QUALITY MANUAL - Nimt.or.th
Edition 10Revision 00QUALITY MANUAL.enercnsosrpea ted."paitnrinephnly w ed whenolled ontrollorton d unccsint sidereemcu s conodisIt i"ThQSWGNIMT1 February 2019
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National Institute of Metrology (Thailand)Quality ManualFOREWORD TO CURRENT EDITIONThis edition is established in order to improve NIMT’s management system to comply with thenew ISO/IEC 17025:2017 and ISO/ IEC 17034:2016. The contents of this QM are developed tocorrespond to the structure of ISO/IEC17025:2017 and ISO/IEC 17034:2016.enercnsosrpea ted."paitnrinephnly w ed whenolled ontrollorton d unccsint sidereemcu s conodisIt i"ThEdition: 10Revision: 00Prepared by: QSWGIssued on: 1 February 2019Section: Index of ContentPage: 3/76
National Institute of Metrology (Thailand)Quality Manual.enercnsosrpea ted."paitnrinephnly w ed whenolled ontrollorton d unccsint sidereemnis intentionally left blank.ThiscupageoocdsisIt i"ThEdition: 10Revision: 00Prepared by: QSWGIssued on: 1 February 2019Section: Index of ContentPage: 4/76
National Institute of Metrology (Thailand)Quality ManualTABLE OF CONTENTThis page is intentionally left blank. . 4TABLE OF CONTENT . 5COMMITMENT TO QUALITY . 7DEFINITIONS . 8INTRODUCTION . 173.13.2DESCRIPTION . 17SCOPE . 17n.eersc4.1 IMPARTIALITY .18nosr4.2 CONFIDENTIALITY .18pea ted."paitnrinSTRUCTURAL REQUIREMENTS .20ephnwely ed whn5.1 ORGANIZATION .20oldlelolro .ntrtoRESOURCE REQUIREMENTS29nconcusidnt sidere6.1 PERSONNELe.29munco6.2 FACILITIESdo tANDs cENVIRONMENTAL CONDITIONS . 31isihIT EXTERNALLY PROVIDED PRODUCTS AND SERVICES . 33"6.3GENERAL REQUIREMENTS . 186.46.56.6PROVISION OF PRODUCTS, SERVICES AND SUPPLIES . 34EQUIPMENT . 35METROLOGICAL TRACEABILITY . 38PROCESS REQUIREMENTS. 397.17.27.37.47.57.67.77.87.98.REVIEW OF REQUESTS, TENDERS AND CONTRACTS. 39SAMPLING . 41HANDLING OF MEASUREMENT SERVICES . 42METHODS AND MEASUREMENT PROCEDURES . 44REPORTING THE RESULTS . 46ENSURING THE VALIDITY OF RESULTS . 48CONTROL OF NONCONFORMING WORK . 49COMPLAINTS . 50DISTRIBUTION SERVICE OF RM . 51PRODUCTION REQUIREMENT . . .52Edition: 10Revision: 00Prepared by: QSWGIssued on: 1 February 2019Section: Index of ContentPage: 5/76
National Institute of Metrology (Thailand)Quality Manual8.1 REFERENCE MATERIAL PRODUCTION PLANNING AND CONTROL . 528.2 MATERIAL PROCESSING, HOMOGENEITY AND STABILITY ASSESSMENT ANDCHARACTERIZATION . 529.MANAGEMENT SYSTEM REQUIREMENTS . .539.1 MANAGEMENT SYSTEM .539.2 CONTROL OF MANAGEMENT SYSTEM DOCUMENTS . 599.3 CONTROL OF RECORDS. 619.4 IMPROVEMENT . 659.5 CORRECTIVE ACTION. 669.6 ACTIONS TO ADDRESS RISKS AND OPPORTUNITIES . 679.7 INTERNAL AUDIT . 689.8 MANAGEMENT REVIEW . 709.9 SERVICE TO THE CUSTOMER . 71n.eersc 72ANNEX .norsaep10.1 CROSS REFERENCE .ap inted." 72tihen hen prwly ed wnolled ontrollorton d unccsint sidereemcu s conodisIt i"ThEdition: 10Revision: 00Prepared by: QSWGIssued on: 1 February 2019Section: Index of ContentPage: 6/76
National Institute of Metrology (Thailand)Quality ManualCOMMITMENT TO QUALITYThe National Institute of Metrology, Thailand (NIMT), under administration of the TopManagement, guarantees and enhances continuous quality improvement in measurements servicesprovided to its customers. Additionally, the Top Management shall ensure the accomplishment ofthe stated quality policies as appeared in 9.1.2 of this Quality Manual (QM).NIMT recognizes the importance of impartiality and confidentiality in promoting confidence whenconducting its measurement activities.NIMT are fully committed to providing all services to the customer in an open, independent andimpartial manner.n.eerscnorsaepap inted."tin organizationalThis QM describes NIMT’s quality management structure epr processes necessaryh andnweto fulfill the objective goals in quality assurancely for alledNIMT’swh measurement services. Itnoguarantees that organizational and technicalareollplanned, supervised and controlled, andlledactivitiesrtorntn rules andunthecoguidelines concluded with all accreditation bodiesothethat provisions of the contracts,csiedt compliedrnand/or peer-reviewersarewith.eedmsiuncoocisthe NIMT Laboratory declares its willingness to ensure that the impartialityisasdthe holdertNIMTofhIT"The NIMT staff and all of its organizational units, which are directly or indirectly involved inproviding the measurement services, are herewith bound to carry out their tasks in accordance withthe quality policies laid down in this QM.of the NIMT Laboratory’s staff is guaranteed for all measurement services certified byaccreditation bodies and/or peer-reviewers.Ajchara CharoensookDirectorNational Institute of Metrology (Thailand)Edition: 10Revision: 00Prepared by: QSWGIssued on: 1 February 2019Section: 1Page:7/76
National Institute of Metrology (Thailand)Quality ManualDEFINITIONSa)Terms of quality assuranceThis QM uses the term and definitions given in ISO/IEC Guide 99 and ISO/IEC 17000 and thefollowing apply. ISO and IEC maintain terminological databases for use in standardization at thefollowing address:- ISO Online browsing platform: available at https://www.iso.org/obp-IEC Electropedia: available at http://electropedia.org/and definitions of quality assurance terms in accordance with the International Vocabulary ofMetrology — Basic and General Concepts and Associated Terms (VIM) (JCGM200: 2012) andseries of international standards and guidelines including various applicable ISO standards and EAstandards.n.eerscImpartialitynorsPresence of objectivityaepap inted."tir resolved so as notNote 1 to entry: Objectivity means that conflicts of interestor parehdoennot exist,nwely e(3.6)whnto adversely influence subsequent activities of thelaboratorydolled ontrollortonare usefulNote 2 to entry: Other terms thatinncconveying the element of impartiality includecusider“freedomnoft interests”,“freedom from conflictfrom bias”, “lack of prejudice”, “neutrality”,eedimsunoc“fairness”, “open-mindedness”,co “even-handedness”, “detachment”, “balance”.dsisitI"Th(SOURCE: ISO/IEC 17021-1:2015, 3.2, modifield-The words “the certification body” have beenreplaced by “the laboratory” in Note 1 to entry, and the word “independence” has been deletedfrom the list in Note 2 to entry.)ComplaintExpression of dissatisfaction by any person or organization to a laboratory (3.6), relating to theactivities or results of that laboratory, where a response is expected(SOURCE: ISO/IEC 17000:2004, 6.5, modified-The words “other than appeal” have been deleted,and the words “conformity assessment body or accreditation body, relating to the activities of thatbody” have been replaced by “a laboratory, relating to the activities or results of that laboratory”.)Interlaboratory comparisonorganization, performance and evaluation of measurements or tests on the same or similar itemsby two or more laboratories in accordance with predetermined conditions(SOURCE : ISO/IEC 17043:2010, 3.4)Edition: 10Revision: 00Prepared by: QSWGIssued on: 1 February 2019Section: 2Page:8/76
National Institute of Metrology (Thailand)Quality ManualIntralaboratory comparisonOrganization, performance and evaluation of measurements or tests on the same or similar itemswithin the same laboratory (3.6) in accordance with predetermined conditionsProficiency testingEvaluation of participant performance against pre-established criteria by means of interlaboratorycomparisons (3.3)(SOURCE : ISO/IEC 17043:2010, 3.7, modified – Notes to entry have been deleted)LaboratoryBody that performs one or more of the following activities:- testing;- calibration;- sampling, associated with subsequent testing or calibrationn.eerc aboveNote 1 to entry: In the context of this document, “laboratory activities” refer tothesthreenorsamentioned activities.epap inted."tihen hen prDecision rulewlyis accountednd wfor when stating conformity withRule that describes how measurement uncertaintyoeldleoll controa specified requirementrtnco ed unsiterVerification mendisunocobjectiveisevidenceco that a given item fulfils specified requirementsprovisionofdsitI"ThEXAMPLE 1: Confirmation that a given reference material as claimed is homogeneous for thequantity value and measurement procedure concerned, down to a measurement portion having amass of 10 mg.EXAMPLE 2: Confirmation that performance properties or legal requirements of a measuringsystem are achieved.EXAMPLE 3: Confirmation that a target measurement uncertainty can be met.NOTE 1: When applicable, measurement uncertainty should be taken into consideration.NOTE 2: The item may be, e.g. a process, measurement procedure, material, compound, ormeasuring system.NOTE 3: The specified requirements may be, e.g. that a manufacturer's specifications are met.Edition: 10Revision: 00Prepared by: QSWGIssued on: 1 February 2019Section: 2Page:9/76
National Institute of Metrology (Thailand)Quality ManualNOTE 4: Verification in legal metrology, as defined in VIML[53], and in conformity assessmentin general, pertains to the examination and marking and/or issuing of a verification certificate fora measuring system.NOTE 5: Verification should not be confused with calibration. Not every verification is avalidation.NOTE 6 In chemistry, verification of the identity of the entity involved, or of activity, requires adescription of the structure or properties of that entity or activity.(SOURCE: JCGM 200:2012, 2.44)Validationverification, where the specified requirements are adequate for an intended usen.eerscnorsaepap inted."tien en prhw(SOURCE: JCGM 200:2012, 2.45)ly ed whnodollterms calibration (VIM 2.39)lleandrtornb) Fundamental metrological conceptsassociatedtoon ind aufirstncstep,csioperation that, under specifiedconditions,establishes a relation between the quantityetrneedm uncertaintiessi provided by measurement standards and correspondingvalues with measurementuncoocis measurement uncertainties and, in a second step, uses this informationindicationsis dwith associatedthIT"to establish a relation for obtaining a measurement result from an indicationEXAMPLE A measurement procedure, ordinarily used for the measurement of mass concentrationof nitrogen in water, may be validated also for measurement of mass concentration of nitrogen inhuman serum.NOTE 1: A calibration may be expressed by a statement, calibration function, calibration diagram,calibration curve, or calibration table. In some cases, it may consist of an additive or multiplicativecorrection of the indication with associated measurement uncertainty.NOTE 2: Calibration should not be confused with adjustment of a measuring system, oftenmistakenly called “self-calibration”, nor with verification of calibration.reference material, RM (ISO Guide 30: 2015, 2.1.1)material, sufficiently homogeneous and stable with respect to one or more specified properties,which has been established to be fit for its intended use in a measurement processNote 1 to entry: RM is a generic term.Note 2 to entry: Properties can be quantitative or qualitative, e.g. identity of substances or species.Edition: 10Revision: 00Prepared by: QSWGIssued on: 1 February 2019Section: 2Page:10/76
National Institute of Metrology (Thailand)Quality ManualNote 3 to entry: Uses may include the calibration of a measurement system, assessment of ameasurement procedure, assigning values to other materials, and quality control.Note 4 to entry: ISO/IEC Guide 99:2007 has an analogous definition, but restricts the term“measurement” to apply to quantitative values. However, Note 3 of the definition in ISO/IECGuide 99:2007 specifically includes qualitative properties, called “nominal properties”.certified reference material, CRM (ISO Guide 30: 2015, 2.1.2)reference material (RM) characterized by a metrologically valid procedure for one or morespecified properties, accompanied by an RM certificate that provides the value of the specifiedproperty, its associated uncertainty, and a statement of metrological traceabilityNote 1 to entry: The concept of value includes a nominal property or a qualitative attribute suchas identity or sequence. Uncertainties for such attributes may be expressed as probabilities or levelsof confidencen.eerscnorsaepNote 2 to entry: Metrologically valid procedures for the productionandcertificationap inted."of RMs aretigiven in, among others, ISO Guide 35.hen hen prwly ed wnoNote 3 to entry: ISO Guide 31 gives guidanceoll of RM certificates.lled onothercontentstornton99:2007dhasnanc analogous definition.cusiNote 4 to entry: ISO/IECGuident sidereemn RMP (ISO Guide 30: 2015, 2.3.5)cu producer,oocdreferencematerialsisIt i"Thbody (organization or company, public or private) that is fully responsible for project planning andmanagement; assignment of, and decision on property values and relevant uncertainties;authorization of property values; and issuancemetrological traceability, traceability (VIM 2.41)property of a measurement result whereby the result can be related to a reference through adocumented unbroken chain of calibrations, each contributing to the measurement uncertaintyNOTE 1: For this definition, a ‘reference’ can be a definition of a measurement unit through itspractical realization, or a measurement procedure including the measurement unit for a non-ordinalquantity, or a measurement standard.NOTE 2: Metrological traceability requires an established calibration hierarchy.Edition: 10Revision: 00Prepared by: QSWGIssued on: 1 February 2019Section: 2Page:11/76
National Institute of Metrology (Thailand)Quality ManualNOTE 3: Specification of the reference must include the time at which this reference was used inestablishing the calibration hierarchy, along with any other relevant metrological informationabout the reference, such as when the first calibration in the calibration hierarchy was performed.NOTE 4: For measurements with more than one input quantity in the measurement model, eachof the input quantity values should itself be metrologically traceable and the calibration hierarchyinvolved may form a branched structure or a network. The effort involved in establishingmetrological traceability for each input quantity value should be commensurate with its relativecontribution to the measurement result.national measurement standard, national standard (VIM 5.3)measurement standard recognized by national authority to serve in a state or economy as the basisfor assigning quantity values to other measurement standards for the kind of quantity concernedn.eerscnorsaepap inted."tinprhe5.7)working measurement standard, working standard (VIMnwely oredverifywh measuring instruments orncalibratemeasurement standard that is used routinelyd toolle ontrollomeasuring systemsrton d unccsire is usually calibrated with respect to a referencent sidestandardeNOTE 1: A workingmeasurementmcu s conomeasurementstandard.disIt i"Threference measurement standard, reference standard (VIM 5.6)measurement standard designated for the calibration of other measurement standards for quantitiesof a given kind in a given organization or at a given locationNOTE 2: In relation to verification, the terms “check standard” or “control standard” are alsosometimes used.measurement uncertainty, uncertainty of measurement, uncertainty (VIM 2.26)non-negative parameter characterizing the dispersion of the quantity values being attributed to ameasurand, based on the information usedNOTE 1: Measurement uncertainty includes components arising from systematic effects, such ascomponents associated with corrections and the assigned quantity values of measurementstandards, as well as the definitional uncertainty. Sometimes estimated systematic effects are notcorrected for but, instead, associated measurement uncertainty components are incorporated.NOTE 2: The parameter may be, for example, a standard deviation called standard measurementuncertainty (or a specified multiple of it), or the half-width of an interval, having a stated coverageprobability.Edition: 10Revision: 00Prepared by: QSWGIssued on: 1 February 2019Section: 2Page:12/76
National Institute of Metrology (Thailand)Quality ManualNOTE 3: Measurement uncertainty comprises, in general, many components. Some of these maybe evaluated by Type A evaluation of measurement u
Quality Manual Edition: 10 Prepared by: QSWG Section: Index of Content Revision: 00 Issued on: 1 February 2019 Page: 3/76 FOREWORD TO CURRENT EDITION This edition is established in order to improve NIMT’s management system to comply with the new ISO/IEC 17025:2017 and ISO/ IEC 17034:2016. The contents of this QM are developed to correspond to the structure of ISO/IEC17025:2017 and ISO/IEC .
The Bubble Map is for describing using adjectives; Identifying the sensory, logical and emotional qualities of any topic or concept. Who Am I, My Story: My Qualities - Bubble Map name quality quality quality quality quality examples influences name quality quality quality quality quality 8 your name name 2
Management Systems are managed by the joint UoA – NHSG Quality Assurance Manager (QAM). 5.1 Quality Manual This Quality Manual is the statement by UoA of its documented Quality Management System which conforms with ISO/IEC 17025:2017. Conformance with the requirements stated in the Quality Manual and in the UoA IMS Standard Operating
Quality Manual Third edition Revision 05 02 April 15 Page 9 of 43 3.2 Abbreviations In the text the following abbreviations recur: QMS, QS Quality Management System QMan Quality Manual PRO Quality Procedure ISO 9001 UNI EN ISO 9001: 2008 PEW Pressure Equipment Workshop ATW Assembly Workshop
3. Quality management system 12 3.1 Quality policy 12 3.1.1 Quality levels 12 3.1.1.1 Academic research 12 3.1.1.2 Cooperative research 13 3.1.1.3 Laboratory work of students 13 3.2 Purpose of the quality system 13 3.3 Responsibilities 13 3.4 Structure of the quality management system 13 3.4.1 Quality manual 14
For purposes of this plan, Quality is defined as the degree of excellence a product possesses; Quality Control (QC) activities are actions taken to obtain a quality product, while Quality Assurance (QA) activities are procedures used to ensure a quality product. In pr actice, the division between Quality Control and Quality Assurance may not be .
Feb 15, 1999 · ISO 9002:1994, Quality systems -Model for quality assurance in production, installation, and servicing. ISO 9003:1994, Quality systems -Model for quality assurance in final inspection and test. ISO 9004-1:1994, Quality management and quality system elements -Part 1: Guidelines. ISO 9004-2:1991, Quality management and quality system elementsFile Size: 1MB
Formal definitions of software quality and the cost of software quality model are introduced by defining: 1. Software Quality; 2. Good versus Poor-quality Software; 3. The cost of software quality model and its evolution; 4. Categories of Cost of Poor Software Quality (CPSQ); and 5. Categories of Cost of Good Software Quality (CGSQ).
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