noise).Project in coordination with respective IN CHARGE determines and manages the work environment needed to achieve conformity to product requirement and reviewed ongoing basis.7.1.5 Monitoring and measuring resources7.1.5.1 GeneralXxx is determined and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements. The organization shall ensure that the resources provided1.are suitable for the specific type of monitoring andmeasurement activities being undertaken2.are maintained to ensure their continuing fitness for theirpurposeXxx is retained appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources7.1.5.2 Measurement traceabilityXxx is measurement traceability is maintained requirement if applicable for the instruments or is considered by them to be an essential part of providing confidence in the validity of measurement results,1.calibrated or verified, or both, at specified intervals, orprior to use, against measurement standards traceable to international or national measurement standards; when no such standards exist, the basis used for calibration or verification shall be retained as documented information2.identified in order to determine their status3.safeguarded from adjustments, damage or deteriorationthat would invalidate the calibration status and subsequent measurement resultsXxx is determined the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose, and shall take appropriate action as necessary.Control of Monitoring & Measuring Equipments. Measurement & Monitoring system is well equipped and the system has complete control over the monitoring andMeasuring Equipment. The measurement methods used are evaluated to ensure that they are appropriate and reliable. To ensure that the measuring equipment operates effectively and give reliable results, we have taken the following steps:Equipments are maintained properly and are calibrated & adjusted as and when needed. Necessary safeguards are in place to take care of adjustments that could lead to invalid results.Calibrations are carried out as per national standards (by NABL accredited laboratories only). Where no such standard exists, the basis used for calibration or verification is recorded. The calibration records include the last date of calibration, calibrating agency (for the external agency), calibration result, and frequency of calibration as per the process and/or instrument requirement and the next calibration date. The required accuracy is identified and compared to the measurement that meets expectations. Identification of appropriate equipment is accomplished by tagging, labelling, numbering or by including it in a calibration/maintenance database.。

公司ISO9001_2015质量管理体系全套文件(管理手册与程序文件)

公司ISO9001_2015质量管理体系全套文件(管理手册与程序文件)

ISO9001-2015质量管理体系全套文件(管理手册及程序文件)编号:HJ-QM-2017XXX依据ISO19001:2015 idt GB/T19001-2016 《质量管理体系—要求》编制控制类型:文件版本: C/0受控号:持有者:发布日期: 2017 年 9 月 26 日实施日期: 2017 年 9 月 26 日质量手册目录章节号章节名称0.1 质量手册颁布令0.2 管理者代表任命书0.3 公司概况1 前言2 概述2.1 总则2.2 应用2.2.1 覆盖本公司的管理活动2.2.2 覆盖产品围2.2.3 规性引用文件2.2.4 术语和定义2.2.5 质量手册管理3 质量方针和质量目标4 组织环境4.1 理解组织及其环境4.2 理解相关方的需求和期望4.3 确定质量管理体系的围4.4 质量管理体系及其过程5 领导作用5.1 领导作用和承诺5.1.1 总则5.1.2 以顾客为关注焦点5.2 方针5.2.1 制定质量方针5.2.2 沟通质量方针5.3 组织的岗位、职责和权限6 策划6.1 应对风险和机遇的措施6.2 质量目标及其实现的策划6.3 变更的策划7 支持7.1 资源7.1.1 总则7.1.2 人员7.1.3 基础设施7.1.4 过程运行环境7.1.5 监视和测量资源7.1.6 公司知识7.2 能力7.3 意识7.4 沟通7.5 形成文件的信息7.5.1 总则7.5.2 创建和更新7.5.3 形成文件的信息的控制7.5.4 记录控制8 运行8.1 运行策划和控制8.2 产品和服务的要求8.2.1 顾客沟通8.2.2 与产品有关要求的确定8.2.3 与产品有关要求的评审8.3 产品的设计和开发8.3.1 总则8.3.2 设计和开发策划8.3.3 设计和开发输入8.3.4 设计和开发控制8.3.5 设计和开发输出8.3.6 设计和开发更改8.4 外部提供过程、产品和服务的控制8.4.1 总则8.4.2 控制类型和度程度8.4.3 外部供方的信息8.5 生产和服务提供8.5.1 生产和服务提供的控制8.5.2 标识和可追溯性8.5.3 顾客或外部供方的财产8.5.4 防护8.5.5 交付后的活动8.5.6 更改控制8.6 产品的放行8.7 不合格品的控制9 绩效评价9.1 监视、测量、分析和评价9.1.1 总则9.1.2 顾客满意9.1.3 分析与评价9.2 部审核9.3 管理评审9.3.1 总则9.3.2 管理评审输入9.3.2 管理评审输出10 改进10.1 总则10.2 不合格与纠正措施10.3 持续改进附录:附录 A:组织图附录 B:职能分配表附录 C:部门职责和权限附录 D:工艺流程图附录 E:程序文件目录附录 F:手册修改记录0.1颁布令为进一步完善公司部质量管理,不断提高公司对外质量保证能力,遵守公司领导层要求,在原已依据ISO9001:2008 标准建立质量管理体系的基础上,实施向ISO9001:2015版标准的转换。

ISO9001:2015版质量手册(完整)

ISO9001:2015版质量手册(完整)

*本文件盖有红色“受控”印章时方为受控文件
4.4.10.通过对管理体系的策划,确定本公司所要控制的过程和过程间的相互关系及其在
管理体系中的作用 (详见过程模式关系图) 。

我司将过程分为:顾客导向过程
(COP),支持过程(SP),管理过程(MP),并进行识别,以确保顾客导向过程(COP)对
客户的满意程度的有效性.( 详见过程策划一览表<附件三>和质量管理体系过程
关系图<附件五>)。

4.4.11本公司QMS的基本框架如下图所示:
相关文件:
(1)《相关方管理及沟通程序》******-CX-03
5 领导作用
5.1 领导作用和承诺
明确公司总经理的各项职责要求,包括:管理与承诺、以客户为关注焦点的落实、质量方针和质量目标的制定、质量管理体系策划、管理评审、职责和权限及内部沟通等,确保客户的要求得到满足,增强客户的满意。

5.1.1总则
公司总经理通过以下活动,对其建立、实施质量管理体系并持续改进其有效性、遵守有关法律法规和其他要求的承诺提供证据。

a) 采取培训、宣传资料或会议等方式向组织成员传达满足客户要求和法律法规要求的重
要性,树立和增强全员的质量意识;
b) 制定质量方针和确保质量目标的实现;
c) 为质量管理体系的建立和实施提供指导和框架;
d) 确保将质量管理体系要求融入组织的业务过程;
e) 为质量管理体系的建立、实施和改进提供人、物、设备、设施、原材料、技术等资源
附件五:质量管理体系过程关系图附件六:文件清单
附件六:质量管理体系品质流程图。

ISO9001_2015质量管理体系全套文件最新版

ISO9001_2015质量管理体系全套文件最新版
0批准令
0.1发布令
0.2任命书
1范围
2引用标准和术语
2.1引用标准
2.2通用术语和定义
2.3专用术语
3概况
3.1公司概况
3.2手册管理
4公司的背景
4.1理解公司及其背景
4.3质量管理体系范围的确定
4.4质量管理体系及其过程
5领导作用
5.1领导作用和承诺
5.2质量方针
5.3公司的角色 、职责和权限
6策划
质量目标:
产品一次交验合格率:》98% (废品率<2%)
顾客满意率:>90%
公司根据质量方针给出的框架,确定了上述质量目标,确保销售给顾客的产品100%合格。我公 司产品生产在受控条件下进行,严格按工艺规程操作,控制不合格品流入下道工序,以达到出厂产品100%合格。
用我们良好的售后服务,及时处理顾客的各种意见和抱怨,确保顾客满意率在90%以上。
f)就质量管理体系有关事宜的外部联络
总经理:
2018年1月12日
0.3质量方针和质量目标
公司为保证产品质量始终得到顾客的满意,经管理代表组织员工按总经理对方针、目标的要求, 进行了讨论,形成了公司的质量方针和目标,并经过了批准。现发布如下:
质量方针:
质量第一、降本增效、精益求精、持续改进
在质量管理中,公司认真按照GB/T19001-2015 idt IS09001:2015进行质量管理,生产中严格
.专业学习资料
重0%
不仅追求装备的先进性,同时对在用设备进行良好维护,保证现场使用设施设备完好率保持在
90%以上。
总经理:
2018年1月12日
1范围
1.1覆盖的产品
本手册覆盖的产品:XXXXXXXXXXXXXXXXXXXXXXXX

公司ISO9001质量管理体系全套文件(管理手册及程序文件)

公司ISO9001质量管理体系全套文件(管理手册及程序文件)

ISO9001-2015质量管理体系全套文件(管理手册及程序文件)编号:HJ-QM-2017XXX有限公司质量手册依据ISO19001:2015 idt GB/T19001-2016 《质量管理体系—要求》编制控制类型:文件版本:C/0受控号:持有者:发布日期:2017 年9 月26 日实施日期:2017 年9 月26 日XXX有限公司GBT19001-2016质量管理体系文件管理手册文件名质量管理手册文件编号HJ-QM-2017质量手册目录章节号章节名称0.1 质量手册颁布令0.2 管理者代表任命书0.3 公司概况1 前言2 概述2.1 总则2.2 应用2.2.1 覆盖本公司的管理活动2.2.2 覆盖产品范围2.2.3 规范性引用文件2.2.4 术语和定义2.2.5 质量手册管理3 质量方针和质量目标4 组织环境4.1 理解组织及其环境4.2 理解相关方的需求和期望4.3 确定质量管理体系的范围4.4 质量管理体系及其过程5 领导作用5.1 领导作用和承诺XXX有限公司GBT19001-2016质量管理体系文件管理手册文件名质量管理手册文件编号HJ-QM-2017 5.1.1 总则5.1.2 以顾客为关注焦点5.2 方针5.2.1 制定质量方针5.2.2 沟通质量方针5.3 组织的岗位、职责和权限6 策划6.1 应对风险和机遇的措施6.2 质量目标及其实现的策划6.3 变更的策划7 支持7.1 资源7.1.1 总则7.1.2 人员7.1.3 基础设施7.1.4 过程运行环境7.1.5 监视和测量资源7.1.6 公司知识7.2 能力7.3 意识7.4 沟通7.5 形成文件的信息XXX有限公司GBT19001-2016质量管理体系文件管理手册文件名质量管理手册文件编号HJ-QM-2017 7.5.1 总则7.5.2 创建和更新7.5.3 形成文件的信息的控制7.5.4 记录控制8 运行8.1 运行策划和控制8.2 产品和服务的要求8.2.1 顾客沟通8.2.2 与产品有关要求的确定8.2.3 与产品有关要求的评审8.3 产品的设计和开发8.3.1 总则8.3.2 设计和开发策划8.3.3 设计和开发输入8.3.4 设计和开发控制8.3.5 设计和开发输出8.3.6 设计和开发更改8.4 外部提供过程、产品和服务的控制8.4.1 总则8.4.2 控制类型和度程度8.4.3 外部供方的信息8.5 生产和服务提供XXX有限公司GBT19001-2016质量管理体系文件管理手册文件名质量管理手册文件编号HJ-QM-2017 8.5.1 生产和服务提供的控制8.5.2 标识和可追溯性8.5.3 顾客或外部供方的财产8.5.4 防护8.5.5 交付后的活动8.5.6 更改控制8.6 产品的放行8.7 不合格品的控制9 绩效评价9.1 监视、测量、分析和评价9.1.1 总则9.1.2 顾客满意9.1.3 分析与评价9.2 内部审核9.3 管理评审9.3.1 总则9.3.2 管理评审输入9.3.2 管理评审输出10 改进10.1 总则10.2 不合格与纠正措施10.3 持续改进XXX有限公司GBT19001-2016质量管理体系文件管理手册文件名质量管理手册文件编号HJ-QM-2017附录:附录 A:组织机构图附录 B:职能分配表附录 C:部门职责和权限附录 D:工艺流程图附录 E:程序文件目录附录 F:手册修改记录XXX有限公司GBT19001-2016质量管理体系文件管理手册文件名质量管理手册文件编号HJ-QM-20170.1颁布令为进一步完善公司内部质量管理,不断提高公司对外质量保证能力,遵守公司领导层要求,在原已依据ISO9001:2008 标准建立质量管理体系的基础上,实施向ISO9001:2015版标准的转换。

ISO9001:2015质量管理体系全套文件最新版

ISO9001:2015质量管理体系全套文件最新版

质量手册QUALITY MANUAL(依据GB/T19001-2015 idt ISO9001:2015标准)文件编号:QM01--2018受控状态:发布日期:2018年1月12日实施日期:2018年1月12日总目录0批准令0.1发布令0.2任命书1范围2引用标准和术语2.1引用标准2.2通用术语和定义2.3专用术语3概况3.1公司概况3.2手册管理4 公司的背景4.1 理解公司及其背景4.2 理解相关方的需求和期望4.3 质量管理体系范围的确定4.4 质量管理体系及其过程5 领导作用5.1 领导作用和承诺5.2 质量方针5.3 公司的角色、职责和权限6 策划6.1 风险和机遇的应对措施6.2 质量目标及其实施的策划6.3 变更的策划7 支持7.1 资源7.2 能力7.3 意识7.4 沟通7.5 形成文件的信息8 运行8.1 运行的策划和控制8.2产品和服务的要求8.3 产品和服务的设计和开发8.4 外部提供过程、产品和服务的控制8.5 生产和服务的提供8.6 产品和服务放行8.7 不合格输出的控制9 绩效评价9.1 监视、测量、分析和评价9.2 内部审核9.3 管理评审10 持续改进10.1 总则10.2不合格和纠正措施10.2 持续改进11 附录:附录1:生产工艺流程图0 批准令0.1发布令为规范公司行为,保证产品质量满足顾客和法定要求,提高公司信誉和产品竞争能力,增强顾客满意,公司建立了系统化、文件化的质量管理体系。

该体系符合GB/T19001-2015 idt ISO9001:2015标准的要求,编制了《质量手册》,规定了质量管理体系的组织结构、管理职责和质量管理体系过程的控制要求。

根据公司发展和管理提升的需要,结合2015版标准等要求,经领导层决策,发布本《质量手册》。

《质量手册》阐述了我公司新阶段的质量方针和质量目标,是实施、保持公司质量管理体系的纲领性文件和进行质量管理的公司法规,也是向顾客提供质量保证的证实文件,并作为第三方质量管理体系认证的依据,要求全体员工必须严格贯彻执行。

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Ningbo XXX Material TechnologyCo.,LtdISO9001:2015 Quality ManualRevision [A/0] - [2018/3/1](c) [Copyright Year Of 2018] [Ningbo XXX Material Technology Co.,Ltd]; all rights reserved. This document may contain proprietary information and may only be released to third parties with approval of management. Document is uncontrolled unless otherwise marked; uncontrolled documents are not subject to update notification.Revision [A/0] - [2018/3/1]Page 1 of 19TABLE OF CONTENTS0.0 Revision History and Approval ...................................................................................................................... 3 1.0 Welcome to Ningbo XXX Material Technology Co.,Ltd ................................................................................ 4 2.0 XXX Material: Who We Are ........................................................................................................................... 4 2.1 Determining Our Strategic Direction ......................................................................................................... 4 2.2 Scope of the Management System ........................................................................................................... 4 2.2.1 Scope Statement ............................................................................................................................... 4 2.2.2 Facilities Within the Scope ................................................................................................................ 4 2.2.3 Permissible Exclusions ..................................................................................................................... 5 2.2.4 Scope of the ISO9001:2015 Quality Manual ..................................................................................... 5 3.0 Quality Policy................................................................................................................................................. 5 4.0 Management System Structure and Controls ............................................................................................... 5 4.1 Process Approach .................................................................................................................................... 5 4.1.1 Process Identification ........................................................................................................................ 5 4.1.2 Process Controls & Objectives .......................................................................................................... 6 4.1.3 Outsourced Processes ...................................................................................................................... 7 4.2 Documentation & Records ....................................................................................................................... 7 4.2.1 General .............................................................................................................................................. 7 4.2.2 Control of Documents ....................................................................................................................... 7 4.2.3 Control of Records ............................................................................................................................ 7 4.3 Change Management ................................................................................................................................ 8 4.4 Risks and Opportunities ............................................................................................................................ 8 5.0 Management & Leadership ........................................................................................................................... 8 5.1 Management Leadership and Commitment .............................................................................................. 8 5.2 Customer Focus ........................................................................................................................................ 9 5.3 Quality Policy ............................................................................................................................................. 9 5.4 Organizational Roles Responsibilities & Authorities ................................................................................. 9 5.5 Internal Communication ............................................................................................................................ 9 5.6 Management Review .............................................................................................................................. 10 6.0 Resources ................................................................................................................................................... 10 6.1 Provision of Resources ........................................................................................................................... 10 6.2 Human Resources .................................................................................................................................. 10 6.3 Infrastructure ........................................................................................................................................... 11 6.4 Work Environment ................................................................................................................................... 11 6.5 Organizational Knowledge ...................................................................................................................... 11 7.0 Operation ..................................................................................................................................................... 11 7.1 Operational Planning and Control ........................................................................................................... 12 7.2 Customer-Related Activities .................................................................................................................... 12 7.2.1 Capture of Customer Requirements ............................................................................................... 12 7.2.2 Review of Customer Requirements ................................................................................................ 12 7.2.3 Customer Communication ............................................................................................................... 12 7.3 Design and Development ........................................................................................................................ 13 7.4 Purchasing .............................................................................................................................................. 13 7.5 Provision of [Production of adhesive tape] .............................................................................................. 13 7.5.1 Control of Provision of [Production of adhesive tape] ..................................................................... 13 7.5.2 Identification and Traceability .......................................................................................................... 14 7.5.3 Property Belonging to Third Parties ................................................................................................ 14 7.5.4 Preservation .................................................................................................................................... 14 7.5.5 Post-Delivery Activities .................................................................................................................... 14 7.5.6 Process Change Control ................................................................................................................. 15 7.5.7 Measurement and Release of [Production of adhesive tape] ......................................................... 15 7.5.8 Control of Nonconforming Outputs .. (15)Revision [A/0] - [2018/3/1]Page 2 of 198.0 Improvement ............................................................................................................................................... 15 8.1 General .................................................................................................................................................... 15 8.2 Customer Satisfaction ............................................................................................................................. 15 8.3 Internal Audit ........................................................................................................................................... 16 8.4 Corrective and Preventive Action ............................................................................................................ 16 Appendix A: Overall Process Sequence & Interaction ........................................................................................ 17 Appendix B: ISO 9001:2015 Cross Reference . (18)Revision [A/0] - [2018/3/1] 0.0 Revision History and ApprovalRev. Nature of changes Approval DateA/0 Original release. XXX 2018/3/1Page 3 of 19Revision [A/0] - [2018/3/1] 1.0 Welcome to Ningbo XXX Material Technology Co.,LtdNingbo XXX Material Technology Co., Ltd. Was established in 2000, with the UAE businessmen to build the joint venture company; 2004 Ming Shan founded Nissin special adhesive tape and adhesive tape company; 2008 due to the strategic adjustment of 3 company merger and reorganization, the establishment of Ningbo letter mountains adhesive products Manufacturing Co., Ltd..PVC insulation tape is one of China’s national standard drafting unit, the field of adhesive products governing unit of China, Ningbo, adhesives and related products Industry Association, honorary president of the unit.We produce more than 1000 varieties of products of 11 categories. The annual throughput more than 100,000,000 square of the adhesive and 10,000 ton of the adhesive.Our company located in Ningbo which the city of the east China sea, beside 500 kilometers of shanghai, 20 kilometers from Ningbo list airport and 50 kilograms of the Ningbo seaport. The transport is very convenient (Easy to ship to everywhere on the world).2.0 XXX Material: Who We Are2.1 Determining Our Strategic DirectionXXX Material has reviewed and analyzed key aspects of itself and its stakeholders to determine the strategic direction of the company. This involves:∙Understanding our core products and services, and scope of management system (see 2.2 below).∙Identifying “interested parties” (stakeholders) who receive our [Production of adhesive tape], or who may be impacted by them, or those parties who may otherwise have a significant interest in our company. These parties are identified in the document [Requirements and expectations list of interested parties].∙Understanding internal and external issues that are of concern to XXX Material and its interested parties; also identified in the document [Requirements and expectations list of interested parties]. Many such issues are identified through an analysis of risks facing either XXX Material or the interested parties. Such issues are monitored and updated as appropriate, and discussed as part of management reviews.This information is then used by senior management to determine the company’s strategic direction. This is defined in records of management review, and periodically updated as conditions and situations change.2.2 Scope of the Management System2.2.1 Scope StatementBased on an analysis of the above issues of concern, interests of stakeholders, and in consideration of its products and services, XXX Material has determined the scope of the management system as follows:Production of adhesive tapePage 4 of 19Revision [A/0] - [2018/3/1]Page 5 of 192.2.2 Facilities Within the ScopeThe quality system applies to all processes, activities and employees within the company. The facility is located at: Factory Add :XXX Tel :XXX Fax :XXX XXX XXX2.2.3 Permissible ExclusionsThe following clauses of ISO 9001 were determined to be not applicable to XXX Material.∙ 8.3 Design and development of products and services 2.2.4Scope of the ISO9001:2015 Quality ManualThis manual is prepared for the purpose of defining the company’s interpretations of the ISO 9001:2015 international standard, as well as to demonstrate how the company complies with that standard.This manual does not follow the numbering structure of ISO 9001. Instead, Appendix B presents a cross reference between the sections of this manual and the clauses of ISO 9001:2015.This manual presents “Notes” which are used to define how XXX Material has tailored its management system to suit its purposes. These are intended to clarify implementation approaches and interpretations for concepts which are not otherwise clearly defined in ISO 9001:2015. Notes appear in italics, with gray background.Where subordinate or supporting documentation is reference in this manual, these are indicated by bold italics .∙ Quality PolicyThe Quality Policy of XXX Material is as follows:Quality first, customer satisfaction;Scientific management, continuous improvement. ∙ Management SystemStructure and Controls 4.1Process Approach4.1.1 Process IdentificationXXX Material has adopted a process approach for its management system. By identifying thetop-level processes within the company, and then managing each of these discretely, this reduces the potential for nonconforming [Production of adhesive tape] discovered during final processes or after delivery. Instead, nonconformities and risks are identified in real time, by actions taken within each of the top-level processes.Note: not all activities are considered “processes” – the term “process” in this context indicates the activity has been elevated to a higher level of control and management oversight.The controls indicated herein are applicable only to the top-level processes identified.。

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