Element 4: Management System 管理体系 4.1General requirements 一般要求 4.2 Documentation and Records 文档和记录6.1Has the organization established a documented procedure for establishingthe required management measures and established records to provideproof of conformity with the requirements and effective functioning of themanagement system, and are they being maintained? (4.2)? Authority to approve documents? Records of document approval? Availability of documents at different locations? Knowledge of the documents’ location? Accessibility of documents? Storage and disposal of obsolete documents? Procedures for communicating/distributing documents of internal andexternal origin? Review and approval of revised documents? Establishment of archiving period compared with customer requirements,as well as legal and government requirements;? Disposal of records after expiration of the required archiving period;该机构是否已建立以建立必要的管理标准为目的的备有文档的程序，是否已建立以提供要求和管理体系的有效机能的一致性证明为目的的记录，同时它们是否会被持续。*批准文档的权力。*批准文件的记录*不同区域中文档的有效可用性*文档的区域的专门知识*易理解的文档*旧档案的存放和处理*内部外部分发传达文档的程序*修正的文档的检查和批准*与客户要求、法规、政府要求相比较制定的存档周期*归档期限届满后的记录处置6.2Does senior management ensure that the company policy and goal aresuitable for the purpose of the organization? (5.3)? Documented company policy with clearly communicated and measurablecompany goals, approved by company management? Records on improvements? Company goals, integrated in/related to business plan? Scope of application of the company goals? Direct surveys with random sampling of select employees of theorganization? Proof of periodic review of the company policy? Company goals are established for the respective functional divisionsand levels within the organization, including those goals necessary to fulfillthe requirements of products高级管理手段是否能够确保公司的方针和目标与该机构意图相适应*有文档记录的被公司管理认可的清晰传达的公司政策、可衡量的公司目标*改进记录*公司目标，完整地相关的商业计划*公司目标的应用范围*机构中随机选取的员工的直接调查*公司政策的检查周期证明*在机构内为不同职能区和级别设立公司目标，包括那些产品要求必须执行的目标5.4.2 Planning the Quality Management System质量管理体系计划编制6.3Does senior management of the organization ensure thata) The management system is planned to fulfill the requirements in section4.1 of ISO9001:2000 and to reach the company goals?b) The function of the management system is maintained, if changes to themanagement system are planned and implemented? (5.4.2)Results of internal auditsA）该机构的高级管理手段是否确保管理体系按计划执行ISO9001：2000 4.1单元的要求以及达到公司的目标B）如果改变管理体系已被计划和执行，该机构的高级管理手段是否确保管理体系的功能被保持良好（5.4.2）内部评审结果5.5 Responsibility, Authority, and Communication Responsibility and Authority5.5责任、权力、沟通5.5.1责任和权力6.4Are the responsibility, tasks, duties in the company / organizationaldivisions/units? Established and documented through a written assignment ofresponsibilities, tasks, and duties? (5.5.1)Tasks, responsibilities, and authorities should be clearly established for thedivisions and employees. Coordination and interfaces between differentdivisions and activities should be clearly defined. Suitable formats for thesedefinitions are, for example:? Operational procedures? Matrix of responsibilities? Organizational charts? Task/job descriptions公司/机构部门/单位的职责、任务、义务是否已经制定并以书面的形式被记录（5.5.1)应清晰的为公司和员工制定任务、职责、权利。不同部门与行动间的协调与界面应被明确定义说明。定义的格式例如：*操作程序*职责矩阵*机构图*任务/工作说明5.5.2 Senior Management Appointee 高级管理人 5.5.3 Internal communication 内部联系5.6 Management Review 管理回顾6.5Does senior management check and evaluate the management system ofthe organization to ensure its continual suitability, appropriateness, andeffectiveness? ? Reviewof all elements of the management system to ensure its continual suitabilityand effectiveness.? Review of cost indicators for quality.? Management review report, attendance, and appropriate frequency.? Action plans and follow-up.? Proof of projects for continual improvement that were initiated on thebasis of management reviews.? Archiving of management review reports.高级管理手段是否检查和评估该机构的管理体系，以确保其持续的适宜性、针对性和有效性*检查管理体系的所有元素成分以确保其持续适宜性和有效性*检查质量成本指标*管理审查报告，出席人数和频率*行动计划和跟进动作*管理审查的基础上发起的持续改进措施的计划论证*管理审查报告存档Element 6: Resource Management 资源管理 6.1 Provision of Resources 预备资源 6.2 Human Resources人力资源 6.3 Infrastructure下部结构 6.4 WorkEnvironment 工作环境 Element 7: ProRealization产品实现 7.1 Planning Product Realization 产品实现规划6.6Does the organization have a process for controlling and responding tochanges that affect the product realization, including those caused by asupplier? (7.1) Thisrequirement applies to ANY change in product realization, both for productand production process changes. Experience shows that uncontrolledchanges lead to quality problems in the organization and at the customers.The defined process, including change authorization, consistentimplementation, and communication are important factors that need to beexamined.Examples include:? Production control plans? Customer requirements? Development documentation? Test instructions? Machine process parameters? Material specifications/reports? Measuring equipment? Requirements of product release? Technical drawings? Work instructionsIf there are changes in the product realization that concern customerrequirements, the customer should be notified and his approval obtained.If necessary, the customer will decide on necessary changes to theschedule for sampling inspections and SOP.该组织是否有产品实现改变时的控制和应急程序，包括那些由供应商导致的原因（7.1）这个要求将应用于在产品实现中的任何改变，连同产品和生产过程改变。经验表明，未经控制的改变会在该机构和客户方导致质量问题。详细的程序包括变7.2 Customer-Related Processes 客户相关的程序 7.2.1Determining the Requirements Related to the Product 确定涉及产品的要求7.2.2 Evaluating the Requirements Related to the Product 评估涉及产品的要求 7.2.3 Communication with Customers 与客户交流6.7Does the organization ensure thata) The product requirements have been established?b) Any differences between the contract or order and the previousrequirements are eliminated?c) The organization is capable of fulfilling the specified requirements?(7.2.2) Customer order reviewProduct specification reviewElimination of differencesFeasibility study.Records on contract review.Approval of the inspection plan for development and production validationwith acceptance criteria该机构是否能确保A）产品要求已确定B）任何合同或订单中的不同点和前期要求已排除C）该机构能够执行指定的要求客户订单检查产品规格检查排除不同点可行性研究合同检查回顾记录带有被接受的标准的开发和生产确认的检查计划的正式批准6.8Has the organization established and implemented effective rules forcommunication with the customers on the following items:a) Product information?b) Inquiries, contracts, or order processing, including changes?c) Feedback from customers including customer complaints? (7.2.3)Common language at the interface levelElectronic Data Interchange (EDI) is a computerized system for the onlineexchange of planning data, such as computer-aided development data(CAD) and delivery schedules. CAD uses the capabilities of computersystems to automate creation and editing of the geometry, dimensions, andother concept notes, which enable the user to define the shape and physicalcharacteristics of an object. Signs of capability are, for example:Common language for technical specifications and important documents;Effective interfaces with customers.下列项目中该机构是否已制定和贯彻与客户交流的有效规则A）产品信息B）质询、合同、订单处理，包括变更C）客户反馈包括客户抱怨（7.2.3）电子数据交换（EDI）是在线计划编制数据交换系统，如CAD数据和传递进度时间表。CAD运用计算机系统性能进行自动创造和编辑几何、尺寸及其他概念，使使用者能够自己定义图形和目标的物理特性。其表现出的能力如：技术规格和重要文件的共同语言化与客户有效的界面7.3 Development 开发7.4 Procurement采购 7.4.1 Procurement Process采购程序6.9Does the organization ensure that procured products fulfill the establishedprocurement requirements? (7.4.1)• Incoming goods inspection of the organization• Inspection of the procurement source• Process audit at the supplier’s location该机构是否能购保证采购的产品能够达到已制定的采购要求（7.4.1）*该机构的来料检查*采购源检查*供应商所在地的过程审核7.4.2 Procurement Information 采购信息6.10Does the procurement information of the organization describe the productto be procured, including (where applicable):a) Requirements for approving products, procedures, processes,environmental protection, occupational safety, and equipment?b) Requirements of personnel qualification?c) Requirements of the QM-system?Order /releaseCommercial agreement该机构的采购信息是否包含以下被采购的产品的描述（如适用）：A）产品审批、程序、过程、环境保护、职业安全和设备的要求B）人员资格要求C）质保体系要求订单/许可商业协议7.4.3 Verification of Procured Products 采购产品的核查7.5 Production and Performance of Services 生产和履行的服务7.5.1 Operations Control操作控制 7.5.2 Validation of Production and Service Processes 生产确认和服
6.11Does the organization establish the required inspections or other activitiesthat ensure that the procured product fulfills the procurement requirements,and does it perform the inspections? (7.4.3)Incoming goods inspection schedules.Suppliers and sub-suppliersOrder and contractIncoming goods inspectionFor attributive characteristics, the acceptance criterion.Inspection of the supply sourceAuditing of suppliers’ production locations by supplier’s customers orindependent third partiesIndependent evaluation of acceptability of the products by specified thirdparties该机构是否建立必要的检查或其他手段以保证采购的产品执行了采购要求，是否完成了检查（7.4.3）来料检查时间计划表供应商和分供商订单和合同来料检查特定特性，验收标准货源检查由客户或独立的第三方审核供应商生产地点由指定的第三方独立评估合格产品6.12Has the organization established rules for all processes for production andperformance of services that contain (where applicable):Established criteria for the evaluation and approval of processes?Approval of equipment and employee qualification?Application of specific methods and procedures?Record requirements?Repeat validation? (7.5.2) • Results ofprocess/ capability analyses• Specification of requirements for processes, equipment, and personnelPertinent qualification recordsFrequency and conditions of repeat validation该机构是否已建立对于所有生产和履行的服务的过程的标准，包含（如适用）已建立评价标准和审批程序设备批准和员工资格运用的详细地方法和程序备案要求反复验证（7.5.2）过程结果/能力分析过程、设备、人员资格记录的详细要求反复验证的频率和环境7.5.3 Marking and Traceability标识和追溯 7.5.4 Customer Property 客户财产 7.5.5 Product Maintenance 产品维护 7.6 Measuring and Monitoring Equipment Contro和监控6.13Has the organization introduced processes to ensure that monitoring andmeasuring can be performed in compliance with monitoring and measuringrequirements? (7.6)The test equipment must be released and calibrated and monitoredregularly to ensure accuracy over the entire life (incl. storage times).Monitoring should cover, for example:Measuring sensors (PH electrode, temperature sensor, etc.),Measuring instruments (noise meter, etc.)Transducers.In addition, the test equipment must be maintained at regular intervals (e.g.,according to the manufacturer’s recommendations). This maintenanceshould be documented.The test intervals should be established depending on the frequency of use;they should be visible on the test equipment or accompanyingdocumentation. Calibration and measured values should be documentedand saved.该机构是否已引入确保监控和调节能够依照监控和调节的要求来执行的程序（7.6）测试装备必须有规律的检测、效准和监控，已确保其在整个寿命中保持精度（包括存储时间）监控必须覆盖，例如：传感器调节（PH电极、温度传感器等）仪器调节（噪声计）传感器另外，测试设备必须每隔一定时期被维护（如依据生产厂商的介绍），维护必须被记录。测试间隔应该根据使用频率确定；其应该是在设备上可见的或带有附属文档。标准和调节值应该被记录和保存。Element 8: Measurement, Analysis, and Improvement 调节、分析、改进8.1 General 一般情况 8.2 Measuring and Monitoring调节、监控 8.2.1 Customer
Satisfaction客户满意度6.14Does the organization monitor information about customer perception onwhether the organization has fulfilled customer requirements as a measurefor the performance of the quality management system? (8.2.1)Internal and external customers should be taken into consideration.• Evaluation of information regarding customer satisfaction performedroutinely at certain intervals• Performance indicators for customer satisfaction该机构是否监控客户意见信息，不论该机构是否按照履行质量管理体系措施执行客户要求（8.2.1）内部客户与外部客户都应考虑*在确定的时间间隔内完成客户满意度调查*客户满意度绩效指标8.2.2 Internal Audit 内部评审6.15Does the organization perform internal audits at regular intervals in order todetermine whether the management system:a) Meets the planned regulations (see 7.1), the requirements ofISO9001:2000, and the requirements of the management systemestablished by the organization?b) Is maintained effectively and efficiently? (8.2.2)• Audit timetableRecords of audits performed该机构是否在一定间隔内进行内部评审，以便确定管理体系是否：A）符合计划的标准（见7.1），要求ISO9001：2000，和该机构制定的管理体系要求B）维持效率和效力（8.2.2）* 平审时间表评审执行记录8.2.3 Monitoring and Measuring of Processes 监控和调节程序6.16Does the organization ensure that the customer’s requirements establishedin the production process and product release procedure are fulfilled?(8.2.3) • Current Cpk/Ppk versus Cpk/Ppkapproved by the customer• Existing response plan• Verification of correctness of the Cpk/Ppk calculation该机构是否保证客户的要求能够在生产程序和产品发放程序中被严格执行（8.2.3）*当前的Cpk/Ppk对于客户的额定Cpk/Ppk*现有的应急预案*验证正确的Cpk/Ppk计算8.2.3 Monitoring and Measuring of Product产品的监控和调节6.17Does the organization monitor and measure the product characteristics toverify fulfillment of product requirements? (8.2.4)• Production control plans• Test instructions• Records该机构是否监控和测控产品的特性以便验证产品要求的执行状况*生产控制计划*测试方法*记录8.3 Control of Nonconforming Products 不良品控制6.18If a defective product is detected after delivery or in use, does theorganization take measures that are appropriate for the consequences orpossible consequences of the defect? (8.3)• Follow one or more cases of deviations and verify the procedure(marking, separation, etc.).如果有缺陷的产品在交付或使用后被发现，该机构是否有适当的或可能的处理措施（8.3）*一个或多个偏差案例和验证程序（标记，隔离等）8.4 Data Analysis数据分析6.19Does the organization determine, record, and analyze suitable data topresent the suitability and effectiveness of the management system and toevaluate where continual improvements of the effectiveness could bemade? (8.4) Data records can be inthe form of an operational/location balance sheet and should be evaluatedunder the aspects of influencibility and relevance.• Internal performance data, such as:o Cost indicators for poor qualityo Effectiveness and efficiency of production processeso Test resultso Process capability datao Quality auditso Results of product testingo Internal and external quality datao Evaluation of subcontractorso Customer reportso Employee information该组织是否确定、记录及分析相关数据以便提出适当的和有效的管理体系并评估何处需要做出有效的持续改进（8.4）数据记录可以以可操作的/制定区域内的平衡的表格的形式出现，应该在中肯适当的有影响的方面做出评估*内部数据，如次品成本指标生产过程的效力和效率测试结果过程能力数据质量评审产品试验结果内部外部质量数据分供商评估客户报告员工信息8.5 Improvement 改进 8.5.1Continual Improvement持续改进 8.5.2 Corrective Measures 纠正措施 8.5.3 Preventive Measures 预防措施6.20Is the effectiveness of the management system continually improvedthrough tools such as company policy, company objectives, audit results,data analysis, corrective and preventive measures, as well as managementreview of the organization and Does the organization establish correctivemeasures to eliminate the root causes of possible defects in order toprevent their occurrence? (8.5)• Examples of continuing projects, initiated by company policy, companyobjectives, audit results, data analysis, corrective and preventivemeasures, as well as management review.The following could be helpful:Plant inspectionsTraining plansMaintenance plansAudit plans有效的管理体系是否持续改进，如通过公司政策、目标、评审结果、数据分析、矫正和预防措施及该机构的管理检查等。该机构是否建立了矫正措施以便从根源上杜绝可能缺陷，以防止它们再次发生（8.5 ）*如持续的计划，发布公司政策、目标、评审结果、数据分析、矫正和预防措施及管理检查等以下的应有帮助：车间视察培训计划技术维护计划评审计划 5.5.1rastructure下部结构 6.4 Work Element 7: Product求流
and Service Processes 生产确认和服务程序ng and Monitoring Equipment Control 设备调节ring调节、监控 8.2.1 Customer预防措施