【正文】 in conflict with each other.應(yīng)對(duì)這些輸入的適用性進(jìn)行評(píng)審﹐所有的需求都應(yīng)滿足﹐表述清楚且各部分間接口清楚。 Design and development outputs 設(shè)計(jì)和開(kāi)發(fā)輸出The outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be approved prior to release.設(shè)計(jì)和開(kāi)發(fā)過(guò)程的輸出應(yīng)提供一種格式﹐以驗(yàn)証設(shè)計(jì)和開(kāi)發(fā)的輸入及實(shí)現(xiàn)的預(yù)先設(shè)計(jì)。Design and development outputs shall設(shè)計(jì)和開(kāi)發(fā)輸出應(yīng)﹕a) meet the input requirements for design and development, 符合設(shè)計(jì)和開(kāi)發(fā)輸入的要求。b) provide appropriate information for purchasing, production and for service provision, 提供適當(dāng)?shù)牟少?gòu)﹑生產(chǎn)﹑和服務(wù)的資訊。c) contain or reference product acceptance criteria, and 包括或引用設(shè)計(jì)或開(kāi)發(fā)產(chǎn)品接受的標(biāo)準(zhǔn)。d) specify the characteristics of the product that are essential for its safe and proper use. 定議對(duì)產(chǎn)品安全及適當(dāng)用途之必要的特性。 Design and development review 設(shè)計(jì)和開(kāi)發(fā)評(píng)審At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements (see )在適當(dāng)階段﹐組織應(yīng)對(duì)設(shè)計(jì)和開(kāi)發(fā)進(jìn)行系統(tǒng)的評(píng)審以確保與計(jì)劃安排的相一至。()a) to evaluate the ability of the results of design and development to meet requirements, and 評(píng)估設(shè)計(jì)和開(kāi)發(fā)滿足需求的能力。b) to identify any problems and propose necessary actions. 識(shí)別問(wèn)題并建議解決方案。Participants in such reviews shall include representatives of functions concerned with the design and development stage(s) being reviewed. Records of the results of the reviews and any necessary actions shall be maintained (see ).參與評(píng)審的人員包括各職能部門的參與設(shè)計(jì)和開(kāi)發(fā)各階段評(píng)審的代表﹐評(píng)審的結(jié)果記錄及采取的相關(guān)行動(dòng)應(yīng)給予保存。 Design and development verification 設(shè)計(jì)和開(kāi)發(fā)驗(yàn)証Verification shall be performed in accordance with planned arrangements (see ) to ensure that the design and development outputs have met the design and development input requirements. Records of the results of the verification and any necessary actions shall be maintained (see ).應(yīng)實(shí)施設(shè)計(jì)和開(kāi)發(fā)驗(yàn)証以確保輸出符合設(shè)計(jì)和開(kāi)發(fā)輸入要求。驗(yàn)証結(jié)果及隨后的跟進(jìn)措施應(yīng)予以記錄() Design and development validation 設(shè)計(jì)和開(kāi)發(fā)確認(rèn)Design and development validation shall be performed in accordance with planned arrangements (see ) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known. Wherever practicable, validation shall be pleted prior to the delivery or implementation of the product. Records of the results of validation and any necessary actions shall be maintained (see ).應(yīng)實(shí)施設(shè)計(jì)和開(kāi)發(fā)確認(rèn)設(shè)計(jì)和開(kāi)發(fā)出的產(chǎn)品能夠滿足特殊或預(yù)期的使用要求﹐無(wú)論如何﹐應(yīng)在交付或?qū)崿F(xiàn)產(chǎn)品前完成確認(rèn)。確認(rèn)驗(yàn)証結(jié)果及隨后的跟進(jìn)措施應(yīng)予以記錄() Control of design and development changes 設(shè)計(jì)和開(kāi)發(fā)變更的控制Design and development changes shall be identified and records maintained. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered.應(yīng)識(shí)別設(shè)計(jì)和開(kāi)發(fā)變更并記錄其修訂。變更在執(zhí)行前應(yīng)予以評(píng)審﹑檢驗(yàn)﹑確認(rèn)﹐必要時(shí)應(yīng)進(jìn)行批準(zhǔn)。Records of the results of the review of changes and any necessary actions shall be maintained (see ).變更評(píng)審結(jié)果的記錄及隨后的跟進(jìn)措施應(yīng)予以保存() Purchasing 采購(gòu) Purchasing process 采購(gòu)流程The organization shall ensure that purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product.組織應(yīng)確保采購(gòu)的產(chǎn)品符合采購(gòu)需求?？刂频念愋秃统潭葢?yīng)取決于其對(duì)隨后的實(shí)現(xiàn)過(guò)程和輸出的作用。The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization39。s requirements. Criteria for selection, evaluation and reevaluation shall be established. Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained (see ).組織應(yīng)根據(jù)提供符合組織要求產(chǎn)品的能力來(lái)評(píng)估和選擇供方。選擇標(biāo)準(zhǔn)對(duì)供方進(jìn)行定期的評(píng)估﹐評(píng)估結(jié)果和隨后的躍進(jìn)措施應(yīng)予以記錄. Purchasing information 采購(gòu)資料Purchasing information shall describe the product to be purchased, including where appropriate采購(gòu)資料應(yīng)包含對(duì)所采購(gòu)產(chǎn)品的適當(dāng)描述﹐包括﹕a) requirements for approval of product, procedures, processes and equipment, 產(chǎn)品﹑程序﹑流程﹑設(shè)備的認(rèn)可條件。c) requirements for qualification of personnel, and 人員資格要求﹔d) quality management system requirements. 質(zhì)量管理體系要求﹔The organization shall ensure the adequacy of specified purchase requirements prior to their munication to the supplier.組織應(yīng)確保采購(gòu)資料所包含的規(guī)定要求適當(dāng)后才發(fā)出。 Verification of purchased product 采購(gòu)產(chǎn)品的驗(yàn)証The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements.組織應(yīng)識(shí)別并實(shí)施對(duì)采購(gòu)進(jìn)行驗(yàn)証或其他必須的活動(dòng)﹐確保采購(gòu)的產(chǎn)品符合采購(gòu)需求。Where the organization or its customer intends to perform verification at the supplier39。s premises, the organization shall state the intended verification arrangements and method of product release in the purchasing information.當(dāng)組織或其客戶提出在供方貨源處進(jìn)行驗(yàn)証活動(dòng)時(shí)﹐組織應(yīng)在采購(gòu)資料中規(guī)定驗(yàn)証安排和產(chǎn)品放行方法。 Production and service provision 產(chǎn)品和服務(wù)的準(zhǔn)備 Control of production and service provision 產(chǎn)品和服務(wù)的準(zhǔn)備控制The organization shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable組織應(yīng)對(duì)生產(chǎn)和服務(wù)準(zhǔn)備進(jìn)行計(jì)劃和管制﹐包括﹕a) the availability of information that describes the characteristics of the product, 得到規(guī)定產(chǎn)品特性的有效信息。b) the availability of work instructions, as necessary, 必要時(shí)編制工作指導(dǎo)文件﹔c) the use of suitable equipment, 使用相應(yīng)設(shè)備﹔d) the availability and use of monitoring and measuring devices, 提供并使用測(cè)量和監(jiān)控設(shè)備﹔e) the implementation of monitoring and measurement, and 執(zhí)行監(jiān)控活動(dòng)﹔f) the implementation of release, delivery and postdelivery activities. 實(shí)施規(guī)定的放行﹑交付和相應(yīng)的音樂(lè)會(huì)活動(dòng)。 Validation of processes for production and service provision 確認(rèn)產(chǎn)品及服務(wù)準(zhǔn)備流程The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or mea