COMMITTEE DRAFT

1CD 2014-05-28

OIML/TC 3/SC 6/p1: Premarket surveillance activities Convener: New Zealand and the BIML BIML contact: Willem Kool (Willem.Kool@oiml.org)

Circulated to P- and O-members and liaison internal bodies and external organizations for:

Comment only by

28 August 2014 Comments to be sent to the BIML, using the template provided.

TITLE OF THE CD (English):

OIML Dxx:201x:

Conformity to type (CTT) – Pre-market conformity assessment of measuring instruments

Scope for pre-market surveillance activities focused on the conformity assessment of measuring instruments to give assurance that the manufactured (or production) instruments meet their approved type

TITLE OF THE CD (French):

OIML Dxx: 201x:

Conformité au type (CTT) - Pré-marché évaluation de la conformité des instruments de mesure

Champ des activités de surveillance pré-marché porté sur l'évaluation de la conformité des instruments de mesure de donner l'assurance que les instruments fabriqués (ou de production) se réunissent leur type approuvé

Original version in: English

OIMLTC3/SC6:ConformitytoTypeProject1:Premarketsurveillanceactivities

Convener:NewZealandandtheBIML

Date: 2014‐05‐28 Doc.No.: TC3/SC6/P1/N011

Title:

OIMLDxx:201x:Conformity to type (CTT) – Pre‐market conformity assessment ofmeasuringinstruments

Scope for pre‐market surveillance activities focused on the conformity assessment ofmeasuring instruments to give assurance that the manufactured (or production)instrumentsmeettheirapprovedtype

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TableofContents1.DefinitionofCTTfromtheperspectiveoflegalmetrologicalcontrol.................................................2 

2.Problemdefinitionandjustification....................................................................................................................2 

3.Scope...................................................................................................................................................................................3 

4.Conformityassessment—theISO/CASCOtoolbox.....................................................................................3 

5.IECconformityassessmentsystems....................................................................................................................3 

6.ConsiderationsforaCTTprogram.......................................................................................................................5 

7.Issuesidentifiedandpossiblemitigationstrategies....................................................................................8 

8.Examplesofexistingsystemsinthefieldoflegalmetrology..................................................................9 

8.1TheNTEP/VCAPintheUS.................................................................................................................................9 

8.2TheEuropeanNAWI‐directiveandMID.....................................................................................................9 

Annex1  TheISO/CASCOtoolbox........................................................................................................................11 

Annex2  MIDconformityassessmentmodulesBandF...........................................................................12 

A2.1  ModuleB:EU‐typeexamination.......................................................................................................12 

A2.2  ModuleF:Conformitytotypebasedonproductverification............................................14 

Annex3  NTEP/VCAPrequirementsandprocedures................................................................................17 

Annex4  MIDconformityassessmentmoduleH1.......................................................................................20 

Annex5  Technicaldocumentation.....................................................................................................................25 

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1.DefinitionofCTTfromtheperspectiveoflegalmetrologicalcontrolconformitytotypeconformityassessmentprocedurefocusedonassessmentofmeasuringinstrumentstogiveassurancethatmanufactured(orproduction)instrumentsmeettheapprovedtype

The concept of conformity to type as considered in this document refers to a systematicprocedure as a part of the pre‐market conformity assessment procedures applicable tomeasuringinstruments.Itshouldnotbeconfusedwith‘marketsurveillance’,oftenperformedad‐hocbyauthoritiesbasedonriskassessmentandusercomplaints1.

2.ProblemdefinitionandjustificationGenerally,measuringinstrumentsunderlegalcontrolaresubjectedtoconformityassessmentbeforetheymaybe legallyused.Traditionally, suchconformityassessment is in twostages:typeevaluation(andapproval)andverification.

Attypeevaluation [VIML,2.04],oneormore instrumentsaresubjectedtoawiderangeoftests (temperature, electromagnetic compatibility, etc.) that often require specialized andexpensive test facilities and can only be meaningfully performed in a laboratory. Theinstruments submitted for type evaluation testing should be representative of the finalproductionofthetypeofinstrument,butveryoftentheyarestillprototypes,or,atbest,wellpreparedsamples.

Atverification[VIM,2.44],eachindividualinstrumentfromtheproductionisthensubjectedto limited testing, typically at ambient temperature only, to verify whether the instrumentperforms within maximum permissible errors. Verification includes an assessment of thecomplianceofthedesignoftheinstrumentwiththeapprovedtype,asdescribedinthetypeapprovalcertificate.

When this system of conformity assessment was developed,measuring instruments underlegalcontrolwererelativelysimplecompared tomodernelectronic instruments.Theyweremainlymechanical,whilethefirstelectricalandelectronicinstrumentshadcomponentsthatweremoreeasilyrecognizableandsoftwarecouldnotbechangedwithoutbreakingaphysicalsealing.Moreover,manufacturers operated primarily in a nationalmarket and the national(or local) legal metrology inspectors were familiar with the manufacturers and theirproduction processes. Under these circumstances, the system of type approval andverificationworkedquitewelltoensurethatinstrumentsunderlegalcontrolcompliedwithapplicabletechnicalandmetrologicalrequirements.

Some developments that took place over the last decades have put the reliability of thissystemofconformityassessmentinlegalmetrologyintoquestion,forinstance:

New technologiesmake it difficult andoften impossible to verifywhether hardwarecomponents in production instruments have the same function or the samespecificationsasthoseinthesamplesthatweretestedfortypeapproval.

Softwarecanbeeasilymodified,oftenwithouthavingtobreakanyphysicalsealing. Asaresultofglobalizationand increasinglycomplexsupplychains, instrumentsmay

betypeapprovedinonecountry,producedinanothercountrywithcomponentsfromdifferentsources,andverifiedandusedinyetanothercountry.

1UNECEpublicationECE/TRADE/389“Aglossaryofmarketsurveillanceterms”definesmarketsurveillanceas:Theactivitiescarriedoutandmeasurestakenbydesignatedauthoritiestoensurethatproductscomplywiththerequirementssetoutintherelevantlegislationanddonotendangerhealth,safetyoranyotheraspectofpublicinterestprotection.

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Theissuescomingfromthesedevelopmentsarefurtherexacerbatedbytheincreaseduseoftest results obtainedunder bilateral andmultilateral acceptance arrangements, such as theOIMLMutualAcceptanceArrangementformeasuringinstruments(MAA).

Nowadays,itisverydifficultfortheverificationofficertoascertainthattheinstrumentheisverifying is actually in conformance with the design as described in the type approvalcertificate,orincompliancewithallapplicabletechnicalandmetrologicallegalrequirements.

Theproblemmaybeformulatedinthefollowingway:“Traditionalconformityassessmentinlegal metrology (i.e. type approval followed by verification) no longer provides sufficientassurancethatverifiedinstrumentscomplywithallapplicablerequirements”.

Theabsenceofthisassurancecouldresultinthefailureofmutualacceptancearrangementsandtheexposureofmanufacturerstounfaircompetitionfromnon‐compliantinstruments.

TheproblemasdefinedhereisillustratedbyissuesidentifiedinAustraliawith:

Loadcellslackingtemperaturecompensation,

NAWIinstrumentswithdifferentpowersupplies,

EMCcomponentsmissingfrominstruments.

3.ScopeThis document provides considerations for economies or Regional Legal MetrologyOrganizations (RLMOs) that are planning to develop conformity to type programs. Thisdocument also provides illustrative examples of conformity to type systems currently inoperation.

4.Conformityassessment—theISO/CASCOtoolboxConformityassessmentisdefinedas:demonstrationthatspecifiedrequirementsrelatingtoaproduct, process, system, person or body are fulfilled [VIML, A.1]. Typical conformityassessmentactivitiesinclude:testing[VIML,A.10],certification[VIML,A.18]andinspection[VIML, A.11]. Accreditation [VIML, A.9] is also considered conformity assessment (ofconformity assessment bodies), while the concept of testing includes calibration andmeasurement,and‘certification’mayrelatetoproducts,managementsystemsandpersons.

ISO/CASCOistheISOConformityAssessmentCommittee.ISO/CASCOhasdevelopedaseriesofstandardsdealingwiththevariousaspectsofconformityassessment.Thesestandardsarecollectivelyreferredtoasthe“ISO/CASCOtoolbox”.Themajorityofthesestandardsaremoreapplicabletotypeevaluation,butwehave listedexamplesrelevant toconformitytotype inAnnex1.

For the majority of measuring instruments under legal control, the applicable legislationspecifies conformity assessment procedures involving third party attestation, even if themanufacturer, or another body is authorized to do certain activities that are traditionallyperformed by metrological authorities. In such cases, the authorization is the third partyattestation.

5.IECconformityassessmentsystemsTofacilitateinternationaltradeinelectricalequipment,primarilyintendedforuseinhomes,offices, workshops, healthcare facilities and similar locations, for benefit of consumers,industries,authoritiesetc,andtoprovideconvenience formanufacturersandotherusersoftheservicesprovidedbyvariousnationalcertificationbodies(NCBs),aninternationalschemeis operated by the IECEE (IEC System for Conformity testing and Certification ofElectrotechnicalEquipmentandComponents),knownastheCBScheme.

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TheCBSchemeisbasedontheprincipleofmutualrecognition(reciprocalacceptance)byitsmembersoftestresultsforobtainingcertificationorapprovalatnationallevel.

ParticipationofthevariousNCBswithintheCBSchemeis intendedtofacilitatecertificationor approval according to IEC standards. Where national standards are not yet completelybased on IEC standards, declared national differenceswill be taken into account; however,successful operation of the CB Schemepresupposes that national standards are reasonablyharmonizedwiththecorrespondingIECstandards.

UseoftheCBSchemetoitsfullestextentwillpromotetheexchangeofinformationnecessaryin assistingmanufacturers around theworld to obtain certification or approval at nationallevel.

The CB Scheme is based on the use of CB Test Certificates which provide evidence thatrepresentativespecimensof theproducthavesuccessfullypassed tests toshowcompliancewiththerequirementsoftherelevantIECstandard.2

Asupplementaryreportprovidingevidenceofcompliancewithdeclarednationaldifferencesin order to obtain national certification or approval may also be attached to the CB TestReport.

The first step for an NCB, intending to operate in the CB Scheme, is to be accepted as aRecognizingNCB. Such anNCB is prepared to recognizeCBTestCertificates as a basis forcertificationorapprovalatnationallevelforoneormorecategoriesofproducts.

The secondstep foranNCB,which canbe takenat the same timeas the first step, is tobeaccepted as an Issuing and Recognizing NCB. Such an NCB is entitled to issue CB TestCertificates for the categories of equipment for which it recognizes CB Test Certificates. Itshould,however,benotedthatanNCBmayrecognizeCBTestCertificatesformorecategoriesofequipmentthanforwhichitisentitledtoissueCBTestCertificates.

The IECEECertificationBody(CB)FullCertificationScheme(CB‐FCS) isanextensionof theIECEECBSchemeandisanoptiontobeexercisedbytheparticipantsintheCBSchemeandbyapplicantsunderthesameIECEEmanagementstructure.

MemberNCBstowhichanapplicantappliesforanationalcertificationorapproval(NCBs“B”)acceptthe"ConformityAssessmentCertificate"(CAC)andassociated“ConformityAssessmentReport”(CAR)issuedbyNCB“A”asabasisforsuchcertificationorapproval.AsaNCBB,anNCB’snationalcertificationproceduresshouldasfaraspossiblebeharmonizedwiththeCB‐FCSRulesofProcedure;however,ifdifferencesexist,theyareformallydeclaredtotheIECEESecretariat for publication in order that Member NCBs are able to properly cover thesecertificationdifferenceswhenactingasNCB“A”.

CB‐FCSisaproductcertificationsystem5asdefinedinISO/IEC17065.Asystem5includesproduct type testing, product certification and assessment of the involved manufacturer’squalitymanagement system. Surveillance of the qualitymanagement system is carried outandsamplesoftheproductmaybetakenfromeitherthemarketorthepointofproductionorbothandmaybeassessedforongoingconformity.Theextenttowhichthethreeelementsofongoing surveillance are carried out can be adjusted for a given situation. As a result, thissystemprovidessignificantflexibilityforongoingsurveillance.

WhetherornottheNCBAissuesitscertificationmark,itremainsresponsiblefortheongoingconformityoftheproduct(s)forwhichtheCAChasbeengranted.

CB‐FCSincludesthefollowingfortheNCBA:

a)typetesting(byanacceptedtestlaboratory)onsample(s)andissuanceofaCAR;

2 The IECEE CB Scheme for electrotechnical equipment is comparable to the OIML Mutual AcceptanceArrangementformeasuringinstruments(MAA).

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b) initial factory inspection including the evaluation of the factory’s quality managementsystem(QMS);

c)issuanceoftheCAC;

d) follow‐up factory inspection by NCB A that in addition to assess the product, themanufacturingprocessandtheQMSwillalsoincludesamplingofthecertifiedproductforthepurposeofre‐testingwhenapplicable.

CB‐FCSincludesthefollowingfortheNCBB:

a)evaluationofCACandCARincluding,ifnecessary,directseparateconsultationwithNCBAtoensurevalidity,initialinspection,followupinspection,QMSsurveillanceandcompletenessofCACandCAR;

b)nottorequiretestsample(s)ifCACandCARarecompleteanddeterminedtobevalid;

c)IssuanceoftheNCB’scertificationmarkandimplementationofitscertificationprocedure.

6.ConsiderationsforaCTTprogramConformity to type is an integral part of legal metrological control [VIML, 2.01] formeasuringinstrumentsforwhichnationallegislationrequirestypeevaluation [VIML,2.04]andtypeapproval[VIML,2.05]beforesuchinstrumentsmaybeplacedonthemarket.

Legal metrological control systems may be considered as consisting of a sequence ofconformityassessmentprocedurescoveringthevariousphasesofthelifecycleofmeasuringinstruments:thedesignphase,theproductionphase,andthein‐servicephase.

Legal metrological control systems may exist in different forms, i.e. consist of differentconformityassessmentprocedures.Conformitytotypemayappearasaseparateconformityassessment procedure, or be part of another conformity assessment procedure (initialverification, surveillance), but always in the production phase. This is illustrated byconsideringthreedifferentlegalmetrologicalcontrolsystems:A,BandC(seeFigure1).

SystemAincludes

type evaluation, with tests performed on one or more specimen instruments andresultinginanationalorregionaltypeapprovalcertificate.ThetestsmaybecoveredbyanOIML(MAAorBasic)certificate;

initial verification [VIML, 2.12], where individual instruments are assessed forcompliancewiththetechnicalandmetrologicalrequirementsthatapplytothemandresulting in the application of averificationmark [VIML, 3.04] on the instruments.For those requirements for which compliance cannot be assessed during initialverification, the assessment of the conformity of the instrument with the approvedtype (i.e. conformity to type) shouldensure that the instrument complieswith thoserequirements;

conformityassessmentproceduresafterplacingonthemarket[VIML,2.24],aspartofmarketsurveillanceand in‐service inspectionbymetrologicalauthorities [VIML,1.05],orsubsequentverification[VIML,2.13].

Examplesofa‘systemA’legalmetrologicalcontrol:

traditionaltypeapprovalandverificationproceduresformeasuringinstrumentsusedfortrade:weighinginstruments,petrolpumps,etc.

Europeanmeasuring instruments directive (MID) conformity assessmentmodules B(Type examination) + F (Declaration of conformity to type based on productverification).See8.2andAnnex2fordetails.

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SystemBincludes

typeevaluation,asinsystemA;

conformity to type as a separate conformity assessment procedure, resulting in theaffixingofaconformitymarkingontheinstrument;

initial verification, where the conformity of the instrument to the approved type isdemonstrated by the conformity marking on the instrument, resulting in theapplicationofaverificationmarkontheinstrument;

conformityassessmentproceduresafterplacingonthemarket,asinsystemA.

Thissystemmayapplytoaregionallybasedconformancesystemwhereaconformitymarkisagreedandutilizedbyparticipatingeconomies.Typically,thetypeapprovalwouldtakeplaceinonejurisdictionandproduction(andinitialverification)inanother.Thiscouldresultintheneedforaconformitymark.

SystemCincludes

typeevaluation(as insystemA)andsurveillanceof theproductionby thebody thatissued the type approval certificate. Here, conformity to type would be part of thesurveillance. A conformity marking would be affixed during the production of theinstruments,

initialverification,asinsystemB,

conformityassessmentproceduresafterplacingonthemarket,asinsystemsAandB.

ExampleofsystemC:

The Verified Conformity Assessment Program of the National Type EvaluationProgram (NTEP/VCAP) administered by the National Conference on Weights andMeasures(NCWM)intheUS.Fordetails,see8.1andAnnex3.

A variation of system C would be the casewhere themanufacturer has a certified qualitysystem covering both the design and production phases and is authorized to apply averificationmark.Inthiscase,conformitytotypeispartofthecertifiedqualitysystem.

Example:

TheEuropeanMeasuringinstrumentsdirective(MID),conformityassessmentmoduleH1 (Declaration of conformity based on full quality assurance plus designexamination).Fordetailssee8.2andAnnex4.

Othervariationsofthesystemsconsideredheremayexist.Forinstance:verificationsmaybeperformed either by metrological authorities, or, under certain conditions, by themanufacturerorauthorizedprivatecertificationbodies.Suchvariations,however,wouldnotaffecttheroleofconformitytotype.

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Legalmetrologicalcontrolsystems

Stage A B C

Design

      

  

  

Production      

Pre‐market    

  

         

Use

 

Post‐market 

− Market Surveillance  

− Inspections 

− Re‐verification 

− Market Surveillance  

− Inspections 

− Re‐verification 

− Market Surveillance  

− Inspections 

− Re‐verification 

 

Type Evaluation & 

Surveillance 

 

 

Type Evaluation 

 

Type Evaluation 

 OIML Certificate 

National or Regional 

Type Approval 

Certificate

OIML Certificate OIML Certificate 

National or Regional 

Type Approval 

Certificate

Initial Verification 

National or Regional 

Type Approval 

Certificate 

Conformity to Type

Conformity to Type  

Conformity Mark 

Surveillance 

  Conformity to Type  

Verification Mark 

Initial Verification 

Verification Mark 

Initial Verification 

Verification Mark

Figure1

Note:

‘Surveillance’duringtheproductionphaseinsystemCisperformedaspartofthecertification(type evaluation) process where non‐compliances may lead to the withdrawal of thecertificate.Itshouldnotbeconfusedwith‘marketsurveillance’performedbyauthorities.

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Elementstobeconsideredforinclusioninaconformitytotypeprocedure:

comparingproductioninstrumentswiththedesignoftheapprovedtypeasdescribedinthetypeapprovaldocumentation(foranexampleofrequirementsfortypeapprovaldocumentation,seeAnnex5);

repeating(partofthe)typeevaluationtestsononeormoreproductioninstruments,aspartofasurveillanceandsamplingprogram.Thesamplingmaybead‐hoc,orbasedona statistical sampling plan. The extent of such a program may be based on a riskassessment,ortakeaccountofthenumberofinstrumentsplacedonthemarket;

productionofinstrumentsunderanappropriatecertifiedqualitysystem;

affixingamarkontheinstrumenttodemonstrateitsconformitytotheapprovedtype;

sealing of the instrument to ensure that it cannot be modified until its initialverification;

linking the renewal of a type approval certificate (sunset clause) to the testing ofproductioninstruments(formalconformitytotypeassessment);

regionallyorinternationallysharingtheresultsofconformitytotypesurveillanceandtesting.

For consideration by economies in a region that do not have the capabilities to do typeevaluation:

todevelopaseparateCTTprocedure(asinsystemB)asdescribedinISO/IEC17067,type3.

7.Issuesidentifiedandpossiblemitigationstrategiesa) The description of the approved type in the type approval certificate may not be

detailedenoughtoidentifycriticalpartsorcomponentsoftheinstrument.

Provide guidance on the details of the description of the type in the typeapprovalcertificate.

b) Possibleconflictsofinterestwhereprivatebodiesperformconformitytotypepaidforbythemanufacturer.

Developan industrycodeofpractice (voluntary) for themanufacturer tosignup to, clearly defining roles and responsibilities, including requirements onsharingofinformation.

c) Fundingofconformitytotypeactivities.

Startsmall;provebenefitstomanufacturers.Considerstartingwithanational,bilateralorregionalapproach.Focusonspecifictypesofinstrumentorindustry(e.g.watermetercodeofpracticedevelopedinNewZealand3).

d) Sharingofinformationbetweenregulatorsonanationalandinternationalbasisraisesprivacyissuesandissuestodowithsecuringintellectualpropertyrights.

Set up an information sharing system such as RAPEX in Europe, sharing infousing templates and limiting access to participating issuing authorities andregulators nominated by the CIML Member. Operation based on a code ofpracticewithvoluntaryparticipation.

3NewZealandWaterandWasteAssociation(NZWWA):WatermetercodeofPractice,2003,see:http://www.nzwwa.org.nz/Folder?Action=View%20File&Folder_id=101&File=110118_water_meter_cop.pdf

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e) Lack of market surveillance, so that existing CTT procedures cannot be adequatelyevaluatedfortheireffectiveness.

Increase sharing and coordination of market surveillance activities betweenauthorities

8.Examplesofexistingsystemsinthefieldoflegalmetrology

8.1TheNTEP/VCAPintheUSIn the US, the National Conference on Weights and Measures (NCWM) administers theNational Type Evaluation Program (NTEP). NTEP performs type evaluations of measuringinstruments and issues Certificates of Conformance. In addition, NTEP has developedconformity assessment procedures to ensure conformance of production instrumentswiththeirapprovedtype.OneoftheelementsistheNTEPVCAP(VerifiedConformityAssessmentProgram). The scope of this program is currently restricted to weighing equipment.ManufacturersofinstrumentsorcomponentswithinthescopeofVCAPandwhicharesubjecttoinfluencefactorsasdefinedinNISTHandbook44,musthaveinplaceaVerifiedConformityAssessment Program, to ensure that these instruments and components are produced at alevelconsistentwiththatofthepreviouslycertifiedinstrumentorcomponent.

The VCAP requirements are detailed inNCWM/NTEP Publication 14:Administrativepolicy,Section S:ConformityAssessment, 1.c:NTEPVerifiedConformityAssessmentProcedures (SeeAnnex3).

Non‐compliancewith the VCAP requirementsmay result in the Certificate of Conformancebecoming“inactive”.

8.2TheEuropeanNAWI‐directiveandMIDTheMemberStatesoftheEuropeanUnionarerequiredtoimplementtheEuropeandirectiveon non‐automatic weighing instruments (NAWI Directive)4 and the European measuringinstrumentsdirective(MID)5whenexercisinglegalcontrolonmeasuringinstrumentsfortheapplicationsmentionedinthosedirectives.

TheNAWIDirectiveandtheMIDprovidefortheaffixingoftheCEmarkingonthemeasuringinstrumentswithintheirscopethatwillbeplacedonthemarketof theEuropeanEconomicArea(EEA)6andTurkey.

ThemanufacturerisresponsiblefortheconformityoftheinstrumentswiththeprovisionsofallapplicableEuropeanUnionlegislationandfortheaffixingoftheCEmarking.ByaffixingtheCEmarking, amanufacturer is declaring conformity, irrespective ofwhether ornot a thirdpartyhasbeeninvolvedintheconformityassessmentprocess.

Conformity assessment procedures are composed of one or two conformity assessmentmodules, covering both design and production phases. For more information about theconformity assessment procedures for products by European legislation providing for the

4Directive2014/31/EUoftheEuropeanParliamentandtheCouncilof26February2014ontheharmonizationof the laws of theMember States relating to the making available on themarket of non‐automatic weighinginstruments.

5Directive2014/32/EUoftheEuropeanParliamentandtheCouncilof26February2014ontheharmonizationofthelawsoftheMemberStatesrelatingtothemakingavailableonthemarketofmeasuringinstruments.

6TheEEAconsistsoftheEuropeanUnionMemberStates,Norway,IcelandandLichtenstein.

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affixingof theCEmarking,seeparagraph5.1of the2014editionof the“BlueGuide”ontheimplementationofEUproductrules.7

Manufacturers generally may choose one from several alternative conformity assessmentprocedures.TheproceduresmostfrequentlyprovidedforintheMIDare

moduleB(EU‐typeexamination)followedbymoduleD(ConformitytoEU‐typebasedonqualityassuranceoftheproductionprocess),

moduleB(EU‐typeexamination)followedbymoduleF(ConformitytoEU‐typebasedonproductverification),seeAnnex2,

moduleG(Conformitybasedonunitverification),and

moduleH1(Conformitybasedonfullqualityassuranceplusdesignexamination),seeAnnex4.

Inallcases,conformitytotypeisassessedonthebasisonthetechnicaldocumentationthatthe manufacturer has submitted to the notified body for the purpose of type (or design)examination and that has been included or referenced in the type (or design) approvalcertificate.

Therequirementsforthetechnicaldocumentationarecontainedinarticle18oftheMID(seeAnnex5).

7 Available for download from the EU Commission, DG Enterprise and Industry web site at:http://ec.europa.eu/enterprise/policies/single‐market‐goods/documents/internal‐market‐for‐products/new‐legislative‐framework/index_en.htm#h2‐3

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Annex1 TheISO/CASCOtoolbox

StandardsundertheresponsibilityofISO/CASCO(theISO/CASCOtoolbox)withrelevancetoCTT.

ISO/IECGuide28:2004 Conformityassessment‐‐Guidanceonathird‐partycertificationsystemforproducts

ISO/IECGuide53:2005 Conformityassessment‐‐Guidanceontheuseofanorganization'squalitymanagementsysteminproductcertification

ISO/IECGuide60:2004 Conformityassessment‐‐Codeofgoodpractice

ISO/IEC17011:2004 Conformityassessment‐‐Generalrequirementsforaccreditationbodiesaccreditingconformityassessmentbodies

ISO/IEC17020:2012 Conformityassessment‐‐Requirementsfortheoperationofvarioustypesofbodiesperforminginspection

ISO/IEC17021:2011 Conformityassessment‐‐Requirementsforbodiesprovidingauditandcertificationofmanagementsystems

ISO/IECDIS17021‐1 Conformityassessment‐‐Requirementsforbodiesprovidingauditandcertificationofmanagementsystems‐‐Part1:Requirements

ISO/IECTS17022:2012 Conformityassessment‐‐Requirementsandrecommendationsforcontentofathird‐partyauditreportonmanagementsystems

ISO/IEC17025:2005 Generalrequirementsforthecompetenceoftestingandcalibrationlaboratories

ISO/IEC17025:2005/Cor1:2006

ISO/IECAWITR17026 Conformityassessment‐‐Guidanceonathird‐partycertificationsystemforproducts

ISO/IEC17030:2003 Conformityassessment‐‐Generalrequirementsforthird‐partymarksofconformity

ISO/IEC17065:2012 Conformityassessment‐‐Requirementsforbodiescertifyingproducts,processesandservices

ISO/IEC17067:2013 Conformityassessment‐‐Fundamentalsofproductcertificationandguidelinesforproductcertificationschemes

ISOGuide27:1983 Guidelinesforcorrectiveactiontobetakenbyacertificationbodyintheeventofmisuseofitsmarkofconformity

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Annex2 MIDconformityassessmentmodulesBandF

A2.1 ModuleB:EU‐typeexamination1.‘EU‐typeexamination’isthepartofaconformityassessmentprocedureinwhichanotifiedbodyexaminesthetechnicaldesignofaninstrumentandverifiesandatteststhatthetechnicaldesignoftheinstrumentmeetstherequirementsofthisDirectivethatapplytoit.

2.EU‐typeexaminationmaybecarriedoutineitherofthefollowingmanners:

(a) examinationof a specimen, representativeof theproductionenvisaged, of the completemeasuringinstrument(productiontype),

(b)assessmentoftheadequacyofthetechnicaldesignoftheinstrumentthroughexaminationof the technical documentation and supporting evidence referred to in point 3, plusexaminationofspecimens,representativeoftheproductionenvisaged,ofoneormorecriticalpartsoftheinstrument(combinationofproductiontypeanddesigntype);

(c)assessmentoftheadequacyofthetechnicaldesignoftheinstrumentthroughexaminationof the technical documentation and supporting evidence referred to in point 3, withoutexaminationofaspecimen(designtype).

Thenotifiedbodydecidesontheappropriatemannerandthespecimensrequired.

3.ThemanufacturershalllodgeanapplicationforEU‐typeexaminationwithasinglenotifiedbody8ofhischoice.

Theapplicationshallinclude:

(a) the name and address of the manufacturer and, if the application is lodged by theauthorisedrepresentative,hisnameandaddressaswell;

(b) a written declaration that the same application has not been lodged with any othernotifiedbody;

(c)thetechnicaldocumentationasdescribedinArticle189.Thetechnicaldocumentationshallmake it possible to assess the instrument’s conformitywith the applicable requirements ofthis Directive and shall include an adequate analysis and assessment of the risk(s). Thetechnical documentation shall specify the applicable requirements and cover, as far asrelevantfortheassessment,thedesign,manufactureandoperationoftheinstrument.

Theapplicationshallinadditioncontain,whereverapplicable:

(d)thespecimens,representativeoftheproductionenvisaged.Thenotifiedbodymayrequestfurtherspecimensifneededforcarryingoutthetestprogramme;

(e)thesupportingevidencefortheadequacyofthetechnicaldesignsolution.Thissupportingevidenceshallmentionanydocumentsthathavebeenused,inparticularwheretherelevantharmonised standards, and/or normative documents have not been applied in full. Thesupporting evidence shall include, where necessary, the results of tests carried out inaccordancewithotherrelevanttechnicalspecificationsbytheappropriate laboratoryof themanufacturer,orbyanothertestinglaboratoryonhisbehalfandunderhisresponsibility.

4.Thenotifiedbodyshall:

Fortheinstrument:

8 A notified body is a certification body designated by national authorities to perform certain certificationactivitiesprescribedinEuropeanlegislation(suchastheNAWI‐directiveandtheMID)andsubsequentlynotifiedaccordingtoaproceduredetailedintheappropriateEuropeanlegislation.

9SeeAnnex6.

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4.1.examinethetechnicaldocumentationandsupportingevidencetoassesstheadequacyofthetechnicaldesignoftheinstrument;

Forthespecimen(s):

4.2. verify that the specimen(s) have been manufactured in conformity with the technicaldocumentationand identify theelementswhichhavebeendesigned inaccordancewith theapplicableprovisionsoftherelevantharmonisedstandardsand/ornormativedocuments,aswellas theelementswhichhavebeendesigned inaccordancewithotherrelevant technicalspecifications;

4.3.carryoutappropriateexaminationsandtests,orhavethemcarriedout,tocheckwhether,where the manufacturer has chosen to apply the solutions in the relevant harmonisedstandardsandnormativedocuments,thesehavebeenappliedcorrectly;

4.4.carryoutappropriateexaminationsandtests,orhavethemcarriedout,tocheckwhether,wherethesolutionsintherelevantharmonisedstandards,and/ornormativedocumentshavenotbeenapplied,thesolutionsadoptedbythemanufacturerapplyingotherrelevanttechnicalspecificationsmeetthecorrespondingessentialrequirementsofthisDirective;

4.5. agreewith themanufacturer on the locationwhere the examinations and testswill becarriedout.

Fortheotherpartsofthemeasuringinstrument:

4.6.examinethetechnicaldocumentationandsupportingevidencetoassesstheadequacyofthetechnicaldesignoftheotherpartsofthemeasuringinstrument.

5.Thenotifiedbodyshalldrawupanevaluationreportthatrecordstheactivitiesundertakeninaccordancewithpoint4andtheiroutcomes.Withoutprejudicetoitsobligationsvis‐à‐vis,thenotifyingauthorities,thenotifiedbodyshallreleasethecontentofthatreport,infullorinpart,onlywiththeagreementofthemanufacturer.

6.Where the typemeets therequirementsof thisDirective, thenotifiedbodyshall issueanEU‐typeexaminationcertificate tothemanufacturer.Thatcertificateshallcontainthenameandaddressofthemanufacturer,theconclusionsoftheexamination,theconditions(ifany)for its validity and the necessary data for identification of the approved type. The EU‐typeexaminationcertificatemayhaveoneormoreannexesattached.

TheEU‐typeexaminationcertificateanditsannexesshallcontainallrelevantinformationtoallowtheconformityofmanufacturedmeasuring instrumentswiththeexaminedtypetobeevaluated and to allow for in‐service control. In particular, to allow the conformity ofmanufactured instruments to be evaluated with the examined type regarding thereproducibility of their metrological performances, when they are properly adjusted usingappropriatemeans,contentshallinclude:

—themetrologicalcharacteristicsofthetypeofinstrument;

—measuresrequiredforensuringtheintegrityoftheinstruments(sealing,identificationofsoftware,etc.);

— informationonotherelementsnecessary for the identificationof the instrumentsand tochecktheirvisualexternalconformitytotype;

— if appropriate, any specific information necessary to verify the characteristics ofmanufacturedinstruments;

—inthecaseofasub‐assembly,allnecessary informationtoensure thecompatibilitywithothersub‐assembliesormeasuringinstruments.

TheEU‐typeexaminationcertificateshallhaveavalidityof10yearsfromthedateofitsissue,andmayberenewedforsubsequentperiodsof10yearseach.

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Where the type does not satisfy the applicable requirements of this Directive, the notifiedbodyshall refuse to issueanEU‐typeexaminationcertificateandshall informtheapplicantaccordingly,givingdetailedreasonsforitsrefusal.

7.Thenotifiedbodyshallkeepitselfappraisedofanychangesinthegenerallyacknowledgedstate of the art which indicate that the approved type may no longer comply with theapplicablerequirementsofthisDirective,andshalldeterminewhethersuchchangesrequirefurtherinvestigation.Ifso,thenotifiedbodyshallinformthemanufactureraccordingly.

8. Themanufacturer shall inform the notified body that holds the technical documentationrelatingtotheEU‐typeexaminationcertificateofallmodificationstotheapprovedtypethatmayaffecttheconformityoftheinstrumentwiththeessentialrequirementsofthisDirectiveor the conditions for validity of that certificate Suchmodifications shall require additionalapprovalintheformofanadditiontotheoriginalEU‐typeexaminationcertificate.

9.EachnotifiedbodyshallinformitsnotifyingauthorityconcerningtheEU‐typeexaminationcertificates and/or any additions thereto which it has issued or withdrawn, and shall,periodically or upon request, make available to its notifying authority the list of suchcertificatesand/oranyadditionstheretorefused,suspendedorotherwiserestricted.

TheCommission,theMemberStatesandtheothernotifiedbodiesmay,onrequest,obtainacopy of the EU‐type examination certificates and/or additions thereto. On request, theCommissionandtheMemberStatesmayobtainacopyofthetechnicaldocumentationandtheresultsoftheexaminationscarriedoutbythenotifiedbody.

Thenotifiedbody shall keep a copyof theEU‐type examination certificate, its annexes andadditions, as well as the technical file including the documentation submitted by themanufactureruntiltheexpiryofthevalidityofthatcertificate.

10.ThemanufacturershallkeepacopyoftheEU‐typeexaminationcertificate,itsannexesandadditionstogetherwiththetechnicaldocumentationatthedisposalofthenationalauthoritiesfor10yearsaftertheinstrumenthasbeenplacedonthemarket.

11. Themanufacturer’s authorised representativemay lodge the application referred to inpoint3andfulfiltheobligationssetoutinpoints8and10,providedthattheyarespecifiedinthemandate.

A2.2 ModuleF:Conformitytotypebasedonproductverification1. Conformity to type based on product verification is the part of a conformity assessmentprocedurewherebythemanufacturerfulfilstheobligationslaiddowninpoints2,5.1and6,and ensures and declares on his sole responsibility that the measuring instrumentsconcerned,whichhavebeensubject totheprovisionsofpoint3,are inconformitywiththetype described in the EU‐type examination certificate and satisfy the requirements of thisDirectivethatapplytothem.

2.Manufacturing

Themanufacturershalltakeallmeasuresnecessarysothatthemanufacturingprocessanditsmonitoringensureconformityofthemanufacturedmeasuringinstrumentswiththeapprovedtype described in the EU‐type examination certificate and with the requirements of thisDirectivethatapplytothem.

3.Verification

Anotifiedbodychosenbythemanufacturershallcarryouttheappropriateexaminationsandtests,orhavethemcarriedout,toverifytheconformityoftheinstrumentswiththetypeasdescribed in the EU‐type examination certificate and the appropriate requirements of thisDirective.

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Theexaminationsand tests toverify the conformityof themeasuring instrumentswith theappropriate requirements shall be carried out, at the choice of themanufacturer, either byexaminationand testingofevery instrument as specified inpoint4, or byexaminationandtestingofthemeasuringinstrumentsonastatisticalbasisasspecifiedinpoint5.

4.Verificationofconformitybyexaminationandtestingofeveryinstrument

4.1.Allmeasuringinstrumentsshallbeindividuallyexaminedandappropriatetestssetoutinthe relevantharmonised standard(s) and/or normativedocuments, and/or equivalent testssetoutinotherrelevanttechnicalspecifications,shallbecarriedoutinordertoverifytheirconformitywiththeapprovedtypedescribedintheEU‐typeexaminationcertificateandwiththeappropriaterequirementsofthisDirective.

Intheabsenceofaharmonisedstandardornormativedocument,thenotifiedbodyconcernedshalldecideontheappropriateteststobecarriedout.

4.2.Thenotifiedbodyshallissueacertificateofconformityinrespectoftheexaminationsandtestscarriedout,andshallaffixitsidentificationnumbertoeachapprovedinstrumentorhaveitaffixedunderitsresponsibility.

The manufacturer shall keep the certificates of conformity available for inspection by thenationalauthoritiesfor10yearsaftertheinstrumenthasbeenplacedonthemarket.

5.Statisticalverificationofconformity

5.1. Themanufacturer shall take allmeasures necessary so that themanufacturingprocessand its monitoring ensure the homogeneity of each lot produced, and shall present hismeasuringinstrumentsforverificationintheformofhomogeneouslots.

5.2.Arandomsampleshallbetakenfromeachlotaccordingtotherequirementsofpoint5.3.Allmeasuring instruments inasampleshallbe individuallyexaminedandappropriatetestsset out in the relevant harmonised standard(s) and/or normative document(s), and/orequivalenttestssetoutinotherrelevanttechnicalspecifications,shallbecarriedoutinordertoverifytheirconformitywiththetypedescribedintheEU‐typeexaminationcertificateandwith the applicable requirements of this Directive, and to determine whether the lot isacceptedorrejected.Intheabsenceofsuchharmonisedstandardornormativedocument,thenotifiedbodyconcernedshalldecideontheappropriateteststobecarriedout.

5.3.Thestatisticalprocedureshallmeetthefollowingrequirements:

Thestatisticalcontrolwillbebasedonattributes.Thesamplingsystemshallensure:

(a) a level of quality corresponding to a probability of acceptance of 95 %, with a non‐conformityoflessthan1%;

(b)alimitqualitycorrespondingtoaprobabilityofacceptanceof5%,withanon‐conformityoflessthan7%.

5.4. If a lot is accepted, allmeasuring instruments of the lot shall be considered approved,exceptforthosemeasuringinstrumentsfromthesamplethathavebeenfoundnottosatisfythetests.

The notified body shall issue a certificate of conformity in respect of the examinations andtestscarriedout,andshallaffixitsidentificationnumbertoeachapprovedinstrumentorhaveitaffixedunderitsresponsibility.

The manufacturer shall keep the certificates of conformity at the disposal of the nationalauthoritiesfor10yearsaftertheinstrumenthasbeenplacedonthemarket.

5.5. If a lot is rejected, the notified body shall take appropriate measures to prevent theplacingonthemarketof that lot. Intheeventof frequentrejectionof lots thenotifiedbodymaysuspendthestatisticalverificationandtakeappropriatemeasures.

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6.ConformitymarkingandEUdeclarationofconformity

6.1.ThemanufacturershallaffixtheCEmarkingandthesupplementarymetrologymarkingsetoutinthisDirective,and,undertheresponsibilityofthenotifiedbodyreferredtoinpoint3,thelatter’s identificationnumbertoeachindividual instrumentthatis inconformitywiththe approved type described in the EU‐type examination certificate and satisfies theapplicablerequirementsofthisDirective.

6.2. The manufacturer shall draw up a written EU declaration of conformity for eachinstrumentmodelandkeepitatthedisposalofthenationalauthoritiesfor10yearsaftertheinstrumenthasbeenplacedonthemarket.TheEUdeclarationofconformityshallidentifytheinstrumentmodelforwhichithasbeendrawnup.

AcopyoftheEUdeclarationofconformityshallbemadeavailabletotherelevantauthoritiesuponrequest.

AcopyoftheEUdeclarationofconformityshallbesuppliedwitheachmeasuringinstrumentthatisplacedonthemarket.However,thisrequirementmaybeinterpretedasapplyingtoabatchorconsignmentratherthanindividualinstrumentsinthosecaseswherealargenumberofinstrumentsisdeliveredtoasingleuser.

If y the notified body referred to in point 3 agrees and under its responsibility, themanufacturer may also affix the notified body’s identification number to the measuringinstruments.

7. If the notified body agrees and under its responsibility, themanufacturer may affix thenotifiedbody’sidentificationnumbertothemeasuringinstrumentsduringthemanufacturingprocess.

8.Authorisedrepresentative

Themanufacturer’sobligationsmaybefulfilledbyhisauthorisedrepresentative,onhisbehalfandunderhisresponsibility,providedthattheyarespecifiedinthemandate.Anauthorisedrepresentativemaynotfulfilthemanufacturer’sobligationssetoutinpoints2and5.1.

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Annex3 NTEP/VCAPrequirementsandprocedures

NationalConferenceonWeightsandMeasures/NationalTypeEvaluationProgram

Publication14Administrativepolicy:SectionS.ConformityAssessment

S.Conformityassessmentprocess(…)

S.1Mainelementsa.Initialverification

(…)

[The tests performed at initial verification] offer an invaluablemeans to check productiondevices and many, but not all, of their features against the current requirements ofNISTHandbook44andtoverifytheinformationprovidedintheNTEPCertificateofConformanceisbothaccurateandcorrect.

NTEPwilluse[feedbackfromtheinitialverification]toassistintheprocessofverifyingthatproductiondevicesremainincomplianceandthattheinformationontheNTEPCertificateofConformanceremainsaccurate.

b.AdministrativereviewofaNTEPCertificateofConformance

The administrative review of all NTEP Certificates of Conformance will be periodicallyconductedbyNTEP.

(…)

c.NTEPVerifiedConformityAssessmentProgramProcedures

Introduction

ManyNTEPcertifieddevicesmustmeetNISTHandbook44requirementsforinfluencefactors.It is not possible to verify these requirements during the initial verification in the field.Therefore, manufacturers of metrological devices (instruments) and/or components(modules)whicharesubjecttoinfluencefactors,asdefinedinNISTHandbook44,musthaveaVerifiedConformityAssessmentProgram(VCAP) inplace toensure that thesemetrologicaldevices and/or components are produced to perform at a level consistentwith that of thedeviceand/orcomponentpreviouslycertified.

TheVerifiedConformityAssessmentProgramauditwillbeatoneormoresitesasrequiredtoverifycompliance.

Forweighingdevicesthataresubjecttoinfluencefactors,NTEPwillrequireaninitialon‐siteaudit of themanufacturer’s quality system and on‐site random testing and/or review of aproductiondevice(s)(instrument(s))bytheRegistrartoverifythatallitemslistedbelowarecurrently implemented and functioning to verify compliance to the appropriate sections ofNISTHandbook44.

Devicesthatmustmeetthisrequirementarelimitedtothelistbelow:

(…)

Requirements:

1. TheNTEPCCHolder’scontrolfacilityresponsibilities

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1.1. AdocumentedQualityManagementSystemgoverningthedesignandmanufacturerofthedevice.(…)

1.2. Appropriate statistical methods are implemented to ensure that the process is incontrolasdefinedbytheNTEPCCholder’squalitymanagementsystem.

1.3. Anappropriatesamplingplan,andacceptancecriteriaisinplaceandoperating.(…)

1.4. Required operator’s manuals and calibration procedures or other controlleddocumentationforallappropriatedevicesandcomponents(eithermanufactureredorpurchased).

1.5. Anon‐conformingmaterialsystemtocontrolnon‐conforming/noncompliantdevicesandcomponents(eithermanufacturedorpurchased).(…)

1.6. Adequate control over subcontractors and sub‐tier suppliers shall bedefined in theNTEPCCholder’squalitymanagementsystem.(…)

1.7. Appropriate corrective action system to deal with non‐conforming/non‐compliantdevices.(…)

1.8. An engineering change system to control engineering/design changes affecting anyMSCs.(…)

1.9. A document and data control (including software and firmware) system to controlchangesaffectinganyMSCsorcomponentsoftheVCAPprogram.(…)

1.10. AproductioncontrolsystemtocontrolchangesaffectinganyMSCs.(…)

1.11. An identification and traceability system (including serialization and lot/batchcontrolasapplicable)applied,asaminimum,toMSCs.

1.12. Documentationthatpersonnelhavebeenproperlytrained.

1.13. If the NTEP CC holder contracts with an outside testing facility to conduct theinfluencefactortesting,thatfacilitywillbesubjecttoallpertinentVCAPrequirements.

1.14. The NTEP CC holder shall plan and implement a program of internal self‐assessment.(…)

1.15. Subsequent audits will be held on‐site to verify conformance to these standards.Subsequent audits will be conducted every three years until objective evidence isobtainedtomovetoamaximumofeveryfiveyears.(…)

2. CertificationBody’sresponsibilities:

2.1. TheselectedcertificationbodyistobeaccreditedbyANSI‐ASQNationalAccreditationBoard (ANAB). TheANSI‐ASQNationalAccreditationBoard is theU.S. accreditationbodyformanagementsystems.ANABaccreditscertificationbodies(CBs)forISO9001quality management systems (QMS) and ISO 14001 environmental managementsystems(EMS),aswellasanumberofindustry‐specificrequirements,orequivalent.

2.2. With accreditation to Standard Industry Classification (SIC) codes (3596/3821) orequivalent.(…)

2.3. Theselectedcertificationbodyshallhaveinternationalauditorsavailable.

2.4. The certification body is required to notifyNCWMwhen amajorbreakdownof theNTEPCCholder’sVCAPprogramisfound.

2.5. Thecertificationbodyshallsubmitacompleted“SystemsAuditChecklist”toNCWM.SubmitteddocumentsmustcontainaclearstatementofcomplianceasaresultoftheVCAPaudit.

3. NCWMResponsibilities

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3.1. Fornewcertificateholders,ensurethatVCAPcertificationhasbeencompleted,withinaoneyearcycleofthefirstmaintenancefee,butnottoexceed18months(example:ifNTEPcertifiedinJuly2011,VCAPcertificationwouldberequiredbyNovember2012).

3.2. Aspartofannualmaintenance,NCWMshallensurethatVCAPauditreportsareonfile,current,andthatallnon‐conformanceshavebeenaddressed.

3.3. Ensurethatanappealsprocessisinplaceandmadeavailabletocertificateholders.

4. Samplesizes

4.1. Thefollowingsamplesizesaretobeusedbasedonannualproduction.(…)

S.2. ConsequencesIf a certificate holder fails to submit an application for the administrative review, whenrequested,bythereviewdatespecified,theNTEPCertificateofConformancewillbeinactive.

Ifacertificateholderofadevicesubjecttoinfluencefactorsfailstosubmitdocumentation,bythe required date, indicating that it has and continues to maintain a VCAP for influencefactors,theNTEPCertificateofConformancewillbeinactive.

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Annex4 MIDconformityassessmentmoduleH1

ModuleH1: Conformitybasedonfullqualityassuranceplusdesignexamination

1. Conformity based on full quality assurance plus design examination is the conformityassessmentprocedurewherebythemanufacturerfulfilstheobligationslaiddowninpoints2and 6, and ensures and declares on his sole responsibility that themeasuring instrumentsconcernedsatisfytherequirementsofthisDirectivethatapplytothem.

2.Manufacturing

Themanufacturershalloperateanapprovedqualitysystemfordesign,manufactureandfinalproductinspectionandtestingofthemeasuringinstrumentsconcernedasspecifiedinpoint3,andshallbesubjecttosurveillanceasspecifiedinpoint5.

Theadequacyofthetechnicaldesignofthemeasuringinstrumentsshallhavebeenexaminedinaccordancewithpoint4.

3.Qualitysystem

3.1.Themanufacturershalllodgeanapplicationforassessmentofthequalitysystemwiththenotifiedbodyofhischoiceforthemeasuringinstrumentsconcerned.

Theapplicationshallinclude:

(a) the name and address of the manufacturer and, if the application is lodged by theauthorisedrepresentative,hisnameandaddressaswell;

(b)allrelevantinformationfortheinstrumentcategoryenvisaged;

(c)thedocumentationconcerningthequalitysystem;

(d) a written declaration that the same application has not been lodged with any othernotifiedbody.

3.2. The quality system shall ensure compliance of the measuring instruments with therequirementsofthisDirectivethatapplytothem.

All the elements, requirements and provisions adopted by the manufacturer shall bedocumented inasystematicandorderlymanner inthe formofwrittenpolicies,proceduresandinstructions.Thisqualitysystemdocumentationshallpermitaconsistentinterpretationofthequalityprogrammes,plans,manualsandrecords.

Itshall,inparticular,containanadequatedescriptionof:

(a)thequalityobjectivesandtheorganisationalstructure,responsibilitiesandpowersofthemanagementwithregardtodesignandproductquality;

(b)thetechnicaldesignspecifications,includingstandards,thatwillbeappliedand,wheretherelevantharmonisedstandardsand/ornormativedocumentswillnotbeapplied in full, themeansthatwillbeusedtoensurethattheessentialrequirementsofthisDirectivethatapplytothemeasuringinstrumentswillbemet,applyingotherrelevanttechnicalspecifications;

(c) the design control and design verification techniques, processes and systematic actionsthat will be used when designing themeasuring instruments pertaining to the instrumentcategorycovered;

(d) the corresponding manufacturing, quality control and quality assurance techniques,processesandsystematicactionsthatwillbeused;

(e)theexaminationsandteststhatwillbecarriedoutbefore,duringandaftermanufacture,andthefrequencywithwhichtheywillbecarriedout;

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(f)thequalityrecords,suchasinspectionreportsandtestdata,calibrationdata,qualificationreportsonthepersonnelconcerned;

(g)themeansofmonitoringtheachievementoftherequireddesignandproductqualityandtheeffectiveoperationofthequalitysystem.

3.3. The notified body shall assess the quality system to determinewhether it satisfies therequirementsreferredtoinpoint3.2.Itshallpresumeconformitywiththoserequirementsinrespect of the elements of the quality system that comply with the correspondingspecificationsoftherelevantharmonisedstandard.

Inadditiontoexperienceinqualitymanagementsystems,theauditingteamshallhaveatleastone member experienced as an assessor in the relevant instrument field and instrumenttechnology concerned, andknowledge of the applicable requirements of thisDirective.Theauditshallincludeanassessmentvisittothemanufacturer’spremises.

The manufacturer or his authorised representative shall be notified of the decision. Thenotificationshallcontaintheconclusionsoftheauditandthereasonedassessmentdecision.

3.4.Themanufacturershallundertaketofulfiltheobligationsarisingoutofthequalitysystemasapprovedandtomaintainitsothatitremainsadequateandefficient.

3.5. The manufacturer shall keep the notified body that has approved the quality systeminformedofanyintendedchangetothequalitysystem.

The notified body shall evaluate any proposed changes and decide whether the modifiedqualitysystemwillcontinuetosatisfytherequirementsreferredtoinpoint3.2orwhetherare‐assessmentisnecessary.

It shall notify the manufacturer or his authorised representative of its decision. Thenotification shall contain the conclusions of the examination and the reasoned assessmentdecision.

3.6.Eachnotifiedbodyshallinformitsnotifyingauthorityofqualitysystemapprovalsissuedorwithdrawn,andshallperiodicallyoruponrequest,makeavailabletoitsnotifyingauthoritythelistofqualitysystemapprovalsrefused,suspendedorotherwiserestricted.

4.Designexamination

4.1. The manufacturer shall lodge an application for examination of the design with thenotifiedbodyreferredtoinpoint3.1.

4.2. The application shall make it possible to understand the design, manufacture andoperation of the instrument, and to assess the conformity with the requirements of thisDirectivethatapplytoit.

Itshallinclude:

(a)thenameandaddressofthemanufacturer;

(b) a written declaration that the same application has not been lodged with any othernotifiedbody;

(c)thetechnicaldocumentationasdescribedinArticle18.Thedocumentationshallmakeitpossible to assess the instrument’s conformity with the relevant requirements, and shallincludeanadequateanalysisandassessmentoftherisk(s).Itshall,asfarasrelevantforsuchassessment,coverthedesignandoperationoftheinstrument;

(d) the supporting evidence for the adequacy of the technical design. This supportingevidenceshallmentionanydocumentsthathavebeenused,inparticularwheretherelevantharmonisedstandardsand/ornormativedocumentshavenotbeenapplied in full,andshallinclude,wherenecessary, the resultsof tests carriedout in accordancewithother relevant

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technical specifications, by the appropriate laboratory of the manufacturer, or by anothertestinglaboratoryonhisbehalfandunderhisresponsibility.

4.3. The notified body shall examine the application, and where the design meets therequirements of this Directive that apply to the instrument it shall issue an EU designexaminationcertificatetothemanufacturer.Thatcertificateshallgivethenameandaddressofthemanufacturer,theconclusionsoftheexamination,theconditions(ifany)foritsvalidityandthedatanecessaryforidentificationoftheapproveddesign.Thatcertificatemayhaveoneormoreannexesattached.

Thatcertificateanditsannexesshallcontainallrelevantinformationtoallowtheconformityofmanufacturedmeasuring instruments with the examined design to be evaluated and toallow for in‐service control. It shall allow theevaluationof conformityof themanufacturedinstruments with the examined design regarding the reproducibility of their metrologicalperformances,whentheyareproperlyadjustedusingappropriatemeans,including:

(a)themetrologicalcharacteristicsofthedesignoftheinstrument;

(b)measuresrequiredforensuringtheintegrityoftheinstruments(sealing,identificationofsoftware,etc.);

(c) informationonother elementsnecessary for the identificationof the instrument and tocheckitsvisualexternalconformitytothedesign;

(d) if appropriate, any specific information necessary to verify the characteristics ofmanufacturedinstruments;

(e) inthecaseofasub‐assembly,allnecessaryinformationtoensurethecompatibilitywithothersub‐assembliesormeasuringinstruments.

ThenotifiedbodyshallestablishanevaluationreportinthisregardandkeepitatthedisposaloftheMemberStatethatdesignatedit.WithoutprejudicetoArticle27(10),thenotifiedbodyshall release the content of this report, in full or in part, only with the agreement of themanufacturer.

Thecertificateshallhaveavalidityof10yearsfromthedateofitsissue,andmayberenewedforsubsequentperiodsof10yearseach.

Where thedesigndoesnotsatisfytheapplicablerequirementsof thisDirective, thenotifiedbodyshallrefusetoissueanEUdesignexaminationcertificateandshallinformtheapplicantaccordingly,givingdetailedreasonsforitsrefusal.

4.4.Thenotifiedbodyshallkeepitselfapprisedofanychangesinthegenerallyacknowledgedstate of the art which indicate that the approved design may no longer comply with theapplicablerequirementsofthisDirective,andshalldeterminewhethersuchchangesrequirefurtherinvestigation.Ifso,thenotifiedbodyshallinformthemanufactureraccordingly.

Themanufacturer shall keep the notified body that has issued the EU design examinationcertificateinformedofanymodificationtotheapproveddesignthatmayaffecttheconformitywith the essential requirements of this Directive or the conditions for validity of thecertificate.Suchmodificationsshallrequireadditionalapproval–fromthenotifiedbodythatissued theEUdesignexamination certificate– in the formof anaddition to theoriginalEUdesignexaminationcertificate.

4.5. Each notified body shall inform its notifying authority of the EU design examinationcertificates and/or any additions thereto which it has issued or withdrawn, and shall,periodicallyorupon request,makeavailable to itsnotifyingauthority the listof certificatesand/oranyadditionstheretorefused,suspendedorotherwiserestricted.

TheCommission,theMemberStatesandtheothernotifiedbodiesmay,onrequest,obtainacopy of the EU design examination certificates and/or additions thereto. On request, the

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CommissionandtheMemberStatesmayobtainacopyofthetechnicaldocumentationandoftheresultsoftheexaminationscarriedoutbythenotifiedbody.

ThenotifiedbodyshallkeepacopyoftheEUdesignexaminationcertificate,itsannexesandadditions, as well as the technical file including the documentation submitted by themanufactureruntiltheexpiryofthevalidityofthecertificate.

4.6.ThemanufacturershallkeepacopyoftheEUdesignexaminationcertificate,itsannexesandadditionswiththetechnicaldocumentationatthedisposalofthenationalauthoritiesfor10yearsaftertheinstrumenthasbeenplacedonthemarket.

5.Surveillanceundertheresponsibilityofthenotifiedbody

5.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils theobligationsarisingoutoftheapprovedqualitysystem.

5.2.Themanufacturer shall, forassessmentpurposes, allow thenotifiedbodyaccess to thedesign, manufacture, inspection, testing and storage sites, and shall provide it with allnecessaryinformation,inparticular:

(a)thequalitysystemdocumentation;

(b)thequalityrecordsasprovidedforbythedesignpartofthequalitysystem,suchasresultsofanalyses,calculations,tests,etc.;

(c)thequalityrecordsasprovidedforbythemanufacturingpartofthequalitysystem,suchas inspection reports and test data, calibration data, qualification reports on thepersonnelconcerned,etc.

5.3. The notified body shall carry out periodic audits to make sure that the manufacturermaintainsandapplies thequality systemandshallprovide themanufacturerwithanauditreport.

5.4.Inaddition,thenotifiedbodymaypayunexpectedvisitstothemanufacturer.Duringsuchvisitsthenotifiedbodymay,ifnecessary,carryoutinstrumenttests,orhavethemcarriedout,in order to check the proper functioning of the quality system. It shall provide themanufacturerwithavisitreportand,iftestshavebeencarriedout,withatestreport.

6.ConformitymarkingandEUdeclarationofconformity

6.1.ThemanufacturershallaffixtheCEmarkingandthesupplementarymetrologymarkingsetoutinthisDirective,and,undertheresponsibilityofthenotifiedbodyreferredtoinpoint3.1, the latter’s identification number to each individual instrument that satisfies theapplicablerequirementsofthisDirective.

6.2. The manufacturer shall draw up a written EU declaration of conformity for eachinstrumentmodelandkeepitatthedisposalofthenationalauthoritiesfor10yearsaftertheinstrumenthasbeenplacedonthemarket.TheEUdeclarationofconformityshallidentifytheinstrumentmodelforwhichithasbeendrawnupandshallmentionthenumberofthedesignexaminationcertificate.

AcopyoftheEUdeclarationofconformityshallbemadeavailabletotherelevantauthoritiesuponrequest.

AcopyoftheEUdeclarationofconformityshallbesuppliedwitheachmeasuringinstrumentthatisplacedonthemarket.However,thisrequirementmaybeinterpretedasapplyingtoabatchorconsignmentratherthanindividualinstrumentsinthosecaseswherealargenumberofinstrumentsisdeliveredtoasingleuser.

7.Themanufacturershall,foraperiodending10yearsaftertheinstrumenthasbeenplacedonthemarket,keepatthedisposalofthenationalauthorities:

(a)thedocumentationconcerningthequalitysystemreferredtoinpoint3.1,

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(b)theinformationrelatingtothechangereferredtoinpoint3.5,asapproved;

(c)thedecisionsandreportsofthenotifiedbodyreferredtoinpoints3.5,5.3and5.4.

8.Authorisedrepresentative

Themanufacturer’sauthorisedrepresentativemaylodgetheapplicationreferredtoinpoints4.1and4.2andfulfiltheobligationssetoutinpoints3.1,3.5,4.4,4.6,6and7,onhisbehalfandunderhisresponsibility,providedthattheyarespecifiedinthemandate.

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Annex5 Technicaldocumentation

Asanexampleof therequirements for technicaldocumentationofameasuring instrument,refer to the European MID (Measuring instruments directive), Annex B (EU‐typeexamination).

Whenapplyingfortype(ordesign)examination,themanufacturerhastosubmitthetechnicaldocumentation as described in article 18 of theMID (see below). The documentation shallenableassessmentof theconformityof the instrumentandshall,as farasrelevant forsuchassessment,coverthedesign,manufactureandoperationoftheinstrument.

“Article18

TechnicalDocumentation

1. The technical documentation shall render the design, manufacture and operation of themeasuring instrument intelligibleandshallpermitanassessmentof itsconformitywiththeapplicablerequirementsofthisDirective.

2.Thetechnicaldocumentationshallbesufficientlydetailedtoensurecompliancewiththefollowingrequirements:

(a)thedefinitionofthemetrologicalcharacteristics;

(b)thereproducibilityofthemetrologicalperformancesofproducedmeasuringinstrumentswhenproperlyadjustedusingappropriateintendedmeans;

(c)theintegrityofthemeasuringinstrument.

3.Thetechnicaldocumentationshallinsofarasrelevantforassessmentandidentificationofthetypeand/orthemeasuringinstrumentincludethefollowinginformation:

(a)ageneraldescriptionofthemeasuringinstrument;

(b)conceptualdesignandmanufacturingdrawingsandplansofcomponents,sub‐assemblies,circuits,etc.;

(c)manufacturingprocedurestoensureconsistentproduction;

(d)ifapplicable,adescriptionoftheelectronicdeviceswithdrawings,diagrams,flowdiagramsofthelogicandgeneralsoftwareinformationexplainingtheircharacteristicsandoperation;

(e)descriptionsandexplanationsnecessaryfortheunderstandingoftheinformationreferredtoinpoints(b),(c)and(d),includingtheoperationofthemeasuringinstrument;

(f)alistoftheharmonisedstandardsand/ornormativedocuments10referredtoinArticle14,appliedinfullorinpart,thereferencesofwhichhavebeenpublishedintheOfficialJournaloftheEuropeanUnion;

(g)descriptionsofthesolutionsadoptedtomeettheessentialrequirementswheretheharmonisedstandardsand/ornormativedocumentsreferredtoinArticle14havenotbeenapplied,includingalistofotherrelevanttechnicalspecificationsapplied;

(h)resultsofdesigncalculations,examinations,etc.;

10TheMID(nottheNAWIDirective)recognizes‘normativedocuments’asequivalenttoharmonized(European)standards providing presumption of conformity to the relevant essential requirements of the directive. AnumberofOIMLRecommendationsserveasnormativedocumentsundertheMID.

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(i)theappropriatetestresults,wherenecessary,todemonstratethatthetypeand/orthemeasuringinstrumentscomplywiththefollowing:

—therequirementsofthisDirectiveunderdeclaredratedoperatingconditionsandunderspecifiedenvironmentaldisturbances,

—thedurabilityspecificationsforgas‐,water‐,thermalenergy‐metersaswellasforliquidsotherthanwater;

(j)theEU‐typeexaminationcertificatesorEUdesignexaminationcertificatesinrespectofmeasuringinstrumentscontainingpartsidenticaltothoseinthedesign.

4.Themanufacturershallspecifywheresealsandmarkingshavebeenapplied.

5.Themanufacturershallindicatetheconditionsforcompatibilitywithinterfacesandsub‐assemblies,whererelevant.”