E02.03 Review of requirements related to the product
The organization shall review the requirements related to the product. This review shall be conducted prior to the organization's commitment to supply a product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure that: 組織應(yīng)評(píng)審與產(chǎn)品有關(guān)的要求。這檢討應(yīng)在本組織將供應(yīng)的產(chǎn)品給客戶承諾之前 (例如提交投標(biāo)、接受合同或訂單，接受合同或訂單的更改)，并應(yīng)確保︰
a) Product requirements are defined and documented, 定義并記錄，a）產(chǎn)品要求
b) Contract or order requirements differing from those previously expressed are resolved, and b）合同或順序不同于那些以前表示要求是解決，和
c) The organization has the ability to meet the defined requirements. c）本組織有能力滿足規(guī)定的要求。
Records of the results of the review and actions arising from the review shall be maintained (see 4.2.4).
Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organization before acceptance.
Where product requirements are changed, the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements審查和行動(dòng)所作的檢討結(jié)果的記錄應(yīng)予保持（見(jiàn)4.2.4）。
若顧客提供的要求沒(méi)有形成的文件，應(yīng)由組織驗(yàn)收前證實(shí)客戶的要求。
若產(chǎn)品要求發(fā)生變更，組織應(yīng)確保相關(guān)文件得到修改，并確保相關(guān)人員知道已變更的要求
E03.18 Control of design and development changes
After the design has been "frozen" changes still may be necessary during the project phase. A systematic change process and subsequent implementation approach must be in place設(shè)計(jì)已被"凍結(jié)后"仍可能必須更改項(xiàng)目階段。制度變遷過(guò)程和隨后的實(shí)施方法必須到位
E05.05 Control Plans
Preferably "Control plans" should contain the following items: 最好是"控制計(jì)劃"應(yīng)包含下列項(xiàng)目
- Sample size樣本大小
- Measuring devices to use要使用的測(cè)量設(shè)備
- Frequency of testing進(jìn)行測(cè)試的頻率
- Upper and lower limits for passing傳遞的上限和下限
- Work instructions to perform the measurements作業(yè)指導(dǎo)書(shū)執(zhí)行測(cè)量
- Out of control instructions從控制指令
Good practices can be found in other industries (Automotive: (QS 9000). The information may be contained in more than one document. 良好做法可以發(fā)現(xiàn)在其他行業(yè) (汽車(chē): (QS 9000)。信息可能包含多個(gè)文檔中。
E05.07 Defining Maintenance and Repair requirements
Already during the product design phase, the policies on preventive maintenance on machines and equipment need to be defined in order to support quality control during the production phase已經(jīng)在產(chǎn)品設(shè)計(jì)階段，對(duì)機(jī)器和設(shè)備的預(yù)防性維修政策需要定義以支持在生產(chǎn)階段的質(zhì)量控制。
E06.01 Production Approval new parts
Before parts or products may be used in regular production, they have to go through a systematic release process. This release must deliver evidence that the manufacturing process is capable to produce repetitive parts that meet customer requirements. 零件或產(chǎn)品可能在正常生產(chǎn)中使用之前，他們必須通過(guò)系統(tǒng)的發(fā)布過(guò)程。此版本必須提供證據(jù)的制造過(guò)程是能夠生產(chǎn)出滿足客戶要求的重復(fù)部分。
E06.02 Qualification of Processes
Before parts or products may be used in regular production, they have to go through a systematic release process. This release must deliver evidence that the manufacturing process is capable to produce repetitive parts that meet customer requirements. 零件或產(chǎn)品可能在正常生產(chǎn)中使用之前，他們必須通過(guò)系統(tǒng)的發(fā)布過(guò)程。此版本必須提供證據(jù)的制造過(guò)程是能夠生產(chǎn)出滿足客戶要求的重復(fù)部分。
E14.01 The development process ensures reliable products in the market place
Designing reliable products means that analytical techniques, experience with predecessor products, failure mode analysis, testing, HALT, etc are combined to take care that the product operates reliable in the market place設(shè)計(jì)可靠的產(chǎn)品意味著分析技術(shù)，經(jīng)驗(yàn)與前任產(chǎn)品，失效模式分析、測(cè)試、停止等聯(lián)合照顧工作可靠，在市場(chǎng)上的產(chǎn)品。