GUIDE NAWI - Cyprus Organization for the Promotion of Quality

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Guide on NAWI DirectiveEuropeAid /114385/D/SV/CYCOMMON PROVISIONS AND CONFORMITY DOCUMENTATIONCOMMON PROVISIONSThe documents and correspondence relating to any of the procedures are to be drafted in an officiallanguage of the Member State where the procedure is to be carried out, or in a language accepted by thenotified body.The EC declaration of type conformity, the EC verification and the EC unit verification procedures may becarried out at the manufacturer’s works or at any other location: if transport to the place of use does notrequire dismantling of the instrument; if the taking into service at the place of use does not requireassembly of the instrument or other technical installation work likely to affect the instrument’sperformance; and if the gravity value at the place of putting into service is taken into consideration or if theinstrument’s performance is insensitive to gravity variations. In all other cases, they shall be carried out atthe place of use of the instrument.If the instrument’s performance is sensitive to gravity variations, those procedures may be carried out intwo stages. The second stage is to comprise all examinations and tests the outcome of which is gravitydependent;and the first stage is to comprise all other examinations and tests. The second stage is to becarried out at the place of use of the instrument. If a Member State has established gravity zones on itsterritory, the expression ‘at the place of use of the instrument’ may be read as ‘in the gravity zone of use ofthe instrument’.If a manufacturer has opted to have a procedure carried out in two stages, and if those two stages are tobe carried out by different parties, an instrument which has undergone the first stage of the procedureconcerned is to carry the identification symbol of the notified body involved in that stage. The party whichhas carried out the first stage of the procedure is to issue for each of the instruments a certificate (seespecimen C and D) containing the necessary data for identification of the instrument and specifying theexaminations and tests that have been carried out. The party which carries out stage two of the procedureis to carry out those examinations and tests that have not yet been carried out.The manufacturer who has opted for the EC declaration of type conformity in stage one may either usethis same procedure in stage two or decide to continue in stage two with EC verification.CONFORMITY DOCUMENTATIONThis section sets out examples of conformity documents required to be presented with an instrument atvarious stages in the verification procedure.ADECLARATION OF CONFORMITYFor completion by the manufacturer or his authorised representative prior to verification.The form which may be included in the operator’s manual of the instrument is required to beavailable at the site of installation.This declaration should include a statement that it is only valid with a certificate of conformityissued by a notified body. The statement does not appear if the manufacturer operates a qualitysystem and declares conformity in accordance with Annex II.2 of the Directive.In case of verification in two stages the validity of the declaration of conformity may depend onevidence (or proof) of the carrying out of the second stage of verification.
Guide on NAWI DirectiveEuropeAid /114385/D/SV/CYBCERTIFICATE OF CONFORMITYFor completion by the notified body at the time of verification (EC unit verification and ECverification) and presented to the manufacturer or his authorised representative.One certificate of conformity may be used for many instruments of the same type by including allserial numbers. The certificate of conformity is to be made available by the manufacturer or hisauthorised representative.CCERTIFICATE ON TESTS OF THE 1ST STAGEFor completion by the notified body at the time of 1st stage verification (EC unit verification andEC verification) and presented to the manufacturer or his authorised representative. Thiscertificate must be presented with the instrument at the time of 2nd stage verification.DCERTIFICATE ON TESTS OF THE 1ST STAGEFor completion by the manufacturer or his authorised representative at the time of 1st stageverification (EC declaration of type conformity). This certificate must be presented with theinstrument at the time of 2nd stage verification.Certificates of Conformity and Declarations of Conformity and Certificates of Tests of 1st stage verificationmay be combined on one document.
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GUIDE NAWI - Cyprus Organization for the Promotion of Quality

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