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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)

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。

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

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

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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

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 rep)


5.5.2条款 (管理者代表)
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
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
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
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)

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

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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

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 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。

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

Clause 8.2.3 (Monitoring / Measurement of process)


8.2.3条款 (过程的监视和测量)
O Note added to clarify that when deciding on appropriate methods, the organization should consider
impact on the conformity to product requirements and on the effectiveness of the quality
management system.
增加了注解,阐明在决定采用适宜的方法时,组织应考虑到其对符合产品要求和质量管理体系有效性
的影响。

The ISO Standards Development Process


ISO标准的开发过程
ISO standards are always user-driven, and in the case of ISO 9001, the standard is always the result of extensive
communication to determine the needs and expectations of all interested parties (certified organizations,
purchasers, regulatory bodies, certification bodies, governmental organizations, consultants and others). After an
analysis of user needs and expectations, the design specifications for a new or revised standard are developed
and agreed. Drafting work then begins, and Working Drafts (“WD’s”) are developed by the drafting groups that are
made up of nominated experts from ISO member bodies. These very rough drafts are not normally circulated
outside of the drafting groups themselves. As the draft standards mature, they pass through the Committee Draft
(“CD”) phase, during which they are circulated among ISO members for analysis and comment, the Draft
International Standard (“DIS”) phase and Final Draft International Standard (“FDIS”) phase, both of which result in
a formal ballot of ISO members, prior to the official publication of the International Standard (“IS”). At all stages,
verification activities are carried out to ensure that the draft standards meet the requirements of the design
specifications, and at later stages (typically the CD and DIS phase) validation exercises may take place with actual
users of the standards.

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ISO标准始终是用户推动型的,就ISO 9001来说,该标准始终是广泛沟通以确定所有相关方(获证组织,买方,制
定规章的团体,认证机构,政府组织,咨询方及其他)的需求和期望的结果。在分析了用户的需求和期望后,开发
新标准或修订标准的设计规范就会被开发并得到同意。起草工作从这时开始,由ISO成员团体中被提名的专家组成起
草小组,并由起草小组草拟工作草案(“WD’s”)。这些非常粗略的草案通常不会流传到起草小组之外。当这些草案
标准成熟了,他们经过委员会草案(“CD”)阶段(在此阶段他们在ISO成员中流传以获取分析和评价),国际标准草
案(“DIS”) 阶段和最终版国际标准草案(“FDIS”)阶段,后两阶段都在正式发行国际标准(“IS”)之前进行,并将进行ISO
成员的正式投票。在所有阶段,均将实施验证活动以确保草案标准能满足设计规范的要求,在后期阶段(典型的是
CD和DIS阶段)确认活动可吸收标准的实际用户参与。

Figure 1

The ISO standards development Process

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图1
ISO标准的开发过程

验证

准备

规范
国际
需求&期望 项目 标准

委员会 国际标 最终版


委员会
工 作 草案 2 准草案 国际标
草案 1
草 案 准草案

确认

Design Specification for ISO 9001:2008


ISO 9001:2008的设计规范
Based on surveys carried out in 2003/2004 to assess the acceptance of the ISO 9000:2000 standards, and the
need for improvements, very few changes are being proposed for the 2008 version of ISO 9001. The clear
message given in over 1500 comments from 63 different countries received as part of the web-based survey was
that users are happy with the process model, and they wanted to avoid any changes that would cause major
impact to their existing systems.
基于在2003/2004进行的评估ISO 9000:2000标准的接受度的调查,以及改进的要求,仅有非常少的变化被提议应用
到ISO 9001的2008版。作为基于网络调查的一部分,收集到的来自63个不同国家、超过1500条的建议清晰地表明:
对于过程模式用户是喜欢的,他们希望避免任何可能导致对现有体系有重大影响的变化。

As a result, ISO/TC176 agreed on a design specification that adopts an “impact vs benefit” approach to analyse
every individual change to ISO 9001 that might be proposed. The design specification recommends limiting any
changes to those where there are clear benefits to users and where the potential impact to users is deemed to be
only “low” or “medium” (see Figure 2). Whilst ISO makes no formal distinction between a “revision” and an
“amendment” to its standards, the decision to describe the next revision of ISO 9001 as an “amendment” is
intended to send a clear message to the more than 750,000 certificate holders worldwide that only those changes
necessary for clarification of the document, ease of use, consistency with the ISO 9000 Family or for achieving
greater alignment with the ISO 14001 environmental management system standard will be considered. Any
proposed change that would lead to a change in the focus, structure and content of the standard will not be
considered in this amendment.
因此,ISO/TC176在一份设计规范中同意采用“影响与利益比较”的方法,以分析每一个对ISO 9001变化的提议。该设
计规范建议将变化限制在对用户有明显利益的变化以及对用户的潜在影响被认为只是“低”或“中等”(见图2)的变化。
尽管ISO没有正式区分对标准的“修订”和“修正”,将ISO 9001的下一次修订描述为“修正”的决定意在向全球750,000份
证书的持有者传递一个明确的信号:只有那些对于文件的清楚说明、易于使用、与ISO 9000族标准的一致性或达到
与ISO 14001环境管理体系标准更好结合所必需的变化才会被考虑。任何导致标准的关注焦点、结构和内容的变化的

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提议在本修正版中将不会被考虑。

The design specification for ISO 9001 makes a total of 48 recommendations that could potentially affect 32
requirements of the standard if accepted by the drafters. However, the design specification recommends the
drafters to consider the potential impact of any changes as follows:
ISO 9001的设计规范共提出48个建议,这些建议如果都被起草者接受的话,将会潜在地影响到标准的32个要求。
尽管如此,设计规范建议起草者考虑任何变化的潜在影响,如下所示:

z “High impact” if the proposed change:


“高度影响”,如果所建议的变化:

O Requires extensive changes to documents


要求文件的大范围的变化
O Requires extensive change to processes
要求过程的大范围的变化
O Recertification required within a defined transition period
在设定的转换期内,要求换发新证
O Extensive (for example one to five days) training required
要求大范围的培训(例如:1至5天的培训)

z “Medium impact” if the proposed change:


“中度影响”,如果所建议的变化:
O Requires minimum changes to documents
要求文件的最小变化
O Requires minimum change to processes
要求过程的最小变化
O Requires minimal training such as half-day awareness training)
要求最少的培训(如:半天的认知培训)
O Permits recertification within the certified organization’s existing certification cycle
允许已获认证的企业在现有认证周期中换证

z “Low impact ” if:


“低度影响”,如果:
O No additional training is required
不需要额外的培训
O No change to documents is needed
不需要文件的变化
O No change to processes is needed
不需要过程的变化
O No effect on current certification is needed
对现有证书没有影响

In the “benefit” category, the drafters are recommended to consider the potential benefit to users as:
从“利益”角度,建议起草者考虑对用户的潜在利益,如下所示:

z “High” if it:
“高度利益”,如果:
 
O Removes ambiguity in the requirements
消除了标准要求中的含糊之处
O Considerably increases compatibility with ISO 14001
相当程度地增加了与ISO 14001的兼容性
O There is no evidence of inconsistency with the ISO 9000 family of standards

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没有与ISO 9000族标准矛盾的证据
O Results in significant improvement in translatability
在可译性方面有显著改进

z “Medium” if it:
“中度利益”,如果:
O Provides better clarity than before
提供了比以前好的清晰性
O Improves the compatibility with ISO 14001
改进了与ISO 14001的兼容性
O Improves consistency with the ISO 9000 family of standards
改进了与ISO 9000族标准的一致性
O Results in a slight improvement in translatability
在可译性方面有所改进

z “Low” if it:
“低度利益”,如果:
O Does not improve the clarity
没有改进清晰性
O Has no impact on the compatibility with ISO 14001
对与ISO 14001的兼容性没有影响
O Has no impact on consistency with the ISO 9000 family of standards
对与ISO 9000族标准的一致性没有影响
O Results in no improvement in translatability
在可译性方面没有改进

The expected results of this impact/benefit analysis and the disposition of any proposed changes are shown
schematically in Figure 2:
这种“影响/利益”分析的期望结果和任何提议的变化的分布在图2中加以示意:

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Figure 2
Impact analysis

图2
影响分析
影响 利益
3
高度 中度 低度
1 低度 1 2 3
2 中度 2 4 6
3 高度 ﹡3 6 9

1-2 吸收变化
2-4 在作决定前,应进行额外的分析
不吸收变化。
6-9 注:“﹡3-高度影响 × 高度利益” – 不允许进行变化,但需要记录建议的变
化的细节,以为未来修订提供输入。

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