1.0范围
1.0 Range
本手册根据依据GB/T 19001-2016《质量管理体系 要求》标准编制,是本公司质量管理的纲领性文件。
This manual is prepared in accordance with the standard of GB/T 19001-2016 "Quality Management System Requirements", and is a programmatic document of the company's quality management.
1.1管理体系范围:管理体系覆盖的塑料制品的生产、过程和活动形成文件。
1.1 Scope of management system: The production, process and activities of plastic products covered by the management system form documents.
1.2产品范围:
1.2 Product Range:
1.3本公司暂无外包过程。
1.3 The Company does not have an outsourcing process.
2.0 规范性引用文件
2.0 Normative References
GB/T19000-2016《质量管理体系 基础和术语》
GB/T19000-2016
GB/T 19001-2016《质量管理体系 要求》
GB/T 19001-2016
3.0 术语和定义
3.0 Terms and Definitions
本手册采用GB/T19000-2016《质量管理体系 基础和术语》标准中的术语和定义。
This manual adopts the terms and definitions in the GB/T19000-2016 "Quality Management System Basics and Terms" standard.
4.0质量管理体系及其过程
4.0 Quality management system and its process
4.0.1总则
4.0.1 General
本公司依据GB/T19001-2016《质量管理体系 要求》建立了质量管理体系、过程及其相互作用,并形成文件,本公司全体员工将有效地贯彻执行并持续改进其有效性。
The company has established a quality management system, process and its interaction in accordance with GB/T19001-2016 "Quality Management System Requirements", and formed a document, and all employees of the company will effectively implement and continuously improve its effectiveness.
本公司以确定质量管理体系所需的过程及其在整个组织中的应用,且应:
The Company shall identify the processes required for a quality management system and its application throughout the organization and shall:
a) 确定这些过程所需的输入和期望的输出;
a) Determine the inputs required and the desired outputs for these processes;
b) 确定这些过程的顺序和相互作用;
b) determine the sequence and interaction of these processes;
c) 确定和应用所需的准则和方法(包括监视、测量和相关的绩效指标),以确保这些过程的运行和有效控制;
c) identify and apply the guidelines and methodologies required (including monitoring, measurement and related performance indicators) to ensure the operation and effective control of these processes;
d) 确定并确保获得这些过程所需的资源;
d) Identify and ensure access to the resources required for these processes;
e) 规定与这些过程相关的的责任和权限;
e) Define responsibilities and competence in relation to these processes;
f) 按照6.1的要求确定的风险和机遇;
f) the risks and opportunities identified in accordance with the requirements of 6.1;
g) 评价这些过程并实施所需的变更,以确保实现这些过程的预期结果;
g) evaluate these processes and implement the required changes to ensure that the expected outcomes of these processes are achieved;
h) 改进过程和质量管理体系。
h) Improvement of processes and quality management systems.
4.0.2过程方法
4.0.2 Process Method
4.0.3本公司按照GB/T19001-2016《质量管理体系 要求》要求运用过程方法对本公司的质量管理活动进行控制,确保质量管理体系的有效实施,并实现本公司的质量方针目标。
4.0.3. In accordance with the requirements of GB/T19001-2016 "Quality Management System Requirements", the company uses process methods to control the company's quality management activities to ensure the effective implementation of the quality management system and achieve the company's quality policy objectives.
4.0.4在必要的程度上,组织应:
4.0.4 To the extent necessary, the organization shall:
a) 保持形成文件的信息以支持过程运行;
a) Maintain documented information to support the operation of the process;
b) 保留确认其过程按策划进行的形成文件的信息。
b) Retain documented information confirming that its process proceeded as planned.
4.0.5本公司通过以下活动对过程实施控制:
4.0.5. The Company controls the process through the following activities:
4.0.6本公司对管理体系所需要的过程进行确定,主要过程的识别如下:
4.0.6. The company determines the process required by the management system, and the main processes are identified as follows:
质量:客户、相关需求——合同评审——产品过程实现——生产过程——交付——发货——客户服务。
Quality: Customer, related needs - contract review - product process realization - production process - delivery - delivery - customer service.
4.0.7公司对生产和服务活动每个过程所需的输入和期望的输出,确定这些过程的顺序和相互作用,制定相关质量的控制计划。为确保达成顾客和相关的满意,在公司各层面提供并履行相关职能和实施活动,如管理工作层的经营计划、内容审核、管理评审、持续改进;过程活动的文件记录控制;人力资源;基础设施与工作环境提供与控制、标识和可追溯性管理;采购;监视测量资源;监视和测量、分析和评价、不合格(不符合)控制等。
4.0.7 The company determines the sequence and interaction of these processes for the inputs and expected outputs of each process of production and service activities, and formulates the relevant quality control plan. To ensure customer and related satisfaction, provide and perform relevant functions and implementation activities at all levels of the company, such as managing management of management level business plans, content review, management review, continuous improvement; Documentation control of process activities; Human resources; infrastructure and working environment provision and control, identification and traceability management; Procurement; monitoring of measurement resources; Monitoring and measurement, analysis and evaluation, non-conformance (non-conformance) control, etc.
4.0.8制定文件确定过程实施所需的准则、方法、测量及相关的绩效指标,以确保这些过程的有效运行和控制;
4.0.8 Develop documents to identify the guidelines, methods, measurements and associated performance indicators required for the implementation of processes to ensure the effective operation and control of these processes;
4.0.9确定和提供每个过程实施所需的资源;
4.0.9 Identify and provide the resources required for the implementation of each process;
4.0.10规定每个过程相关执行人员的职责和权限;
4.0.10 Stipulate the responsibilities and authority of the relevant executive personnel of each process;
4.0.11依照规定实施各个流程,以实现策划的结果;
4.0.11 Implement each process in accordance with the regulations to achieve the results of the plan;
4.0.12对过程进行监测和分析,定期进行体系评审,必要时变更过程,以确保过程持续产生公司期望的结果;
4.0.12 Monitor and analyze the process, conduct regular system reviews, and change the process if necessary to ensure that the process continues to produce the results expected by the company;
4.0.13采取改进措施,确保持续改进过程以及实现结果。
4.0.13 Take improvement measures to ensure continuous improvement of the process and the achievement of results.
5 领导作用
5 Leadership
5.1领导作用和承诺
5.1 Leadership and commitment
5.1.1总则
5.1.1 General
公司总经理应证实其对质量管理体系的领导作用和承诺,通过:
The General Manager of the Company shall confirm his leadership and commitment to the quality management system by:
5.1.1.1对质量管理体系的有效性承担责任;
5.1.1.1 Take responsibility for the effectiveness of the quality management system;
5.1.1.2 确保制定质量管理体系的质量方针和质量目标,并与组织环境和战略方向相一致;
5.1.1.2 Ensure that the quality policy and quality objectives of the quality management system are formulated and consistent with the organizational environment and strategic direction;
5.1.1.3 确保质量境管理体系要求融入与组织的业务过程;
5.1.1.3 Ensure that the requirements of the quality environment management system are integrated into the business processes of the organization;
5.1.1.4 促进使用过程方法和基于风险的思维;
5.1.1.4 Promote the use of process approaches and risk-based thinking;
5.1.1.5 确保获得质量管理体系所需的资源;
5.1.1.5 Ensure access to the resources required for the quality management system;
5.1.1.6 沟通有效的质量管理和符合质量管理体系要求的重要性;
5.1.1.6 Communicate the importance of effective quality management and compliance with the requirements of the quality management system;
5.1.1.7 确保实现质量管理体系的预期结果;
5.1.1.7 Ensure that the expected results of the quality management system are achieved;
5.1.1.8 促使、指导和支持员工努力提高质量/环境管理体系的有效性;
5.1.1.8 motivate, guide and support staff in their efforts to improve the effectiveness of the quality/environmental management system;
5.1.1.9 推动改进;
5.1.1.9 Drive improvements;
5.1.1.10 支持其他管理者履行其相关领域的职责。
5.1.1.10 Support other managers in the performance of their responsibilities in the relevant field.
5.1.2 以顾客为关注焦点
5.1.2 Focus on the customer
5.2质量方针
5.2 Quality Policy
5.2.1 制定质量方针
5.2.1 Formulate a quality policy
本公司总经理负责组织制定质量方针,体现满足顾客要求及持续改进的承诺,并使其在各层次得到充分的理解及切实的执行。方针应满足以下要求(但不限于):
The General Manager of the Company is responsible for organizing the formulation of the quality policy, reflecting the commitment to meet customer requirements and continuous improvement, and ensuring that it is fully understood and implemented at all levels. Policies should meet the following requirements (but are not limited to):
5.2.1.1与本公司的宗旨相适应;
5.2.1.1 Compatible with the purpose of the Company;
5.2.1.2考虑本公司活动、产品和服务的特点;
5.2.1.2 consider the characteristics of the Company's activities, products and services;
5.2.1.3包括对满足要求和持续改进的承诺;
5.2.1.3 include a commitment to meet requirements and continuous improvement;
5.2.1.4提供制定和评审质量目标的框架;
5.2.1.4 Provide a framework for setting and reviewing quality objectives;
5.2.1.5满足相关法律法规的要求;
5.2.1.5 Meet the requirements of relevant laws and regulations;
5.2.1.6相关方的要求与期望;
5.2.1.6 Requirements and expectations of relevant parties;
5.2.1.7对污染预防的承诺。
5.2.1.7 Commitment to pollution prevention.
经充分考虑本组织特点,遵守国家法规及善尽社会责任,持续经营企业,特制定本公司质量方针,方针及其含义见手册0.4章所述。
After fully considering the characteristics of the organization, complying with national laws and regulations and fulfilling social responsibilities, and continuing to operate the enterprise, the company's quality policy is formulated, and the policy and its meaning are described in Chapter 0.4 of the manual.
5.2.2 沟通质量方针
5.2.2 Communicate the quality policy
质量方针应通过以下方式进行沟通:
The quality policy should be communicated in the following ways:
5.2.2.1管理层通过各种宣传方式,将质量方针宣传到本公司各层次,确保质量方针得到正确的理解和实施。
5.2.2.1 The management publicizes the quality policy to all levels of the company through various publicity methods to ensure that the quality policy is correctly understood and implemented.
5.2.2.2在每次管理评审会议上,总经理须组织对质量方针的持续适宜性和有效性进行评审,并根据评审结果对其做出必要的调整。
5.2.2.2 At each management review meeting, the general manager shall organize a review of the continued suitability and effectiveness of the quality policy, and make necessary adjustments to it according to the review results.
5.2.2.3 当有相关方需要公司提供质量方针时,可通过公司网站进行获取。
5.2.2.3 When there are relevant parties who need the company to provide quality policy, they can obtain it through the company's website.
5.3 组织的角色、职责和权限
5.3 Roles, Responsibilities and Authority of the Organization
5.3.1公司总经理根据产品要求、顾客要求以及公司生产和发展的要求建立适合于公司自身情况的公司组织架构(见0.5组织机构图),分配各部门职责权限及岗位要求来规范公司各级组织架构及相应岗位职责的控制,确保各层次职责、权限和相互关系予以规定并得到沟通和互相理解;以:
5.3.1 The general manager of the company establishes the company's organizational structure suitable for the company's own situation according to product requirements, customer requirements and the requirements of the company's production and development (see 0.5 organizational chart), assigns the responsibilities and responsibilities of each department and the job requirements to standardize the company's organizational structure at all levels and the control of the corresponding job responsibilities, and ensures that the responsibilities, authority and mutual relations at all levels are specified and communicated and understood by each other; In order to:
确保质量管理体系符合本标准的要求;
Ensure that the quality management system meets the requirements of this standard;
确保各过程获得其预期输出;
ensure that each process achieves its intended output;
各部门报告质量管理体系绩效及其改进机遇(见10.1),特别向总经理报告;
Each department reports on the performance of the quality management system and opportunities for improvement (see 10.1), in particular to the General Manager;
确保在整个组织推动以顾客为关注焦点;
Ensure that customer-centricity is driven across the organization;
确保在策划和实施质量管理体系变更时,保持其完整性。
Ensure that changes to the quality management system are planned and implemented in a way that maintains its integrity.
5.3.2各部门、人员职责权限
5.3.2 Responsibilities and authority of various departments and personnel
5.3.2.1总经理
5.3.2.1 General Manager
总经理是本公司经营管理、安全管理的第一责任人。
The general manager is the first person responsible for the company's operation management and safety management.
全面领导公司的经营管理工作,直接负责公司安全监督,确保安全技术措施经费的提取和使用。
Comprehensively lead the company's operation and management, directly responsible for the company's safety supervision, and ensure the extraction and use of safety technical measures.
对公司财务运作、资金运作、资本运作、收支两线运作具有行政决策权。
It has administrative decision-making power over the company's financial operation, capital operation, capital operation, and revenue and expenditure operation.
整体把握公司人事安排,对部门以下人事任免具有决策权,对部门编制具有决策权。
Grasp the company's personnel arrangement as a whole, have decision-making power over the appointment and dismissal of personnel below the department, and have decision-making power over the establishment of departments.
负责建立有效的质量管理体系,并确保其有效实施。
Responsible for establishing an effective quality management system and ensuring its effective implementation.
负责向全公司传达满足顾客要求和法律法规要求的重要性。
We are responsible for communicating the importance of meeting customer requirements and legal and regulatory requirements throughout the company.
制定公司的管理体系方针,组织制定公司的管理体系目标。
Formulate the company's management system policy, and organize the formulation of the company's management system objectives.
全面负责质量管理工作。
Fully responsible for quality management.
主持管理评审,持续改进质量管理体系。
Preside over management reviews and continuously improve the quality management system.
确定和配备管理体系所需的资源。
Identify and equip the resources required for the management system.
5.3.2.2总务部
5.3.2.2 General Affairs Department
负责员工招聘、解聘、岗位调整、任免、办理人员退休手续等人事管理,并建立健全公司人力资源档案。
Responsible for personnel management such as employee recruitment, dismissal, post adjustment, appointment and dismissal, and handling personnel retirement procedures, and establish and improve the company's human resources files.
负责公司员工职业技能培训、岗位管理培训工作。
Responsible for the company's employee vocational skills training and post management training.
负责与质量有关文件和资料的控制和存档管理,使之受控。
Responsible for the control and archiving management of quality-related documents and materials, so that they are controlled.
协助总经理监督管理综合管理体系的策划和运行。
Assist the general manager to supervise and manage the planning and operation of the integrated management system.
负责制定管理评审议程、评审报告,并做好会议记录。
Responsible for formulating the management review agenda, review report, and keeping meeting minutes.
负责记录的管理工作。
Responsible for the management of records.
负责内部管理体系的审核工作。
Responsible for the audit of the internal management system.
负责公司办公区域内危险源辨识,保证管理方案的资金提供。
Responsible for the identification of hazards in the company's office area and ensure the provision of funds for the management plan.
负责员工职业健康体检,负责劳保用品发放。
Responsible for the occupational health examination of employees and the distribution of labor insurance supplies.
对纠正和纠正措施情况进行监督评价并报告总经理。
Supervise and evaluate the situation of corrections and corrective actions and report to the general manager.
总务部负责年度计划培训的制定.
The General Affairs Department is responsible for the development of the annual plan training.
5.3.2.3物流部
5.3.2.3 Logistics Department
负责销售产品的采购供应工作;负责外部提供的服务管理.负责合同评审和合同修订评审及其他各类信息的传递,合同的登记、归档和合同履行情况的动态管理。
Responsible for the procurement and supply of sales products; Responsible for the management of services provided externallyResponsible for the transmission of contract review, contract revision review and other types of information, contract registration, archiving and dynamic management of contract performance.
负责顾客满意度的调查和产品回访工作。
Responsible for customer satisfaction surveys and product return visits.
组织不合格(项)评审,并将评审结果报告总经理。
Organize the unqualified (item) review, and report the review results to the general manager.
采购科负责供应商ROHS材料的确认与ICP报告的确认.确保购入材料符合ROHS要求.
The Purchasing Section is responsible for the confirmation of the supplier's ROHS materials and the confirmation of the ICP report. Ensure that the purchased materials meet the requirements of ROHS.
营业科负责客户ROHS要求的传达及环保异常发生的沟通.
The Sales Division is responsible for communicating the customer's ROHS requirements and communicating the occurrence of environmental anomalies.
5.3.2.4 生产部
5.3.2.4 Production Department
1)生产计划的设定与修定。
1) Setting and revision of production plans.
2)订单的审核、登记及分发。
2) Review, registration and distribution of orders.
3)订单交货期核定及异常反应。
3) Order delivery time verification and abnormal reaction.
4)生产班组产质量的考核。
4) Assessment of the quality of the production team.
5)生产进度安排及控制。
5) Production schedule and control.
6)生产人员的调度及团休、公休及员工事假、病假的审批。
6) Scheduling of production personnel and approval of group leave, public leave and employee personal leave and sick leave.
7)用料管理及异常的追踪、改善。
7) Material management and abnormal tracking and improvement.
8)交货期异常反应及处理。
8) Abnormal reaction and treatment of delivery time.
9)产销、交货期、质量等有关事项协调。
9) Coordination of production and marketing, delivery time, quality and other related matters.
10)年度生产总结、班组生产总结。
10) Annual production summary, team production summary.
11)负责机械设备相关设施的检查和维修;
11) Responsible for the inspection and maintenance of machinery and equipment related facilities;
12)负责全公司供能设施的安装、改造、维修、保养工作;
12) Responsible for the installation, transformation, repair and maintenance of the company's energy supply facilities;
13)负责生产过程中不添加任何有害物质.
13) Responsible for not adding any harmful substances in the production process.
5.3.2.5财务部
5.3.2.5 Finance Department
1)对公司的产品成本和运行成本控制的实时化、数字化、真实性负责;
1) Responsible for the real-time, digital and authenticity of the company's product cost and operating cost control;
2)负责财务分析,为总经理及时提供环境资源配置的财务信息及决策依据;
2) Responsible for financial analysis, providing financial information and decision-making basis for environmental resource allocation for the general manager in a timely manner;
3)负责资金筹措、分配和监督使用;
3) Responsible for fund raising, distribution and supervision;
4)负责环境成本核算,控制、分析环境经济效益。
4) Responsible for environmental cost accounting, control and analysis of environmental and economic benefits.
5.3.2.6工程
5.3.2.6 Engineering
1)工艺卡的设定与修订,产品标准工时的设定与修订。
1) The setting and revision of the process card, the setting and revision of the standard working hours of the product.
2)各项操作规范的制订。
2) Formulation of various operating specifications.
3)工作方法的改善、简化、策划与推行。
3) Improvement, simplification, planning and implementation of working methods.
4)模具设计、修正、制作的完成、模具维护修理,模具外协加工安排及跟进质量检查。.
4) Mold design, correction, production completion, mold maintenance and repair, mold outsourcing processing arrangement and follow-up quality inspection.
5)样品、原材料、标准用量的计算,原料产品质量标准制定及培训。
5) Calculation of samples, raw materials, standard dosage, formulation and training of raw material product quality standards.
6)客户原样、监图的研究与保管,产品的开发、设计,样品进度制作的控制。
6) Research and storage of the customer's original and supervised drawings, product development, design, and sample progress production control.
7)新素材的资料收集、分类、归纳。
7) Data collection, classification, and induction of new materials.
8)设备定期保养计划拟定与执行,机械设备维护、电器设备的故障修护。
8) Formulation and implementation of regular equipment maintenance plan, mechanical equipment maintenance, and fault repair of electrical equipment.
9)负责样品材料的确认,并确保提供的样品材料符合ROHS要求.
9) Responsible for the confirmation of the sample material and ensure that the sample material provided meets the ROHS requirements.
5.3.2.7品质
5.3.2.7 Quality
1)原物料入厂质量检验的执行及异常的反应与处理。
1) The implementation of the quality inspection of raw materials entering the factory and the abnormal response and treatment.
2)过程中的质量检查及记录。
2) Quality inspection and recording in the process.
3)成品检查及记录。
3) Finished product inspection and recording.
4)成品各项功能性测验。
4) Functional tests of finished products.
5)检验器具的使用。
5) The use of inspection equipment.
6)质量异常处理及追踪。
6) Quality exception handling and tracking.
7)客诉质量异常的会同处理。
7) The quality of customer complaints is abnormal.
8)各项质量有关工作协调。
8) Coordination of various quality-related work.
9)执行质量管理的各种活动。
9) Carry out various activities of quality management.
10)质量不良原因分析、报告。
10) Analysis and reporting of the causes of poor quality.
11)年度工作总结。
11) Annual work summary.
12)负责对员工宣传方针及目标
12) Responsible for publicizing the policy and objectives to employees
13)负责内部、供应商材料及产品的ROHS检查与控制
13) Responsible for ROHS inspection and control of internal, supplier materials and products
14)主导ROHS管控并按照计划提供物料进行第三方检测,并负责ROHS异常发生时的处理.
14) LEAD ROHS CONTROL AND PROVIDE MATERIALS FOR THIRD-PARTY TESTING ACCORDING TO THE PLAN, AND BE RESPONSIBLE FOR THE HANDLING OF ROHS ABNORMALITIES
6.1 质量目标及其实现的策划
6.1 Planning of quality objectives and their realization
6.1.1 质量管理目标
6.1.1 Quality Management Objectives
公司质量管理目标见管理手册0.4章节。
The company's quality management objectives are described in section 0.4 of the management manual.
6.1.1.1 总经理负责批准发布公司质量目标的管理。
6.1.1.1 The general manager is responsible for approving the management of the company's quality objectives.
6.1.1.2为确保公司质量管理目标的实现, 公司应对质量管理体系所需的相关职能、层次和过程设定分目标,即在相关的部门建立分目标。
6.1.1.2 In order to ensure the realization of the company's quality management objectives, the company should set sub-objectives for the relevant functions, levels and processes required by the quality management system, that is, establish sub-objectives in relevant departments.
6.1.1.3这些目标应满足可测量要求,并与质量方针保持一致,内容应包括:
6.1.1.3 These objectives shall meet measurable requirements and be consistent with the quality policy, and shall include:
1) 产品和服务要求;
1) Product and service requirements;
2) 为满足顾客要求所进行的活动等;
2) Activities to meet customer requests, etc.
3) 目标应考虑企业面向市场目前和未来的需要,产品和服务及顾客满意的状况,体现持续改进要求。
3) The goal should take into account the current and future needs of the enterprise for the market, the status of products and services and customer satisfaction, and reflect the requirements for continuous improvement.
4)质量管理目标应可测量(可行时);
4) Quality management objectives should be measurable (when feasible);
5)质量管理目标应得到监视;
5) Quality management objectives should be monitored;
6.1.1.4 各部门每年应对管理目标的实施情况进行评价,对实施结果与现有管理目标的所示差距,应不断寻找改进机会,设定新的管理目标,必要时予以更新。
6.1.1.4 Each department shall evaluate the implementation of management objectives every year, and shall continuously look for opportunities for improvement in the gap between the implementation results and the existing management objectives, set new management objectives, and update them as necessary.
6.1.1.5 质量管理目标应与相关部门及相关方进行必要的沟通。
6.1.1.5 The quality management objectives should be communicated with relevant departments and relevant parties as necessary.
6.1.2质量目标及其实现的策划的制定
6.1.2. Formulation of quality objectives and planning for their realization
为保证公司质量目标和指标的实现,以确保目标的实现,组织应确定:
In order to guarantee the achievement of the company's quality objectives and indicators to ensure the achievement of the objectives, the organization should determine:
a)采取的措施;
a) measures taken;
b)需要的资源;
b) the resources required;
c)由谁负责;
c) who is responsible;
d)何时完成;
d) when it will be completed;
e)如何评价结果。
e) How the results will be evaluated.
6.1.3质量管理方案的检查与修订
6.1.3. Inspection and revision of quality management plan
各责任部门对质量管理方案的实施情况进行检查;在质量目标、指标发生变化或制定的措施不适应及出现新的质量影响因素等情况时需要更改质量管理方案。总经理要及时组织各单位对质量管理方案进行修订。
Each responsible department inspects the implementation of the quality management program; When the quality objectives and indicators change or the measures formulated are not suitable and new quality influencing factors appear, it is necessary to change the quality management plan. The general manager should organize all units to revise the quality management plan in a timely manner.
修订后的质量管理方案要经总经理(特殊情况下可授权的人员)进行审批。
The revised quality management plan shall be approved by the general manager (a person who can be authorized under special circumstances).
6.2 变更的策划
6.2 Planning of Changes
当出现新的情况,体系有变更需要时(如组织机构发生重大变化、特定的项目或合同要求等,公司明确规定,需要对管理体系的变更进行策划,并保证这些策划不仅符合本条款要求,还必须与公司管理体系文件规定的其它要求一致,以保持管理体系的完整性。
When there is a new situation and the system needs to be changed (such as major changes in the organizational structure, specific project or contract requirements, etc., the company clearly stipulates that it is necessary to plan the changes to the management system, and ensure that these plans not only meet the requirements of this clause, but also must be consistent with other requirements stipulated in the company's management system documents to maintain the integrity of the management system.
组织应考虑:
Organizations should consider:
a) 变更目的及其潜在后果;
a) the purpose of the change and its potential consequences;
b) 质量管理体系的完整性;
b) the integrity of the quality management system;
c) 资源的可获得性;
c) availability of resources;
d) 责任和权限的分配与再分配。
d) Assignment and redistribution of responsibilities and authority.
7支持
7 Support
7.1 资源
7.1 Resources
7.1.1 总则
7.1.1 General
公司总经理负责以适当方式确定并提供必需的资源(包括人力资源、基础设施、过程运行环境、监视测量资源、组织的知识等),并建立《人力资源管理程序》、《信息沟通控制程序》、《文件资料和记录管理程序》;并对其进行有效的管理,以保证本公司质量管理体系建立、保持与持续改进。
The general manager of the company is responsible for determining and providing the necessary resources (including human resources, infrastructure, process operating environment, monitoring and measurement resources, organizational knowledge, etc.) in an appropriate manner, and establishing the "Human Resources Management Procedures", "Information Communication Control Procedures", and "Documents and Records Management Procedures"; And effectively manage it to ensure the establishment, maintenance and continuous improvement of the company's quality management system.
公司对各类资源及能源进行有效管理,在保证正常运作的情况下尽可能节约资源及能源,使资源及能源的利用率最大。
The company carries out effective management of all kinds of resources and energy, and saves resources and energy as much as possible under the condition of ensuring normal operation, so as to maximize the utilization rate of resources and energy.
7.1.2 人员
7.1.2 Personnel
公司总经理根据公司生产和服务提供过程的需要,设置合理的职能部门,总务部制定《人力资源管理程序》以建立人力资源管理系统,明确对各岗位人员录用、教育、培训和考核的控制要求,再结合个人技能和经历各方面的情况,以确保给质量管理体系中相应的岗位委派能胜任的人员,为实现质量方针、质量目标提供人力资源保证。
According to the needs of the company's production and service provision process, the general manager of the company sets up reasonable functional departments, and the general affairs department formulates the "human resource management procedures" to establish a human resource management system, clarifies the control requirements for the recruitment, education, training and assessment of personnel in various positions, and then combines personal skills and experience in all aspects to ensure that the corresponding positions in the quality management system are assigned competent personnel. Provide human resources guarantee for the realization of quality policy and quality objectives.
7.1.3 基础设施
7.1.3 Infrastructure
7.1.3.1由工程组织建立和保持《设备管理程序》,以确定、提供并维护为达到产品符合要求(符合顾客要求、法律法规要求、公司及其他相关方要求)所必需的基础设施。这些基础设施包括:
7.1.3.1 The Engineering Organization shall establish and maintain the Equipment Management Procedures to identify, provide and maintain the infrastructure necessary to meet the requirements of the Products (customer requirements, legal and regulatory requirements, and the requirements of the Company and other related parties). These infrastructures include:
1)建筑物、工作场所和相关的设施(如厂房、车间、仓库、办公楼、试验室等)。
1) Buildings, workplaces and related facilities (such as factories, workshops, warehouses, office buildings, laboratories, etc.).
2)过程设备(硬件和软件,如绘图工具、生产设备、检测设备、生产工具、软件等)。
2) Process equipment (hardware and software, such as drawing tools, production equipment, testing equipment, production tools, software, etc.).
3)运输资源(如运输车辆等)
3) Transportation resources (e.g. transport vehicles, etc.)
4)信息和通讯技术(如信息软件、通讯设施、办公设备、网络等)
4) Information and communication technology (such as information software, communication facilities, office equipment, networks, etc.)
7.1.4 过程运行环境
7.1.4 Process Operating Environment
根据公司作业的具体需要,公司考虑工作环境中必要的人性和生理因素,确保员工的职业安全、健康和心情愉快,包括:
According to the specific needs of the company's operations, the company considers the necessary human and physiological factors in the working environment to ensure the occupational safety, health and well-being of employees, including:
a) 社会因素(如不歧视、和谐稳定、不对抗);
a) Social factors (e.g. non-discrimination, harmony and stability, non-confrontation);
b) 心理因素(如降低压力、倦怠预防、情感保护);
b) psychological factors (e.g. stress reduction, burnout prevention, emotional protection);
c) 物理因素(温度、热度、湿度、照明、空气流通、卫生、噪音)
c) Physical factors (temperature, heat, humidity, lighting, air circulation, hygiene, noise)
公司建立和保持《设备管理程序》,以确定并管理所需的工作环境。
The company establishes and maintains a "Facility Management Program" to identify and manage the required working environment.
7.1.5 监视和测量资源
7.1.5 Monitoring and Measuring Resources
工程建立《设备一览表》及《设备履历表》,对监视和测量设备进行控制,确保其测量能力和测量要求相一致,当要求保持有效结果时,测量设备应:
The project establishes the "Equipment List" and "Equipment Resume" to control the monitoring and measuring equipment to ensure that its measurement capabilities and measurement requirements are consistent
对照能溯源到国际或国家基准的设备,定期或在使用前进行校准和调整。当不存在上述基准时,应记录校准的依据;
Calibration and adjustment against equipment traceable to international or national benchmarks on a regular basis or prior to use. When the above reference is not present, the basis for the calibration should be recorded;
防止发生可能使校准失效的调整;
Prevent adjustments that could invalidate the calibration;
在搬运、维护和贮存期间防止损坏或失效;
Prevent damage or failure during handling, maintenance and storage;
具有校准结果的记录;
Documentation of calibration results;
在随后发现偏离校准状态时,再评价以往结果的有效性形成记录并采取纠正措施;
When deviations from the calibration state are subsequently discovered, the validity of the previous results is re-evaluated, a record is made, and corrective actions are taken;
必要时进行调整或再调整。
Adjust or readjust as necessary.
注:我司无用于监视和测量规定要求的软件。
Note: We do not have software for monitoring and measuring the requirements of the regulations.
7.2 能力
7.2 Capabilities
公司制定并执行《人力资源管理程序》,对从事影响产品要求符合性工作的人员、从事与环境有关的岗位,都必须按不同岗位及所承担工作任务的需要委派合适的人员,并通过教育和培训确保公司员工都具备相应的的专业技能、质量意识或专业能力要求。
The company formulates and implements the "Human Resource Management Procedures", and appoints appropriate personnel according to the needs of different positions and tasks for personnel engaged in work that affects the compliance of product requirements and positions related to the environment, and ensures that the company's employees have corresponding professional skills, quality awareness or professional ability requirements through education and training.
公司各工作岗位,均须明确岗位职责,并根据岗位工作需要确定任职人员的基本要求,包括文化程度、工作经历、培训和特殊资格要求。
Each position of the company must clarify the job responsibilities, and determine the basic requirements of the incumbent according to the needs of the post, including education level, work experience, training and special qualification requirements.
任职人员的能力鉴定,由总务部按《人力资源管理程序》组织进行,鉴定结果经各部门责任人审核(必要时,还应报请总经理审批)后委派人员到岗。岗位任职资格的鉴定包括新入职员工和本程序开始执行时的在职员工。
The ability appraisal of the incumbents shall be organized by the General Affairs Department in accordance with the "Human Resources Management Procedures", and the appraisal results shall be reviewed by the responsible persons of each department (if necessary, they should also be reported to the general manager for approval) and then appoint personnel to the post. The identification of job qualifications includes new employees and current employees at the beginning of this procedure.
总务部定期对各岗位员工的能力保持和实际工作表现进行考核评价,定期评价结果应全面反映各岗位员工的实际工作能力、接受的培训、专业资格和服务意识。
The General Affairs Department regularly evaluates the ability of employees in each position and the actual work performance, and the results of the regular evaluation should fully reflect the actual work ability, training, professional qualifications and service awareness of the employees in each position.
总务部定期对各岗位员工的能力保持和实际工作表现进行考核评价,定期评价结果应全面反映各岗位员工的实际工作能力、接受的培训、专业资格和服务意识。
The General Affairs Department regularly evaluates the ability of employees in each position and the actual work performance, and the results of the regular evaluation should fully reflect the actual work ability, training, professional qualifications and service awareness of the employees in each position.
7.3 意识
7.3 Awareness
7.3.1各部门根据实际工作需求对员工培训需求进行识别,确定不同的培训要求,并形成相应的员工培训计划。培训需求的类型包括:
7.3.1 Each department identifies the training needs of employees according to the actual work needs, determines different training requirements, and forms corresponding employee training plans. Types of training needs include:
员工的入职培训;
Induction training for employees;
质量意识教育;
quality awareness education;
质量业务知识和专业技能培训;
quality business knowledge and professional skills training;
质量特殊工作所需的资格培训等。
Qualification training required for quality special work, etc.
7.3.2培训工作必须按计划、有组织地进行,各部均有责任配合总务部开展培训工作。各项具体培训活动都必须明确培训的目的、内容、考核方式及负责组织的部门/人员,总务部负责监督培训的实施及控制。
7.3.2 The training must be carried out according to the plan and in an organized manner, and all ministries have the responsibility to cooperate with the General Affairs Department to carry out the training work. Each specific training activity must clarify the purpose, content, assessment method and department/personnel responsible for the organization, and the General Affairs Department is responsible for supervising the implementation and control of the training.
7.3.3总务部负责结合培训考核、意见反馈和实际工作表现,定期对培训效果进行评估,以利改进培训活动。
7.3.3 The General Affairs Department is responsible for regularly evaluating the training effect in combination with training assessment, feedback and actual work performance, so as to facilitate the improvement of training activities.
7.3.4培训活动的开展及效果评价,必须包含:
7.3.4 The development and effect evaluation of training activities must include:
a)遵守质量方针和满足本公司质量管理体系要求的重要性;
a) the importance of complying with the quality policy and meeting the requirements of the company's quality management system;
b)各岗位员工的作业活动对质量会产生现实的或潜在的显着影响;
b) the work activities of employees in various positions will have a real or potentially significant impact on quality;
c)提高个人能力的好处;
c) the benefits of improving the individual's capabilities;
d)在遵守质量、环境方针和程序以及满足本公司质量管理体系的要求方面,各岗位员工的角色和职责;
d) the roles and responsibilities of employees in each position in complying with quality and environmental policies and procedures and meeting the requirements of the company's quality management system;
e)背离规定的程序可能导致的结果。
e) Deviation from the prescribed procedure may result from the results.
7.3.5公司各项培训活动结束后均应按《人力资源管理程序》的规定进行记录。
7.3.5 After the completion of the company's training activities, it should be recorded in accordance with the provisions of the "Human Resources Management Procedures".
7.4 沟通
7.4 Communication
7.4.1内部沟通和外部信息交流
7.4.1 Internal communication and external information exchange
为确保质量管理体系的内部、外部信息交流的畅通有效,公司建立并保持《信息沟通控制程序》。
In order to ensure the smooth and effective exchange of internal and external information of the quality management system, the company has established and maintained the "Information Communication Control Procedure".
7.4.2 信息的来源与职责
7.4.2 Sources and Responsibilities of Information
a)总务部品质负责公司与上级主管部门、公司附近居民及团体之间的环境信息交流,负责接收及统筹处理公司内、外部门所反馈的环境信息,是公司内外环境信息的反馈、处理中枢;
a)The quality department of the general affairs department is responsible for the exchange of environmental information between the company and the superior authorities, residents and organizations near the company, and is responsible for receiving and coordinating the environmental information fed back by the company's internal and external departments, and is the feedback and processing center of the company's internal and external environmental information;
b)负责公司与顾客之间质量及内部产品质量信息的交流。
b)Responsible for the exchange of quality and internal product quality information between the company and customers.
c)品质/总务部负责质量管理体系日常监控、内、外部审核、管理评审结果的内部交流;
c) The Quality/General Affairs Department is responsible for the daily monitoring of the quality management system, internal and external audits, and internal communication of management review results;
d)物流部负责公司与供应商、承包方之间质量、环境信息的交流;
d) The logistics department is responsible for the exchange of quality and environmental information between the company and suppliers and contractors;
f)各部门负责部门内质量的反馈、传达,并按规定落实有关质量的处理措施。
f) Each department is responsible for the feedback and communication of quality within the department, and implements the relevant quality treatment measures in accordance with the regulations.
7.4.3 交流内容
7.4.3 Communication
公司的质量方针、质量目标及管理方案,公司质量体系的监测、审核、管理评审的结果,产品质量信息,顾客相关投诉,公司的质量、环境绩效及质量、环境改进情况,质量事故等一切与质量管理相关的信息均可作为交流的内容。
The company's quality policy, quality objectives and management plan, the results of the company's quality system monitoring, audit, management review, product quality information, customer complaints, the company's quality, environmental performance and quality, environmental improvement, quality accidents and other information related to quality management can be used as the content of communication.
7.4.4 公司内各级人员都有责任和义务对所发现的质量、环境问题逐级向上反馈,受理者对此应妥善处理,并做好必要的记录。
7.4.4 Personnel at all levels in the company have the responsibility and obligation to give feedback on the quality and environmental problems found step by step, and the acceptor shall properly deal with them and make necessary records.
7.4.5 公司自上而下的采用提案、会议、通知、电话、网络、公告、发文、培训、日常报表等各种方式向全体员工传达质量信息。
7.4.5 The company uses various methods such as proposals, meetings, notices, telephones, networks, announcements, documents, training, and daily reports to convey quality information to all employees from top to bottom.
7.4.6 公司各部门负责与业务范围内的相关方进行外部信息交流,交流时做好必要的确认、查询、处理和记录等.
7.4.6 Each department of the company is responsible for the external information exchange with the relevant parties within the scope of business, and make necessary confirmations, inquiries, processing and records during the exchange
7.4.7 公司通过网络或宣传的方式向社会公开公司质量方针。
7.4.7 The company discloses the company's quality policy to the public through the network or publicity.
7.5 形成文件的信息
7.5 Documented Information
7.5.1总则
7.5.1 General
公司根据GB/T 19001-2016《质量管理体系 要求》标准的要求,结合本公司的特点,建立和保持形成文件信息的质量管理体系,并建立《文件资料和记录管理程序》明确公司文件和记录的管理要求,以保证公司通过规范化的管理,实现公司的质量目标,向顾客提供满意的产品。形成文件信息的质量、环境管理体系覆盖公司所有影响产品质量的业务过程、公司制订书面程序,明确规定公司各类文件和资料的发放范围和控制方法,确保质量管理体系的各个场所都能得到相应文件的有效版本,防止误用。
According to the requirements of GB/T 19001-2016 "Quality Management System Requirements" standard, combined with the characteristics of the company, the company establishes and maintains a quality management system that forms documents and information, and establishes the "Document and Record Management Procedures" to clarify the management requirements of the company's documents and records, so as to ensure that the company achieves the company's quality objectives through standardized managementCustomers provide satisfactory products. The quality and environmental management system of the formation of document information covers all the business processes that affect the company's product quality, and the company formulates written procedures to clearly stipulate the scope and control methods of the company's various documents and materials, so as to ensure that the effective version of the corresponding documents can be obtained in each place of the quality management system to prevent misuse.
质量管理体系形成文件的信息的多少与详略程度应考虑:
The amount and degree of detail of the information documented by the quality management system should be considered:
a) 本组织的规模,以及活动、过程、产品和服务的类型;
a) the size of the Organization, as well as the type of activities, processes, products and services;
b) 过程的复杂程度及其相互作用;
b) the complexity of the process and its interactions;
c) 人员的能力。
c) Competence of personnel.
7.5.2 创建和更新
7.5.2 Creation and Updates
在创建和更新形成文件的信息时,组织应确保适当的:
When creating and updating documented information, organizations should ensure appropriate:
a)对文件应按类别、级别、适用范围、来源、使用和保管、版本和修订状态等特征进行标识和编号。每个文件的流水编号应是唯一的;
a) Documents should be identified and numbered according to their characteristics, such as category, level, scope of application, source, use and safekeeping, version and revision status. The flow number should be unique for each file;
b)应执行文件收发登记制度;
b) the registration system for the receipt and dispatch of documents shall be implemented;
c) 按文件类别、级别、适用范围等,规定制定、评审、更改和批准的权限,使文件在发布前得到批准,原则是层层授权,层层控制,确保文件是充分与适宜的。。
c) According to the category, level, scope of application, etc., stipulate the authority to formulate, review, change and approve, so that the document can be approved before release, the principle is to authorize and control at all levels, to ensure that the document is adequate and appropriate.
7.5.3 形成文件的信息的控制
7.5.3 Control of Documented Information
7.5.3.1 应控制质量管理体系和本标准所要求的形成文件的信息,以确保:
7.5.3.1 The quality management system and the documented information required by this standard shall be controlled to ensure that:
a) 确保在各使用部门可获得适用的文件;
a) Ensure that applicable documents are available in all sectors of use;
b) 予以妥善保护(如防止失密、不当使用或不完整)。
b) Appropriate protection (e.g. against confidentiality, misuse or incompleteness).
7.5.3.2 为控制形成文件的信息,适用时,组织应关注下列活动:
7.5.3.2 In order to control documented information, the Organization shall, where applicable, pay attention to the following activities:
a) 按公司的实际情况,将公司文件加以分类管制,并作相应的文件一览表;
a) According to the actual situation of the company, the company's documents are classified and controlled, and the corresponding documents are listed;
b)确保对公司所有执行记录的储存、保护、检索、保管期限和处理方式的文件,得到有效的管制,
b) to ensure that the documents of storage, protection, retrieval, retention period and processing of all execution records of the company are effectively controlled,
以提供符合质量管理系统要求和有效运作的证据。;
to provide evidence of compliance with the requirements of the quality management system and effective operation.
c) 文件必须有版本规定,以识别文件版本状态;并在修订时须重新经过核准,经修订的文件必须保留修订或更改的证据;
c) The document must have a version specification to identify the document version status; and must be re-approved when amended, and evidence of the amendment or alteration must be retained in the amended document;
d) 保留和处置。
d) Retention and Disposal.
对策划和运行质量管理体系所必需的来自外部的原始的形成文件的信息,订定外来文件的识别及管制准则。
Establish guidelines for the identification and control of external documents for the information of external raw documents necessary for the planning and operation of the quality management system.
8运行
8 runs
8.1 运行策划和控制
8.1 Operational planning and control
8.1.1 公司质量管理体系为满足产品和服务和(或)服务的符合性策划的过程为,建立和实施《过程设计管理程序》确保实施产品过程开发及管理:
8.1.1 The company's quality management system is to meet the compliance of products and services and/or services planning the process, establish and implement the "process design management procedures" to ensure the implementation of product process development and management
文件化体系管理控制过程;
Documented system management and control process;
体系策划与审核管理过程;
system planning and audit management process;
产品和服务实现的策划过程;
the planning process for the realization of products and services;
与顾客有关的评审、服务与顾客信息反馈管理控制过程;
Customer-related review, service and customer information feedback management and control process;
采购控制及物流控制过程;
procurement control and logistics control processes;
销售服务及外包过程;
sales services and outsourcing processes;
产品和服务的监视测量与不合格品的管理控制过程;
monitoring and measurement of products and services and the management and control process of nonconforming products;
资源的提供与管理过程(包括人力资源、基础设施与工作环境);
the process of providing and managing resources (including human resources, infrastructure and working environment);
数据分析与持续改进控制过程。
Data analysis and continuous improvement of control processes.
8.1.2 对确定所需产品和服务的实现过程,制定相应程序、或流程、或验收准则,分别规定其控制要求和方法,以满足产品和服务符合性要求。应考虑:
8.1.2 Formulate corresponding procedures, or processes, or acceptance criteria for the realization process of determining the required products and services, and stipulate their control requirements and methods respectively to meet the compliance requirements of products and services. Consideration should be given to:
1)存在哪些风险和机遇;
1) what are the risks and opportunities;
2)管控要求及管控目标;
2) Control requirements and control objectives;
3)产品和服务的要求;
3) requirements for products and services;
8.1.3 组织应对计划内的变更进行控制,并对非预期性变更的后果予以评审,必要时,应采取措施降低任何有害影响。
8.1.3 The organization shall control the planned changes and review the consequences of unintended changes and, if necessary, take measures to mitigate any harmful effects.
8.1.4顾客对公司无特殊要求的产品和服务,采用管理手册中所确定过程的现有控制方法,以满足产品和服务符合性要求。
8.1.4 Customers have no special requirements for the company's products and services, using the existing control methods of the process determined in the management manual to meet the product and service compliance requirements.
8.1.5公司在体系运行过程中应控制策划的更改,评审非预期变更的后果,必要时,采取措施消除不利影响。
8.1.5 The company should control the planned changes in the operation of the system, review the consequences of unexpected changes, and take measures to eliminate adverse effects if necessary.
8.1.6公司按相关规定要求,应确保外包过程受控,保证质量管理体系的持续有效运行。
8.1.6 In accordance with the requirements of relevant regulations, the company shall ensure that the outsourcing process is controlled and ensure the continuous and effective operation of the quality management system.
8.2 产品和服务要求
8.2 Product and Service Requirements
8.2.1 顾客沟通
8.2.1 Customer Communication
公司建立和实施《订单评审及客户服务程序》,由营业科负责在售前、售中、售后有效地与顾客进行沟通,就确定与实施顾客沟通的有效安排做出了如下规定:
The company establishes and implements the "Order Review and Customer Service Procedures", and the sales department is responsible for effectively communicating with customers before, during and after the sale, and has made the following provisions on determining and implementing effective arrangements for customer communication:
a)与顾客沟通的内容:
a) Content of communication with customers:
产品和服务的信息:包括顾客的要求或潜在要求,以国际或国家的法规、行业标准为依据;
Product and service information: including customer requirements or potential requirements, based on international or national regulations and industry standards;
问询、合同或订单的处理,包括对其修改;
processing of enquiries, contracts or orders, including their modifications;
顾客反馈,包括顾客抱怨;
customer feedback, including customer complaints;
顾客财产的处理和控制;
the handling and control of the Customer's property;
关系重大时,制定有关应急措施的特定要求。
When the stakes are significant, specific requirements for emergency measures are established.
b)与顾客沟通的办法:
b) How to communicate with customers:
1)利用订货会、展览会、派发各种宣传资料、拜访顾客等形式及时地向顾客提供公司的产品信息;
1) Provide customers with the company's product information in a timely manner in the form of order fairs, exhibitions, distribution of various promotional materials, and customer visits;
2)通过走访、电话、传真,收集顾客质量信息反馈,解答顾客问询,及时了解顾客的要求和期望,向顾客提供服务信息;
2) Through visits, telephone and fax, collect customer quality information feedback, answer customer inquiries, timely understand customer requirements and expectations, and provide service information to customers;
3)认真答复顾客的有关咨询;
3) Respond carefully to inquiries from customers;
4)认真处理并答复顾客投诉,分析原因,提出纠正措施或预防措施,满足顾客的要求和期望;
4) Conscientiously handle and reply to customer complaints, analyze the causes, propose corrective measures or preventive measures, and meet customer requirements and expectations;
5)就合同/订单的处理(包括修订)与顾客建立有效的联络,确保与顾客取得一致意见,等等。
5) Establish effective communication with customers regarding the processing (including amendment) of contracts/orders, ensure agreement with customers, etc.
8.2.2 与产品和服务有关的要求的确定
8.2.2 Determination of requirements relating to products and services
8.2.2.1营业科应明确顾客对公司提供产品和服务的各项要求,应获得的信息包括:
8.2.2.1 The sales department shall clarify the requirements of customers for the company's products and services, and the information to be obtained includes:
1) 产品和服务标准,包括法律法规的要求、公司认为必要的要求;
1) Product and service standards, including the requirements of laws and regulations, and the requirements that the company deems necessary;
2) 合同意向书、订单,一般以具体的合同条款为准;
2) The letter of intent and order of the contract are generally subject to the specific terms of the contract;
3) 顾客规定的产品和服务要求,包括有关可用性、交付和支持方面的要求及价格、交货期、服务等要求;
3) Product and service requirements specified by the customer, including requirements for availability, delivery and support, price, delivery time, service, etc.;
4) 产品和服务预期用途所必需的要求;
4) requirements necessary for the intended use of the products and services;
5) 公司确定的附加要求。
5) Additional requirements as determined by the Company.
8.2.2.2营业科通过市场调查、查阅法律法规文件、合同/订单评审、与顾客的交流、项目评估以及对自身能力的评估等方式,确定上述与产品有关的要求,并将这些要求形成相关文件(如合同、协议、产品标准、销售文件等),以证实满足其所提供的产品和服务的要求。
8.2.2.2 The sales department determines the above-mentioned product-related requirements through market research, review of legal and regulatory documents, contract/order review, communication with customers, project evaluation and evaluation of its own capabilities, etc., and forms these requirements into relevant documents (such as contracts, agreements, product standards, sales documents, etc.) to confirm that the requirements of the products and services it provides are met.
8.2.3 与产品和服务有关的要求的评审
8.2.3 Review of requirements related to products and services
8.2.3.1营业科负责组织相关部门对已识别的与产品有关的要求(含顾客要求及公司确定的附加要求等)进行评审。
8.2.3.1 The sales department is responsible for organizing the relevant departments to review the identified product-related requirements (including customer requirements and additional requirements determined by the company).
8.2.3.2若顾客提供的要求没有形成文件,公司应在接受顾客要求前以“口头订单”等形式对顾客要求进行确认,并形成确认记录。可采用适宜的确认方法(如书面记录后请客户签字回传),以保证“口头要求”理解正确,没有遗漏或不一致。
8.2.3.2 If the request provided by the customer is not documented, the Company shall confirm the customer's request in the form of an "oral order" before accepting the customer's request, and form a confirmation record. Appropriate confirmation methods (e.g., asking the customer to sign back after a written record) can be used to ensure that the "verbal requirements" are understood correctly and that there are no omissions or inconsistencies.
8.2.3.3评审应在公司向顾客做出提供产品的承诺之前进行(如接受合同或订单及接受合同或订单的梗概),并应确保:
8.2.3.3 The assessment shall be carried out before the Company makes an undertaking to the Customer to supply the Products (e.g. acceptance of the contract or order and acceptance of the summary of the contract or order) and shall ensure that:
1)产品要求得到规定(包括规格、数量、交货期、交货地点、价格、结算方式等)。
1) Product requirements are specified (including specifications, quantity, delivery time, delivery location, price, settlement method, etc.).
2)与以前表述不一致的合同或订单的要求已予解决;包括对顾客的例外要求(如时间、费用等)特别予以评审其可实现性。
2) the requirements of the contract or order that are inconsistent with the previous formulation have been resolved; This includes a special review of the customer's exception requirements (e.g., time, cost, etc.) for their achievability.
3)公司有能力满足规定的要求。这种能力是基于针对资源配置的评审来判断的,并得到经授权的相应负责人甚至总经理的最终批准或确认。
3) The company has the ability to meet the specified requirements. This competency is judged on the basis of a review of resource allocation and is subject to final approval or confirmation by the appropriate authorized responsible person or even the general manager.
8.2.3.4评审工作应由有一定资格的人员进行,这种资格应是有相当的技术业务知识和工作经验。
8.2.3.4 The review should be carried out by qualified personnel, who should have considerable technical and business knowledge and work experience.
8.2.3.5对合同、订单中不清楚的方面以及评审中认为需要调整的方面由销售部出面与顾客协商。
8.2.3.5 The sales department will negotiate with the customer on the unclear aspects of the contract and order and the aspects that need to be adjusted in the review.
8.2.3.6在进行预期产品的合同评审时(该项活动往往与新项目的导入评审结合一并进行),公司将研究、确认该产品的制造可行性,包括风险分析,并形成报告。
8.2.3.6 When conducting the contract review of the expected product (this activity is often combined with the introduction review of the new project), the company will study and confirm the manufacturing feasibility of the product, including risk analysis, and form a report.
8.2.4 产品和服务要求的变更
8.2.4 Changes to Product and Service Requirements
产品和服务要求发生变更时,应按原评审程序的规定,由营业科组织对变更内容评审,并将评审结果以会议记录或通知单或联络书等形式通知相关部门,以确保相关文件得到修改,相关人员获悉已变更的要求。评审后,要记录评审的结果及评审中提出的跟踪措施。
When there is a change in the requirements of products and services, the sales department shall organize a review of the change content in accordance with the provisions of the original review procedure, and notify the relevant departments of the review results in the form of meeting minutes or notices or contact letters, so as to ensure that the relevant documents are modified and the relevant personnel are informed of the changed requirements. After the review, the results of the review and the follow-up measures proposed in the review should be recorded.
8.3 产品和服务的设计和开发(不适用)
8.3 Design and development of products and services (not applicable)
本公司为加工型企业,所有产品依客户图纸、样品生产,故GB/T19001-2016标准“8.3产品和服务的设计和开发”款条不适用。
The company is a processing-oriented enterprise, and all products are produced according to customer drawings and samples, so the GB/T19001-2016 standard "8.3 design and development of products and services" is not applicable.
过程设计按《过程设计管理程序》实施。
The process design is implemented according to the "Process Design Management Procedure".
8.4 外部提供过程、产品和服务的控制
8.4 Control of external delivery processes, products and services
8.4.1 总则
8.4.1 General
公司为确保外部提供的过程、产品和服务符合要求,由采购科组织建立和保持《采购和供应商管理程序》,以规范采购作业过程及对供应商的控制管理(包括选择、评价和重新评价供应商的准则);及公司对外包的任何影响到产品符合性的过程,应确保对其实施控制。本公司目前外包过程有:无。
In order to ensure that the processes, products and services provided externally meet the requirements, the Procurement Section organizes the establishment and maintenance of the "Procurement and Supplier Management Procedures" to standardize the procurement process and the control and management of suppliers (including the criteria for selecting, evaluating and re-evaluating suppliers); and the Company shall ensure that controls are exercised over any processes outsourced that affect product conformity. The company's current outsourcing process includes: None.
对于这些活动和由评价引发的任何必要的措施,组织应保留所需的形成文件的的信息。
The organization should retain the required documented information for these activities and any necessary measures arising from the evaluation.
8.4.2 控制类型和程度
8.4.2 Type and degree of control
8.4.2.1由采购科根据公司要求建立并执行《采购和供应商管理程序》,对材料供应商及外协加工厂商均应按其提供产品生产能力、检验能力等进行评鉴和选择(已通过ISO9001等系统验证之厂商优先考虑,但至少需通过ISO9001体系的认证),并建立合格供应商名单,供应商评定记录表并予保存。
8.4.2.1 The Procurement Department shall establish and implement the "Procurement and Supplier Management Procedures" according to the requirements of the company, and the material suppliers and outsourcing processing manufacturers shall evaluate and select according to the production capacity and inspection capabilities of the products they provide (the manufacturers that have passed the system verification of ISO9001 are preferred. However, it is necessary to at least pass the certification of the ISO9001 system), and establish a list of qualified suppliers, and keep a supplier assessment record form.
8.4.2.2 建立合格环保供应商评鉴规定和方法,并对不合格的供应商要限期改善,必要时取消其供应商资格。
8.4.2.2 Establish qualified environmental protection supplier evaluation regulations and methods, and improve the unqualified suppliers within a time limit, and cancel their supplier qualifications if necessary.
8.4.2.3 对供应商应定期或不定期进行考核,并保存记录。
8.4.2.3 Suppliers shall be assessed regularly or irregularly, and records shall be kept.
8.4.2.4 所采购的产品、物料均应符合实用的法律法规要求。
8.4.2.4 The purchased products and materials shall comply with the requirements of practical laws and regulations.
8.4.2.5公司销售产品不做库存,由采购科在供方的货源处依据采购文件中规定验证的安排和产品放行的方法进行产品出厂验证,确保采购产品满足规定的采购要求。
8.4.2.5 The company sells products without inventory, and the procurement department conducts product factory verification in accordance with the verification arrangements and product release methods specified in the procurement documents at the source of the supplier, so as to ensure that the purchased products meet the requirements of the procurement.
8.4.3 外部供方信息
8.4.3 External supplier information
8.4.3.1公司需依《采购和供应商管理程序》以采购文件的形式清楚地表述拟采购产品的采购信息,内容包括:
8.4.3.1 The company shall clearly state the procurement information of the products to be purchased in the form of procurement documents in accordance with the "Procurement and Supplier Management Procedures", including:
1)采购产品的信息:
1) Information on purchased products:
a.产品的名称、类别、型号、规格、价格、数量、供货时间等;
a. Product name, category, model, specification, price, quantity, delivery time, etc.;
b.重要产品或较特殊产品的质量要求、验收要求。
b. Quality requirements and acceptance requirements for important products or special products.
2)适当时,还应包括:
2) Where appropriate, it should also include:
a.对供应商的产品、程序、过程和设备提出的批准要求;
a. Approval requirements for suppliers' products, procedures, processes and equipment;
b.对供应商的人员提出的资格鉴定要求;
b. Qualification requirements for the supplier's personnel;
c.对供应商的质量管理体系提出的要求。
c. Requirements for the supplier's quality management system.
8.4.3.2采购文件发出前,应经审核和批准,以对采购要求的准确性、充分性及适宜性进行审查。
8.4.3.2 Before the procurement documents are issued, they shall be reviewed and approved to review the accuracy, adequacy and suitability of the procurement requirements.
8.5 生产和服务的提供
8.5 Provision of Production and Services
8.5.1 生产和服务提供
8.5.1 Production and provision of services
生产和服务提供的控制,本公司在下述方面考虑并实施生产和服务的提供安排;
control of production and provision of services, the Company considers and implements arrangements for the provision of production and services in the following areas;
a)可获得形成文件的信息,以规定以下内容:
a)that documented information is available to provide for the following:
1) 所销售的产品、提供的服务或进行的活动的特征;
1) Characteristics of the products sold, services provided or activities carried out;
2) 提供产品规定特性的信息;
2) Provide information on the specified characteristics of the product;
b) 可获得和使用适宜的监视和测量资源(见本手册9.1);
b) the availability and use of appropriate monitoring and measurement resources (see 9.1 of this manual);
c) 在适当阶段实施监视和测量活动,以验证是否符合过程或输出的控制准则及产品和服务的接收准则(见本手册9.1);
c) to carry out monitoring and measurement activities at appropriate stages to verify compliance with process or output control guidelines and acceptance criteria for products and services (see 9.1 of this manual);
d) 为过程的运行提供适宜的基础设施和环境(见本手册7.1);
d) Provide the appropriate infrastructure and environment for the operation of the process (see 7.1 of this manual);
e) 配备具备能力的人员,包括所要求的资格(见本手册7.1);
e) Staffing competent personnel, including the required qualifications (see 7.1 of this manual);
f) 对公司特殊过程进行有效地控制,使其按照规定的方法和程序在受控状态下运行,确保产品质量符合规定要求。经识别本公司销售过程为需要确认过程,按以下要求进行控制:本公司由生产部负责保证对关键过程和特殊过程能力。保持记录的完整和具有可追溯性;保持设备认可、人员资格鉴定、过程能力评定等活动记录。
f) Effectively control the company's special processes, so that they operate in a controlled state in accordance with the prescribed methods and procedures, and ensure that the product quality meets the specified requirements. After identifying the company's sales process as a process that needs to be confirmed, it is controlled according to the following requirements: the company's production department is responsible for ensuring the ability of key processes and special processes. Maintain complete and traceable records; Maintain records of activities such as equipment accreditation, personnel qualification, and process capability assessment.
g) 采取措施防止人为错误;
g) take measures to prevent human error;
h) 实施放行、交付和交付后活动(见本手册8.5.5与8.6)。
h) Implement release, delivery and post-delivery activities (see 8.5.5 and 8.6 of this manual).
8.5.2 标识和可追溯性
8.5.2 Identification and Traceability
本公司建立和实施《产品标识和可追溯程序》对产品进行标识,防止错用产品,标识采用挂牌或卡片形式进行标识(内容包括:产品品种、规格/型号、供方、生产日期、状态等)或随行文件(记录)的标识方式。
The company establishes and implements the "Product Identification and Traceability Procedures" to identify the products, prevent the misuse of products, and identify them in the form of tags or cards (including: product variety, specification/model, supplier, production date, status, etc.) or accompanying documents (records).
本公司产品检验试验的状态标识分为:合格、不合格、待检。
The status identification of the company's product inspection test is divided into: qualified, unqualified, and to be inspected.
相关责任部门/人员根据检验/试验的结果通过标识、分区、隔离的方式对产品的检验试验状态进行标识。
According to the results of the inspection/test, the relevant responsible departments/personnel shall identify the inspection and test status of the product by means of identification, partition and isolation.
在有可追溯性要求的场合,建立并保持形成文件的程序,对每个或每批产品都应有唯一标识,并对这种标识加以记录。
Where traceability is required, establish and maintain a documented procedure that uniquely identifies each product or lot and records such identification.
8.5.3 顾客或外部供方财产
8.5.3 Property of the Customer or External Supplier
本公司涉及顾客提供的图纸或样品之类的财产。公司把客户知识产权或客户个人信息列入顾客财产范围。以上顾客财产除公司内部使用外,未经客户许可,公司任何人不得复制、演示、传播客户财产,不得向第三方泄露,以达到保密管理之要求。
The Company is involved in the property such as drawings and samples provided by the customer. The Company includes the Customer's intellectual property rights or the Customer's personal information in the scope of the Customer's property. Except for the internal use of the company's property, no one in the company shall copy, demonstrate, or disseminate the customer's property without the permission of the customer, and shall not disclose it to a third party to meet the requirements of confidentiality management.
8.5.4 防护
8.5.4 Protection
8.5.4.1公司物流部组织建立和保持《产品防护交付管理程序》以确保在产品实现的全过程中(包括在内部处理和交付到预定的地点期间)相关部门能采取适宜的防护措施对产品提供防护,保证产品的符合性。
8.5.4.1 The company's logistics department organizes the establishment and maintenance of the "Product Protection Delivery Management Procedures" to ensure that in the whole process of product realization (including during internal processing and delivery to the predetermined location), the relevant departments can take appropriate protective measures to provide protection for the product and ensure the compliance of the product.
8.5.4.2产品防护包括标识、搬运、包装、贮存和保护。防护也适用于产品的组成部分。
8.5.4.2 Product protection includes identification, handling, packaging, storage and protection. Protection also applies to the components of the product.
8.5.5 交付后活动
8.5.5 Post-Delivery Activities
由营业科负责产品销售后交付后的活动,以控制满足与产品和服务相关的交付后活动的要求。在确定交付后活动的覆盖范围和程度时,公司应考虑:
The Sales Division is responsible for post-delivery activities after the sale of products and controls the fulfillment of post-delivery activities related to products and services. In determining the coverage and extent of post-delivery activities, companies should consider:
a) 与产品和服务有关的潜在不期望的后果;
a) potential undesirable consequences in relation to products and services;
b) 产品和服务的性质、用途和预期寿命;
b) the nature, use and life expectancy of the products and services;
c) 顾客规定的要求,包括对交付及交付后活动的要求,如既有产品本身的质量要求,也包括交货期、包装、运输、价格、售后服务等要求。并在此过程中,考虑需要提供潜在的重大环境影响的信息。;
c) The requirements specified by the customer, including the requirements for delivery and post-delivery activities, such as the quality requirements of the product itself, as well as the requirements for delivery, packaging, transportation, price, after-sales service, etc. and, in doing so, consider the need to provide information on potentially significant environmental impacts.
d) 顾客反馈。
d) Customer feedback.
e)公司所确定的任何附加要求(如公司在说明书、书面承诺等文件中明确的责任义务)。
e) Any additional requirements determined by the company (such as the company's responsibilities and obligations specified in the prospectus, written commitments, etc.).
8.5.6 更改控制
8.5.6 Change Control
公司建立和实施《工程管理规定》,在产品实现过程中,当条件、环境或人员等因素发生变化,对产品质量有影响或不满足顾客要求时,营业科根据实际情况组织生产部商议销售更改事项,将结果及时通报相关部门及人员,并保留相关文件信息作为更改实施的依据,确保产品和服务的完整性。
The company establishes and implements the "Engineering Management Regulations", in the process of product realization, when the conditions, environment or personnel and other factors change, which has an impact on product quality or does not meet customer requirements, the sales department organizes the production department to discuss sales changes according to the actual situation, and timely informs the relevant departments and personnel of the results, and retains relevant documents and information as the basis for the implementation of the change. Ensure the integrity of products and services.
8.6 产品和服务的放行
8.6 Release of Products and Services
8.6 .1在实现产品和服务的过程的规定不同阶段中实施产品监视和测量。
8.6.1 Implement product monitoring and measurement at the specified different stages of the process of realizing products and services.
8.6 .2公司按《产品检验程序》的要求对产品检验合格的记录进行控制,以保持产品符合接收准则的证据,在记录上载明有权放行产品的人员。
8.6.2 The company controls the records of product inspection in accordance with the requirements of the "Product Inspection Procedures" to maintain evidence that the products meet the acceptance criteria, and the personnel who have the right to release the products are indicated on the records.
8.6 .3除非得到有关授权人员的批准,适用时得到顾客的批准,否则在策划的安排(见8.1)已圆满完成前不得放行产品和交付服务。
8.6.3 The Products and Delivery of the Services shall not be released until the planned arrangements (see 8.1) have been satisfactorily completed, except with the approval of the relevant Authorised Officer and, where applicable, the Customer.
8.7 不合格输出的控制
8.7 Control of Non-Conforming Outputs
8.7.1为确保不符合产品要求的产品得到识别和控制,以防止不合格品非预期的使用或交付,由品质组织建立和保持《不合格品管理程序》,。不合格品的控制(如标识、隔离、评审)以及不合格品处置的有关职责和权限在文件中做出明确的规定。
8.7.1 In order to ensure that products that do not meet product requirements are identified and controlled, so as to prevent unintended use or delivery of nonconforming products, the Quality Organization establishes and maintains the "Nonconforming Product Management Procedures". The control of nonconforming products (such as identification, isolation, review) and the relevant responsibilities and authority for the disposal of nonconforming products are clearly stipulated in the document.
8.7.2公司可通过下列一种或几种途径处置不合格品:
8.7.2 The company can dispose of nonconforming products in one or more of the following ways:
8.7.2.1采取措施,消除已发现的不合格(如“重投”、“返工”);
8.7.2.1 take steps to eliminate identified non-conformities (e.g. "re-submission", "rework");
8.7.2.2经有关授权人员批准,适用时经顾客批准,让步使用、放行或接收不合格品(如“让步接收”,有关处置权责和程序于《不合格品管理程序》中进行了说明);
8.7.2.2 With the approval of the relevant authorized personnel, and with the approval of the customer when applicable, the use, release or receipt of non-conforming products is allowed to be used (such as "concession acceptance", the relevant disposal rights and responsibilities and procedures are explained in the "Non-conforming Products Management Procedures");
8.7.2.3采取措施,防止不合格品原预期的使用或应用(如“报废”、“退货”等)。
8.7.2.3 Take measures to prevent the intended use or application of non-conforming products (such as "scrapping", "return", etc.).
8.7.3公司保持不合格的记录以及随后采取的任何措施的记录,包括所批准的让步的记录。
8.7.3 The Company maintains a record of the non-conformity and any subsequent action taken, including a record of the concessions granted.
8.7.4在不合格品得到纠正之后(如返工、分选),公司将对其再次进行验证,以证实符合要求。
8.7.4 After the nonconforming products have been corrected (such as rework and sorting), the company will verify them again to confirm that they meet the requirements.
8.7.5当在交付或开始使用后发现产品不合格时,公司将采取与不合格的影响或潜在影响的程度相适应的紧急处理措施。
8.7.5 When a product is found to be non-conforming after delivery or commencement of use, the Company will take emergency measures appropriate to the extent of the impact or potential impact of the non-conformity.
8.7.6对生产和管理活动过程中环境发生不符合或事故,按《纠正和预防措施控制程序》,应采取报告、处置、调查、实施、验证、预防等措施,保留形成文件的信息。
8.7.6 In the process of production and management activities, environmental non-conformities or accidents, according to the "Corrective and Preventive Measures Control Procedures", measures such as reporting, disposal, investigation, implementation, verification, and prevention should be taken, and the information that was documented should be retained.
8.9 应急准备和响应
8.9 Emergency Preparedness and Response
8.9.1公司应建立、实施和保持《应急准备与响应控制程序》以准备和响应潜在的紧急情况,对可能发生的环境事故以及自然灾害等突发事件采取应急措施,预防和减少财产损失、人身伤害以及对环境的影响。并应:
8.9.1 The Company shall establish, implement and maintain the Emergency Preparedness and Response Control Procedures to prepare for and respond to potential emergencies, take emergency measures against possible environmental accidents and natural disasters and other emergencies, and prevent and reduce property damage, personal injury and environmental impact. and shall:
a) 按照计划活动准备响应以防止或减缓紧急情况时的负面环境影响;
a) Prepare responses in accordance with planned activities to prevent or mitigate negative environmental impacts in the event of an emergency;
b) 对实际的紧急情况进行响应;公司潜在的事故和紧急情况包括:火灾、爆炸、危险化学品泄漏、自然灾害、触电等。
b) Respond to actual emergencies; The company's potential accidents and emergencies include: fire, explosion, hazardous chemical spills, natural disasters, electric shock, etc.
c) 采取措施防止或减缓紧急情况和事故的发生的后果;
c) Take measures to prevent or mitigate the consequences of emergencies and accidents;
d) 如果可行,定期测试程序;
d) test procedures on a regular basis, if feasible;
e) 定期地评审和修订程序。尤其在事故,紧急情况发生或演习之后;
e) Review and revise the procedures on a regular basis. Especially after an accident, emergency or drill;
f) 提供与紧急准备和响应的相关的信息和培训,适用时,包括在组织控制下的相关方;
f) provide information and training related to emergency preparedness and response, where applicable, including relevant parties under the control of the organization;
8.9.2应急预案
8.9.2 Emergency plan
各相关部门根据每一类紧急情况,制订应急预案并形成文件,经部门领导审核、公司主管领导批准后下发至每个相关岗位。应急预案内容包括:
According to each type of emergency, all relevant departments shall formulate emergency plans and form documents, which shall be reviewed by department leaders and approved by the company's competent leaders and issued to each relevant post. The emergency plan includes:
1) 组织机构和相关人员的职责;
1) Responsibilities of the organization and related personnel;
2) 内、外部应急联系方式;
2) Internal and external emergency contact information;
3) 消防设备、应急、救援装置;
3) Fire-fighting equipment, emergency and rescue devices;
4) 安全隔离装置的布置;
4) Arrangement of safety isolation devices;
5) 应急措施及疏散程序;
5) Emergency measures and evacuation procedures;
6) 事故现场的保护等。
6) Protection of the accident scene, etc.
8.9.3应急准备
8.9.3 Emergency Preparedness
定期组织对相关人员进行培训,熟悉应急响应过程,以便在事故或自然灾害发生时,能够进行有效的控制;
Regularly organize training for relevant personnel to familiarize themselves with the emergency response process, so that they can be effectively controlled in the event of an accident or natural disaster;
各主管部门应组织应急预案演练,提高应变反应能力,填写“演练记录表”;
The competent departments should organize emergency plan drills, improve response capabilities, and fill in the "drill record form";
对应急响应措施进行评审,演练后对应急预案进行评审,对存在的不足进行修改、完善;
Review the emergency response measures, review the emergency plan after the drill, and modify and improve the existing deficiencies;
对潜在的事故、紧急情况发生点,进行醒目标志并配备必要的警示语、应急物资和器材;
Carry out conspicuous signs and equip necessary warnings, emergency supplies and equipment for potential accidents and emergencies;
定期进行检查、维护,对过期失效的器材,要及时进行更换,确保其完好性;
Conduct regular inspection and maintenance, and replace expired equipment in time to ensure its integrity;
各主管部门定期对潜在事故、紧急情况发生点进行检查,以减少事故的隐患;对检查中发现的问题,以“整改通知单”的形式下达整改要求并限期整改;检查内容包括:
The competent departments regularly inspect the occurrence points of potential accidents and emergencies to reduce the hidden dangers of accidents; For the problems found in the inspection, the rectification requirements shall be issued in the form of a "rectification notice" and rectified within a time limit; Inspections include:
─ 防火设施、设备和消防器材的完好性;
- Integrity of fire protection facilities, equipment and fire fighting equipment;
─ 设备防护、电气运行等隐患;
─ Hidden dangers such as equipment protection and electrical operation;
─ 员工作业行为是否规范;
─ Whether the employee's work behavior is standardized;
─ 易燃、易爆物品的贮存、管理和使用与规章制度符合性情况;
- Storage, management and use of flammable and explosive materials in compliance with rules and regulations;
─ 劳保用品发放及佩戴情况等。
─ Distribution and wearing of labor protection equipment, etc.
8.9.4应急响应
8.9.4 Emergency Response
紧急情况发生时,发生部门立即报告主管部门,同时启动应急预案,按预定分工抢险自救,疏散人员、物资等,尽量减少生命财产损失;
When an emergency occurs, the department immediately reports to the competent department, and at the same time activates the emergency plan, rescues and rescues according to the predetermined division of labor, evacuates personnel, materials, etc., and minimizes the loss of life and property;
主管部门及时向上级部门报告险情,寻求支援和抢救;
The competent department shall report the danger to the higher authorities in a timely manner and seek support and rescue;
主管部门组织人员保护现场,设置隔离带,为分析事故原因创造条件。
The competent department organized personnel to protect the scene, set up isolation belts, and created conditions for analyzing the causes of the accident.
8.9.5纠正和完善
8.9.5 Correction and Improvement
事故、紧急情况发生后,组织有关部门和人员进行事故调查、分析和处理;
After an accident or emergency occurs, organize relevant departments and personnel to investigate, analyze and deal with the accident;
事故、紧急情况发生后,对应急预案进行评审,必要时进行修改,使其不断完善。
After an accident or emergency occurs, the emergency plan is reviewed and modified if necessary to make it continuously improved.
公司应保留文件化信息以表明程序被按计划执行。
The Company shall retain documented information to show that the program was carried out as planned.
9 绩效评价
9 Performance Evaluation
9.1 监视、测量、分析和评价
9.1 Monitoring, Measurement, Analysis and Evaluation
9.1.1 总则
9.1.1 General
公司对监视、测量、分析和改进的过程进行了策划,由相关部门建立并保持《订单评审及客户服务程序》、《产品检验程序》、《内审、管理评审管理程序》、控制计划及必要时的质量计划等文件,对监视、测量、分析和改进活动的适用方法(含统计技术在内)及其应用程度做出详细规定,以评价质量管理体系绩效和有效性。公司应保留适当的形成文件的信息作为结果的证据。
The company has planned the process of monitoring, measuring, analyzing and improving, and the relevant departments have established and maintained documents such as "Order Review and Customer Service Procedures", "Product Inspection Procedures", "Internal Audit, Management Review Management Procedures", control plans and quality plans if necessary, and made detailed provisions on the applicable methods (including statistical techniques) and their application methods for monitoring, measurement, analysis and improvement activities to evaluate the performance and effectiveness of the quality management system. The company should retain the appropriate documented information as evidence of the results.
9.1.2 顾客满意
9.1.2 Customer satisfaction
9.1.2不论是否符合顾客要求,总务部将监视与顾客感受有关的信息,以作为对质量管理体系绩效的一种测量。
9.1.2 The General Affairs Department will monitor information related to the customer's feelings as a measure of the performance of the quality management system, regardless of whether the customer's requirements are met or not.
9.1.2有关获得与使用此信息的方法,请参阅《订单评审及客户服务程序》的规定。
9.1.2 Please refer to the Order Review and Customer Service Procedures for how to obtain and use this information.
9.1.3 分析和评价
9.1.3 Analysis and evaluation
为证实质量管理体系的适宜性和有效性,并评价在何处可以持续改进质量管理体系的有效性,公司建立和保持《订单评审及客户服务程序》、《产品检验程序》,以确定、收集和分析适当的质量数据和环境方面的信息。应利用分析质量、环境方面结果并予以准确评价:
In order to verify the suitability and effectiveness of the quality management system and to evaluate where the effectiveness of the quality management system can be continuously improved, the Company establishes and maintains Order Review and Customer Service Procedures and Product Inspection Procedures to identify, collect and analyze appropriate quality data and environmental information. The results should be analyzed and accurately evaluated in terms of quality and environment
a) 产品和服务的符合性;
a) Conformity of products and services;
b) 顾客满意程度;
b) customer satisfaction;
c) 质量管理体系绩效和有效性;
c) Quality management system performance and effectiveness;
d) 策划是否得到有效实施;
d) whether the plan is being effectively implemented;
e) 针对风险和机遇所采取措施的有效性;
e) the effectiveness of measures taken to address risks and opportunities;
f) 外部供方的绩效;
f) the performance of external suppliers;
g) 质量管理体系改进的需求。 注:分析数据的方法可以包括统计技术。
g) The need for quality management system improvement. Note: Methods for analyzing data can include statistical techniques.
9.1.4品质对质量监测和测量进行策划,确定监测项目、方法、频次和绩效指标,并将其分解到各部门。
9.1.4 Quality planning for quality monitoring and measurement, determining monitoring items, methods, frequency and performance indicators, and decomposing them into various departments.
9.1.4.1监测和测量设备的管理
9.1.4.1 Management of monitoring and measuring equipment
总务部环境监测和测量使用的设备、仪表,按规定进行校准(检定)或在使用前进行确认并标识。
The equipment and instruments used in environmental monitoring and measurement by the General Affairs Department shall be calibrated (verified) according to the regulations or confirmed and marked before use.
9.1.4.2 各主管部门应保存内、外部监测和测量及检查形成文件的信息
9.1.4.2 Administrations shall keep information documented by internal and external monitoring and measurements and inspections
9.2 内部审核
9.2 Internal Audits
本公司制定并实施《内审、管理评审管理程序》,有计划地通过内审来衡量本公司的质量、环境管理体系是否符合组织自身的其质量管理体系要求、标准要求、文件、顾客及要求;是否有效地实施和保持。
The company formulates and implements the "Internal Audit and Management Review Management Procedures", and measures whether the company's quality and environmental management system meets the organization's own quality management system requirements, standard requirements, documents, customers and requirements through internal audit in a planned manner; Whether it is implemented and maintained effectively.
9.2.1内审策划
9.2.1 Internal audit planning
总经理负责内审的总体组织及策划,任命适宜的人员于每年年初制定年度内审计划并于每次内审前制定详细的内审计划。审核计划(包括时间)应基于被审核活动和区域的状况,重要性及以往审核的结果,规定审核目的,范围,频次和方法。进行内部审核的人员应经过相应的培训并合格,且应独立于被审核部门。
The general manager is responsible for the overall organization and planning of the internal audit, appoints appropriate personnel to formulate the annual internal audit plan at the beginning of each year, and formulates a detailed internal audit plan before each internal audit. The audit plan (including timing) should specify the purpose, scope, frequency and methodology of the audit based on the status and importance of the audited activities and areas and the results of previous audits. The personnel conducting the internal audit should be properly trained and qualified, and should be independent of the audited department.
9.2.2内审实施
9.2.2 Internal audit implementation
审核组根据计划安排按程序对审核范围内的部门/过程进行审核,将审核发现形成记录,就不合格发出不符合报告,并由组长对本公司管理体系的符合性和有效性作出总体评价,审核的基本情况、发现及总体评价均应作为内审报告中的内容。审核报告应交总经理审核,并提交管理评审。
According to the plan, the audit team will audit the departments/processes within the scope of the audit according to the procedures, record the audit findings, issue a non-conformance report on the non-conformity, and make an overall evaluation of the compliance and effectiveness of the company's management system by the team leader, and the basic situation, findings and overall evaluation of the audit shall be used as the content of the internal audit report. The audit report shall be submitted to the general manager for review and submitted to the management review.
9.2.3纠正措施及其跟踪、验证
9.2.3 Corrective actions and their tracking and verification
针对审核中发现的不合格,责任部门应分析原因、制定并实施相应的纠正措施,其完成情况由审核组负责跟踪、验证。
For the nonconformities found in the audit, the responsible department shall analyze the reasons, formulate and implement corresponding corrective measures, and the audit team shall be responsible for tracking and verifying the completion of the nonconformity.
9.2.4保留作为实施方案以及审核结果的证据的形成文件的信息
9.2.4 Retain documented information as evidence of the implementation of the plan and the results of the audit
9.3 管理评审
9.3 Management Reviews
9.3.1总则
9.3.1 General
本公司制定并实施《内审、管理评审管理程序》,由总经理负责定期组织质量体系的管理评审,以确保其持续的保持适宜性、充分性和有效性,并与组织的战略方向相一致。
The company formulates and implements the "Internal Audit and Management Review Management Procedures", and the general manager is responsible for organizing the management review of the quality system on a regular basis to ensure that it continues to maintain its suitability, adequacy and effectiveness, and is consistent with the strategic direction of the organization.
公司总经理按照计划的时间间隔评审本公司的质量管理体系,评审包括评价质量、环境管理体系改进的机会和变更的需要。管理评审应按规定程序提前通知相关人员,以保证评审所需资料的准备完整、准确。
The general manager of the company reviews the company's quality management system at planned intervals, including the evaluation of opportunities for quality and environmental management system improvement and the need for change. The management review shall notify the relevant personnel in advance in accordance with the prescribed procedures to ensure the complete and accurate preparation of the materials required for the review.
9.3.2管理评审输入
9.3.2 Management Review Input
策划和实施管理评审时应考虑下列内容:
The following should be considered when planning and implementing a management review:
a )以往管理评审所采取措施的实施情况;
a) the implementation of measures taken in previous management reviews;
b)与质量管理体系相关的内外部因素的变化;
b) changes in internal and external factors related to the quality management system;
c)有关质量管理体系绩效和有效性的信息,包括下列趋势性信息:
c)Information on the performance and effectiveness of the quality management system, including the following trends:
1)顾客满意和相关方的反馈、需求和期望,包括合规性义务;
1) customer satisfaction and feedback, needs and expectations of interested parties, including compliance obligations;
2)质量目标的实现程度;
2) the degree of achievement of quality objectives;
3)过程绩效以及产品和服务的符合性;
3) process performance and compliance with products and services;
4)不合格以及纠正措施;
4) Non-conformity and corrective action;
5)监视和测量结果;
5) monitoring and measuring results;
6)审核结果;
6) Audit results;
7)外部供方的绩效,与外部相关方的沟通(包括投诉)。
7) Performance of external suppliers, communication with external stakeholders (including complaints).
d)资源的充分性;
d) the adequacy of resources;
e)应对风险和机遇所采取的措施的有效性;
e) the effectiveness of measures taken to address risks and opportunities;
f)改进的机会。
f) Opportunities for improvement.
g)组织的重要环境因素。
g) Important environmental factors of the organization.
9.3.3 管理评审输出
9.3.3 Management Review Output
管理评审的输出应包括与以下方面有关的决定和措施:
The output of the management review should include decisions and measures related to:
a) 改进的机会;
a) opportunities for improvement;
b) 质量管理体系变更的需求;
b) the need for changes to the quality management system;
c) 资源需求;
c) resource requirements;
d)组织战略方向的任何影响。
d) any impact on the strategic direction of the organization.
公司应保留作为管理评审结果证据的形成文件的信息。
The Company shall retain the information documented as evidence of the outcome of the management review.
10 改进
10 Improvements
10.1 总则
10.1 General
为确保产品符合要求,减少不良发生,公司建立和保持《不合格品管理程序》、《不符合和纠正措施管理程序》,以确定并选择改进机会,采取必要措施,满足顾客要求和增强顾客满意。
In order to ensure that the products meet the requirements and reduce the occurrence of defects, the company establishes and maintains the "Nonconforming Product Management Procedures" and "Nonconforming and Corrective Action Management Procedures" to identify and select improvement opportunities and take necessary measures to meet customer requirements and enhance customer satisfaction.
适用时,应包括:
Where applicable, this should include:
a) 改进产品和服务,以满足要求并关注未来的需求和期望;
a) To improve products and services to meet requirements and focus on future needs and expectations;
b) 纠正、或减少不利影响;
b) to correct, or reduce adverse effects;
c) 改进质量管理体系绩效和有效性。
c) Improve the performance and effectiveness of the quality management system.
改进的示例可以包括纠正、纠正措施、持续改进、突变、创新或重组。
Examples of improvement can include corrections, corrective actions, continuous improvement, mutations, innovations, or restructuring.
10.2 不合格与纠正措施
10.2 Nonconformities and Corrective Actions
10.2.1 若出现不合格,包括投诉所引起的不合格,组织建立和保持《不合格品管理程序》应:
10.2.1 In the event of non-conformity, including non-conformity caused by complaints, the organization shall establish and maintain the "Non-Conforming Product Management Procedures" shall:
对不合格做出应对,适用时:
Responding to non-conformities, where applicable:
1) 采取措施予以控制和纠正;
1) take measures to control and correct;
2) 处置产生的后果;
2) the consequences of disposal;
10.2.1.2公司建立和保持《不符合和纠正措施管理程序》,相关部门将依据程序的要求采取纠正措施以消除不合格的原因,避免其再次发生或者在其他场合发生。应通过下列活动,评价是否需要采取措施:
10.2.1.2 The company establishes and maintains the "Non-conformity and Corrective Action Management Procedures", and the relevant departments will take corrective measures according to the requirements of the procedures to eliminate the causes of non-conformity and avoid its recurrence or other occasions. The need for measures should be evaluated through the following activities:
1)评审分析不合格;
1) Unqualified review and analysis;
2)确定不合格的原因;
2) determine the reasons for the non-conformity;
3)确定是否存在或可能发生类似的不合格;
3) determine if there is or is likely to be a similar non-conformity;
10.2.1.3 实施所需的措施;
10.2.1.3 implement the measures required;
10.2.1.4评审所采取的纠正措施的有效性;
10.2.1.4 review the effectiveness of the corrective actions taken;
10.2.1.5需要时,更新策划期间确定的风险和机遇;
10.2.1.5 Update the risks and opportunities identified during the planning period when necessary;
10.2.1.6需要时,对质量管理体系进行变更。
10.2.1.6 Make changes to the quality management system when necessary.
纠正措施应与所产生的不合格的影响相适应。
Corrective actions should be commensurate with the impact of the resulting nonconformity.
10.2.2 组织应保留形成文件的信息,作为以下方面的证据:
10.2.2 The Organization shall retain documented information as evidence of:
a) 不合格的性质以及随后所采取的措施;
a) The nature of the non-conformity and the subsequent measures taken;
b) 纠正措施的结果。
b) The results of corrective actions.
10.2.3不符合、纠正和预防措施
10.2.3 Non-conformity, corrective and preventive actions
公司编制并实施《不符合和纠正措施管理程序》,对环境活动中出现的事故、事件进行调查和处理,通过实施纠正和预防措施,避免或减少类似事故、事件的发生。
The company prepares and implements the "Non-conformance and Corrective Action Management Procedures" to investigate and deal with accidents and incidents that occur in environmental activities, and avoid or reduce the occurrence of similar accidents and incidents through the implementation of corrective and preventive measures.
10.2.3.1 事故、事件的报告
10.2.3.1 Accident and incident reporting
a) 发生环境污染、安全生产等事故时,现场有关人员应及时报告,同时积极开展抢险和救护工作,尽量减少人员和财产损失;
a) In the event of environmental pollution, production safety and other accidents, the relevant personnel on the scene should report in a timely manner, and at the same time actively carry out rescue and rescue work to minimize the loss of personnel and property;
b) 事故、事件情况发生后,相关部门依据国家相关法律法规,根据事故、事件的严重程度,组织调查,进行严肃认真的处理。必要时,对责任人给予适当的行政或经济处罚或依法追究刑事责任;
b) After the occurrence of an accident or incident, the relevant departments shall organize an investigation and deal with it seriously in accordance with the relevant national laws and regulations and the severity of the accident or incident. When necessary, appropriate administrative or economic penalties shall be imposed on the responsible persons or criminal liability shall be pursued in accordance with the law;
c) 根据调查的结果,识别、评价采取纠正和预防措施的需求。
c) Identification and evaluation of the need for corrective and preventive action based on the results of the survey.
10.2.3.2 纠正措施的信息来源
10.2.3.2 Sources of information on corrective actions
a) 内审、外审中发现不符合;
a) Non-compliance found in internal and external audits;
b) 管理评审中发现的问题及缺陷;
b) Problems and deficiencies identified in the management review;
c) 管理体系内部监测和测量及日常检查中发现不符合;
c) Non-conformities found in the internal monitoring and measurement of the management system and daily inspections;
d) 相关方投诉或信息反馈;
d) Complaints or feedback from relevant parties;
e) 政府管理部门检查、监察和抽查中提出意见,发出指令性整改通知或罚款通知;
e) The government management department makes comments during inspections, inspections and spot checks, and issues mandatory rectification notices or fine notices;
针对上述已经发生的不符合,采取必要的纠正措施,防止不符合的再次发生。
In view of the above-mentioned non-conformities, necessary corrective measures shall be taken to prevent the recurrence of non-conformities.
10.2.3.3 纠正措施的控制
10.2.3.3 Control of Corrective Actions
a) 在制定纠正措施时,应充分考虑实际或潜在问题的严重程度和面临的环境影响、风险;
a) When formulating corrective measures, the severity of the actual or potential problems and the environmental impacts and risks faced should be fully considered;
b) 针对事故、事件或不符合制定纠正措施前,总务部/品质应组织对拟采取的纠正或预防措施进行评审,确保所实施的纠正措施与所遇到问题的严重性和伴随的环境影响和风险相适应;
b) Before formulating corrective measures for accidents, incidents or non-conformities, the General Affairs Department/Quality Department shall organize a review of the corrective or preventive measures to be taken to ensure that the corrective measures implemented are appropriate to the severity of the problems encountered and the accompanying environmental impacts and risks;
c) 总务部/品质以“纠正措施表”的形式向责任部门下达纠正或预防措施通知。
c) The General Affairs Department/Quality issues a notice of corrective or preventive action to the responsible department in the form of a "Corrective Action Sheet".
10.2.3.5纠正措施的制定与实施
10.2.3.5 Formulation and implementation of corrective measures
责任部门收到“纠正措施表”后,应对不符合产生的原因进行分析,制定纠正措施,明确责任人和完成日期。
After receiving the "corrective action form", the responsible department should analyze the causes of non-conformity, formulate corrective measures, and clarify the responsible person and completion date.
10.2.3.6纠正措施实施效果验证
10.2.3.6 Verification of the implementation effect of corrective measures
a) 纠正措施完成后,责任部门应将“纠正措施表”及相关材料上交总务部/品质部,总务部/品质对措施实施有效性进行验证,并记录验证结果;
a) After the corrective measures are completed, the responsible department shall submit the "Corrective Action Form" and related materials to the General Affairs Department/Quality Department, and the General Affairs Department/Quality Department shall verify the effectiveness of the implementation of the measures and record the verification results;
b) 因纠正措施的实施涉及体系文件更改时,应及时进行修订和补充;
b) When the implementation of corrective measures involves changes in system documents, they should be revised and supplemented in a timely manner;
c) 应将纠正措施的实施情况的相关信息进行内、外部交流与沟通。
c) Information on the implementation of corrective measures should be communicated internally and externally.
10.2.3.7记录的保存
10.2.3.7 Retention of Records
总务部/品质应保留纠正和预防措施实施及验证情况记录。
The General Affairs Department/Quality Department shall keep records of the implementation and verification of corrective and preventive actions.
10.3 持续改进
10.3 Continuous Improvement
公司用PDCA管理循环的原理,对产品、管理体系、管理活动进行持续改进,不断完善本公司的质量管理体系。
The company uses the principle of PDCA management cycle to continuously improve products, management systems and management activities, and continuously improve the company's quality management system.
公司利用质量方针、质量、环境目标、审核结果、资料分析、纠正措施以及管理评审等活动以确定是否存在持续改进的需求或机会,以持续改进质量管理体系的适宜性、充分性和有效性。
The Company uses activities such as quality policy, quality, environmental objectives, audit results, data analysis, corrective actions, and management reviews to determine whether there is a need or opportunity for continuous improvement to continuously improve the suitability, adequacy, and effectiveness of the quality management system.
附录:
Appendix:
程序文件清单
List of program documents
质量管理体系职能分配
Assignment of quality management system functions
序号 serial number | 程序文件名称 The name of the program file | 文件编号 Document number | 主责部门 Responsible department | 备注 remark |
1 | 订单评审及客户服务程序 Order review and customer service procedures | FLCOP1 | 营业 Business | |
2 | 设计管理程序 Design a hypervisor | FLCOP2 | 工程 engineering | |
3 | 生产管理程序 Production management program | FLCOP3 | 生产部 Production Department | |
4 | 产品防护交付管理程序 Product Guard Delivery Management Procedures | FLCOP4 | 物流部 Logistics Department | |
5 | 内审、管理评审管理程序 Internal audit, management review management procedures | FLCOP5 | 管理层 Management | |
6 | 不符合和纠正措施管理程序 Non-conformance and corrective action management procedures | FLCOP6 | 品质 quality | |
7 | 设备管理程序 Device Management Programs | FLCOP7 | 工程 engineering | |
8 | 人力资源管理程序 Human resource management procedures | FLCOP8 | 总务部 Department of General Affairs | |
9 | 采购和供应商管理程序 Procurement and supplier management procedures | FLCOP9 | 采购科 Procurement Section |
| 采购 procurement | 采购科 Procurement Section |
| |
10 | 文件资料和记录管理程序 Documentation and records management procedures | FLCOP10 | 总务部 Department of General Affairs | |
11 | 产品标识和可追溯程序 Product identification and traceability procedures | FLCOP11 | 品质 quality | |
12 | 产品检验程序 Product Inspection Procedures | FLCOP12 | 品质 quality | |
13 | 不合格品管理程序 Non-conforming product management procedures | FLCOP13 | 品质 quality | |
14 | 模具管理程序 Mold management program | FLCOP14 | 工程 engineering | |
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| | FLCOP10 | 总务部 Department of General Affairs |
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