QS Assessment Checklist - PED

DNV-GL EU DIRECTIVE 2014/68/EU ON PRESSURE EQUIPMENT QS ASSESSMENT CHECKLIST - PED AUDIT ~ MODULE D/D1/E/E1/H/H1 - PART 2 (Manufacturers keeping a valid ISO 9001 QS) ‘Guestion Yes | No | Cominents > 7 DOCUMENTATION REQUIREMENTS, ‘Does the Wanufacturer nave an 'SO qually eysem carTed bby DNVGL, or by another accreted ceritetion body win EEA? FEZ] Does the manatecurerVave a Guay sytem Tr welding accarding to [SO 26947 no FB CCG SATE HH mOR— A — watt hlifestg | 42S | Are checktsts for Essonlal Satay Requrements ‘stabished fr fabrication, nal inspecton and marking of the eauipment?_ 2A | Ooes the quality sysiem include Fstucons wo Warm the Notifed Body about statue and prograss inthe production echedule? ee o 0 a FES] ts rove a qually mancaVhandbook ndualng oF wih oO — oO oO fclroneas to rotos coveing 204SBE0? TE5 [Wee esse att requrersnts aor amOXT ZoVasaiU afiresad fa svelue wa TET—_[ethar estar forza aaa? 428] Does he marecurer ide andar feaiical Spelcatons ee: ogutos for be mutase ana teste ate prosuc 423 | Control of documents SZI1_| ee are process to one Dat a NOW BSH formed soos changas tothe approved sly stom an that hese changes ate not empiri ete Nalitee Sosy has velo er TEIT| Dovs the company have a syst Gr Savoa fosments supped by he cintome eltng tthe prods being supled Serurents generated er supply oe customer wth the product SH docements tat consis te Techical osimenatenrequted by snexs athe veapocive modes? ai EIT] Dose te company abla sak cantata Rarmoneed | CT Slaatés anda conta coy of 2014687EU? A2Sa_| Have expen coctmorts ord manuocure'sdooamaris | C] been conveeg? ESE | bo tho docimented poSeTaeE sss Tt orate —} ET] confines wan manvscrer'sSocomors fe compatble Srinenpment documents. Th monvctzer sat eat ‘aly approve or subsequoty amend rated davis ‘nies thay aren compares wih ie chetue dwg 236] The aia sytem shal ene atm elo (996 a harastersie postion ee) eating wine ec! Speurmenatonemosiee without approval off ent Sots Bs La EST] What ns 8 COM Soheoue Tangs aeeoaeg —| TT] Uinmre nanore EC sianinaton contest we ere & ocumeried syste to ensure simteneousy econ he vent of pn smendmania such Savings [ii | Control of records moddd a ddd qg Dale 2016-02-12 ‘Doce Revsion 7 OP 46911-2662 ‘Appiaved by Giovanni Cortes Page 1 ofa 4244 Te i owing asde To a aly reais Records of design eviews? Verifeation of design? Recorss of suppers? *Assesement of suppliers? (Documents contming traceabity? [Doeuments contiming qualification of processes, equipment and personne’? Dedataton of conformity? Hazard anaiysis? ‘Type examination cortiatee? Design review cericates? Bravings? ‘Technical documentstion and type examination {he type of equipment described inthe tecnical documentation ara io Drectve 2014/68EU? eazs ‘re all the elements, requirements and provisions sdopled by te manufacturer cocumented in a systematic and afderty manner ne form of will poles, procedures and instructions? Does the qully system documentation Berita consent interpretation of qualy programmes, Bens, manvals and records? 99999 dd djfda Baza Has the manufacturer lecitated an arangemiont whereby the NB may sue aspects of the supplare operations that effoct the type of equipment? (The Ne rosaries te right fo aut 8 manufectrer's Supplier evaluations which may involve assessment tthe ‘supplier’ premises, ifthe NB considers 1 be necessary The manulaturer shal demonstrate tnat thas been Sstabaned an agreament ih fs suppers thatthe NB may ‘aut aspects ofthe supalio’s operations that effect the ype ‘ot protection) 4 a SoA Responsibility and authority EAE functone? + Responsibie NB contact Metoil handling and raceabity ‘Qualiteation of personne! ‘Quaieation and testing of products ‘Qualitcation of production processes talycontrot Final inspection and marking Manufacturer's declaration TIS ey personel appt 0 cavers TRG o Saiz ‘cortact wih tho estabished reprosertatve wihin EU? The merulocurer snot estabarad win EES, hee | CT] CT ‘Author Toneny SecensrEoT Dae Reviewed by Ping Coo Revision ‘Approved by Giovanni Cortest 2oT6-022 ‘Docie top 46311-2608 2 Page 2078180, 2000) 9001: Question e513 Te Rsotbadin ie dosenaon the need foliage wth the NB responsibe for the isue of EC-examinalion certicate wih respect to any proposal ‘change fo the dosign andlor the tecrical ‘Socumentation? ~ the need to ise with the NB responce for the ) assossment ofthe qual system wit rspectio proposed changes to tne quelty systort? = Dre need of iorning its customers of any appicable special condone for sala use and any schedule of limitations? 56a Gonoral S81 ‘Does the agenda fore management review eompice _—) [J fexamining the continuing sulabilly and efeciveness of the qualtysyetom? + eneuring thatthe quay system satisfies the supplor’s ‘Staleg qualty pay and ebjectvas and requemenis of BIcUsIDREC? BeAr ‘Te maximum itervals BaqWean rovGws SHOUT normaly BE 2 moni. Bars ‘Does the top management chal The review? 6.2.2 ‘Competence, awareness and training Ba2F pressure equipment had appcoprae airing as regards ZOVA/BS/EU and necessary qualicatons? Saaz ‘re approptale recor of aning maintained TO years aist the latest pressure equioment vas produced” PLANNING OF PRODUCT REALIZATION Tg tere a convol pan for each new type of pressure ‘equipment tc show how al the essential safely requrements | sre sts? For one-of vessels and equipment in eslagory Il (acto edlon 12 under the module H procedure) coos the quay plan denity thet nal essossman for each unt to be Exriod oul bythe Notified Body? To tis end does the ‘manfecurerssue 9 contoied copy ofthe proposed production seheduls? a a Have atthe personnel drecly avowed in procucion of | CT] ia) oq 0 TEA Determination of requirements related to the product TEA is thre a system for obtainng “Paricular Matoral U Aporelest when required? ia Ts tre manufacturer aware of he reguvement forthe EC- | TJ] ‘approved products in Module 8 or Bt with respect tothe items below (for Module D1 and &t Ine requvements apply forthe prepered technical fey Gade of materials approved for the design. Extent ane type of testing required for he approved cetign. = fry heal vestment of the prosuet during he fabrcation process. ‘tional markingivarrings required forthe approved ‘esi. ‘Any nsalaton and operating marual needed forthe protuct. Tas a contrac reviews include Gocsions whether 20TaReTEU_| CJ] sill be applied or nol, which module to be applied? 722 Review of requirements related to the product 1228 ‘Does tho review eneuro that any taled customer requirements compat wih te EC-pxarination tetifeate andor teenieal Socomentation? Q 7.3 DESIGN AND DEVELOPMENT Tai Ts Ihe res of th contract review taken io conelderaton when imposing he design input requirements? Taz Ts the design ouput documented? 733 Ty Teit-varied thatthe design output heels he devigninpat’ | L} ‘equements and #30 are records maintained rae Hat the euplerdained whats buendod by ochoea!——| T] acamentaon ty secorsance wt the vant Nes? Gon ‘Author TORGNY SEGERSTEOT Dale Reviewed by Ping Cao Revision ‘Approves by Gloverni Cortesi 2ote-02-12 DOG" lop 463112602 Page 30f8

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