7.4 Purchasing 采購
7.4.1Purchasing process 采購過程
The organizationshall document procedures (see 4.2.4) to ensure thatpurchased product conforms to specified purchasing information.
組織應當建立采購程序（見4.2.4）來保證采購的產(chǎn)品符合特定采購要求。
The organization shall establishcriteria for the evaluation and selection of suppliers. The criteria shall be:
組織應當確定用于評估和選擇供應商的標準，標準應當包括：
a) based on the supplier’s abilityto provide product that meets the organization’s requirements;
供應商供應產(chǎn)品的能力，且產(chǎn)品要滿足組織要求；
b) based on the performance of thesupplier;
供應商的業(yè)績；
c) based on the effect of thepurchased product on the quality of the medical device;
供應的產(chǎn)品在醫(yī)療器械質量上影響。
d) proportionate to the riskassociated with the medical device.
與醫(yī)療器械風險相適應。
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.
組織應當制定監(jiān)控和再評估供應商的計劃。針對采購的產(chǎn)品,應當控符合需求的供應商業(yè)績。監(jiān)控的結果應當作為供應商在評估過程的輸入。
Non-fulfilment of purchasingrequirements shall be addressed with the supplier proportionate to the riskassociated with the purchased product and compliance with applicable regulatoryrequirements.
非履行的采購需求應當依據(jù)與供應商采購產(chǎn)品相適應的風險進行登記，并且符合相應的法律法規(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).
評估、選擇、控制和供應商能力或業(yè)績的再評估以及由這些活動所引出的任何必要措施的記錄都應當予以保留（見4.2.5）
7.4.2 Purchasing information 采購信息
Purchasinginformation shall describe or reference the product to be purchased, includingas appropriate:
采購信息應當描述或涉及擬采購的產(chǎn)品，適當時應包括：
a) productspecifications;
產(chǎn)品標準
b) requirementsfor product acceptance, procedures, processes and equipment;
產(chǎn)品接收、程序、過程和設備的需求；
c) requirementsfor qualification of supplier personnel;
供應商人員資質的需求；
d) qualitymanagement system requirements.
質量管理體系需求。
The organizationshall ensure the adequacy of specified purchasing requirements prior to their communicationto the supplier.
組織在與供應商溝通前應當確保有足夠的有針對性的采購要求。
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.
采購信息應當包括，如適用，書面的批準，在任何擬采購產(chǎn)品的變更實施之前供應商應當向組織進行告知，這些變更可能會影響到擬采購產(chǎn)品符合特定采購要求的性能。（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，組織應當以文檔（見4.2.4）和記錄（見4.2.5）的形式保存這些采購信息。
7.4.3 Verification of purchased product 采購產(chǎn)品的確認
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.
組織應當確定和實施檢查或其他的必要措施來保證所采購產(chǎn)品符合特定的采購需求。確認活動的范圍應當基于供應商評估結果并且與采購產(chǎn)品有關的風險相適應。（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.
當組織發(fā)現(xiàn)采購產(chǎn)品任何變更時，組織應當確定這些變化是否影響產(chǎn)品的實現(xiàn)過程或影響到醫(yī)療器械。組織應當在采購信息中陳述產(chǎn)品放行的方法和意圖的確認措施。（新增）
Records of theverification shall be maintained (see 4.2.5).
確認的記錄應予以保留（見4.2.5）