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.
組織應(yīng)當(dāng)確定所需實(shí)施監(jiān)控和測量，以及應(yīng)用的設(shè)備以便于提供符合產(chǎn)品特定要求的證據(jù)。
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.
組織應(yīng)當(dāng)形成程序文件來保證監(jiān)控和測量的實(shí)施，并與監(jiān)控和測量需求相一致的方式進(jìn)行。
As necessary toensure valid results, measuring equipment shall:
為了保證結(jié)果有效，測量設(shè)備應(yīng)當(dāng)：
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);
在指定的時(shí)間間隔或使用之前進(jìn)行校準(zhǔn)或確認(rèn)，或兩個(gè)都進(jìn)行。測量標(biāo)準(zhǔn)應(yīng)能溯源到國際或國家測量標(biāo)準(zhǔn)：如果沒有相應(yīng)的標(biāo)準(zhǔn)，用于校準(zhǔn)或確認(rèn)的依據(jù)應(yīng)當(dāng)進(jìn)行記錄（見4.2.5）；
b) be adjustedor re-adjusted as necessary: such adjustments or re-adjustments shall berecorded (see 4.2.5);
必要進(jìn)行調(diào)整或再調(diào)整：調(diào)整或重新調(diào)整應(yīng)進(jìn)行記錄（見4.2.5）；（新增）
c) haveidentification in order to determine its calibration status;
得到識別用以確定其校準(zhǔn)狀態(tài)；
d) besafeguarded from adjustments that would invalidate the measurement result;
應(yīng)防止可能使測量結(jié)果失效的調(diào)整；
e) be protectedfrom damage and deterioration during handling, maintenance and storage.
在處理、維護(hù)和存儲期間應(yīng)保護(hù)設(shè)備免受危害和退化；
The organizationshall perform calibration or verification in accordance with documentedprocedures.
組織應(yīng)當(dāng)依據(jù)批準(zhǔn)的程序?qū)嵤┬?zhǔn)或確認(rèn)。
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，當(dāng)發(fā)現(xiàn)設(shè)備不符合要求時(shí)，組織應(yīng)當(dāng)評價(jià)和記錄以往的測量結(jié)果。組織應(yīng)當(dāng)對受影響的設(shè)備和產(chǎn)品采取相應(yīng)的措施。
Records of theresults of calibration and verification shall be maintained (see 4.2.5).
校準(zhǔn)和確認(rèn)結(jié)果的記錄應(yīng)當(dāng)予以保留（見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.
組織應(yīng)當(dāng)建立用于監(jiān)控和測量需要的計(jì)算機(jī)軟件應(yīng)用驗(yàn)證程序，在使用之前應(yīng)對其軟件應(yīng)用進(jìn)行驗(yàn)證，相應(yīng)的，在應(yīng)用之后或其他變更時(shí)也要進(jìn)行驗(yàn)證。（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).
與軟件驗(yàn)證相關(guān)的措施和特定方法以及在驗(yàn)證應(yīng)當(dāng)與軟件使用對應(yīng)的風(fēng)險(xiǎn)相適應(yīng)，包括符合標(biāo)準(zhǔn)產(chǎn)品能力的影響。驗(yàn)證的結(jié)論和結(jié)果以及由驗(yàn)證引伸出來的相關(guān)措施的記錄都應(yīng)當(dāng)予以保留（見4.2.4和4.2.5）。（新增）
NOTE Furtherinformation can be found in ISO 10012.
注：進(jìn)一步信息見ISO 10012