ISO9001程序文件-中英文
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质量环境职业健康与安全手册
1. Catalogue目录
1.Catalogue目录 (2)
1.1 Management representative Appointment Letter管理者代表任命书 (4)
1.2 Employee Representative Appointment Letter员工代表任命书 (5)
2.General situation of Quality environment Occupational health and safety management system质量环境职业健康与安全管理体系概况 (6)
2.1 Company introduction 公司简介 (6)
2.2 Quality /Environment/Safety Policy and Objective质量环境职业健康与安全方针与目标 (7)
2.3 XXX Management 埃孚组织架构 (8)
2.4 Quality Environment Occupational Health and Safety Responsibility Distribution Matrix质量环境职业健康与安全管理职能分配表 (9)
3. General situation of Manual手册概述 (14)
3.1 Coverage and exclusion覆盖范围及删减说明 (14)
3.2 Normative reference引用标准 (14)
4. Quality, Environment and Safety Management System质量环境安全管理体系 (14)
4.1 General requirements总要求 (14)
4.2 Control of documents文件控制 (15)
4.3 Control of records记录控制 (16)
5. Management responsibility管理职责 (16)
5.1 Management commitment管理承诺 (16)
5.2 Customer orientation 以顾客为关注焦点 (16)
5.3 Quality environment safety policy质量、环境、职业健康安全方针 (17)
5.4 Planning策划 (17)
5.4.1 Quality environment Occupational health and safety objectives质量环境职业健康与安全目标 (17)
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环境因素识别、评价、更新控制的策划 (18)
5.4.4 Planning of hazard determination and risk evaluation and control (18)
危险源辨识、风险评价和风险控制的策划 (18)
5.4.5 Statuary and regulatory requirements and others法律法规和其他要求 (18)
5.4.6 Environment and safety management program环境、安全管理方案 (18)
5.5 Responsibility, authority and communication职责、权限、协商与沟通 (19)
5.5.1 Responsibility, authority职责与权限 (19)
5.5.2 Management representative管理者代表 (19)
5.5.3 Communication, participation and consultation信息沟通、参与和协商 (19)
5.6 Management review管理评审 (20)
5.6.1 General总则 (20)
5.6.2 Review input管理评审的输入 (20)
5.6.3 Review output管理评审的输出 (21)
6. Resource management资源管理 (21)
6.1 Provision of resources资源提供 (21)
6.2 Human resources人力资源 (21)
6.2.1General总则 (21)
6.2.2Competence, awareness and training能力、意识和培训 (21)
6.3 Infrastructure基础设施 (22)
6.3.1 Scope 设施范围 (22)
6.3.2 Infrastructure provision设施的提供 (22)
6.3.3 Usage, maintenance and repair of equipment设施的使用、维护和保养 (22)
6.4 Work environment工作环境 (22)
7. Product realization and operational control of environment and safety (23)
产品实现与环境、职业健康与安全运行控制 (23)
7.1 Planning of product realization产品实现的策划 (23)
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7.2.2 Review of requirements related to the product与产品有关的要求的评审 (23)
7.2.3 Customer communication顾客沟通 (24)
7.2.4 Communication in other interested parties与其他相关方的信息交流 (24)
7.3 Design and development设计和开发 (24)
7.4 Purchasing采购 (24)
7.4.1 Purchasing process采购过程 (24)
7.4.2 Purchasing information采购信息 (25)
7.4.3 Verification of purchased product产品的验证 (25)
7.5 Production and service provision, operational control of environment and occupational health and safety生产和服务的提供、环境、职业健康与安全运行控制 (25)
7.5.1 Control of production and service provision生产和服务提供的控制 (25)
7.5.2 Operational control of environment and occupational health and safety (25)
环境、职业健康与安全的运行控制 (25)
7.5.3 Emergency preparedness and response应急准备和响应 (25)
7.5.2 Validation of processes for production and service provision生产和服务提供过程的确认 (26)
7.5.3 Identification and traceability标识和可追溯性 (26)
7.5.4 Customer property—face to face negotiation顾客财产 (26)
7.5.5 Preservation of product产品防护 (26)
7.6 Control of monitoring and measuring devices监视和测量设备的控制 (27)
8. Measurement, analysis and improvement测量、分析和改进 (27)
8.1 General总则 (27)
8.2 Monitoring and measurement监视和测量 (27)
8.2.1 Customer satisfaction顾客满意 (27)
8.2.2 Internal audit内部审核 (27)
8.2.3 Monitoring and measurement of processes过程的监视和测量 (28)
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量 (28)
8.2.6 Evaluation of compliance合规性评价 (28)
8.3 Control of nonconforming product and nonconformity不合格产品及不符合控制 .. 28
8.3.1 Control of nonconforming Products不合格产品的控制 (28)
8.3.2 Occupational health and safety Incident investigation职业健康与安全事件调查 (29)
8.3.3 Control of nonconformity不符合的控制 (29)
8.4 Analysis of data数据分析 (29)
8.5 Improvement改进 (29)
8.5.1 Continual improvement持续改进 (29)
8.5.2 Corrective action纠正措施 (30)
8.5.3 Preventive action预防措施 (30)
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1.1 Management representative Appointment Letter管理者代表任命书
In order to carry out ISO9001：2008 Quality Management System--Requirements, ISO14001：2004 Environment Management System--Requirements and Implementation Guidelines and OHSMS18001：2007 Occupational Health and Safety management System--Specifications and strengthen the leadership for operating quality, environment and safety integration management systems, Mr. Gao Peng is hereby specially appointed as Management Representative. 为贯彻执行ISO9001:2008《质量管理体系要求》、ISO14001:2004《环境管理体系要求及使用指南》和OHSAS18001:2007《职业健康安全管理体系规范》标准，加强对质量环境安全一体化管理体系运作的领导，特任命高鹏为管理者代表。 Responsibilities of Management Representative管理者代表的职责：
1. To ensure the procedure of quality, environment and safety management systems could be identified; the management system could be established and maintained.
确保质量环境安全管理体系的过程得到识别，管理体系得到建立和保持；
2. Representation on top-managements to take management responsibility of quality, environment and safety systems. To organize, coordinate and rule the major issues of quality, environment and safety management systems;
代表最高管理者行使质量环境安全管理职责，组织、协调、裁定质量环境安全管理中的重大事项；
3. Giving reports to top-managements on the performance and improved requirements of quality, environment and safety systems, timely managing and coordinating problems of quality, environment and safety management systems running.
向最高管理者报告质量环境安全管理体系的业绩和改进的需求，及时协调处理质量环境安全管理体系运行的有关问题；
4. To organize, propagandize and implement laws, regulations, and institutions of quality, environment and safety management systems; to ensure the whole company could improve the awareness of fulfilling customer requirements and society commitment.
组织宣传贯彻有关质量环境安全方面的法律法规、制度、标准，确保全公司员工提高满足顾客要
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environment and safety systems.
负责质量环境安全管理体系有关事宜的对外联络。
6. Assuring the product with the marking from the certification institute fulfilling all the certification requirement
确保加贴该认证标志的产品符合认证标准要求
7. Be responsible to organize to set up written procedure to assure the certification marking is proper kept and used within the organization.
负责建立文件化的程序，确保认证标志妥善保管和使用；
8. Be responsible to organize to set up written procedure to assure that no attaching certification marking to the non-conforming product and product which has been changed but without confirmation from the certification institute.
负责组织建立文件化的程序，确保不合格品和获证产品变更后未经认证机构确认，不加贴标志。
GM总经理：Alohn
2012年(y) 3月(m)23日(d)
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1.2 Employee Representative Appointment Letter员工代表任命书
In order to carry out OHSMS18001：2007 Occupational Health and Safety Management System--Specifications and strengthen the leadership for operating quality, environment and safety management systems, Mr XXX is hereby specially appointed as quality, environment and safety management systems Employee Representative of XXX Co., Ltd Company. 为贯彻执行OHSMS18001：2007《职业健康安全管理体系规范》，加强对质量环境安全管理体系运作的领导，特任命XX为XXX有限公司的质量环境安全管理体系员工代表。 Whose main responsibilities are to:其主要职责为：
1. Be involved in establishing and reviewing the OH&S policy, other policies, objectives and plans;
参与公司职业健康安全方针、各项政策、目标、计划的制定、评审；
2. Be involved in the hazard identification and assessment, the controlling measures formulation, accidents investigation and handling;
参与公司危险源辨识、评价与控制措施的制定及事故调查处理；
3. Be involved in discussion of improving the employees’ operation status;
参与改善公司员工作业状况的商讨；
4. Be responsible for reporting to the superiors about the employees’ requirements in the aspect of OH&S;
负责上报员工对职业健康安全方面的要求；
5. Be responsible for participating in saving and recording all the OH&S affairs of the company.
负责保存参与公司职业健康安全事务的各项记录。
GM总经理：Alohn 2012年(y)3月(m) 23日(d)
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2. General situation of Quality environment Occupational health and safety management system 质量环境职业健康与安全管理体系概况
2.1 Company introduction 公司简介
- XXX Solar Production Co., Ltd. manufactures high-quality solar modules using mono- and polycrystalline solar cells for XXX solar AG, which distributes the modules to the international photovoltaic market.
XXX有限公司是一家专门从事晶体硅太阳能电池组件生产的高新技术企业。
- It operates one of the most modern production facilities in Gaomi , province Shandong, China. The operation started since 2008. In 2011.7, XXX completed its expansion to 100 MW of an annual production capacity.
公司坐落于山东省高密市。公司拥有功能完善、设施齐全的生产车间。公司于2008年正式投产，2011年7月公司完成扩产，产能达100MW。
- XXX is a Sino-German Joint Venture by XXX solar AG, Germany and the XXXX Group, Gaomi, China, founded in 2008. One year after production start XXX passed the ISO9001:2008 and VDE certification in 2009; the UL-Certification in 2010.
公司由XXX和XXX集团共同投资建立。2009年公司通过ISO900：2008认证和VDE认证，2010年通过CSA 认证。
- The company has a great geographical advantage, only 30 minutes’ drive to reach Qingdao airport or Qingdao harbor..The products manufactured are distributed to the international Photovoltaic Market exclusively by XXX solar, and have the competitive advantage on both price and cost. Based on the raw materials, the changes in market price, the company is optimizing its production matrix regularly, to save the cost, thereby offer the maximized profit to the customer.
公司地理位置优越，乘车30分钟即可到达青岛机场和青岛港。公司产品由德国XXX光伏销往国际光伏市场。产品在价格和成本方面具有竞争优势。公司根据原材料市场价格变动，定期优化生产结构，削减生产成本，将最大利润提供给客户。
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公司凭借规范化的操作工艺，严格的质量标准，完善的管理制度，高素质的员工团队，为客户打造品质卓越的晶体硅太阳能电池。
2.2 Quality /Environment/Safety Policy and Objective质量环境职业健康与安全方针与目标
Quality /Environment/Safety Policy：质量环境安全方针：
Full of accuracy, integrity, dedication and prompt action to pursue excellence going green to protect the earth People oriented to create harmonious 准诚敬捷追求卓越倡导绿色呵护地球以人为本塑造和谐
Quality Objective质量目标： Bosch Brand modules . A rate ≥99% XXX/XXX Brand modules.A1 rate ≥99% Cell production breakage rate ≤0.3% 博世品牌组件A等级比率≥99%；XXX和XXX品牌组件A1率≥99%；电池片生产破损率≤0.3%； Customer satisfaction degree, greater than 85% 顾客满意度达85%以上
Environmental Objective环境目标和指标：
a) Waste emission in accordance with national regulation 废弃物排放符合国家规定
b) Unit consumption of materials under effective control
原材料的单耗控制在指标之内
Material 材料名称Unit 单位Planned piece yardage:计划单耗Tabbing ribbon 焊带kg 千克≤0.15
Flux 助焊剂L 升≤0.03
Barcode 条形码标签m 米≤0.032
c) Unit consumption of electricity descends 1% each year (KW.h/ produced W)
电的单耗每年下降1% (千瓦.小时/生产的瓦数） Occupational Health and Safety Objective 职业健康安全目标：
a) No injury accident 不发生伤害事故
b) Nonoccurrence of fire accident、explosive accident and Electric shock accident
不发生火灾事故、爆炸事故和触电事故
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2.4 Quality Environment Occupational Health and Safety Responsibility Distribution Matrix 质量环境职业健康与安全管理职能分配表
- Remarks 备注：▲—Main Responsibilities 主要职责；△—Executive responsibility 相关职责
C h a p t e r o f t h e M a n u a l
手册章节号
Process 过程名称
Standard clause 标准
M R 管理者代表
O F E 综合部
L O G 物流&仓库
Q M S 品保部
E N G 技术部
M F G 生产部
I S O 9001：2008
I S O 14001: 2004
O H S A S 18001:2007
4 Quality, Environment and Safety Management System 质量环境安全管理体系 4 4 4 4.1 General requirements 总要求 4.1 4.1 4.1 ▲ △ △ △ △ △ 4.2 Control of documents 文件控制 4.2.3 4.4.
5 4.4.5 △ △ △ ▲ △ △ 4.3 Control of records 记录控制 4.2.4 4.4.5 4.4.5 △
△
△
▲
△
△ 5 Management responsibility 管理职责 5 4.4.1 4.4.1 5.1 Management commitment 管理承诺
5.1 4.4.1 4.4.1 ▲ △ △ △ △ △ 5.2 Customer orientation 以顾客为关注焦点
5.2 4.3.2 4.3.2 ▲ △ △ △ △ △ 5.3 Quality environment safety policy 质量、环境、职业健康安全方针 5.3 4.2 4.2 ▲ △ △ △ △ △ 5.4 Planning 策划
5.4 4.3 4.3 5.4.1 Quality environment safety objectives 质量环境安全目标 5.4.1 4.3.3 4.3.3 ▲ △ △ △ △ △ 5.4.2 Management system planning 管理体系策划
5.4.2 4.3.3 4.4.3 △ △ △ ▲ △ △ 5.4.3
Control planning of identification, evaluation and update of environment aspects.环境因素识别、评价、更新控制的策划
NA
4.3.1
4.3.1
△
△
△
▲
△
△
5.4.4 Planning of hazard determination and risk evaluation and control 危险源辨识、风险评价和风险控制的策划
NA 4.3.1 4.3.1 △ △ △ ▲ △ △
5.4.5 Statuary and regulatory requirements and others 法律法规和其他要求 NA 4.3.1 4.3.1 △ △ △ ▲ △ △ 5.4.6 Environment and safety management program 环境、安全管理方案 NA 4.3.3 4.3.3 △
△
△
▲
△
△ 5.5 Responsibility, authority and communication 职责、权限、协商与沟通 5.5 4.4 4.4
5.5.1 Responsibility and authority 职责和权限 5.5.1 4.4.1 4.4.1 ▲ △ △ △ △ △ 5.5.2 Management representative 管理者代表 5.5.2 4.4.1 4.4.1 ▲ △ △ △ △ △ 5.6 Management review 管理评审 5.6 4.6 4.6 ▲ △ △ △ △ △ 6 Resource management 资源管理 6 4.4 4.4
6.1 Provision of resources 资源提供 6.1 4.4.1 4.4.1 ▲ △ △ △ △ △ 6.2 Human resources 人力资源 6.2 4.4.2 4.4.2 6.2.1 General 总则
6.2.1 4.4.2 4.4.2 ▲ △ △ △ △ △ 6.2.2 Competence, awareness and training 能力、意识和培训 6.2.2 4.4.2 4.4.2 △ ▲ △ △ △ △ 6.3 Infrastructure 基础设施 6.3 4.4.1 4.4.1 △ ▲ △ △ △ △ 6.3.1 Scope 设施范围
6.3 4.4.1 4.4.1 △ ▲ △ △ △ △ 6.3.2 Infrastructure provision 设施的提供
6.3 4.4.1 4.4.1 △ ▲ △ △ △ ▲ 6.3.3 Usage, maintenance and repair of equipment 设施的使用、维护和保养 6.3 4.4.1 4.4.1 △ ▲ △ △ △ ▲ 6.4 Work environment 工作环境
6.4 NA NA △ ▲ △ △ △ ▲ 7
Product realization and operational control of environment and safety 产品实现与环境/安全运行控制
7
4.4
4.4
7.1 Planning of product realization 产品实现的策划 7.1 4.4.6 4.4.6 ▲ △ △ △ △ △ 7.2 Customer-related processes 与顾客有关的过程
7.2 4.4.6 4.4.6 7.2.1 Determination of requirements related to the product 与产品有关的要求的确定 7.2.1 4.4.6 4.4.6 △ △ △ △ ▲ △ 7.2.2 Review of requirements related to the product 与产品有关的要求的评审 7.2.2 4.3.1 4.3.1 △ △ △ △ ▲ △
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C h a p t e r o f t h e M a n u a l
手册章节号
Process 过程名称
Standard clause 标准
M R 管理者代表
O F E 综合部
L O G 物流&仓库
Q M S 品保部
E N G 技术部
M F G 生产部
I S O 9001：2008
I S O 14001: 2004
O H S A S 18001:2007
7.4 Purchasing 采购
7.4 4.4.6 4.4.6 7.4.1 Purchasing process 采购过程 7.4.1 4.4.6 4.4.6 △ ▲ △ △ △ △ 7.4.2 Purchasing information 采购信息
7.4.2 4.4.6 4.4.6 △ ▲ △ △ △ △ 7.4.3 Verification of purchased product 采购品的验证 7.4.3 4.4.6 4.4.6 △ ▲ △ △ △ △ 7.5 Production and service provision 生产和服务的提供
7.5 4.4.6 4.4.6 △ △ △ △ △ ▲ 7.5.1 Control of production and service provision 生产和服务提供的控制
7.5.1 4.4.6 4.4.6 △ △ △ △ △ ▲ 7.5.2
Validation of processes for production and service provision 生产和服务提供过程的确认
7.5.2
NA
NA
7.5.3 Identification and traceability 标识和可追溯性 7.5.3 NA NA △ △ ▲
▲
△ ▲ 7.5.4 Customer property 顾客财产 7.5.4 NA NA △ ▲ △ △ △ △ 7.5.5 Preservation of product 产品防护 7.5.5 4.4.6 4.4.6 △ △ △ △ △ ▲ 7.5.6 Operational control 运行控制
NA 4.4.6 4.4.6 △ △ △ △ ▲ △ 7.6 Control of monitoring and measuring devices 监视和测量设备的控制 7.6 4.5.1 4.5.1 △ △ △ △ △ △ 7.7 Emergency preparedness and response 应急准备和响应 NA 4.4.7 4.4.7 △ △ △ △ △ △ 8 Measurement, analysis and improvement 测量、分析和改进 8 4.5 4.5 △ △ △ △ ▲ △ 8.1 General 总则
8.1 4.5.1 4.5.1 △ △ △ △ ▲ △ 8.2 Monitoring and measurement 监视和测量 8.2 NA NA △ △ △ △ ▲ △ 8.2.1 Customer satisfaction 顾客满意 8.2.1 NA NA △ △ △ △ ▲ △ 8.2.2 Internal audit 内部审核
8.2.2 4.5.5 4.5.5 △ △ △ △ ▲ △ 8.2.3 Monitoring and measurement of processes 过程的监视和测量 8.2.3 4.5.1 4.5.1 △ △ △ △ ▲ △ 8.2.4 Monitoring and measurement of product 产品的监视和测量
8.2.4 4.5.2 4.5.2 △ △ △ △ ▲ △ 8.2.5 Monitoring and measurement of environment and safety 环境/安全项目的监视和测量 NA 4.5.1 4.5.1 △ △ △ △ ▲ △ 8.2.6 Evaluation of compliance 合规性评价 NA 4.5.2 4.5.2 △ △ △ △ ▲ △ 8.3 Control of nonconformities 不合格品控制 8.3 NA NA △ △ △ △ ▲ △ 8.3.1 Control of nonconforming Products 不合格品控制
8.3 NA NA △ △ △ △ ▲ △ 8.3.2
Accident, nonconformity, corrective- and preventive actions 事故、事件、不符合、纠正和预防措施
NA
4.5.3
4.5.3
△
△
△
△
▲
△
8.4 Analysis of data 数据分析 8.4 4.5.1 4.5.1
8.5 Improvement 改进
8.5 NA NA △ △ △ △ ▲
△ 8.5.1 Continual improvement 持续改进 8.5.1 4.5.3 4.5.3 8.5.2 Corrective action 纠正措施 8.5.2 4.5.3 4.5.3 8.5.3
Preventive action 预防措施
8.5.3
4.5.3
4.5.3
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3. General situation of Manual手册概述
3.1 Coverage and exclusion覆盖范围及删减说明
. Coverage of the quality management system: processes of production, sales and service related to the company products. 质量管理体系覆盖：本公司所有产品的生产、销售和服务过程；
. Coverage of the environmental management system: processes of production, sales, service and relevant management of all products in the company.
环境管理体系覆盖：本公司区域内公司所有产品的生产、销售服务过程及相关管理活动；
. Coverage of the occupational health and safety management system: processes of production, sales, service and relevant management of all products in the company.
职业健康安全管理体系覆盖：本公司区域内公司所有产品的生产、销售服务过程及相关管理活动；
. The company has no Special Process, therefore, the manual excludes 7.5.2 “Validation of processes for producti on and service provision” in ISO9001:2008 idt GB/T19001-2008, and the exclusion has no effect on the ability and responsibility of satisfying customer requirements and applying laws and regulations.
本公司无特殊过程，所以删减ISO9001:2008 idt GB/T19001-2008标准中7.5.2“生产和服务提供过程的确认”条款；该删减不影响本公司提供满足顾客要求和适用法律法规要求的能力和责任。
3.2 Normative reference引用标准
. ISO9001: 2008 idt GB/T19001-2008 Quality Management Systems-Requirements《质量管理体系要求》；
. ISO14001: 2004 idt GB/T24001-2004 Environmental Management Systems-Requirements With Guidance for Use《环境管理体系要求及使用指南》；
. OHSAS18001: 2007 idt GB/T28001-2011 Occupational Health and Safety Management Systems -Requirements《职业健康安全管理体系规范》；
. IEC 61215 Design Qualification and Type Approval of PV Modules《地面用晶体硅光伏组件—设计鉴定和定型》；
. IEC 61730 PV Module Safety Qualification《光伏组件安全鉴定》。
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Vocabulary《质量管理体系基础和术语》
4. Quality, Environment and Safety Management System质量环境安全管理体系
4.1 General requirements总要求
- In accordance with ISO 9001: 2008 Quality Management System-Requirements, ISO 14001: 2004 Environmental management system-Requirements and OHSAS 18001:2007 Occupational Health and Safety Management Systems-Requirements, the company shall establish and maintain documented management systems, develop the quality, environment and safety policies and objectives, define the organization structure and responsibilities, conduct effective control to environment aspects and hazards of all procedures affecting the quality of product realization, and continually improve the effectiveness of management systems on the basis of PDCA and statutory and regulatory requirements.
本公司根据ISO 9001:2008《质量管理体系要求》、ISO 14001:2004《环境管理体系要求及使用指南》以及OHSAS 18001:2007《职业健康安全管理体系规范》三个标准，建立并保持文件化的管理体系，制定质量环境安全方针和目标，规定组织结构和职责，通过持续的PDCA过程循环，并依据相关法律法规和其他要求，对本公司产品实现过程中影响质量的各个环节的环境因素、危险源进行有效控制，持续改进管理体系的有效性。
- The company shall establish and maintain quality, environment and safety management systems and realize the management by the Model of Processes.
本公司建立并保持质量环境安全管理体系，并以过程模式进行管理：
. The quality, environment and safety management systems are defined and divided to four processes: management activities, resource management, operation control and measurement-analysis-improvement. Each process can be divided to sub-processes, and processes and sub-processes are all operated based on PDCA.
将质量环境安全管理体系确定为管理活动、资源管理、运行控制及测量、分析和改进四个过程进行管理，四个过程均可进一步确定为相对较小的子过程。过程及其子过程均应用PDCA过程模式；
. In order to manage the processes, the company shall define the organization structure, responsibilities of its each part and personnel of each level provide necessary resources
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通过管理活动过程，规定组织结构、各部门和各级人员的职责，实施培训、人员招聘和岗位调换，适当的资金和设备设施的配置以及沟通过程，确保可以获得必要的资源和信息，以支持这些过程的运行和对这些过程的监视；
. Monitor measure and analyze the processes by operation control, daily management and internal audits, management review or other actions.
通过运行控制、日常管理、内审、管理评审等过程监视、测量和分析这些过程；
. Realize the process planning and continually improve the processes by taking corrective and preventive actions.
通过实施纠正和预防措施，实现对这些过程策划的结果和对这些过程的持续改进。
4.2 Control of documents文件控制
- Document control is under the centralized management of QMS, and each department shall manage the documents in its responsibility scope according to PI-423-QMS-01 “Control of Documents” and PI-421-QMS-01 “Requirement for Documents” in order to assure: 品保部对文件控制进行归口管理，各部门依据PI-423-QMS-01《文件控制》和PI-421-QMS-01《文件要求》对公司文件进行管理，以确保：
. to approve documents for adequacy prior to issue,
文件发布前得到批准，以确保文件是充分与适宜的
. to review and update as necessary and re-approve documents,
必要时对文件进行评审与更新，并再次批准；
. to ensure that changes and the current revision status of documents are identified, 确保文件的更改和现行修订状态得到识别；
. to ensure that relevant versions of applicable documents are available at points of use,确保在使用处可获得有关版本的适用文件
. to ensure that documents remain legible and readily identifiable,
确保文件保持清晰、易于识别；
. to ensure that documents of external origin are identified and their distribution controlled, and确保外来文件得到识别，并控制其分发；
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防止作废文件的非预期使用，若因任何原因而保留作废文件时，对这些文件进行适当的标识。
- The Approving and titles of this manual are different with other Process or work instructions
手册的审批及格式不同于其他文件的控制流程，具体如下
. Approval Procedure： The management representative will organize establishing the manual, and it will be firstly checked by Document manager, secondly checked by department manager, then it will be double checked by management representative, the last step is gotten the final approval from DGM and GM.
审批流程：手册的编写由管理者代表组织进行，由文件管理员进行初审，部门经理再次审核，然后由管理者代表复审，最后一步是获得副总经理和总经理批准。
. Titles ：All titles in the manual are written according to the titles in the iso9001:2008, ISO14001:2004 and OHSAS18001:2007，not according to the titles in FS-421-QMS-01“Form Instruction Document(Word)”
标题：手册的标题是根据iso9001:2008, ISO14001:2004 and OHSAS18001:2007的标题来写的，不是根据FS-421-QMS-01指导类文件格式（Word）。
4.3 Control of records记录控制
- Records derived from the operation of quality, environment and safety management systems shall be controlled, to provide evidence of the effective operation of the systems and of continuing improvements of quality, environment and safety.
通过对质量环境安全管理体系运行中形成的记录进行控制，为体系运行状况提供客观证据，为质量环境安全改进提供依据。
- Each department shall manage the records in its responsibility scope according to PI-423-QMS-01 “Control of Documents”. When storing records, prevent records from losing or damaging.
各部门按照PI-423-QMS-01《记录控制》对记录进行管理。贮存时，应做到防止记录的丢失和损坏。
- A documented procedure shall be established to define the controls needed for the
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- Records shall remain legible, readily identifiable and retrievable.
记录应保持清阳、易于识别和检索。
5. Management responsibility管理职责
5.1 Management commitment管理承诺
- GM shall establish and organize to implement the suitable quality, environment and safety policies and
objectives based on the corporation resources, internal and external environments, management status and customer requirements or other factors, to realize the management commitment.
根据企业资源、内外部环境、安全管理现状、顾客需求等要素，总经理制定并组织贯彻实施适宜的质量环境安全方针和质量、环境、安全目标，使管理承诺得到落实。
- Ensure the availability of resources. 保证资源的可获得性。
- Communicate to the company the requirements of customers and laws and regulations as well as their importance.传达顾客要求和法律法规要求，以及其重要性。
5.2 Customer orientation 以顾客为关注焦点
- The company shall work in a customer-oriented way. The company objectives are based on customer satisfaction, and the customer satisfaction degree could be confirmed by questionnaire.公司应以顾客为关注焦点，公司目标是以顾客满意度为基准，并且顾客满意度可利用调查问卷来确认。
- The company shall determine the other interested parties’ requirements on environment and occupational health and safety including government, employees and their families, contract parties, non-employees, surrounding organizations or any others. Establish the quality, environment and safety management systems and maintain their continuing effectiveness to lower the effects on environment and occupational health and safety to reach the satisfaction of interested parties mentioned above.本公司识别其他相关方的要求，包括政府、员工、员工家属、合同方、外来人员、周围企事业单位等在内的相关方在环境、职业健康安全方面的要求，建立质量环境安全管理体系并保持有效性，以降低环境危害和职业健康安全风险，达到
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requirements on occupational health and safety.
与相关方特别是本公司的员工良好沟通，了解其职业健康安全需求；
. Let the non-employees who enter XXX know the risks of environment and occupational health and safety and controlling measures in the company.
对进入本厂的外来人员施加影响，使其了解本厂存在的环境和职业健康安全风险及其控制措施；
. Let any interested party realize the potential risks on environment and safety from its actions, and regulate their own activities.
使相关方了解其活动带来的环境影响和安全风险，并规范自己的行为；
. When signing a contract, the company shall stipulate the terms on environment and safety to define the environmental and safety responsibilities and commitments of two parties.
与合同方在环境/安全方面签订相关协议，明确双方的环境/安全责任和义务。
5.3 Quality environment safety policy质量、环境、职业健康安全方针
- The quality environment and safety policy shall be established and implemented with the company and meet the requirements of quality, environment and occupational health and safety requirements. 质量环境职业健康安全方针要在公司内开展并实施。方针满足质量、环境、职业健康安全体系的要求。
- GM is responsible for organizing to establish, approving and issuing the policy.
总经理组织制定并批准、发布质量环境职业健康安全方针。
- The suitability of the policy shall be excluded in the management review, and update it as necessary to ensure the policy meet the requirements of internal and external changes and customers and consist to the company aim.
利用管理评审等机会对质量环境安全方针的适宜性进行评审，并在必要时进行修订，确保质量环境安全方针能够适应公司内、外部条件的不断变化，达到与公司的宗旨、顾客的要求相适应。
- See details in 2.2 具体见2.2
5.4 Planning策划
5.4.1Quality environment Occupational health and safety objectives质量环境职业健康与安全目标
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product requirements. The objectives include conformity to product requirements. The objectives include the content of the conformity to product requirements.总经理确保在本公司的相关职能层次上建立并保持质量环境职业健康与安全目标，该目标包括满足产品要求的内容。
. Objectives shall be measurable, and consist to the quality, environment and safety policies, and distributed into relevant functions and levels.质量、环境、安全目标是可测量的并与质量、环境、职业健康安全方针保持一致，并分解到相关的职能和层次；
. Every year, the management representative shall organize to establish the general objective, and the annual objectives shall be submitted to GM for approval and distributed into relevant functions and levels.每年由管理者代表组织制定总的目标，年度目标报总经理批准，并在相关职能层次上分解。
- Quality objectives, environmental objectives and targets, occupational safety objectives shall be reviewed in the management review and updated as necessary.质量目标、环境目标和指标、职业健康安全目标通过管理评审进行评审并在必要时予以更新。
- See details in 2.2具体见2.2
5.4.2Management system planning管理体系策划
- GM shall plan the quality environment and safety management systems to ensure: 总经理对质量环境安全管理体系进行策划，以确保：
. Quality environment and safety management systems conform to quality and safety objectives, and environmental objectives and targets, and all processes be identified and managed in the process model of PDCA.质量环境安全管理体系满足质量、安全目标、环境目标和指标的要求，对所有的过程进行识别并按照过程模式进行PDCA管理。
. The integrity of the management systems shall be maintained when changes to the management systems are planned and implemented.在对管理体系的变更进行策划和实施时，保持管理体系的完整性。
5.4.3Control planning of identification, evaluation and update of environment aspects.
环境因素识别、评价、更新控制的策划
- Environment protection is also one of the company focuses, and the company determines
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可能对环境造成影响的因素加以控制。
- Determination and evaluation shall be conducted once a year, and updated as necessary.
对环境因素的识别与评价每年进行一次，必要时可随时更新。
- See the requirement details in PI-431-QMS-01 “environmental factors identification and assessment control procedures”
具体要求见PI-431-QMS-01《环境因素识别与评价控制程序》
5.4.4Planning of hazard determination and risk evaluation and control
危险源辨识、风险评价和风险控制的策划
- Occupational health and safety is one of the company focuses, and the company determines hazards and conducts risk evaluation, and takes measures to control the determined middle and heavy hazards.本公司以职业健康安全为关注焦点，对可能产生的危险源进行识别，并对危险源进行风险评价，对评价出的中等和重大危险源采取措施进行控制，预防发生事故。
- See the requirement details in PI-446-QMS-01 “Safety Management System”.
具体要求见PI-446-QMS-01安全管理制度
5.4.5Statuary and regulatory requirements and others法律法规和其他要求
- QMS is responsible for organizing to produce the list of applicable requirements from laws, regulations and other aspects, and keep the requirement documented and update them timely. Review on conformity to laws, regulations and standards shall be conducted once a year, and communicate to employees and other interested parties the information arising from the review. 品保部负责组织建立适用于公司的法律法规及其他要求清单，保管法律法规及其他要求文本，并及时更新有关法律法规和其他要求。对法律法规及标准的遵循情况每年评审一次，并将这些信息传达给员工和其他相关方。
- See the requirement details in PI-432-QMS-01“Legal and other requirements control procedures”.具体要求见PI-432-QMS-01《法律法规和其他要求控制程序》
5.4.6Environment and safety management program环境、安全管理方案
- The company shall establish and maintain the environment and safety management program to realize the environment and occupational health and safety objectives, including:
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环境目标和指标、职业健康安全目标；
. Responsibility and authority for realizing the environment and occupational health and safety objectives;为实现环境、职业健康安全目标所赋予的有关职能的职责和权限；
. Method, budget and schedule for realizing the objectives.
实现目标的方法、预算费用和时间表。
- QMS conducts review on the environment and occupational health and safety management programs, at planned intervals, and revises the program according to the new project or changes of activities, products, services and running conditions to ensure their suitability.本公司定期在计划时间间隔内由品保部对环境、职业健康安全管理方案进行评审，必要时针对企业新项目及活动、产品、服务或运行条件的变化对环境、职业健康安全管理方案进行修订，以确保其适应性。
- QMS is responsible for organizing to establish the programs which shall be examined and verified by the management representative and approved by GM.
管理方案由品保部负责组织编制，管理者代表审核，总经理批准。
5.5 Responsibility, authority and communication职责、权限、协商与沟通
5.5.1Responsibility, authority职责与权限
- General management shall ensure that the responsibilities and authorities are defined and communicated within the company. The responsibility and authority organization refers to the organization structure”.
总经理管理层应确保组织内的职责、权限得到规定和沟通。各部门职责具体见组织结构图。
5.5.2Management representative管理者代表
- See details in 1.2.具体见1.2.
5.5.3Communication, participation and consultation信息沟通、参与和协商
- External Communication外部协商与沟通：
. LOG is responsible for information exchanges with customers to meet their demands. For the disposition of the information (including complaints, suggestions, etc.) from customers, relevant departments find out reasons and formulate measures, and QMS solves them
文件管理程序中英文对照
德信诚培训网 更多免费资料下载请进：https://www.sodocs.net/doc/ec8212544.html, 好好学习社区 Document Control Procedure 文件管理程序 1.0 Purpose 目的 Define the requirements and responsibilities for Document control. 定义出文件控制的要求和权责。 2.0 Scope 范围 This procedure applies to all QMS documentation, including: quality manual, procedure, WI, external document and form. 适用于与质量管理体系有关的所有文件。包括:手册、程序文件、操作指导书、外来文件及表单。 3.0 Definitions 定义 3.1 Quality Manual: According to the requirements of International and national standard (such as ISO9001), describe quality management system documentation in Co-active. 3.1质量手册：根据相关国际或国家标准(如ISO9001)要求，阐述本公司质量管理体系的文件。 3.2 Procedure: Define the function of QMS requirement allocation by department. Such as document control, management review, internal audit procedure. 3.2程序文件：描述为实施质量管理体系要求所涉及的各职能部门的活动的文件。如文件控制程序、 管理评审控制程序、内部审核控制程序。 3.3 Working Instruction: Operation procedures, inspection standards, design drawing and etc. 3.3操作指导书：操作规程、检验标准、加工图纸等。 3.4 Form: Records of operation results. 3.4表单：用于记录作业结果所用的文件。 4.0 Procedure 程序 4.1 Responsible for the formulation of documents to file the proper approval, and timely send the electronic document and the paper version to DCC, ensure that the relevant departments to understand the change. Once the document released, the relevant departments must follow procedures. When the file changes do not affect the contents of the file (such as correcting typos,
质量管理体系 文件控制程序
文件控制程序 一、目的：对与组织质量管理体系有关的文件进行控制，确保各相关场所使用文件为有效版本。 二、范围：对与组织质量管理体系有关的文件进行控制，确保各相关场所使用文件为有效版本。 三、职责者：公司总经理、管理者代表、各部门负责收集。 四、内容： 1、职责 1.1总经理负责批准发布质量手册。 1.2管理者代表负责审核质量手册。 1.3各部门负责本部门相关文件的编制、使用和保管。 1.4办公室负责组织对现有体系文件的定期评审。 1.5各部门负责本部门与质量管理体系有关的文件的收集、整理和归档等。 2、程序 2.1文件分类及保管 2.1.1文件一级分类及代号 2.1.2 文件二级分类及代号 每一大类生产质量管理文件下，又规定作二级分类，即分为：
二类分类代号中的字母除SOP，SMP为英文缩写外，其它均为中文的拼音缩写。2.1.3第一级质量管理体系文件为质量手册，第二级质量管理体系文件为程序文件，由办公室备案保存。第三级质量管理体系文件，由各相关部门自行保存并报办公室 备案存档。 2.2文件的编号 2.2.1文件的编号与格式 编号格式 版本号（两位数字） 2.2.2 一级分类、二级分类、三级分类代号的编制按2.1.1、2.1.2的有关规定执行。 2.2.3 顺序号用三个阿拉伯数字表示，按文件编制的顺序排列。 2.2.4 版本号表示文件修订情况，文件的第一版用“00”表示，第一次修订用“01”表示，以后每次修订按顺序递增。 2.2.5例如： 程序文件《文件控制程序》编号：CX-SMP-001-00表示该文件是：程序文件 , 2.3文件的编写、审核、批准、发放文件发布前应得到批准，以确保文件是适宜的： a)质量手册由办公室负责组织编写，由管理者代表审核，上报总经理批准发布， 由办公室负责登记、发放； b)各部门工作文件由各部门负责人组织编写、汇总，由管理者代表审核，报总 经理批准，办公室负责登记、发放； c)应确保文件使用的各场所都应得到相关文件的适用版本。文件的发放、回收 要填写《文件发放、回收记录》。 2.4文件的受控状况 文件分为“受控”和“非受控”两大类，凡与质量体系运行紧密相关的文件应为受控，由各主管部门按规定执行。所有受控文件必须在该文件封面书写“受控”表 明其受控状态，并注明分发号。 2.5文件的修订或替换
ASME程序文件-材料控制规则(中英文)
These rules are supplemented to the QC Manual for material control. 1.Purchasing 1.1 The material requisition prepared by Design Dept. is the basis of material purchasing, and is supplemented with the purchase specification or drawings or other specific procedures which specifies requirements not covered by the material requisition. 1.2 The Purchase Department shall maintain a close contact with vendors and ask for information on procurement status and necessary documents from the vendor such as their procedures, the mill test reports or certificate of compliance etc, for reviewing by the Material QC Engineer. If necessary the Purchase Department will apply for source examination at vendor’s shop. 1.3 The Purchase Department Supervisor shall be responsible for purchasing materials. 1.4 The Purchase Engineer shall prepare the purchase order in accordance with the material requisition accompanying with its supplementary documents. The completed purchase order shall be approved by the Purchase Dept. Supervisor. The Purchase Engineer shall send the purchase order, accompanying with purchase specification as required, to the contracted vendor and also a copy to the Examination Section. 1.5 When any part of the specifications or contract conditions is amended, the revised Purchase Order shall be prepared in the same manner as the original. If the amendment is limited to condition which does not affect the quality or the technical matter, such as delivery date, the amended condition may be informed to the vendor by telephone or telex, and shall be noted on a copy of the Purchase Order retained by the Purchase Dept.. 1.6 All of the purchase orders shall be filed for reference. 2. Receiving Inspection and Storage 2.1 When materials are received, the Material Warehouse Keeper shall place the in-coming material and parts in designated area and request the Material QC Engineer for receiving inspection. 2.2 The receiving inspection/。n shall be made in accordance with the “Rules for Receiving Inspection”(QC P 02) 2.3 Acceptable materials for Code items shall be segregated from those materials for
ISO14001文件管理与控制程序(中英文版)
文件管理与控制程序 Documents management and control procedure 1.目的Purpose 确保环境管理体系文件、适用的外来文件（有关的法律、法规、标准、相关方提供的文 件或规范）使用的有效性。To assure the 2.适用范围 scope 适用于对环境管理体系相关文件及适用的外来文件的控制。It is apply to the environment management system relation documents and usable external documents’ control. 3.职责Responsibility 3.1 环工组：负责环境管理体系文件及适用的外来文件的归口管理；负责监控文件的执行。 The environment team: to manage and be in charge of environment management documents and external documents. 3.2 各部门individual department：确保各相关场所均使用现行文件的有效版本。To ensure The relative workplace is using the current effective documents. 4.工作程序Work procedure 4.1文件控制范围包括：documents control’s scope a）环境管理手册；environment management manual; b）环境管理体系程序文件；environment management system procedure documents; c）环境管理体系作业指导文件；the work instruction documents for environment management system; d）环境记录表格；environment record form; e）外来文件。External documents. 4.2 文件的编写writing the documents 4．2．1环境管理手册和环境管理体系程序文件由环境管理者代表组织各部门人员编写。 Environment management manual and the environment management system procedure documents, which will be written by each department’s people that
质量手册、程序文件的管理制度
编号：SY-AQ-01352 ( 安全管理) 单位：_____________________ 审批：_____________________ 日期：_____________________ WORD文档/ A4打印/ 可编辑 质量手册、程序文件的管理制 度 Management system of quality manual and procedure documents
质量手册、程序文件的管理制度 导语：进行安全管理的目的是预防、消灭事故，防止或消除事故伤害，保护劳动者的安全与健康。在安全管理的四项主要内容中，虽然都是为了达到安全管理的目的，但是对生产因素状态的控制，与安全管理目的关系更直接，显得更为突出。 1、目的与适用范围 为了确保在质量体系运行中的各个场所使用的文件是有效版本,特制 定本制度。 本制度适用于《质量手册》、《程序文件》的更改,发放和回收的管 理。 2、管理要求 2.1全质办是《质量手册》、《程序文件》的归口管理部门。 2.2《质量手册》、《程序文件》在贯彻实施过程中若发现差距或不 符合实际情况时,各职能部门要以书面形式反馈全质办,全质办向管理 者代表提出更改报告,填写文件更改通知单,经管理者代表报准后进行 更改、控版和回收。 2.3全质办指定专人负责《质量手册》、《程序文件》按规定范围进 行发放、更改和因收,对其使用和保管进行监控。
2.4全质办受管理者代表委托解释《质量手册》和《程序文件》的有关内容。 2.5技术科负责对《质量手册》、《程序文件》进行标准化审查。 2.6《质量手册》、《程序文件》持有者要保证其有固定的存放位置,以便在任何情况下都能对其进行更改、回收等。 2.7《质量手册》、《程序文件》持有者要妥善保管,不得丢失,不准外借,更 不准私自提供他人转抄或复印,若发现类似问题,应予以追究责任。 这里填写您的公司名字 Fill In Your Business Name Here
采购控制程序中英文版本
XX有限公司 文件编号： 版本版次： 制定部门： 制定日期： 修定日期： 总页次： 会签：
1.0 目的Purpose 建立公司采购过程的管理程序，对产品采购的过程及价格进行有效控制，以确保所采购的物品/服务质量能符合和满足公司的各项生产需求。 To establish a management procedure for purchasing process control, ensure to control the product purchasing process and price effectively, in order to ensure the products/service purchased can satisfy the company’s requirements and needs. 2.0 范围Scope 本文件适用于公司内部所有采购过程(指满足公司最终产品所需要的各种原材料、辅助材料、设备及维修材料、外协加工服务、工具以及其它物品的采购)。 This procedure apply to all purchase process happen in our company (all kinds of raw material, auxiliary material, equipments and maintain material, outside machining service, tooling and all other goods needed by the company’s production or work.) 3.0 适用文件Applicable documents 以下文件的最新版本有效 The latest issue of the following documents are effect. COP037 《供应商管理程序》
ISO9001：2015全套文件英文版(含质量手册及全套程序文件)
Ningbo XXX Material Technology Co.,Ltd ISO9001:2015 Quality Manual Revision [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 19 TABLE OF CONTENTS 0.0 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)
中英文对照版-管理评审控制程序
ABC用品有限公司 质量管理体系程序文件 编制: 日期: 审核: 日期: 批准: 日期: 发放范围：公司各部门2013年10月01日生效
目录 序号章节名页码 1 目的Objective (2) 2 适用范围Applicable Scope (2) 3 职责Responsibility (2) 4 工作程序Work Procedures (3) 文件更改履历表 (7)
1 目的Objective 最高管理者按规定的时间间隔对质量体系现状进行评审，对所选定的质量体系的适宜性、有效性和充分性做出综合评价，保证满足标准的要求和实现质量方针及质量目标。 The top management shall review the present status of the quality s ystem at a specified time interval and make comprehensive assessment of its suitability, effectiveness and sufficienc y, e nsuring to meet the standards, quality policies and quality objectives. 2适用范围Applicable Scope 适用于最高管理者对现行的QS-9000:1998/ISO9001:1994质量体系的评审。 This is applicable to the review of QS-9000:1998 / ISO9001:1994 Quality System by the top management. 3职责Responsibility 3.1 公司总经理负责主持管理评审会议，审批管理评审报告，并对管理评审的全过程进行监督。 The General Manager is responsible to preside over the management review meeting, examine and approve the management review reports, and supervise the whole process of management review. 3.2 管理者代表负责向总经理汇报质量体系运行情况，提出改进建议，组织编写管理评审报告。负责组织 对管理评审中的持续改进、纠正预防措施的实施跟踪和验证 The management representative is responsible to report the status of quality system to the General Manager, submit improvement recommendations and formulate management review reports. It shall also responsible to follow and verify the continuous improvement and corrective & preventative actions as defined in management review. 3.3 各职能部门负责提供与本部门工作有关的评审资料，负责评审报告中所涉及的与本部门相关联的决定 的落实。 Each functional department is responsible to provide relevant information for review and implement the applicable decisions as in the review reports. 3.4 质量部负责编制管理评审计划，收集并提供管理评审所需的资料，负责对评审的纠正预防措施和持续 改进计划进行跟踪和验证，对管理评审资料整理归档。 The Quality Department is responsible to formulate management review plans, collect and provide necessary information for management review, follow and verify the corrective & preventative
质量管理体系程序文件
【最新资料，WORD文档，可编辑】
受控状态分发号 质量管理体系文件 质量管理体系程序文件 编号JD/QMB4.2.3—01~JD/ QMB8.5.2/8.5.3—05 编制办公室 评审各部门 批准管理者代表 版本号第A/0版
无锡市江达商品混凝土有限公司 文件修改记录表QR4.2.3—0107 文件名称编号 修改日期修改次数版本状态修改内容修改人批准人备注
质量管理体系程序文件目录表 序号ISO9001： 2000 标准条款号 文件编号文件名称 1 4.2.3 JD/QMB4.2.3—01 文件控制程序 2 4.2.4 JD/QMB4.2.4—02 记录控制程序 3 8.2.2 JD/QMB8.2.2—03 内部审核程序 4 8.3 JD/QMB8.3—04 不合格品控制程序 5 8.5.2—8.5.3 JD/QMB8.5.2/8.5.3—05 纠正措施和预防措施程序
质量管理体系程序文件编号JD/QMB4.2.3—01 第A版第0次修改 文件控制程序第1页共5页 1．目的 建立并保持形成文件的程序，以控制与质量管理体系有关的所有文件和资料，使与质量管理体系运行有关的各个场所使用适用文件的有关版本，从所有发放和使用的场所及时撤出失效和作废的文件。 2．范围 适用于本公司质量管理体系有效运行和产品质量有关的文件和资料的控制，包括适当范围的外来文件，如标准、法规、顾客财产的知识产权（提供的图纸）等。 3．引用标准 GB/T19001—2000《质量管理体系——要求》 JD/QMA—2006《质量管理手册》4.2.3《文件控制》 4．职责 4．1办公室负责质量管理体系管理文件的控制。
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