ISO标准如何制定.doc

How are ISO standards developed? ISO标准如何制定？ ISO standards are developed according to the following principles. ISO标准的制定根据以下原则。 Consensus 一致同意 The views of all interests are taken into account: manufacturers, vendors and users, consumer groups, testing laboratories, governments, engineering professions and research organizations.考虑各方利益的意见：生产商、销售商和用户，消费群、检测实验室、政府、工程专业和研究机构。 Industry wide 全行业范围 Global solutions to satisfy industries and customers worldwide.全球解决方案，以满足行业和世界各地的客户。 Voluntary 自愿原则 International standardization is market driven and therefore based on voluntary involvement of all interests in the market-place.国际标准化以市场主导，因此在市场中以所有利益方自愿参与为基础。 There are three main phases in the ISO standards development process as follows.在ISO标准制定过程有如下三个主要阶段。 1. The need for a standard is usually expressed by an industry sector, which communicates this need to a national member body. The latter proposes the new work item to ISO as a whole. Once the need for an International Standard has been recognized and formally agreed, the first phase involves definition of the technical scope of the future standard. This phase is usually carried out in working groups which comprise technical experts from countries interested in the subject matter.通常由一个行业部门提出标准需求，并向国家级成员单位提出该需求。后者向ISO提出新的工作项作为一个整体。国际标准的需求一经得到认可和正式同意，第一阶段涉及到未来标准技术范围的定义。这一阶段通常由工作组进行，工作组由与该标的物相关国家的技术专家组成。 2. Once agreement has been reached on which technical aspects are to be covered in the standard, a second phase is entered during which countries negotiate the detailed specifications within the standard. This is the consensus-building phase.一旦协议已经达成的技术问题是在标准范围，即进入第二个阶段，在此阶段国家间进行标准内细节规范的谈判。这是建立共识阶段。 3. The final phase comprises the formal approval of the resulting draft International Standard (the acceptance criteria stipulate approval by two-thirds of the ISO members that have participated actively in the standards development process, and approval by 75% of all members that vote), following which the agreed text is published as an ISO International Standard.最后阶段包括由此产生的国际标准草案正式批准（验收标准规定三分之二的ISO成员机构已积极参加了标准制定过程，其中75的成员表决通过即为通过），然后将经同意的文本作为一个ISO国际标准发布。 It is also possible to publish interim documents at different stages in the standardization process.它也可以在标准化过程中的不同阶段以临时文件形式发布。Most standards require periodic revision. Several factors combine to render a standard out of date: technological evolution, new methods and materials, new quality and safety requirements. To take account of these factors, ISO has established the general rule that all ISO standards should be reviewed at intervals of not more than five years. On occasion, it is necessary to revise a standard earlier. 大多数标准需要定期修订。导致标准过期主要有以下几个因素：技术革新，新方法和材料，新的质量和安全要求。鉴于这些因素，ISO设立了一般规则，所有的ISO标准应以每次不超过五年的间隔进行复审。有时，要修订的标准还须早于五年。To date, ISOs work has resulted in over 16 000 International Standards, representing more than 620 000 pages in English and French (terminology is often provided in other languages as well).迄今为止，ISO已制定超过16000个国际标准，以英法两种语言提供超过620万页的标准（术语通常还提供其他语种）。 Stages of the development of International Standards国际标准的制定阶段 An International Standard is the result of an agreement between the member bodies of ISO. It may be used as such, or may be implemented through incorporation in national standards of different countries. 国际标准是ISO之间的会员协议的结果。它可以以这种方式，或通过编入不同国家的国家标准来执行。International Standards are developed by ISO technical committees (TC) and subcommittees (SC) by a six-step process:国际标准由ISO技术委员会（TC）和分委员会（SC）分六个步骤制定： Stage 1: Proposal stage第一阶段：申请阶段 Stage 2: Preparatory stage第二阶段：预备阶段 Stage 3: Committee stage第三阶段：委员会阶段 Stage 4: Enquiry stage第四阶段：审查阶段 Stage 5: Approval stage第五阶段：批准阶段 Stage 6: Publication stage第六阶段：发布阶段 If a document with a certain degree of maturity is available at the start of a standardization project, for example a standard developed by another organization, it is possible to omit certain stages.如果文件较成熟，可以开始进行标准化项目，例如，由另一组织制定的标准，有可能省略某些阶段。 In the so-called Fast-track procedure, a document is submitted directly for approval as a draft International Standard (DIS) to the ISO member bodies (stage 4) or, if the document has been developed by an international standardizing body recognized by the ISO Council, as a final draft International Standard (FDIS, stage 5), without passing through the previous stages.在所谓的“快速通道程序”，一个文件直接向ISO成员机构（第4阶段）提交批准为国际标准草案（DIS），或如果该文件已被ISO理事会认可为国际标准化组织制定的，该文件作为最终国际标准草案（FIDS，第5阶段），而无需经过之前的阶段。 The following is a summary of each of the six stages:以下是对六个阶段的摘要： Stage 1: Proposal stage第一阶段：申请阶段 The first step in the development of an International Standard is to confirm that a particular International Standard is needed.国际标准制定第一个步骤是确认一个特别的国际标准是必要的。 A new work item proposal (NP) is submitted for vote by the members of the relevant TC or SC to determine the inclusion of the work item in the programme of work. 由相关TC或SC提交一个新的工作项目申请（NP）进行表决，以决定将工作项目列入工作计划中。 The proposal is accepted if a majority of the P-members of the TC/SC votes in favour and if at least five P-members declare their commitment to participate actively in the project. At this stage a project leader responsible for the work item is normally appointed.如果大多数TC/SC的参加成员（P-MEMBER）表决赞成，且如果至少有五个参加成员（P-MEMBER）宣布积极参与此项目，那么此申请通过。在这个阶段，一个项目负责人负责的工作项目一般是经过委任。 Stage 2: Preparatory stage第二阶段：预备阶段 Usually, a working group of experts, the chairman (convener) of which is the project leader, is set up by the TC/SC for the preparation of a working draft. Successive working drafts may be considered until the working group is satisfied that it has developed the best technical solution to the problem being addressed. At this stage, the draft is forwarded to the working groups parent committee for the consensus-building phase.通常，一个专家工作组主席（召集人）为该项目的负责人，是由TC/ SC建立该专家组以准备工作草案。工作草案不断提出直至工作组满意，该草案已经针对提出的问题制定了最佳的技术解决方案。在此阶段，该草案提交给工作组的上级委员会，进入达成共识阶段。 Stage 3: Committee stage第三阶段：委员会阶段 As soon as a first committee draft is available, it is registered by the ISO Central Secretariat. It is distributed for comment and, if required, voting, by the P-members of the TC/SC. Successive committee drafts may be considered until consensus is reached on the technical content. Once consensus has been attained, the text is finalized for submission as a draft International Standard (DIS).当第一个委员会草案可采纳时，由ISO中央秘书处进行登记。草案进行分布式的评议，如要求，由TC / SC的参加成员（P-MEMBER）进行表决。委员会草案不断提出直至就技术内容达成一致同意。一旦达成一致同意，文本定稿是作为一个国际标准草案（DIS）提交。 Stage 4: Enquiry stage第四阶段：审查阶段 The draft International Standard (DIS) is circulated to all ISO member bodies by the ISO Central Secretariat for voting and comment within a period of five months. It is approved for submission as a final draft International Standard (FDIS) if a two-thirds majority of the P-members of the TC/SC are in favour and not more than one-quarter of the total number of votes cast are negative. If the approval criteria are not met, the text is returned to the originating TC/SC for further study and a revised document will again be circulated for voting and comment as a draft International Standard.国际标准草案（DIS）由ISO中央秘书处在五个月内向所有ISO成员机构传送，以进行表决和评议。如果有三分之二的TC / SC的参加成员（P-MEMBER）以多数赞成，且否定票不超过总投票数的四分之一，即被批准作为国际标准草案（FDIS）定稿提交。如果不符合批准要求，文本退还到原TC/ SC进行进一步研究，经修订的文件将再次投票，并作为国际标准草案再次进行递送已进行表决和评议。 Stage 5: Approval stage第五阶段：批准阶段 The final draft International Standard (FDIS) is circulated to all ISO member bodies by the ISO Central Secretariat for a final Yes/No vote within a period of two months. If technical comments are received during this period, they are no longer considered at this stage, but registered for consideration during a future revision of the International Standard. The text is approved as an International Standard if a two-thirds majority of the P-members of the TC/SC is in favour and not more than one-quarter of the total number of votes cast are negative. If these approval criteria are not met, the standard is referred back to the originating TC/SC for reconsideration in light of the technical reasons submitted in support of the negative votes received. 国际标准草案（DIS）由ISO中央秘书处在两个月内向所有ISO成员机构传送。如果在此期间收到技术类的意见，它们不再在此阶段进行考虑，但会进行登记在将来进行修订时给予考虑。如果有三分之二的