ISO13485-2016中英文对照(七)-产品实现7.4、7.6

7 Product realization7 产品实现7.4Purchasing 采购7.4.1Purchasing process 采购过程The organizationshall document procedur

7 Product realization

7 产品实现

 

7.4Purchasing 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

7.4.2Purchasing 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).

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。

7.4.3Verification 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

7.6 Controlof monitoring and measuring equipment 监控和测量设备的控制

The organizationshall determine the monitoring and measurement to be undertaken and the monitoringand measuring equipment needed to provide evidence of conformity of product to determinedrequirements.

组织应当确定所需实施监控和测量,以及应用的设备以便于提供符合产品特定要求的证据。

The organizationshall document procedures to ensure that monitoring and measurement can be carriedout and are carried out in a manner that is consistent with the monitoring andmeasurement requirements.

组织应当形成程序文件来保证监控和测量的实施,并与监控和测量需求相一致的方式进行。

As necessary toensure valid results, measuring equipment shall:

为了保证结果有效,测量设备应当:

a) be calibratedor verified, or both, at specified intervals, or prior to use, againstmeasurement standards traceable to international or national measurementstandards: when no such standards exist, the basis used for calibration orverification shall be recorded (see 4.2.5);

在指定的时间间隔或使用之前进行校准或确认,或两个都进行。测量标准应能溯源到国际或国家测量标准:如果没有相应的标准,用于校准或确认的依据应当进行记录(见4.2.5);

b) be adjustedor re-adjusted as necessary: such adjustments or re-adjustments shall berecorded (see 4.2.5);

必要进行调整或再调整:调整或重新调整应进行记录(见4.2.5);(新增)

c) haveidentification in order to determine its calibration status;

得到识别用以确定其校准状态;

d) besafeguarded from adjustments that would invalidate the measurement result;

应防止可能使测量结果失效的调整;

e) be protectedfrom damage and deterioration during handling, maintenance and storage.

在处理、维护和存储期间应保护设备免受危害和退化;

The organizationshall perform calibration or verification in accordance with documentedprocedures.

组织应当依据批准的程序实施校准或确认。

In addition, theorganization shall assess and record the validity of the previous measuringresults when the equipment is found not to conform to requirements. Theorganization shall take appropriate action in regard to the equipment and anyproduct affected.

另外,当发现设备不符合要求时,组织应当评价和记录以往的测量结果。组织应当对受影响的设备和产品采取相应的措施。

Records of theresults of calibration and verification shall be maintained (see 4.2.5).

校准和确认结果的记录应当予以保留(见4.2.5)。

The organizationshall document procedures for the validation of the application of computersoftware used for the monitoring and measurement of requirements. Such softwareapplications shall be validated prior to initial use and, as appropriate, afterchanges to such software or its application.

组织应当建立用于监控和测量需要的计算机软件应用验证程序,在使用之前应对其软件应用进行验证,相应的,在应用之后或其他变更时也要进行验证。(新增)

The specific approach and activitiesassociated with software validation and revalidation shall be proportionate to therisk associated with the use of the software, including the effect on theability of the product to conform to specifications. Records of the results andconclusion of validation and necessary actions from the validation shall be maintained(see 4.2.4 and 4.2.5).

与软件验证相关的措施和特定方法以及在验证应当与软件使用对应的风险相适应,包括符合标准产品能力的影响。验证的结论和结果以及由验证引伸出来的相关措施的记录都应当予以保留(见4.2.44.2.5)。(新增)

NOTE Furtherinformation can be found in ISO 10012.

注:进一步信息见ISO 10012

 

    总结:本部分是7.47.6的内容,原本以为没有多大的改变但是变化还是非常大的。7.4采购部分7.4.1有大篇幅的新增内容,主要是针对供应商评估和再评估的;7.4.27.4.3也有一段内容的增加。主要针对变更事项,再次提到变更,另外也提到风险管理。7.6的内容变化不是很明显,但是再次提到计算机系统验证的事情,另外风险管理也被再次提及。

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