ISO9001:2008新标准变更 　　
ISO9001: 2008 new standards change
1.ISO9001:2008的新标准将于2008年10月31目正式发布。 　　
1.ISO9001: 2008 new standards will be in 2008 October 31 released.
2.标准修改的较少，无理由需要“过渡阶段”，ISO将用6～12个月时间来结束ISO9001:2000版的使用。 　　
2 standard modified less, no reason to" transition period", ISO will use 6 to 12 months to the end of the use of ISO9001 : 2000 edition.
3.对于大多数组织而言，通常正常的监督评审过渡即可，不需要额外时间。 　　
3 for most organizations, usually normal supervision appraisal transition can, do not need extra time.
4.审核员只要培训新版的修改之处即可。 　　
As long as the 4 auditor training version of the modified place.
5.以下为变更条款： 　　
5 following the changes clause:
3.0术语与定义，取消了供应链。（供方-组织-顾客） 　　
3 terms and definitions, cancelled the supply chain. ( the supplier organization customer )
4.1增加了外包过程的控制，借助7.4.1的方法对外包方法进行管控。外包并不能减少组织需承担的责任。 　　4.2.1变更了一个单一的文件可以包括一个或多个程序的要求，一个文件化程序的要求也可以在多个文件中体现。（如纠正预防管理程序） 　　
4.1 adds 's control of the outsourced process, using 7.4.1 method to outsourcing method control. Outsourcing can reduce tissue to take responsibility for. 4.2.1 change a single file can include one or more program requirements, a requirement for a documented procedure also can be in multiple files in. ( such as corrective and preventive management program )
4.2.3增加了4.2.3f确保对质量体系策划和运行所必要的外来文件得到识别，并控制其分发。 　　
4.2.3 4.2.3f increased to ensure quality system planning and running the necessary documents of external origin are identified and their distribution, control.
5.5.2管理者代表：即新标准要求管理者代表应是组织内的下属员工或合同制的全日制员工（不可兼职）。 　　
5.5.2 management representative : that the new standards require that the management representative shall be within the tissues of the employees and contract full-time staff ( not to be part-time ).
6.2.1基于教育、培训、技能和经验，从事影响产品质量符合性的工作人员应是能够胜任的（范围较大）。 　　
6.2.1 based on education, training, skills and experience, in the effect of product quality and compliance personnel shall be competent ( range ).
6.2.2能力、意识和培训：评价培训所要求的有效性；确保达到必要的能力（指实际操作方面的能力加严）。 　　
6.2.2 competence, awareness and training: evaluation of the effectiveness of training requirements; ensure that the necessary skills ( refers to the actual operation ability and strict).
6.3 增加了6.3c:增加了支持性服务（如运输 或通讯或信息系统/ERP系统)、策划、提供、维护全方面评价。 　　
6.3 increase in 6.3c: increased support services ( such as transport or communication or information systems / ERP system ), planning, maintenance, to provide all aspects of evaluation.
7.2.1与产品有关的要求的确定：增加了交付后的活动包括保修条款及履行合同的责任，如维修服务和辅助服务（如回收或产品的最终处置）。 　　
7.2.1 determination of requirements related to the product: increased post delivery activities include warranty terms and responsibility for the performance of the contract, such as repair services and ancillary services ( such as recycling or final disposal of the product ).
7.5.1生产和服务提供的控制：生产和服务包括产品的防护（包装-仓储-搬运-回收手册）。 　　
The 7.5.1 control of production and service provision: production and service includes preservation of the products ( packaging warehousing transport Recovery Handbook).
7.5.2生产和服务提供过程的确认：阐明确认特殊过程的重要性，特殊过程（如焊接、培训、热处理等）还有特殊工程的识别。（如：服务、焊工、司机、仪校工程师、内审员资格的确认） 　　
7.5.2 production and service delivery confirmation confirmation of special process: elucidating the importance, special processes (such as welding, training, heat treatment ) and special project identification. ( such as: service, welders, driver, calibration engineer, internal auditor qualification confirmation )
7.5.4顾客财产：增加了注解-阐明知识产权和私人信息为顾客财产（如保险公司，银行等）。 　　
7.5.4 customer property: note added - elucidating the intellectual property and private information for the customer property ( such as insurance companies, banks and other ).
7.6监视和测量装置的控制：增加了测量用计算机软件使用的要求（如公司的软件测试站使用的软件适宜性的验证及配置的管理）。 　　
In 7.6 control of monitoring and measuring devices: increases the measurement computer software use requirements ( such as the company's software test station using software suitability validation and configuration management ).
8.2.1：监控顾客的感受可能包括从如下的来源输入，如顾客满意度调查、已提交产品质量信息、用户意见调查，失去业务的分析、表扬、保证声明、销售报告等。 　　
8.2.1: monitoring the feelings of customers may include from the following sources of input, such as customer satisfaction surveys, has been submitted to product quality, user opinion surveys, lost business analysis, praise, warranty statement, sales report.
8.2.2内部审核：增加了审核记录的保存范围（如内审计划、签到表、内审报告、查检表、不符合报告等记录）。 　　
8.2.2 internal audit: increases the audit record range (such as the audit plan, audit report, attendance list, check sheets, do not accord with report records ).
8.2.3过程的监视和测量：
8.2.3 monitoring and measurement of process:
1.删掉了最后一句话，即，“以确保产品的符合性”
1 deleted the last word, i.e.," to ensure conformity of the product"
2.注解中增加了采用过程控制方法时需考虑的要点，此注释希望组织确定过程监视测量方法时需要考虑到应用的价值。（即范围加大包括：质量体系所有过程）。 　　
2 annotations added by process control method for the key points, this comment hope organization determined process monitoring measurement methods need to take into account the application value. ( i.e., increased range include: quality system of all the process ).
8.3 不合格品的控制：未满足顾客要求的不合格品，只有得到客户同意放行的条件才能放行，组织内部在未得到客户同意时不能放行，如放行是不符合标准要求的，要开立主要不符合项。
8.3 control of nonconforming product: do not meet customer requirements of nonconforming products, only the customer agrees to release conditions can be released, internal organization in the clients have not been agreed not to release, such as the release is not consistent with the standards, to open a major non-conformances.