ISO9001：2008英中对照_
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Update on ISO 9001:2008 ISO 9001:2008中的更新之处
Current status 目前状况
Following a recent meeting of ISO’s Technical Committee TC176 in Helsinki, Finland, from June 11th – 15th 2007, publication of the new version of ISO 9001 has been brought forward from 2009 and is now scheduled to be published in August 2008. Experts representing over 70 ISO member bodies, met to discuss the comments received during circulation of the Committee Draft (“CD”) of the new standard, and concluded that in view of the very limited changes being proposed, the draft is now sufficiently mature to progress directly to the DIS (Draft International Standard) stage (see Figure 1 for an explanation of the various stages in the ISO standards development process). 2007年6月11日至15日，ISO TC176技术委员会在芬兰赫尔辛基举行会议，决定将于2008年8月出版新的ISO9001 版本，比原定2009年出版的时间安排有所提前。超过70个成员团体的专家们出席了会议，会议对新标准委员会草案 版（CD）发行以来所收到的评论进行了讨论，并得出结论：基于仅有非常有限的变化被提议，现在该草案已十分成 熟，可以直接进展至DIS（国际标准草案）阶段（见图1：ISO标准开发过程中所需经历的阶段示例）
O Contractual obligations such as maintenance services 合约责任，如维修服务
O Supplementary services such as recycling or final disposal 辅助服务，如重复利用或最终处置
z Clause 7.3.1 (Design & development planning) 7.3.1条款 (设计和开发策划)
2/10
只要适合于产品和组织，这些活动的实施和记录可分别进行，也可予以合并
z Clause 7.3.3(Design & development outputs) 7.3.3条款 (设计和开发输出)
O Clarifies that information needed for production and service provision includes preservation of the product 阐明生产和服务提供所需的信息应包括产品防护的信息
1/10
z Clause 4.2.3 (Document control) 4.2.3条款 (文件控制)
O Clarification that only external documents relevant to the QMS need to be controlled 阐明只需对与QMS有关的外来文件加以控制
和其他因素
z Clause 7.2.1 (Customer related processes) 7.2.1条款 (与顾客有关的过程)
O Clarifies that post-delivery activities may include: 阐明交付后活动可包括
O Actions under warranty provisions 提供保修服务的活动
z Clause 4.2.4 (Records control) 4.2.4条款 (记录控制)
O Editorial changes only (better alignment with ISO 14001) 只是文字表述上的变化（以与ISO 14001衔接得更好）
z Clause 5.5.2 (Management rห้องสมุดไป่ตู้p) 5.5.2条款 (管理者代表)
z Clause 8.2.1 (Customer satisfaction) 8.2.1条款 (顾客满意) O Note added to explain that monitoring of customer perception may include input from sources such as customer satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, and dealer reports 增加了注解，以说明对顾客感受的监视可包括多种来源的输入，例如顾客满意调查，对已交付产品质 量的消费者数据，使用者意见调查，流失业务的分析，赞扬和经销商报告
operation of the quality management system
阐明能力要求涉及到所有与质量管理体系运行有关的人员
z Clause 6.3 (Infrastructure) 6.3条款 (基础设施)
O Includes information systems as example O 包括了信息系统，以示例形式列出
z Clause 6.4 (Work environment) 6.4条款 (工作环境)
O Clarifies that this includes conditions under which work is performed and includes, for example physical, environmental and other factors such as noise, temperature, humidity, lighting, or weather 阐明工作环境包括工作实施所需的条件，例如噪声、温度、湿度、照明或气候等物理因素、环境因素
z Clause 7.6 (Now retitled Control of Monitoring and Measuring equipment) 7.6条款 (现在标题改为“监视和测量设备的控制”：英文从“device”改为“equipment”) O Explanatory notes added regarding the use of computer software:” Confirmation of the ability of computer software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use.” 对于计算机软件的使用增加了说明性的注解：典型的计算机软件满足预期用途的能力的确认，应包括 对其的验证和配置的管理，以保持其适于使用。
O Clarifies that design and development review, verification and validation have distinct purposes 阐明设计和开发评审、验证和确认具有截然不同的目的
O These may be conducted and recorded separately or in any combination as suitable for the product and the organization
z Clause 7.5.4 (Customer property) 7.5.4条款 (顾客财产) O Explains that both intellectual property and personal data should be considered as customer property 说明知识产权和个人资料均应作为顾客财产
z Clause 1.1 (Scope) 1.1条款 (范围) O Clarification that “product” also includes intermediate product 阐明了“产品”也包括中间产品 O Explanation regarding statutory, regulatory and legal requirements 关于法律法规要求的说明
The main changes being introduced into the new standard are as follows: 新标准的主要变化之处如下：
z Clause 0.2 (Process approach) 0.2条款 (过程方法) O Text added to emphasize the importance of processes being capable of achieving desired outputs 增加了条文，以强调有能力实现期望输出的过程的重要性。
O Clarifies that this must be a member of the organization’s own management 阐明管理者代表必须是组织自身管理层的一员
z Clause 6.2.1 (Human resources)
6.2.1条款 (人力资源)
O Clarification that competence requirements are relevant for any personnel who are involved in the
z Clause 4.1 (General requirements) 4.1条款 (总要求) O Notes added to explain more about outsourcing 增加了注解，以对外包进一步加以说明 O Types of control that may be applied to outsourced processes 可应用于对外包过程的控制方式的类型 O Relationship to clause 7.4 (Purchasing) 与7.4条款（采购）的关系 O Clarification that outsourced processes are still responsibility of the organization and must be included in the quality management system 阐明外包过程仍然是组织的责任，必须被包括在质量管理体系中
z Clause 4.2.1 (Documentation) 4.2.1条款 (文件) O Clarification that QMS documentation also includes records 阐明QMS文件也包括记录 O Documents required by the standard may be combined 本标准所要求的文件可以进行整合 O ISO 9001 requirements may be covered by more than one documented procedure ISO 9001要求可被一个以上形成文件的程序所覆盖
Current status 目前状况
Following a recent meeting of ISO’s Technical Committee TC176 in Helsinki, Finland, from June 11th – 15th 2007, publication of the new version of ISO 9001 has been brought forward from 2009 and is now scheduled to be published in August 2008. Experts representing over 70 ISO member bodies, met to discuss the comments received during circulation of the Committee Draft (“CD”) of the new standard, and concluded that in view of the very limited changes being proposed, the draft is now sufficiently mature to progress directly to the DIS (Draft International Standard) stage (see Figure 1 for an explanation of the various stages in the ISO standards development process). 2007年6月11日至15日，ISO TC176技术委员会在芬兰赫尔辛基举行会议，决定将于2008年8月出版新的ISO9001 版本，比原定2009年出版的时间安排有所提前。超过70个成员团体的专家们出席了会议，会议对新标准委员会草案 版（CD）发行以来所收到的评论进行了讨论，并得出结论：基于仅有非常有限的变化被提议，现在该草案已十分成 熟，可以直接进展至DIS（国际标准草案）阶段（见图1：ISO标准开发过程中所需经历的阶段示例）
O Contractual obligations such as maintenance services 合约责任，如维修服务
O Supplementary services such as recycling or final disposal 辅助服务，如重复利用或最终处置
z Clause 7.3.1 (Design & development planning) 7.3.1条款 (设计和开发策划)
2/10
只要适合于产品和组织，这些活动的实施和记录可分别进行，也可予以合并
z Clause 7.3.3(Design & development outputs) 7.3.3条款 (设计和开发输出)
O Clarifies that information needed for production and service provision includes preservation of the product 阐明生产和服务提供所需的信息应包括产品防护的信息
1/10
z Clause 4.2.3 (Document control) 4.2.3条款 (文件控制)
O Clarification that only external documents relevant to the QMS need to be controlled 阐明只需对与QMS有关的外来文件加以控制
和其他因素
z Clause 7.2.1 (Customer related processes) 7.2.1条款 (与顾客有关的过程)
O Clarifies that post-delivery activities may include: 阐明交付后活动可包括
O Actions under warranty provisions 提供保修服务的活动
z Clause 4.2.4 (Records control) 4.2.4条款 (记录控制)
O Editorial changes only (better alignment with ISO 14001) 只是文字表述上的变化（以与ISO 14001衔接得更好）
z Clause 5.5.2 (Management rห้องสมุดไป่ตู้p) 5.5.2条款 (管理者代表)
z Clause 8.2.1 (Customer satisfaction) 8.2.1条款 (顾客满意) O Note added to explain that monitoring of customer perception may include input from sources such as customer satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, and dealer reports 增加了注解，以说明对顾客感受的监视可包括多种来源的输入，例如顾客满意调查，对已交付产品质 量的消费者数据，使用者意见调查，流失业务的分析，赞扬和经销商报告
operation of the quality management system
阐明能力要求涉及到所有与质量管理体系运行有关的人员
z Clause 6.3 (Infrastructure) 6.3条款 (基础设施)
O Includes information systems as example O 包括了信息系统，以示例形式列出
z Clause 6.4 (Work environment) 6.4条款 (工作环境)
O Clarifies that this includes conditions under which work is performed and includes, for example physical, environmental and other factors such as noise, temperature, humidity, lighting, or weather 阐明工作环境包括工作实施所需的条件，例如噪声、温度、湿度、照明或气候等物理因素、环境因素
z Clause 7.6 (Now retitled Control of Monitoring and Measuring equipment) 7.6条款 (现在标题改为“监视和测量设备的控制”：英文从“device”改为“equipment”) O Explanatory notes added regarding the use of computer software:” Confirmation of the ability of computer software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use.” 对于计算机软件的使用增加了说明性的注解：典型的计算机软件满足预期用途的能力的确认，应包括 对其的验证和配置的管理，以保持其适于使用。
O Clarifies that design and development review, verification and validation have distinct purposes 阐明设计和开发评审、验证和确认具有截然不同的目的
O These may be conducted and recorded separately or in any combination as suitable for the product and the organization
z Clause 7.5.4 (Customer property) 7.5.4条款 (顾客财产) O Explains that both intellectual property and personal data should be considered as customer property 说明知识产权和个人资料均应作为顾客财产
z Clause 1.1 (Scope) 1.1条款 (范围) O Clarification that “product” also includes intermediate product 阐明了“产品”也包括中间产品 O Explanation regarding statutory, regulatory and legal requirements 关于法律法规要求的说明
The main changes being introduced into the new standard are as follows: 新标准的主要变化之处如下：
z Clause 0.2 (Process approach) 0.2条款 (过程方法) O Text added to emphasize the importance of processes being capable of achieving desired outputs 增加了条文，以强调有能力实现期望输出的过程的重要性。
O Clarifies that this must be a member of the organization’s own management 阐明管理者代表必须是组织自身管理层的一员
z Clause 6.2.1 (Human resources)
6.2.1条款 (人力资源)
O Clarification that competence requirements are relevant for any personnel who are involved in the
z Clause 4.1 (General requirements) 4.1条款 (总要求) O Notes added to explain more about outsourcing 增加了注解，以对外包进一步加以说明 O Types of control that may be applied to outsourced processes 可应用于对外包过程的控制方式的类型 O Relationship to clause 7.4 (Purchasing) 与7.4条款（采购）的关系 O Clarification that outsourced processes are still responsibility of the organization and must be included in the quality management system 阐明外包过程仍然是组织的责任，必须被包括在质量管理体系中
z Clause 4.2.1 (Documentation) 4.2.1条款 (文件) O Clarification that QMS documentation also includes records 阐明QMS文件也包括记录 O Documents required by the standard may be combined 本标准所要求的文件可以进行整合 O ISO 9001 requirements may be covered by more than one documented procedure ISO 9001要求可被一个以上形成文件的程序所覆盖