7.4 Purchasing 采购

7.4.1Purchasing process 采购过程

The organizationshall document procedures (see 4.2.4) to ensure thatpurchased product conforms to specified purchasing information.

组织应当建立采购程序（见4.2.4）来保证采购的产品符合特定采购要求。

The organization shall establishcriteria for the evaluation and selection of suppliers. The criteria shall be:

组织应当确定用于评估和选择供应商的标准，标准应当包括：

a) based on the supplier’s abilityto provide product that meets the organization’s requirements;

供应商供应产品的能力，且产品要满足组织要求；

b) based on the performance of thesupplier;

供应商的业绩；

c) based on the effect of thepurchased product on the quality of the medical device;

供应的产品在医疗器械质量上影响。

d) proportionate to the riskassociated with the medical device.

与医疗器械风险相适应。

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.

组织应当制定监控和再评估供应商的计划。针对采购的产品,应当控符合需求的供应商业绩。监控的结果应当作为供应商在评估过程的输入。

Non-fulfilment of purchasingrequirements shall be addressed with the supplier proportionate to the riskassociated with the purchased product and compliance with applicable regulatoryrequirements.

非履行的采购需求应当依据与供应商采购产品相适应的风险进行登记，并且符合相应的法律法规。（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).

评估、选择、控制和供应商能力或业绩的再评估以及由这些活动所引出的任何必要措施的记录都应当予以保留（见4.2.5）

7.4.2 Purchasing information 采购信息

Purchasinginformation shall describe or reference the product to be purchased, includingas appropriate:

采购信息应当描述或涉及拟采购的产品，适当时应包括：

a) productspecifications;

产品标准

b) requirementsfor product acceptance, procedures, processes and equipment;

产品接收、程序、过程和设备的需求；

c) requirementsfor qualification of supplier personnel;

供应商人员资质的需求；

d) qualitymanagement system requirements.

质量管理体系需求。

The organizationshall ensure the adequacy of specified purchasing requirements prior to their communicationto the supplier.

组织在与供应商沟通前应当确保有足够的有针对性的采购要求。

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.

采购信息应当包括，如适用，书面的批准，在任何拟采购产品的变更实施之前供应商应当向组织进行告知，这些变更可能会影响到拟采购产品符合特定采购要求的性能。（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中规定了可追溯性要求的程度，组织应当以文档（见4.2.4）和记录（见4.2.5）的形式保存这些采购信息。

7.4.3 Verification of purchased product 采购产品的确认

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.

组织应当确定和实施检查或其他的必要措施来保证所采购产品符合特定的采购需求。确认活动的范围应当基于供应商评估结果并且与采购产品有关的风险相适应。（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.

当组织发现采购产品任何变更时，组织应当确定这些变化是否影响产品的实现过程或影响到医疗器械。组织应当在采购信息中陈述产品放行的方法和意图的确认措施。（新增）

Records of theverification shall be maintained (see 4.2.5).

确认的记录应予以保留（见4.2.5）