医疗器械ISO13485质量管理体系认证内容

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

Theorganizationshall determine the monitoring and measurement to beundertaken and the monitoringand measuring equipment needed toprovide evidence of conformity of product todeterminedrequirements.

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。

Theorganizationshall document procedures to ensure that monitoring andmeasurement can be carriedout and are carried out in a manner thatis consistent with the monitoring andmeasurementrequirements.

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。

Asnecessary toensure valid results, measuring equipmentshall:

为了保证结果有效，测量设备应当：

a)be calibratedor verified, or both, at specified intervals, or priorto use, againstmeasurement standards traceable to international ornational measurementstandards: when no such standards exist, thebasis used for calibration orverification shall be recorded (see4.2.5);

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 orre-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 calibrationstatus;

得到识别用以确定其校准状态；

d)besafeguarded from adjustments that would invalidate themeasurement 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；

Theorganizationshall perform calibration or verification in accordancewith documentedprocedures.

组织应当依据批准的程序实施校准或确认。

Inaddition, theorganization shall assess and record the validity ofthe previous measuringresults when the equipment is found not toconform to requirements. Theorganization shall take appropriateaction in regard to the equipment and anyproductaffected.

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。

Recordsof 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）。

Theorganizationshall document procedures for the validation of theapplication of computersoftware used for the monitoring andmeasurement of requirements. Such softwareapplications shall bevalidated prior to initial use and, as appropriate, afterchanges tosuch software or 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）

Thespecific approach and activitiesassociated with software validationand revalidation shall be proportionate to therisk associated withthe use of the software, including the effect on theability of theproduct to conform to specifications. Records of the resultsandconclusion of validation and necessary actions from thevalidation 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4.2.4和4.2.5）。（新增）

NOTEFurtherinformation can be found in ISO 10012.

注：信息见ISO10012