IRIS查检表.doc

IRIS标准问题汇总 . 4.1-1Question1: (Close) ISO/4.1 General requirements/一般要求Has the organization established,documented, implemented and maintained a quality management system and continually improved its effectiveness in accordance with ISO9001:2000?组织是否按照ISO9001：2000标准的要求建立、文件化、实施和维持的质量管理体系并持续改进其有效性？ “Defined”-Documented quality management system. -文件化的QMS-2nd / 3rd party certified -第2/3方审核4.1-2Question2: (Open) ISO/4.1 General requirements/一般要求How does the organization a) identify the processes needed for the quality management system and their application throughout the organization? b) determine the sequence and interaction of these processes? c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective?组织如何a)识别质量管理体系所必需的过程及其在组织中的应用？b)如何确定这些过程的顺序以及相互作用？c)如何确定及确保这些过程有效运作并加以控制所必需的判别准则和方法？“Poor”-Management manual -管理手册“Defined”-Management manual -管理手册-Process landscape with links and responsibilities -有相互联系和职责的过程图-Regular review of processes -对过程定期评审 “Qualified”Plus:Implementation of action plans and follow up of actions-加上措施计划的实施和后续的跟踪“Optimized”Plus:Efficiency of actions -加上措施的有效性4.1-3Question3: (Open) ISO/4.1 General requirements/一般要求How does the organization d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes?组织如何d)确保支持这些过程的运作及监控所必要的各种资源与信息的获得？“Poor”-Organization chart -组织机构图“Defined”-Organization chart -组织机构图-Job descriptions -工作描述“Qualified”Plus:Roles & Responsibilities matrix -加上：角色和职责矩阵“Optimized”Plus:Efficiency of actions(regular in management review) -加上：措施的有效性（定期体现在管理评审中）4.1-4Question4: (Open) ISO/4.1 General requirements/一般要求How does the organization e) monitor, measure and analyse these processes? f) implement actions necessary to achieve planned results and continual improvement of these processes and are these processess manage in accordance with ISO 9001:2000?组织如何：e)监视、量测及分析这些过程？f)按照ISO 9001:2000标准对这些过程实施必要的纠正去达成策划结果和持续改进这些过程。“Poor”-Definition of objectives for each process -对每个过程定义了目标“Defined”-Definition of objectives for each process -对每个过程定义了目标-Key Performance Indicators (KPIs) -关键业绩指标-Implementation of action plans -实施措施计划“Qualified”Plus:Systematic Root Analysis Action plans for improvement-加上：系统性的根本原因分析和有措施计划用于改善。“Optimized”Plus:Efficiency of actions -加上措施的有效性。4.1-5Question5: (Open) ISO/4.1 General requirements/一般要求How does the organization ensure the management and the control of any outsourced process and how are such outsourced processess identified within the quality management system?组织如何识别质量管理体系范围内的外包过程并对这些外包过程进行管理和控制？“Poor”-Definition of an outsourcing process -定义了外包过程“Defined”-Definition of an outsourcing process. -定义了外包过程-Supplier evaluation and approval process -供应商评估和批准过程-Qualification certificates requested -要求的资质证明“Qualified”Plus:Specifications(commercial, technical, time) -加上规范（商务、技术、时间）“Optimized”Plus:Efficiency of supplier /process improvement activities -加上供应商/过程改进活动的有效性4.1-6Question6: (Knock-out) IRIS/4.1 General requirements/一般要求In case of transfer or outsourcing of activity within the execution of a contract does a transfer procedure including: feasibility study, risk analysis, planning, communication to customer and FAIs to the appropriate level exist ?当合同执行过程中倘若有转让或外包的情况发生时，是否有转让的程序？在适当的水平上，其内容包括：可行性研究，风险分析，策划，客户沟通和首件检验吗？“Yes”Transfer procedure including feasibility study, risk analysis, planning, communication to customer and FAIs to the appropriate level exists在适当水平上这样的转让程序存在，内容包括可行性研究，风险分析，策划，客户沟通和首件检验。4.1-7Question7: (Open) IRIS/4.1 General requirements/一般要求How does the organization defined and put in place a cost management process to address all business related costs during the whole product life cycle?组织是如何定义、落实成本管理过程的，并被用于涵盖整个产品生命周期中的所有业务相关的成本？“Poor”-Cost Management process, e.g. flowchart -有成本管理过程，如流程图。“Defined”-Cost Managementprocess, e.g. flowchart -有成本管理过程，如流程图。-Cost Management process implemented in relevant areas -成本管理过程在相关领域得到实施。“Qualified”Plus:Cost Management process implemented in all relevant areas, Analyse and actions -加上：成本管理过程在所有相关领域得到实施，分析并采取措施。“Optimized”Plus:Efficiency of cost management improvements -加上成本管理改进的有效性。4.2.1-1Question8: (Close) ISO/4.2 Documentation requirements/4.2文件要求 4.2.1General/通则Does the quality management system documentation include a) documented statements of a quality policy and quality objectives?b) quality manual c) documented and applied procedures as required by ISO 9001:2000质量管理体系文件化是否包括：a）文件化阐明的质量方针与质量目标，b)质量手册，c) ISO 9001:2000标准要求的形成文件并应用的程序？“Defined”Mandatory Documentation: 强制性文件- Quality Policy and Quality objectives 质量方针和质量目标- Quality Manual 质量手册- Control of documents 文件控制- Control of records and记录控制 - Internal audit 内部审核- Control of non-conforming product 不合格品控制- Corrective action 纠正措施- Preventive action 预防措施4.2.1-2Question9: (Open) ISO/4.2 Documentation requirements/4.2文件要求 4.2.1General/通则How does the quality management system documentation cover documents needed by the organization to ensure the effective planning, operation and control of its processes as well as records required by ISO 9001:2000?组织如何确保质量管理体系文件涵盖ISO 9001:2000所要求的组织对各种过程进行有效策划、运作及控制所必需的各种文件、记录？“Poor”-Process description incl. templates, instructions-过程描述含模板，指导书。“Defined”-Process description incl.templates, instructions -过程描述包括模板，指导书。Implementation plan for relevant activities -相关活动的实施计划。“Qualified”Plus:Implementation for all relevant activities with analyzing actions-加上实施所有相关活动，并加以分析。“Optimized”Plus:Efficiency of the process continuously improved-加上过程持续改进的有效性。4.2.1-3Question10: (Open) IRIS/4.2 Documentation requirements/4.2文件要求 4.2.1General/通则Does the quality management system documentation include a technical safety policy and safety objectives?质量管理体系文件是否包括技术安全方针和安全目标？“Defined”-Technical safety policy and safety objectives are part of the management system documentation。 -技术安全方针和安全目标作为质量管理体系文件的一部分。4.2.1-4Question11: (Open) IRIS/4.2 Documentation requirements/4.2文件要求 4.2.1General/通则How does the quality management system documentation cover quality system requirements imposed by the applicable regulatory authorities?质量管理体系文件如何包括质量体系要求的适用的法规要求？“Poor”-Identification of requirements of regulatory authorities-识别了法律法规的要求。“Defined”-Identification of requirements of regulatory authorities -识别了法律法规的要求。-Implementation plan incl.validation of relevant activities 有实施计划，包括相关活动的确认。“Qualified”Plus:Implementation incl.validation of all relevant activities with analyzing actions-加上实施了要求，包括所有相关活动的确认以及分析措施。“Optimized”Plus:Efficiency of the process continuously improved-加上有效率新的过程持续善。4.2.1-5Question12: (Open) IRIS/4.2 Documentation requirements/4.2文件化要求 4.2.1General/通则How does the organization ensure that personnel have access to business management system documentation and are aware of relevant procedures?组织是如何保证相关人员能够获取质量管理质量管理体系的文件和了解相关的程序。“Poor”No regular communication of QM documentation to personnel -未定义质量管理体系文件相关人员的定期交流。“Defined”Regular communication of QM documentation to personnel supported by communication tools (e.g. intranet solution)-通过交流工具，QMS文件相关人员定期交流（如内部网解决方案）。“Qualified”Plus:Training on relevant processes and procedures-加上：对相关过程和程序进行了培训。“Optimized”Plus:Efficiency of the process continuously improved-加上：过程持续改进的有效性。4.2.1-6Question13: (Close) IRIS/4.2 Documentation requirements/4.2文件化要求 4.2.1General/通则Do customer and/or regulatory authority representative have access to quality management system documentation?客户和/或法规机构的代表能够在访问时获得QMS的文件吗？“Defined”-general policy -通用政策-quality manual -质量手册-customer specific documentation -客户特定的文件4.2.2Question14: (Open) ISO/4.2 .2 Quality manual /质量手册Has the organization established and maintain quality manual, which include.a) the scope of the quality management system, including details of and justifications for any exclusions? b) the documented procedures established for the quality management system, or reference to them? c) a description of the interaction between the processes of the quality management system?组织是否建立并维持质量手册，其内容包含a）质量管理体系的范围，包括任何删减细节和理由，b）质量管理体系所建立的文件化程序，或引用这些程序，以及c）质量管理体系各过程的相互作用的描述？“Poor”The scope of the QM system, including details of and justifications for any exclusions -质量管理体系的范围，包括任何删减细节和理由。“Defined”The scope of the QM system, including details of and justifications forany exclusions. -质量管理体系的范围，包括任何删减细节和理由。The documented procedures established for the QM system, or reference to them.建立的文件化的程序或程序的目录。A description of the interaction between the processes of the QM system- 质量管理体系过程之间相互作用的描述。“Qualified”Plus:Relationship between the IRIS requirements and the documented procedures are clearly shown -加上：清楚地说明IRIS的要求同文件化程序的关系。“Optimized”Plus:Efficiency and continuously improvement of inclusion of both standard (IRIS/ISO) -加上：IRIS和ISO标准持续改进的有效性。4.2.3Question15: (Open) ISO/4.2 .3 Control of documents/文件的控制How does the organization control the documents required by the qualiy management system in accordance of ISO 9001:2000? Has a documented procedure been established to define the controls needed to a) approve documents for adequacy prior to issue? b) review and update as necessary and re-approve documents? c) ensure that changes and the current revision status of documents are identified?d) ensure that relevant versions of applicable documents are available at points of use? e) ensure that documents remain legible and readily identifiable? f) ensure that documents of external origin are identified and their distribution controlled? g) prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose?组织如何按照ISO 9001:2000标准要求对管理体系文件进行控制？是否建立了文件化的控制程序对其进行必要的控制 a）文件发布前得到批准，确保文件的充分性，b)必要时对文件进行评审和更新，并再次批准。c)确保文件的更改和现行修订状态得到识别，d）确保在使用处可获得文件的有关版本，e)确保文件保持清晰、易于识别，f)确保外来文件得到识别并控制其分发，g）防止作废文件的非预期，如因任何目的而要保留作废文件时，应加以适当的标识。“Poor”Procedure for control of documents -有文件控制程序。“Defined”Procedure for control ofdocuments. -有文件控制程序。Matrix creator, review, approval, control etc. -“创建者矩阵、评审、批准、控制等。ISO standard for relevant documents -相关文件的ISO标准。“Qualified”Plus:Matrix creator, review,approval, control etc. -加上：“创建者矩阵、评审、批准、控制”等。ISO standard for all documents including IRIS standard -对所有文件的ISO标准，包括IRIS标准。“Optimized”Plus:Efficiency and continuously improvement including ISO and IRIS standard-加上：包括ISO和IRIS持续改进的有效性。4.2.3Question16: (Open) IRIS/4.2 .3 Control of documents/文件的控制How does the organization ensure traceability of customer specification / requirements throughout the whole supply chain for design, manufacturing and field support activities?组织如何确保客户规范/要求在整个供应链中（包括设计、制造和现场支持活动）的可追溯性？“Poor”Process defined -定义了过程“Defined”Process defined. 定义了过程Matrix creator, review, approval, control etc. “创建者矩阵、评审、批准、控制等”ISO standard for all relevant customer engineering standards / specifications -ISO标准所包含的相关的顾客工程标准/规范“Qualified”Plus:Matrix creator, review, approval, control etc. 加上“创建者矩阵、评审、批准、控制”等。ISO standard for all customer engineering standards / specifications with a proactive attitude (asking by the customer for new versions / changes). 用积极的态度收集了所有顾客工程标准/规范（询问顾客的新版本或变化）。“Optimized”Plus:Efficiency and continuously improvement including ISO standard. -加上包含ISO标准持续改进的效率4.2.4-1Question17: (Open) IRIS/4.2 .4 Control of records/记录的控制How are records established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system?如何建立与维护各种记录，以提供证明符合各项要求以及质量管理体系有效运作的证据？“Poor”Procedure for control of records -记录控制程序。“Defined”Procedure to archive, retrieve and destroy of records. Matrix identification, creator, control ISO standard for all relevant records。-程序包含对记录的保存、检索和销毁。控制与ISO有关的所有相关记录的有创建者、识别矩阵。“Qualified”Plus:Retention schedule for all business records available -加上：所有可用的业务记录有保存期限。 Analysis of actions for relevant records. -对相关记录措施的分析 “Optimized”Plus:Efficiency and continuously improvement includingISO standard.-加上：包含ISO的持续改进的有效性。4.2.4-2Question18: (Close) ISO/4.2.4 Control of records/记录控制Do records remain legible, readily identifiable and retrievable?记录是否保持清晰，易于识别和检索？“Defined”Examples of records as defined in the requirements. -记录的样本定义在要求中。Record manager appointed Identification, safeguarded storage (teft), access rights ambient conditions of servers hard & application software stored, if necessary。记录保存指定专人负责，妥善保管。必要时，应用软件存储用服务器硬盘设定访问权限。4.2.4-3Question19: (Open) ISO/4.2 .4 Control of records/记录的控制How has a documented procedure been established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records? How does the documented procedure include approval of results recorded before official release and are records of changes maintained?是否建立文件化程序定义了有关记录的标识、贮存、保护、检索、保存期限和处置的所需的控制？文件化程序如何包含在正式发布前记录结果的批准和保持变更记录。“Poor”Examples of records only few records according procedure -根据程序仅记录有有很少的记录样表。“Defined”Examples of records.记录样表Retention periods for all record series are defined compliant to operational, legal, fiscal and historical quirements (percountry)。定义了所有记录的保存期限，并考虑了业务、法律、财政、历史等要求。All quality records are according procedure and results are approved before officia release所有记录均按照程序和结果要求在正式发布前结果获得批准。“Qualified”Plus:Regular analysis and actions are defined for relevant records.定义了对相关记录的定期分析和采取措施。Archiving media defined methodology for destruction defined-加上对相关的记录定义了定期的分析和行动。“Optimized”Plus: Regular review and continuous improvement of procedure. Electr. record mgmt solution available-加上：定期评审和程序的持续改进。并持续改善过程。4.2.4-4Question20: (Close) IRIS/4.2.4 Control of records/记录控制Are records available at the organization for review by customers and regulatory authorities in accordance with contract or regulatory requirements?记录能够根据合同或法规要求供客户和法规机构评审吗？“Defined”Documentary evidence e.g. Design freeze documentation, FAIs reports, contracts,Failure Modes & Effects Analysiss etc.-书面证据，如设计冻结文件、首件检验报告，合同、失效模式分析等。4.3-1Question21: (Open) IRIS/4.3 Knowledge management/知识管理How are best practices documented and regularly updated to improve organizations process efficiency and product in Quality, Costs and Delivery performances?最佳案例（经验）是如何文件化的，并定期更新，以改进过程的效率和改善产品的质量、成本和交期？“Poor”Some knowledge management activities existing 存在一些知识管理活动。“Defined”best practices documented and regularly updated inregard of e.g.:最佳案例形成文件并定期更新，如 design rules, 设计规则 return of experience after a project,项目完成后的经验 methods/manufacturing engineering standards,方法/制造工程标准 closing major NCR with standards (operating procedures etc.), and主要不符合项关闭后的标准化（运行程序等），以及 return of experience from the field, analysis of failure rates, etc 现场获取的经验、失效分析等“Qualified”Plus:Knowledge management 加上知识管理Process integrated in all business processes and linked to product regarding Quality, Costs and delivery performance. -所有的业务过程的综合并联结有关产品质量、成本和交期。“Optimized”Plus:Knowledge Management 加上知识管理Process integrated in all relevant business processes and link to the efficiency of these processes. 在所有相关的业务过程，并联结到这些过程的效率。5.1-1Question22: (Open) ISO/5.1 Management commitment/管理者承诺Does top management provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectivenessby. a) Communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements?b) establishing the quality policy? c) ensuring that quality objectives are established? d) conducting management reviews? e) ensuring the availability of resources?最高管理者能否通过下列行为提供证据，证明其对质量管理体系的开发，实施以及体系持续改有效性所作的承诺：a）在组织内部沟通满足顾客要求和法令、法规要求的重要性，b)建立质量方针，c)确保质量目标的建立，d)执行管理评审，e)确保资源的获得“Poor”Company policy stressing the importance of meeting customer requirements and quality objectives are clearly defined, reviewed and cascaded through all the levels of the organization -公司方针强调满足客户要求的重要性，质量目标被清晰地定义，评审并传达到组织的所有层次。“Defined”Company policy stressing the importance of meeting customer and statutory requirements and quality objectives are clearly defined and cascaded through all the evels of the organization. -公司方针强调满足客户要求的重要性，质量目标被清晰地定义，评审并传达到组织的所有层级。Management reviews are regularly performed and adequate resources provided.-定期执行管理评审，并提供充足的资源。“Qualified”Plus:Capacity analysis and objectives monitoring through significant KPIs -加上能力分析和通过重要的KPI监控目标。“Optimized”Plus:Action plans to achieve the established objectives and adjust resources availability -加上措施计划去达成建立的目标和调整资源利用率。5.2-1Question23: (Open) ISO/5.2 Customer focus/顾客为中心How does top management ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction?最高管理者如何确保顾客的要求得到确定，并且达到增强高顾客满意的目的？“Poor”Customer main requirements are defined and met-客户主要要求被定义并满足。“Defined”Customer requirements are clearly defined and fulfilled.-客户要求被清楚地定义并被满足。“Qualified”Plus:Regular surveys are carried out to measure customer satisfaction-加上：执行定期调查以测量顾客满意。“Optimized”Plus:Significant indicators allow to deploy effective action plans aimed at customer satisfaction increase. -加上：对重要指标开展有效的行动计划，旨在增强顾客满意。5.2-2Question24: (Open) ISO/5.2 Customer focus/顾客为中心Does the company policy reflect the