Transcription

Edition 10Revision 00QUALITY PROCEDURES.enercsonsrapepad."teitnnihe en prwyonl led whdeoll ontrolrtnconcsuitdreenemdiusoc s condsiIt i"ThQSWGNIMT1 February 2019

.enercsonsrapepad."teitnnihe en prwyonl led whdeoll ontrolrtnconcsuitdreenemdiusoc s condsiIt i"Th

National Institute of Metrology (Thailand)Quality ProceduresFOREWORD TO CURRENT EDITIONIn this edition, the following changes have been applied to accommodate the requirements ofISO/IEC 17025:2017 and ISO 17034:2016:1) In QP-02: The GQM has been added in the procedure.2) In QP-05: The procedure for handling of complaints has been modified to be moretransparent and comply with the new concept of ISO17025: 2017.3) In QP-06: The procedure is improved to allow any staff to raise the nonconforming workwith more examples of nonconforming work.4) In QP-07: The handling of risks and opportunities determined during planning forcorrective actions are defined.5) In QP-08: The risk to impartiality is considered in the procedure for addressing the riskand opportunities.6) In QP-10: The inputs of management review is updated to comply with the new conceptof ISO17025: 20177) In QP-15: The information reported in analysis certificate of CRMs has been updated.enercsonsraOther changes are for typographical errors and grammatical errors. ppet a inted."inhe en prwyonl led whdeoll ontrolrtnconcsuitdreenemdiusoc s condsiIt i"ThEdition: 10Revision: 00Prepared by: QSWGIssued on: 1 February 2019FOREWORDSection Page Number: iSection Number of Pages: 2

National Institute of Metrology (Thailand)Quality Procedures.enercsonsrapepad."teitnnihe en prwyonl led whdeoll ontrolrtncopage is uintentionallyncsiThisleft blank.tdenreemdcu consiodisIt is"ThEdition: 10Revision: 00Prepared by: QSWGIssued on: 1 February 2019FOREWORDSection Page Number: iiSection Number of Pages: 2

National Institute of Metrology (Thailand)Quality ProceduresQP-01:1PROCEDURE FOR CONTROL OF GENERAL QUALITYDOCUMENTSOVERVIEWResponsibilities1.1Quality system staffActivitiesPrepare a draft of documentRelated Documents New / re-issueddocument Master DocumentRegister 1.2QSWGReview the document.enercs New / re-issueddocumentonsrapepad."tetn1.3 Director of NIMTApprove the documenten ii New/re-issuedrhpwnlyhe documentnwodlled ntrolleorton uncocsit1.4 Quality SystemnStaffUpdate Master Documented Master noodcavailabletoallstaffsviathe Electronic documentisIt isintranet and reviews the"Th Original document file document periodically2 Document ReviewRecordPURPOSEThe purpose of this procedure is to establish and maintain a system to control all generalquality documents that relate to the management system of NIMT.3SCOPEThis procedure applies to all general quality documents of NIMT which are under theresponsibility of the Quality Manager.Edition: 10Revision: 00Prepared by: QSWGIssued on: 1 February 2019Section Page Number: 1Section Number of Pages: 4QP-01:Procedure for Control of General Quality Documents

National Institute of Metrology (Thailand)Quality Procedures4DEFINITION4.1General quality documentsGeneral quality documents are documents defined for the general administrative andmanagement system including Quality Manual (QM), Quality Procedure (QP), WorkInstruction (WI) and Forms.5PROCEDURE5.1The Quality system staff prepares a draft of new or re-issued general quality document(hereafter referred to as “document”) as requested by the Quality Manager.A document is uniquely identified by the title, the current edition and revisionnumbers, which are also referred to in the form Fr-DOC-01: Master DocumentRegister, and the date of issue. All pages in all documents must contain pagenumbering with the total number of pages.enercsonsrapepad."teitnniForms required by documents are issued withformheindividualpr number, year of issuewneyand revision identification.onl led whdeolpurpose, scope, definition procedure, andollof overview,rDetails of the QP consistrttnnconcosrelated forms.uitdreenemdiusdocument, the designated personnel will receive an electronicnoInc case sofcaore-issueddsiifileIt of original document from quality system staff. He/she shall have access to"Thpertinent background information prior to instigating a change. For the QM,changes are made as the whole document while changes are made separately foreach individual QP and the number of revision is changed accordingly. Thealtered or new text is marked in such a way to make the change observable.In case of the immediate change in the QM / QP are needed. The Quality Managercan make the amendment by hand. The amendment shall be clearly marked,initialed and dated. The revised document shall be formally re-issued within twomonths.5.2The QSWG reviews the document and makes corrections, if necessary. Then the finaldocument is submitted to the Director of NIMT for the approval.5.3The Director of NIMT approves the document. This document will be considered as theoriginal document.Edition: 10Revision: 00Prepared by: QSWGIssued on: 1 February 2019Section Page Number: 2Section Number of Pages: 4QP-01:Procedure for Control of General Quality Documents

National Institute of Metrology (Thailand)Quality Procedures5.4The Quality System Staff updates the Master Document Register and makes the documentavailable to all staff via the intranet.The Quality System Staff electronically protects the approved document in itselectronic format (read and print only). The protected electronic document isplaced in the intranet server by the server controller. At the same time, theinformation of document issue or change is also provided to all staff via theintranet.When the document is printed, it will be considered as an uncontrolled copy.However, the external distribution of any documents, electronic or paper, shall beprohibited without permission.The Quality System Staff keeps the original paper document and its correspondingelectronic file. Obsolete original document is retained and clearly marked ascancelled or obsolete. Retention period of these documents is 10 years.enercsonsrapecomputerizedThe electronic file of original document maintainedpin." system isadteitduplicated for backing-up purpose prior to eallTherincomputerized systemh nchanges.pwnis protected by the use of passwordunauthorizedaccess.lyto prevent whenoddeelloorganizationsoll to externalThe document may betrgivenand customers for informationrtnnoocpurposes onlypermissionfrom the Quality Manager. Unless otherwiseunis cwithrthetdeneespecified,will be uncontrolled copy.m suchdidocumentuscnoos c documents are re-issued for a new edition after a practical number ofis d TheItwholeihT"changes, but not more than 10 times.The quality documents from external sources, such as regulations and standards, willbe marked as controlled document. The Quality Section will control thesedocuments by the use of the record fileFr-DOC-01: Master Document Register.The QSWG shall review all documents (including the quality documents fromexternal sources) to ensure continuing suitability and compliance with applicablerequirements by a period not exceeding 12 months.Results of the review are retained in the record file Fr-DOC-02: DocumentReview Record.6RELATED FORMS6.1Fr-DOC-01: Master Document Register6.2Fr-DOC-02: Document Review RecordEdition: 10Revision: 00Prepared by: QSWGIssued on: 1 February 2019Section Page Number: 3Section Number of Pages: 4QP-01:Procedure for Control of General Quality Documents

National Institute of Metrology (Thailand)Quality Procedures.enercsonsrapepad."teitnnihe en prwyonl led whdeoll ontrolrtnco pageuniscintentionally leftsiThistednreemdcu consiodisIt is"ThEdition: 10Revision: 00Prepared by: QSWGIssued on: 1 February 2019Section Page Number: 4Section Number of Pages: 4QP-01:Procedure for Control of General Quality Documents

National Institute of Metrology (Thailand)Quality ProceduresQP-02:1PROCEDURE FOR CONTROL OF DEPARTMENTAL ted personnelActivitiesRelated DocumentsPrepare a draft of document New / reissueddocument Master DocumentRegister 1.2Head of LaboratoryReview the document.enercs CP, PP, WI, SOP andFormsonsrapepad."tetn1.3 Head of GroupApprove the documenten ii CP,PP,WI, SOP andrhpwnlyhe Formsnwodlled ntrolleorton uncocsi1.4 Head of Groupntd the document DQM / GQMeReviewreemdiu Document Forms andscnoodcExternal sourceisIt is"Th 1.5Head of DepartmentApprove the document New / reissueddocument 1.6Document ControlPersonnelUpdates Master DocumentRegister, and makes theDQM/GQM available to thestaff via the server Master DocumentRegister Electronic document Original document file 1.7Head of GroupEdition: 10Revision: 00Review the documentperiodically Master DocumentRegister Review RecordPrepared by: QSWGSection Page Number: 1Issued on: 1 February 2019Section Number of Pages: 4QP-02:Procedure for Control of Departmental Quality Documents

National Institute of Metrology (Thailand)Quality Procedures2PURPOSEThe purpose of this procedure is to establish and maintain a system to control alldepartmental quality documents that relate to the management system of NIMT.3SCOPEThis procedure applies to all departmental quality documents which are under theresponsibility of Head of Department.4DEFINITION4.1Departmental quality documents.enercsonsrapepad."teitnnihe en prwyonl led whdeoll ontrolrtn5PROCEDURE is concutdreenemdiusc5.1 Thedodesignatedpersonnelprepares a draft of new or re-issued departmental qualityoncssiitreferred to as document) as requested by the Head of Department."Th documentI(hereafterDepartmental quality documents are documents defined for specific details of operationwithin each Department including the Department Quality Manual (DQM), the GroupQuality Manual (GQM), the Calibration Procedures (CP), the Production Procedure (PP),technical Work Instructions (WI), Standard Operating Procedure (SOP) and Forms.The document is uniquely identified by the title, current edition and revision statusby referring to the record file Fr-DOC-01: Master Document Register, date ofissue, page numbering with the total number of pages.Forms required by the document are issued with individual form number, year ofissue and revision identification.Each DQM / GQM consists of description of the department / group, premises andenvironmental condition, equipment, calibration and/or measurement procedures,handling of the service items and recording and filing system.Each CP as minimum, consists of calibration description, equipment requirements,preliminary operations, calibration procedure in details, basic equations ormeasurement model(s) and description of measurement uncertainty budget.Edition: 10Revision: 00Prepared by: QSWGSection Page Number: 2Issued on: 1 February 2019Section Number of Pages: 4QP-02:Procedure for Control of Departmental Quality Documents

National Institute of Metrology (Thailand)Quality ProceduresEach PP as minimum, consists of RM description, material selection,accommodation and environment condition, equipment requirements,metrological traceability, material processing, certification measurement method,homogeneity and stability assessment, measurement uncertainty and materialhandling and storage.In case of a re-issued document, the designated personnel shall have access topertinent background information prior to instigating a change. Changes to eachdocument are made as a whole document, and the number of revision is changedaccordingly. The altered or new text is marked in such a way to make the changeobservable.5.2The Head of Group reviews the DQM / GQM and Head of Laboratory reviews the CP, PP,WI, SOP and Form.enercsonsrapepad."teitnnihe en prwy5.4 The Document Control Personnel updatesDocumentRegister and makes thehwonlthe Masterddeell in thetrdepartmentDQM / GQM available to allolstaffon the appropriate departmentalolrtnndirectory on NIMT server(s).concosuitdrePersonnel protects the corresponding electronic file of theen ControleTheDocumentmdiusn / GQM to allow only reading and printing, and then places it inoc approvedoDQMdcssiiIt"Ththe departmental directory on NIMT server.5.3The Head of Department approves the DQM / GQM and Head of Group approves the CP,PP, WI, SOP and Form. This document will be considered as the original document.When the DQM / GQM is printed, it will be an uncontrolled copy (using thewatermark).In case of the DQM / GQM , the Document Control Personnel keeps the originaldocument. Obsolete original DQM / GQM is retained and clearly marked ascancelled.In case of the CP, PP,WI, SOP and Form the original document is given to the staffwho performs the operation. Obsolete document (if any) is promptly removedfrom the point of use. It should be clearly marked as cancelled when it is retainedfor knowledge preservation purposes. The minimum retention period is 10 years.The electronic file of the original document maintained in computerized system isduplicated for back-up purpose prior to any changes. The computerized system isprotected by the use of password to prevent unauthorized access.Edition: 10Revision: 00Prepared by: QSWGSection Page Number: 3Issued on: 1 February 2019Section Number of Pages: 4QP-02:Procedure for Control of Departmental Quality Documents

National Institute of Metrology (Thailand)Quality ProceduresThe document may be given with the permission from the Head of Department toexternal organizations and customers for information purposes. Unless otherwisespecified, such document will be uncontrolled copy which is not successivelyupdated.The whole documents are re-issued for a new edition after a practical number ofchanges, but not more than 10 times.5.5The Head of Laboratory shall review CP, PP, WI, SOP and Form and Head of Group shallreview DQM / GQM(including the quality documents from external sources) to ensurecontinuing suitability and compliance with applicable requirements by a period notexceeded 12 months.enercsResults of the review are retained in record file Fr-DOC-02: Document Review Record.onsrapepad."teitnnihe en prwylwhas regulations, standards, andonsources,ddThe quality documents from externalsucheelol the ones which need to control theoll manualsrrttnequipment’s instruction/operation(onlynuncodocument. The Head of Group will control theseis co asrecontrolleddversions), will nbet markedeerecord file Fr-DOC-01: Master Document Register.mdiusdocumentsbytheuseofthecndocossiihtI FORMS"6T RELATEDIn case of the immediate changes in the DQM / GQM, CP, PP are needed, the Head ofGroup can make the amendment by hand. The amendment shall be clearly marked,initialed and dated. The revised document shall be formally re-issued within two months.6.1Fr-DOC-01: Master Document Register6.2Fr-DOC-02: Document Review RecordEdition: 10Revision: 00Prepared by: QSWGSection Page Number: 4Issued on: 1 February 2019Section Number of Pages: 4QP-02:Procedure for Control of Departmental Quality Documents

National Institute of Metrology (Thailand)Quality ProceduresQP-03:1PROCEDURE FOR REVIEW OF REQUESTS,TENDERS ANDCONTRACTSOVERVIEWResponsibilities1.1Customer / Staffof Corporationand PartnershipDevelopmentGroupActivitiesFill in the online request formeasurement services.Related Documentshttp://calservices.nimt.or.th 1.2Staff ofCorporation andPartnershipDevelopmentGroupReview and make necessarycorrections in the onlinedatabase and send ORJ to thesenior staff. .enercsOnline customer’srequest job (ORJ)onsrapepad."teitnnihe en prwyonl led wh deoll ontrolrtn1.3Senior Staff of ORJco Reviewuandncmake benetor the relevant Head ht"T Group I 1.4Head ofDepartmentReview the ORJ and distributeto the relevant Head of Group. ORJ 1.5Head of GroupReview and assign the ORJ tothe relevant laboratory staff. ORJ 1.6RelevantLaboratory staffEdition: 10Revision: 00Fill in necessary information(service fee and additionalcharge) and send to the Headof Group for review.Prepared by: QSWGIssued on: 1 February 2019 Completed ORJSection Page Number: 1Section Number of Pages: 6QP-03:Procedure for Review of Requests,Tenders and Contracts

National Institute of Metrology (Thailand)Quality Procedures 1.7Head of GroupReview the completed ORJand if no changes, forwards tothe Head of Department Completed ORJbecoming reviewed ORJ 1.8Head ofDepartmentMake final review and if thereare no objections, approve thereviewed ORJ and send backto the staff of Corporation andPartnership DevelopmentGroup Reviewed ORJbecoming the approvedORJ (equivalent toapproved CIF)onsrapepad."teitnnihe en prwyonl led whdeoll ontrolrtnconcsuitdreenemdiusoc s condsiIt i"Th1.9Staff ofCorporation andPartnershipDevelopmentGroupReview the approved ORJ,print out the report from thejob onto the CIF template,keep the hardcopy, key in theinformation from the CIF tothe Forma system to issue thequotation and print out thequotation. Send the approvedORJ to the senior staff andconcurrently submit the hardcopies of CIF and quotation tothe senior staff for approval.enercs Approved ORJ CIF (paper version) Quotation 1.10Senior Staff ofCorporation andPartnershipDevelopmentGroupReview the approved CIF andthe quotation to verify theagreement of all informationand submit the online job forpending status (wait forcustomer’s acceptance.) Pending ORJ forconverting to the OnlineWork Order (OWO) CIF Quotation 1.11CustomerEdition: 10Revision: 00Customer accepts or rejects thequotation.Prepared by: QSWGIssued on: 1 February 2019 QuotationSection Page Number: 2Section Number of Pages: 6QP-03:Procedure for Review of Requests,Tenders and Contracts

National Institute of Metrology (Thailand)Quality Procedures2PURPOSEThe purpose of this procedure is to ensure that the customer’s requirements have beenreviewed in a systematic and efficient manner before any work is accepted by NIMT.3SCOPEThe procedure applies to all customers’ requirements for review of requests, tenders, andcontracts by NIMT.4DEFINITION4.1Request - Any inquiry, requirement and request for quotations.4.2Contract - Agreed order or quotation with customer’s signatory.5PROCEDURE.enercsonsrapepad."teitnni5.1 The customer fills in the online request for measurementheservicesenat http://calservices.nimt.or.th.prwynl ed whoDevelopmentd5.2 Staff of the Corporation and Partnershipell Group reviews and makes necessarylloorrttn andncsendson the online customer’s request job (ORJ) to thecorrections in the onlineodatabasecsuisenior staff. entedremdcu consiods seniorIt staffis of the Corporation and Partnership Development Group reviews andThiThe"5.3makes final approval of the ORJ then distribute the ORJ to the relevant Head ofDepartment.5.4The Head of Department reviews the ORJ and forwards to the relevant Head of Group.Refer to quality procedures under the management system according to ISO 9001 forfurther details.In case of the ORJ being distributed incorrectly, the ORJ shall be returned back tothe senior staff of the Corporation and Partnership Development Group for redistribution.5.5Head of Group reviews the job and assigned the ORJ to the relevant Laboratory staff.In case of the ORJ being assigned incorrectly, the ORJ shall be returned back to theHead of Department for re-distribution and the process shall loops back to 5.4 andcontinue.Edition: 10Revision: 00Prepared by: QSWGIssued on: 1 February 2019Section Page Number: 3Section Number of Pages: 6QP-03:Procedure for Review of Requests,Tenders and Contracts

National Institute of Metrology (Thailand)Quality Procedures5.6The relevant Laboratory staff fills in necessary information (service fee and additionalcharge) and sends back to the Head of Group.In case of the ORJ being assigned incorrectly, the ORJ shall be retuned back to theHead of Group for re-assignment and the process shall loop back to 5.5 andcontinue.5.7The Head of Group reviews the completed ORJ and if no changes, forwards to th