7.4 Purchasing 采購(gòu)
7.4.1Purchasing process 采購(gòu)過(guò)程
The organizationshall document procedures (see 4.2.4) to ensure thatpurchased product conforms to specified purchasing information.
組織應(yīng)當(dāng)建立采購(gòu)程序（見4.2.4）來(lái)保證采購(gòu)的產(chǎn)品符合特定采購(gòu)要求。
The organization shall establishcriteria for the evaluation and selection of suppliers. The criteria shall be:
組織應(yīng)當(dāng)確定用于評(píng)估和選擇供應(yīng)商的標(biāo)準(zhǔn)，標(biāo)準(zhǔn)應(yīng)當(dāng)包括：
a) based on the supplier’s abilityto provide product that meets the organization’s requirements;
供應(yīng)商供應(yīng)產(chǎn)品的能力，且產(chǎn)品要滿足組織要求；
b) based on the performance of thesupplier;
供應(yīng)商的業(yè)績(jī)；
c) based on the effect of thepurchased product on the quality of the medical device;
供應(yīng)的產(chǎn)品在醫(yī)療器械質(zhì)量上影響。
d) proportionate to the riskassociated with the medical device.
與醫(yī)療器械風(fēng)險(xiǎn)相適應(yīng)。
The organization shall plan themonitoring and re-evaluation of suppliers. Supplier performance in meetingrequirements for the purchased product shall be monitored. The results of themonitoring shall provide an input into the supplier re-evaluation process.
組織應(yīng)當(dāng)制定監(jiān)控和再評(píng)估供應(yīng)商的計(jì)劃。針對(duì)采購(gòu)的產(chǎn)品,應(yīng)當(dāng)控符合需求的供應(yīng)商業(yè)績(jī)。監(jiān)控的結(jié)果應(yīng)當(dāng)作為供應(yīng)商在評(píng)估過(guò)程的輸入。
Non-fulfilment of purchasingrequirements shall be addressed with the supplier proportionate to the riskassociated with the purchased product and compliance with applicable regulatoryrequirements.
非履行的采購(gòu)需求應(yīng)當(dāng)依據(jù)與供應(yīng)商采購(gòu)產(chǎn)品相適應(yīng)的風(fēng)險(xiǎn)進(jìn)行登記，并且符合相應(yīng)的法律法規(guī)。（新增）
Records of theresults of evaluation, selection, monitoring and re-evaluation of suppliercapability or performance and any necessary actions arising from theseactivities shall be maintained (see 4.2.5).
評(píng)估、選擇、控制和供應(yīng)商能力或業(yè)績(jī)的再評(píng)估以及由這些活動(dòng)所引出的任何必要措施的記錄都應(yīng)當(dāng)予以保留（見4.2.5）
7.4.2 Purchasing information 采購(gòu)信息
Purchasinginformation shall describe or reference the product to be purchased, includingas appropriate:
采購(gòu)信息應(yīng)當(dāng)描述或涉及擬采購(gòu)的產(chǎn)品，適當(dāng)時(shí)應(yīng)包括：
a) productspecifications;
產(chǎn)品標(biāo)準(zhǔn)
b) requirementsfor product acceptance, procedures, processes and equipment;
產(chǎn)品接收、程序、過(guò)程和設(shè)備的需求；
c) requirementsfor qualification of supplier personnel;
供應(yīng)商人員資質(zhì)的需求；
d) qualitymanagement system requirements.
質(zhì)量管理體系需求。
The organizationshall ensure the adequacy of specified purchasing requirements prior to their communicationto the supplier.
組織在與供應(yīng)商溝通前應(yīng)當(dāng)確保有足夠的有針對(duì)性的采購(gòu)要求。
Purchasing information shallinclude, as applicable, a written agreement that the supplier notify the organizationof changes in the purchased product prior to implementation of any changes thataffect the ability of the purchased product to meet specified purchaserequirements.
采購(gòu)信息應(yīng)當(dāng)包括，如適用，書面的批準(zhǔn)，在任何擬采購(gòu)產(chǎn)品的變更實(shí)施之前供應(yīng)商應(yīng)當(dāng)向組織進(jìn)行告知，這些變更可能會(huì)影響到擬采購(gòu)產(chǎn)品符合特定采購(gòu)要求的性能。（新增）
To the extentrequired for traceability given in 7.5.9, theorganization shall maintain relevant purchasing information in the form ofdocuments (see 4.2.4) and records (see 4.2.5).
在7.5.9中規(guī)定了可追溯性要求的程度，組織應(yīng)當(dāng)以文檔（見4.2.4）和記錄（見4.2.5）的形式保存這些采購(gòu)信息。
7.4.3 Verification of purchased product 采購(gòu)產(chǎn)品的確認(rèn)
The organizationshall establish and implement the inspection or other activities necessary forensuring that purchased product meets specified purchasing requirements. The extent of verification activities shall be based on the supplierevaluation results and proportionate to the risks associated with the purchasedproduct.
組織應(yīng)當(dāng)確定和實(shí)施檢查或其他的必要措施來(lái)保證所采購(gòu)產(chǎn)品符合特定的采購(gòu)需求。確認(rèn)活動(dòng)的范圍應(yīng)當(dāng)基于供應(yīng)商評(píng)估結(jié)果并且與采購(gòu)產(chǎn)品有關(guān)的風(fēng)險(xiǎn)相適應(yīng)。（新增）
When theorganization becomes aware of any changes to the purchased product, theorganization shall determine whether these changes affect the product realizationprocess or the medical device. the organization shall state the intendedverification activities and method of product release in the purchasinginformation.
當(dāng)組織發(fā)現(xiàn)采購(gòu)產(chǎn)品任何變更時(shí)，組織應(yīng)當(dāng)確定這些變化是否影響產(chǎn)品的實(shí)現(xiàn)過(guò)程或影響到醫(yī)療器械。組織應(yīng)當(dāng)在采購(gòu)信息中陳述產(chǎn)品放行的方法和意圖的確認(rèn)措施。（新增）
Records of theverification shall be maintained (see 4.2.5).
確認(rèn)的記錄應(yīng)予以保留（見4.2.5）