TL9000质量管理体系要求手册50版内容变化对照仅供参考.docx

1、TL9000质量管理体系要求手册50版内容变化对照仅供参考TL9000质量管理体系要求手册5.0版内容变化对照（仅供参考）TL9000质量管理体系要求手册5.0版已由QuEST Forum发布，并将于2009年11月15日正式实施。5.0版标准与4.0版标准相比，变化情况分两个部分组成：ISO9001标准的基础已变更为ISO9001:2008，其他主要是针对通信行业特点的增补条款发生了部分变化。有关ISO9001:2008标准相对于ISO9000:2000标准变化内容，请参考相关标准和文件，本文不另赘述。下表以4.0版标准中TL9000增补条款为基础，对比介绍5.0版标准的变化，其中文翻译内容

2、仅供参考。（本文仅对标准变化的部分进行了对照，具体相关标准内容请关注标准原文）。4.0版标准条款及相关内容5.0版标准相应条款的内容变化5.2.C.2 ,to solicit and consider customer input for quality planning activities, 促使顾客参与质量策划并考虑其输入删除5.2.C.2-注：(see the document “Guidance for Communication with Customers” in the TL9000 Registration Guidance section of tl9000.org).（顾

3、客沟通指南文件参见tl9000.org的注册指南部分）。改为：(see the document “Guidance for Communication with Customers ”referenced http:/tl9000.org/links.html).（顾客沟通指南文件参见http:/tl9000.org/links.html）5.4.2.C.1-注1 Example factors which might be considered for planning are: 质量策划考虑的因素：a) ，f) 。增加：g）sustainability. 可持续性5.5.3.C.1 Th

4、e organization shall inform employee, 组织告知员工内容增加：including the results of quality management system reviews. 包括质量管理体系评审结果增加：5.5.3.C.1- NOTE：Sensitive organizational information may be excluded from this requirement.5.5.3.C.1- 注：敏感组织的信息可删减本条款的要求。6.2.2.C.4 their jobs.原句子后增加：The type and frequency of E

5、SD refresher training shall be defined by the organization.组织应确定ESD更新培训的类型和频次 6.3.C.1 Security restoration plans shall be developed and periodically assessed.应开发和定期评估安全恢复计划删除 新增：7.1.C.1- NOTE 1：A Life Cycle Model may include consideration and development of alternative solution evaluated against sel

6、ected criteria.7.1.C.1- 注1：针对所选定的标准，生命周期模式可以包括考虑和开发经评价后可供选择的解决方案。新增：7.1.C.1-注2：A Life Cycle Model should take into consideration sustainability practices such as reduction of energy and resource consumption，ecologically-responsible disposal and proper end-of-life treatment7.1.C.1-注2：生命周期模式应考虑到可持续发展的

7、做法，例如减少能源和资源消耗、生态责任处置、适当的寿命终止处理。7.1.C.1-注条款号改为7.1.C.1-注3 内容没变7.1.C.2 The organization shall establish and maintain a documented plans for disaster组织应为灾难建立和保持形成文件的计划its life cycle.增加： disaster and security restoration (see6.3.C.1) 和安全恢复（见6.3.C.1）原句子后增加：Disaster recovery plans shall include at a minim

8、um，crisis management，business continuity，and information technology. Disaster recovery and security restoration plans shall be periodically evaluated for effectiveness and reviewed with appropriate levels of management.灾难恢复计划应至少包括危机管理、业务连续性和信息技术等。灾难恢复和安全恢复计划应定期进行有效性评价并按适用的管理水平进行评审。7.1.C.3 a) ，e) 。增加

9、：f）disposition of the organizations parts and assemblies.f）组织的零件和组件的处置7.1.C.4-注Examples of tools to be considered include: design and development，testing，configuration management, documentation, and diagnostic tools including scripts, customization, dies，as well as software used to build and test pr

10、oduct.需考虑的工具例子包括设计和开发、测试、配置管理、文件和诊断工具，包括：脚本、定制、模具，以及用于开发和测试产品的软件。内容更改为：Examples of tools to be considered include design and development，testing，configuration management,documentation,scripts,customization,dies,stamps,fixtures,and diagnostic tools，as well as software used to build and test product.需

11、考虑的工具例子包括设计和开发、测试、配置管理、文件、脚本、定制、模具、标志、固定装置和诊断工具，以及用于开发和测试产品的软件。7.1.HS.1-注：Work instructions defining general configuration management tasks and responsibilities need not be replicated as part of a specific configuration management plan. 确定通用配置管理任务和职责的作业文件不必重复为特定配置管理计划的组成部分。删除。 7.1.V.1 ，and are not r

12、esponsible for the design and development of that service，（组织）不负责设计和开发服务。删除 7.2.2.C-注：，a)acceptance review process, 接受评审过程b)acceptance criteria， 接收准则 i) method(s) for problem tracking and resolution . 跟踪和解决问题的方法条款号改为7.2.2.C.2-注 删除删除删除其他条款只是序号变化，内容没变。7.2.3.C.1 Problem Report that is service affecting

13、. 对服务影响的问题报告改为：Critical Problem Report 关键问题报告7.2.3.C.2 Problem Severity 问题的严重程度TL9000 Measurements HandbookTL9000测量手册改为：Problem Severity Classification 问题的严重程度分类 改为：TL9000 Quality Management System Measurements Handbook TL9000质量管理体系测量手册7.3.1.C.1 g) (e.g., development)j) management of project quality

14、， 项目质量管理g)增加： (e.g., risk management，development 风险管理j) 增加了：“management of project quality, including appropriate quality measures” 包括适当的质量措施新增：k) design for x plans as appropriate to the product life cycle (Plan examples include, but are not limited to, manufacturability, Reliability, Regulatory, s

15、erviceability, safety, sustainability, and Testability)k)为“X”计划设计，应适合于产品的生命周期（计划的例子至少包括，可制造性，可靠性，调节性，适用性，安全性，持续性和易测性）i)lesson learned from previous post-project analysis i)来自于以往项目的经验教训分析o)变更为p)，原为“以往项目的分析”。增加了改进活动内容，变更为：p)post-project analysis and improvement activities, including root cause analysi

16、s of project lessons learned, and corrective actions to be taken to preclude repetition in future projectp)以往项目的分析和改进活动，包括项目经验教训的根本原因分析，避免问题在将来的项目中再次发生的纠正措施。7.3.1.C.3 a) ，k) 。增加：l)predefined exit criteria 预定的退出标准新增：7.3.1.C.4 Risk Management plan-The organization shall develop and document a plan for

17、 the identification, analysis, and control of risk to the project that can impact cost, schedule, product quality or product performance.7.3.1.C.4风险管理计划。组织应开发并形成一个文件化的计划，用于影响成本、进度、产品质量或产品性能的项目风险的识别、分析和控制。新增：7.3.1.C.4- NOTE Risk Management should be performed during all phases of product development

18、and should includea)the means to determine risk sources, categories, and prioritiesb) identification of significant or critical characteristics and failure modes, including customer experiencec)a definition of risk parameters(e.g., probability of occurrence, severity of impact)to be used in determin

19、ing risk priorities and scoring mechanisms to be use (e.g., FMEA-Failure Mode Effects Analysis)d)how risk will be managed (e.g., tools to be used, action to reduce risk, mitigation strategies, monitoring and reporting requirements)e)inputs from appropriate functional disciplines, andf）a mechanism fo

20、r capturing and applying lessons learned7.3.1.C.4- 注：风险管理应在产品开发的各个阶段实施，并应包括a）确定风险的来源、种类和优先事项的方法；b）重大或关键特性的识别和故障模式，包括客户体验；c）确定风险参数（例如，发生的可能性、影响的严重性），以用于确定优先事项和风险机制（例如失效模式与影响分析）；d）如何进行风险管理（例如，工具的使用、减少风险的行动、减轻战略、监测和报告要求）；e）适当时，来自于功能性学科输入；f）寻求和运用的经验教训的机制新增：7.3.1.C.5 Integration planning-The organization

21、 shall develop and document a plan to integrate the hardware, software, and/or service components into the product to ensure they interact as designed. The plan shall includea)methods and document procedure(s)b)responsibilities,c)schedule for integration, andd)test requirements.7.3.1.C.5整合计划。组织应开发并形

22、成一个文件化的整合计划，将硬件，软件和/或服务部分纳入到产品中，以确保它们的相互作用被设计，计划应包括：a）方法和程序文件；b）职责；c）整合日程安排；d) 测试要求。新增：7.3.1.C.6 Estimation-The organization shall establish and maintain a method for estimating and tracking project factors against the project plan throughout the project life cycle.7.3.1.C.6估算。组织应建立和保持一个方法，用于在项目整个生命

23、周期的项目计划，以估算和跟踪项目的要素。新增：7.3.1.C.6- NOTE Project factors should include product size, complexity, requirements changes, effort, staffing, schedules, cost, quality, reliability, and productivity. Data from the estimation process should be analyzed to compare original estimates to actuals.7.3.1.C.6-注：项目

24、要素应该包括产品的规模、复杂性、要求的变化、工作、人员、时间表、成本、质量、可靠性和生产率数据。估算过程获得的数据应被分析，以对实际的原始分析估算进行比对。7.3.1.HS.1-注1,that the customer purchases and installs separately, 客户购买并单独安装改为：,including that which the customer purchases and installs separately, 包括客户购买并单独安装7.3.1.HS.2原句子后新增：The measures should cover the areas of projec

25、t schedule (life cycle phase transition or milestone monitoring),test execution, and test phase defect monitoring.这些措施应涵盖项目时间表（生命周期阶段变化或转折点监控）、测试执行和测试阶段缺陷监测。7.3.1.HS.2-注In the TL9000 Registration Guidance of tl9000.org 在tl9000.org的TL9000注册指南中改为：referenced at http:/tl9000.org/links.html 参见http:/tl900

26、0.org/links.html7.3.1.S.1 Integration Planning- 整合计划删除7.3.1.S.2 Estimation- 估算删除7.3.1.S.3条款号变为7.3.1.S.1 内容没变7.3.1.S.3-注条款号变为7.3.1.S.1-注 内容没变7.3.1.S.4条款号变为7.3.1.S.2 内容没变增加7.3.2.C.1- NOTE：in conjunction with customer and supplier inputs, the organization should also consider results from competitive a

27、nalyses.7.3.2.C.1-注：与客户和供方间协同信息的输入，组织还应该考虑竞争力的分析结果。7.3.2.C.2e) installability, usability, and maintainability requirements可安装性、可用性和可维护性要求。 改为：e) manufacturability，installability, usability, interoperability, and maintainability requirements. e)可制造性、可安装性、可用性、互操作性和可维护性的要求。增加：i)lessons learned from pre

28、vious project. 来自于以往项目的经验教训。7.3.7.H.1 changes do not adversely affect product quality 变化不影响产品质量改为：changes do not adversely affect conformity to product requirements 变化不影响产品符合要求7.4.1.C.1 j)suppliers are re-evaluated based on defined criteria, and 供应商在确定的标准基础上重新评估k)feedback is provide to key suppliers

29、 based on data analysis of supplier performance 反馈意见提供给主要供应商，用作基于数据的供应商业绩分析删除删除新增加：7.4.1.C.2 Supplier Performance Management-The organization shall plan and perform supplier performance management and development activities so thata) supplier are qualified to established criteria,b)evaluation result

30、s are considered during supplier selection activities,c) suppliers are periodically re-evaluated using established criteria,d) supplier quality performance is tracked and feedback is provided to supplier to drive continual improvement, ande)for identified key suppliers, alignment toward conformity t

31、o TL9000 requirements and measurements or other appropriate quality management system for the suppliers product occurs, with a preference toward TL9000.7.4.1.C.2供应商绩效管理，组织应策划和实施的供应商绩效管理和发展活动，以便a）供应商达到既定标准资格；b）在选择供应商的活动中考虑评价结果；c）使用既定的标准对供应商进行定期重新评估；d）将供应商的质量业绩跟踪和反馈，提供给供应商以推动持续改进；e）为确定关键供应商，使之达到符合TL9000要求和测量要求、或其他适用的供应商产品实现的质量管理体系，优先选择TL9000。新增加：7.4.1.C.2-NOTE 1 supplier performance planning and activities should be in conjunction with the organization improvement processes of Section 8.5.7.4.1.C.2-注：供应商业绩的规划和活动应