测量设备校准程序-英文版

1、Insert your companys name or OgO address.ISO 9001:2015Con trol of Calibrated Equipme ntThis procedureis the property of Your Company . It must not be reproduced in whole or in part or otherwise disclosed without prior written consent.The official controlled copy of this quality manual is the digital

2、ly signed PDF document held within our network server and visible to all authorised users. All printed copies, and all electronic copies and versions, except the ones described above, are considered uncontrolled copies which should be used for reference only.ISO 9001:2015Insert your company' s n

3、ame or logo.Con trol of Calibrated Equipme ntApprovalThe sig natures below certify that this man ageme nt system procedure has bee n reviewed and accepted, and dem on strates that the sig natories are aware of all the requireme nts contained here in and are committed to en suri ng their provisi onNa

4、meSignaturePositionDatePrepared byReviewed byApproved byAme ndme nt RecordThis procedure is reviewed to ensure its continuing relevance to the systems and process that it describes. A record of con textual additi ons or omissi ons is give n below:Page No.ContextRevisionDateCompa ny Proprietary In fo

5、rmatio nThe electro nic versi on of this procedure is the latest revisi on. It is the resp on sibility of the in dividual to en surethat any paper material is the curre nt revisi on. The pr in ted versi on of this man ual is uncon trolled,exceptwhen provided with a document reference number and revi

6、sion in the field below:RevDocument Ref.Uncontrolled CopyControlled CopyDateContents1Con trol of Calibrated Equipme nt31.1 In troducti on & Purpose 31.1.1 Process Activity Map 1.1.2 Refere nces1.1.3 Terms & Defin iti ons 1.2 Applicati on & Scope41.3 Resp on sibilities41.4 Con trolli ng C

7、alibrated Equipme nt41/1.1Exist ing Devices1/1.2New Devices1/1.3Calibrati on Freque ncy1/1.4Calibrati on Due Date1/1.5Calibrati on Label1/1.6Outsourced Calibrati on1/1.7Software1/1.8Non-con form inq Equipme nt1/1.9Review1.5 Forms & Records61.6 Calibrated Equipme nt Process Map 7Document Ref.Page

8、 1 of 8ISO 9001:2015Insert your company' s name or logo.Con trol of Calibrated Equipme nt1Con trol of Calibrated Equipme nt1.1 In troducti on & PurposeThe purpose of this procedure is to define your organizationre§possibilities and activities in order toen sure that all in specti on and

9、 test equipme nt used for product, service and process verificati on is con trolled and calibrated aga inst n ati on ally traceable sta ndards at specified in tervals and that such devices are availableto en sure con ti nuity of measureme nt capability.1.1.1 Process Activity MapWith whatXWith whoCal

10、ibrated equipment log Calibration labels Calibration certificatesProduction teamQuality InspectorQuality ManagerXIn putActivityOutputCustomer requirementsCalibration of new and existing Calibrated equipment Regulatory requirementsmonitoring and measuringMeasurement traceabilityCalibration scheduleeq

11、uipmentContinual improvementConforming processesHowWith what measureCalibration processOn time calibrationSpecifications& standardsCapability studies Forms & reportsWork instructions1.1.2 Refere ncesStandardTitleDescriptionBS EN ISO 9000:2015Quality management systemsFundamentals and vocabul

12、aryBS EN ISO 9001:2015Quality management systemsRequirementsBS EN ISO 9004:2000Quality management systemsGuidelines for performance improvementsBS EN ISO 19011:2011Auditing management systemsGuidelines for auditing1.1.3 Terms & DefinitionsTermISO 9000:2015 DefinitionMeasuring equipmentReference

13、material necessary to realize a measurement process (3.11.5)Metrological characteristiccharacteristic (3.10.1) which can influence the results of measurement (3.11.4)Metrological confirmationOperations to ensure that measuring equipment (3.11.6) conforms to the requirements1.2 Application& Scope

14、This procedure applies to all inspection and test equipment required for product and process verification. There must be con fide nce that equipme nt used to in spect or measure attributes of the desig n is calibrated to an acceptable level of accuracy.The Quality Man ager<ame nd as appropriate&g

15、t;en sures that any devices which do not meet these criteria areisolated from use and recalibrated before being used. Devices used to calibrate equipme nt are traceable to a n ati onal or In ter nati onalsta ndard un it of measureme nt.Eachmeasureme nt in strume nt is traceable throughits own calibr

16、ation record which contains:« Ide ntificati on n umber;« Man ufacturer and model;« Freque ncy of calibrati on;« Refere nce sta ndards used;« Validation certificates and calibration findings;* Details of acti ons take n in case of un satisfactory results.1.3 ResponsibilitiesT

17、he Quality Man ager <ame nd as appropriate> is required to:* Select suitable equipme nt to perform the required measureme nts with accuracy and precisi on;* Exte nd the con trol of in specti on and test equipme nt to all approved suppliers where applicable;* Ensure inspection and test equipmen

18、t cannot be used if they are not registered and calibrated;* Ensure inspection and test equipment is calibrated in a suitable environment;* Con trol all measureme nt, calibrati on and maintenance activities.All employees& Process Owners are required to:* Check that inspection and test equipment

19、is not damaged and is fit for purpose;* Check the calibrati on status of in specti on and test equipme nt prior to use.1.4 Controlling Calibrated Equipment1.1.1 Exist ing DevicesThese steps are to be followed to control the calibration of existing in-house devices:* Remove device from use before cal

20、ibrati on due date;* Determ ine whether calibrati on is to be done in-house or by an exter nal supplier;* Verify n eed for maintenance and un dertake maintenance where required;* Update device details on the con trolled equipme nt log;* Verify device performa ncea nd calibrate;* Affix new calibrati

21、on label;* Update the calibrati on log;* Issue device for use.1.1.2 New DevicesThese steps are to be followed to control the registering and calibration verification new devices:« Assig n device ide ntificati on/asset n umber;« Add device details to the con trolled equipme nt log;«Det

22、ermi ne calibrati on freque ncy;« Determ ine n ext calibrati on date;« Verify device performa nee and calibrate;« Affix Calibration Label ;« Updatethe device details to the calibrati on log;«Issue device for use.1.1.3 Calibrati on Freque ncyCalibrati on freque ncy is determ

23、ined by compari ng the performa nee of the measuri ng equipme nt to:* Equipme nt purpose;* Manufacturer ' s specifications* Degree of usage;* Equipme nt type;* Stability/reliability.1.1.4 Calibratio n Due DateAfter the calibration frequencyhas been established; the specific calibration due date

24、is established anddocume nted.* Attach the calibrati on label to the equipme nt;* Update the calibrati on log;* En sure equipme nt is re-calibrated by the due date.1.1.5 Calibrati on LabelUpon completi on of calibrati on, satisfactory equipme nt is tagged with a calibrati on label in dicat ing:* Cal

25、ibrati on date;* Due date of the n ext in specti on;* In itials of the pers on perform ing the calibrati on.For in specti on and test equipme nt too small to affix a sticker, an alter native method of labelli ng will be used:* Str ing tag on equipme nt;* Label affixed to contain er;* Notati on on ca

26、librati on log.1.1.6 Outsourced Calibrati onA commercial laboratory will be used for calibrati on and repair that cannot be accomplished in-house.* The calibrati on facility must comply with a n ati on ally or intern ati on ally recog ni zed calibrati onsta ndards;* The calibrati on facility will be

27、 evaluated by the Quality Man ager<ame nd as appropriate> ;* Calibrati on certificates will be required.1.1.7 SoftwareTest software developed in house or purchased fromcommercial suppliers is validatedbefore it is used forproduct verificati on.« Stan dard software purchased from commercia

28、l sources is ordered with validati on certificates;« Software developed in-house is validated and approved in accorda nee with customer requireme nts;« Software is re-validated at prescribed in tervals or whe never a cha nge from the orig inal release isin troduced.1.1.8 Non-conforming Equ

29、ipme ntIf con firmedthatin specti onand testequipme ntis out of calibrati on,the QualityMan ager<ame ndasappropriate> is required to:« Remove suspect device from service;« In vestigate the validity of measureme nts for which the equipme nt was previously used;* Assess the accepta nee status of all affected products;* Select appropriate corrective acti ons to mitigate the subseque