Unombuzo? Sinike umnxeba: + 86-13916119950

Ngathi

IShanghai VEN Pharmatech Engineering Co., Ltd.

I-VEN Pharmatech Engineering yinkampani yobunjineli yamazwe ngamazwe ebonelela ngezisombululo zoshishino lwezempilo. Sinikezela ngesisombululo sobunjineli esihlanganisiweyo kwifektri yamayeza kunye nefektri yezonyango ngokuthobela i-EU GMP / US FDA cGMP, WHO GMP, PIC/S GMP umgaqo njl.njl -Izisombululo ezenziwe kubathengi bethu behlabathi lonke, ezibandakanya uyilo lweprojekthi ephucukileyo, izixhobo ezikumgangatho ophezulu, ulawulo lwenkqubo olusebenzayo, kunye nenkonzo epheleleyo yobomi bonke.

Singobani?

I-IVEN yasekwa ngo-2005 kwaye ilinywe ngokunzulu kwishishini leyeza kunye nezonyango, saseka izityalo ezine ezenza umatshini wokuzalisa amayeza kunye nokupakisha, inkqubo yonyango lwamanzi amayeza, ukuhambisa ngobukrelekrele kunye nenkqubo yokulungiselela. sibonelele ngamawaka izixhobo zokuvelisa amayeza kunye nezonyango kunye neeprojekthi ze-turnkey, sakhonza amakhulu abathengi abavela kumazwe angaphezu kwama-50, sincede abathengi bethu baphucule amandla abo okuvelisa amayeza kunye nezonyango, baphumelele isabelo semarike kunye negama elihle kwimarike yabo.

Oko sikwenzayo?

Ngokusekwe kwiimfuno zabathengi abavela kumazwe ahlukeneyo, senza ngokwezifiso isisombululo sobunjineli esihlanganisiweyo sekhemikhali etofwayo kwikhemikhali, ikhemikhali yeziyobisi eyomeleleyo, ikherma yebhayoloji, umzi-mveliso osetyenziswa kunyango, kunye nesityalo esibanzi. Isisombululo sethu sobunjineli esihlanganisiweyo sigubungela igumbi elicocekileyo, izixhobo ezicocekileyo, inkqubo yonyango lwamanzi amayeza, inkqubo yenkqubo yokuvelisa, i-automation yamayeza, inkqubo yokupakisha, inkqubo yezothutho ezikrelekrele, inkqubo yokulawula umgangatho, i-laboratory ephakathi njalo njalo. Ngokwemfuno yabathengi, iVEN inokubonelela ngenkonzo yobuchwephesha ngolu hlobo lungezantsi:

*Ukubonisana ngeprojekthi nokwenzeka
* Uyilo lobunjineli beprojekthi
* Ukukhetha imodeli yezixhobo kunye nokwenza ngokwezifiso
*Ufakelo kunye nogunyaziso
*Ukuqinisekiswa kwesixhobo kunye nenkqubo
*Ukubonisana noLawulo loMgangatho

*Ugqithiso lweteknoloji yemveliso
*Amaxwebhu anzima kwaye athambileyo
*Uqeqesho lwabasebenzi
*Inkonzo emva kokuthengisa ubomi bonke
*Uveliso lwetrasti
*Ukuphuculwa kwenkonzo njalo njalo.

Kutheni Sinje?

Yenza ixabiso kubathengibukubaluleka kobukho buka-Iven, ikwasisikhokelo senzo sawo onke amalungu ethu e-Iven. Inkampani yethu isebenzele abathengi bamazwe aphesheya ngaphezulu kweminyaka eli-16, sinokuyiqonda kakuhle imfuno yabathengi bethu bamazwe aphesheya, kwaye sisoloko sibonelela ngezixhobo ezikumgangatho ophezulu kunye neprojekthi kubathengi ngexabiso elifanelekileyo.

Iingcali zethu zobuchwephesha zineminyaka engamashumi eminyaka yamava kushishino lwamayeza kunye nezonyango, ziqhelene noninzi lweemfuno ze-GMP zamazwe ngamazwe, njenge-EU GMP/US FDA cGMP, WHO GMP, PIC/S GMP umgaqo njl.

Iqela lethu lobunjineli lisebenza nzima kwaye lisebenza kakuhle kakhulu, linamava atyebileyo ohlobo olwahlukileyo lweprojekthi yoxubo mayeza, sakha iprojekthi ekumgangatho ophezulu hayi kuphela ngokuqwalasela iimfuno zangoku zomthengi, kodwa sikwathathela ingqalelo ikamva lomthengi wokonga iindleko zemihla ngemihla kunye nokugcinwa lula, nokuba Ukwandiswa kwexesha elizayo.

Iqela lethu lokuthengisa lifundiswe kakuhle abanombono wamazwe ngamazwe kunye nolwazi oluhambelanayo lwezoxubo lwamayeza, libonelela abathengi ngenkonzo enobubele kunye nesebenzayo ukusuka kwinqanaba lokuthengisa kwangaphambili ukuya kwinqanaba lokuthengisa emva kokuthengisa ngengqiqo enamandla yoxanduva kunye nomsebenzi.

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Ityala lobuNjineli

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包装间Igumbi lokupakisha
厂房外景 Umphandle wefektri
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Ingaba unazo ezi ngxaki zilandelayo?
• Iimbalasane zesindululo soyilo azigqamanga, uyilo aluqiqi.
• Uyilo olunzulu alufani, ukuphunyezwa kunzima.
• Inkqubela phambili yenkqubo yoyilo ayilawuleki, ishedyuli yokwakha ayinasiphelo.
• Umgangatho wesixhobo awunakwaziwa de kusilele ukusebenza.
• Kunzima ukuqikelela iindleko de ulahlekelwe yimali.
• Sichithwe ixesha elininzi ngokundwendwela ababoneleli-nkonzo, sinxibelelana nesiphakamiso soyilo kunye nolawulo lolwakhiwo, thelekisa enye emva kwenye kwaye kwakhona.

I-Iven ibonelela ngesisombululo sobunjineli esihlanganisiweyo semveliso yamayeza kunye neyezonyango kwihlabathi liphela kubandakanya igumbi elicocekileyo, inkqubo yokulawula ngokuzenzekelayo kunye nenkqubo yokubeka iliso, inkqubo yonyango lwamanzi amayeza, ukulungiswa kwesisombululo kunye nenkqubo yokuhambisa, inkqubo yokuzalisa kunye nokupakisha, inkqubo yolungiselelo oluzenzekelayo, inkqubo yokulawula umgangatho kunye nelebhu ephakathi kunye. njl Ngokweemfuno zolawulo loshishino lwamayeza kumazwe ahlukeneyo kunye nemfuno yomthengi ngamnye, i-VEN ilungisa ngononophelo izisombululo zobunjineli beprojekthi ye-turnkey kwaye incede abathengi bethu baphumelele igama eliphezulu kunye newonga kwifayile yoshishino lwamayeza ekhaya.

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Umzi-mveliso wethu

Oomatshini boXhobo bamayeza:

Isakhono sethu se-R&D soomatshini boShishino kwiimveliso zothotho lwezisombululo ze-IV zikwinqanaba elikhokelayo ngokupheleleyo kwinqanaba lasekhaya kunye nenqanaba eliphezulu kumazwe ngamazwe. Ifake isicelo samalungelo awodwa omenzi wechiza angaphezulu kwama-60, inokubonelela ngamaxwebhu emvume eseti epheleleyo kwiimveliso zabathengi kunye nesiqinisekiso se-GMP. Inkampani yethu ithengise amakhulu e-soft bag IV umgca wokuvelisa isisombululo kude kube sekupheleni kwe-2014, yenza i-50% yesabelo semarike; ibhotile yeglasi IV umgca wemveliso isisombululo akhawunti phezu 70% isabelo kwimarike China. Ibhotile yeplastiki IV umgca wokuvelisa isisombululo sele ithengiswe kuMbindi we-Asia kunye ne-Asia-mpuma ye-Asia njl njl. Ifumana indumiso evumelanayo kubo bonke abathengi. Inkampani yethu yakhe ubudlelwane obuhle bentsebenziswano yeshishini kunye nabavelisi besisombululo se-IV abangaphezu kwe-300 e-China, kwaye yafumana igama elihle e-Uzbekistan, ePakistan, eNegeria nakwamanye amazwe angama-30. Siye saba uphawu olukhethwayo Chinese xa ehlabathini jikelele IV abenzi isisombululo abenzi purchasing.Our oomatshini bokwenza amayeza ngomnye wamalungu aphambili China Pharmaceutical Equipment Association, National Technical Committee on Pharmaceutical Equipment Standardization, kunye nomvelisi ohamba phambili kwi-Pharmaceutical Production Machinery e-China. Silawula ngokungqongqo umgangatho woomatshini, ngokusekelwe kwi-ISO9001: 2008, landela i-cGMP, i-European GMP, i-US FDA GMP kunye nemigangatho ye-GMP ye-WHO njl.

Siphuhlise uthotho lwezixhobo zokuhlangabezana neemfuno ezilungiselelweyo, ezinje nge-Non-PVC Soft Bag/ PP ibhotile/ ibhotile yeglasi IV umgca wokuvelisa isisombululo, iampoule ezenzekelayo/i-vial yokuvasa-ukuzalisa-ukutywina umgca wokuvelisa, ulwelo lokuvasa-lomisa-ukuzalisa- umgca wokuvelisa ukutywinwa, isisombululo se-dialysis sokuzalisa-umgca wokuvelisa, umgca wokuvelisa i-syringe efakwe ngaphambili, njl njl.

Izixhobo zokucoca amanzi:
Yinkampani yobuchwephesha obuphezulu obukhethekileyo kwi-R&D kunye neyunithi yokuvelisa i-RO yaManzi acocekileyo, inkqubo ye-multi-effect water distiller ye-Water For Injection, i-generator yomphunga ococekileyo, iinkqubo zokulungiselela isisombululo, zonke iintlobo zamanzi kunye netanki yokugcina isisombululo, kunye neenkqubo zokuhambisa. .

Sinikezela ngoyilo lwezixhobo ezikumgangatho ophezulu kunye nokwenza ngokuhambelana ne-GMP, i-USP, i-FDA GMP, i-EU GMP njl.

Ukupakishwa okuzenzekelayo kunye neSistim yeWarehouse & neZibonelelo zoMzimveliso:
Njengenkokeli yokwenziwa kwenkqubo yokugcina impahla yothungelwano kunye nezenzekelayo ekrelekrele, sigxile ekupakishweni kwe-auto kunye nezibonelelo zenkqubo yokugcina impahla ye-R&D, ukuyila, ukwenza, ukwenza, ubunjineli kunye noqeqesho.

Ukubonelela abathengi ngenkqubo yokudibanisa yonke ukusuka kwi-Auto Packing ukuya kwiWarehouse WMS & WCS ubunjineli obukumgangatho ophezulu kunye nenkonzo egqwesileyo, efana nomatshini wokupakisha webhokisi yeerobhothi, umatshini wokuvula ikhathoni ozenzekelayo ozenzekelayo, inkqubo yoLungiselelo oluzenzekelayo kunye nenkqubo yokugcina indawo enemigangatho emithathu ezenzekelayo njl.

Ngezisombululo ezininzi ezingabizi kakhulu, iiprojekthi zethu kunye neemveliso zisetyenziswa ngokubanzi kumachiza, ukutya, kumashishini e-elektroniki kunye ne-logistics industry njl.

I-Vacuum Blood Collection I-Tube Machinery Plant:
Sigxile kumgangatho ophezulu, osebenzayo, osebenzayo kunye nozinzileyo wezixhobo zokuvelisa ityhubhu yokuqokelela igazi kunye nenkqubo efanelekileyo ezenzekelayo. Samkele eyona teknoloji yokuvelisa iityhubhu yokuqokelela igazi ephucukileyo kule minyaka ingama-20 idlulileyo, kwaye siye saphuhlisa izizukulwana ezininzi zeVacuum Blood Collection Tube Production Lines, ekhuthaze imveliso yokwenziwa kokuqokelela igazi ukuya kwinqanaba eliphezulu kwihlabathi jikelele.

Senza iinzame ezinkulu kumgangatho wemveliso kunye nokusungula izinto ezintsha zobugcisa, siphumelele amalungelo awodwa omenzi wechiza angaphezu kwama-20 kwizixhobo zokuvelisa ityhubhu yokuqokelela igazi. Siphucula umgangatho wezixhobo zobugcisa ngokuqhubekayo kwaye sibe yinkokeli kunye nomdali we-China yokuqokelela igazi lokuvelisa izixhobo zokuvelisa izixhobo.

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Iiprojekthi zaphesheya

Ukuza kuthi ga ngoku, sele sinike amakhulu eesethi zezixhobo zonyango kunye nezixhobo zonyango kumazwe angaphezu kwama-40. Okwangoku, siye sanceda abathengi bethu ukuba bakhe isityalo samachiza kunye nezonyango kunye neeprojekthi ze-turnkey e-Uzbekistan, eTajikistan, e-Indonesia, eThailand, eSaudi, e-Iraq, eNigeria, e-Uganda njl. Zonke ezi projekthi ziphumelele abathengi bethu kunye nezimvo zabo eziphezulu zikarhulumente.

Umbindi weAsia
Kumazwe amahlanu akuMbindi weAsia, uninzi lweemveliso zoxubo mayeza zingeniswa kumazwe angaphandle, kungakhankanywa ngokutofa ngokutofa. Emva kweminyaka eliqela yokusebenza nzima, sele sibanceda baphuma enkathazweni omnye emva komnye. E-Kazakhstan, sakha umzi-mveliso omkhulu wokudibanisa amayeza obandakanya i-Soft Bag IV-Solution Production Lines kunye ne-Ampoules Injection Production Lines ezine.

E-Uzbekistan, sakhe i-PP Bottle IV-Solution Pharmaceutical Factory, enokuvelisa i-18 yezigidi zeebhotile ngonyaka. Lo mzi-mveliso awubaziseli nje ingenelo enkulu kwezoqoqosho kodwa ukwanika abantu basekuhlaleni iingenelo ezibonakalayo kunyango lwamayeza.

Afrika
I-Afrika enabemi abaninzi, apho isiseko soshishino lwamayeza sihlala sibuthathaka, sidinga inkxalabo engakumbi. Okwangoku, sakha i-Soft Bag IV-Solution Pharmaceutical Factory eNigeria, enokuvelisa i-20 yezigidi zeengxowa ezithambileyo ngonyaka. Siya kuqhubeka nokwakha iifektri zamayeza ezikumgangatho ophezulu e-Afrika, kwaye sinqwenela ukuba abantu balapha e-Afrika banokufumana inzuzo ebonakalayo ngokusebenzisa iimveliso zoxubo mayeza ezikhuselekileyo ezenziwa ekhaya.

Phakathi empuma
KuMbindi Mpuma, ishishini loxubo-mayeza likwinqanaba lokuqala, kodwa bebebhekisa kwi-USA FDA enombono ophucukileyo kunye nomgangatho ophezulu wokongamela umgangatho wamayeza abo kunye neefektri zamayeza. Omnye wabathengi bethu osuka eSaudi Arabia usinike umyalelo wokuba senze yonke iSoft Bag IV-Solution Turnkey Project kubo, enokuvelisa ngaphezulu kwe-22 yezigidi zeebhegi ezithambileyo ngonyaka.

Kwamanye amazwe aseAsia, ishishini lamachiza liye labeka isiseko, kodwa kusenzima kubo ukwakha umzi-mveliso we-IV-Solution okumgangatho ophezulu. Omnye wabathengi bethu base-Indonesia naye, emva kokukhetha, wasikhetha, esenza awona mandla abanzi, ukwakha i-IV-Solution Pharmaceutical Factory ekumgangatho ophezulu kwilizwe labo. Siye sagqiba iprojekthi yabo ye-turnkey yesigaba soku-1 kunye neebhotile ze-8000 / iyure eqhuba kakuhle. Kwaye isigaba sabo se-2 kunye neebhotile ze-12000 / iyure, siya kuqalisa ukufakwa ekupheleni kwe-2018.

I-turnkey yoshishino lwamayeza
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IQELA LETHU

• Njengoko iqela lobuchwephesha lineminyaka engaphezu kwe-10 yamava kunye nezibonelelo eziqokelelweyo kushishino loShishino lwaMayeza, uninzi lokuthengwa kweemveliso zisemgangathweni olungileyo, Amaxabiso akhuphisanayo, amaxabiso aphezulu kwaye anengeniso.

• Ngenkqubo yokulawula yobungcali kunye nokuqinisekiswa komgangatho, ukuyila kunye nokwakhiwa kwethu kuhambelana ne-FAD, i-GMP, i-ISO9001 kunye ne-14000 yemigangatho yenkqubo yekhwalithi, Izixhobo zihlala zihlala zihlala zihlala zihlala iminyaka engaphezu kwe-15. (Iimveliso zensimbi ezingenasici zifumaneka ngaphezu kweminyaka engama-20 )

• Iqela lethu loyilo elikhokelwa ngoochwephesha abaninzi abaphezulu kwishishini lezoShishino ngesakhono sobugcisa esigqwesileyo, abanesakhono sokwenza nzulu, ukomeleza iinkcukacha, Ukuqinisekisa ngokupheleleyo ukuphunyezwa kweprojekthi ngempumelelo.

• Ngokubala ngononophelo, ucwangciso oluqiqileyo kunye nocwangciso-mali olukhethekileyo, ulawulo lwesikali kunye nokwandisa iindleko zokwakha zabasebenzi, oko kuqinisekisa ukuba amashishini anenzuzo elungileyo.

• Ngenkxaso yeqela lenkonzo yobuchwephesha kwi-intanethi nangaphandle kweintanethi kwiilwimi ezininzi, ezinje: ngesiNgesi, iSpanish, isiFrentshi, ect, ngaloo ndlela kuqinisekisa umgangatho ophezulu kunye nenkonzo esebenzayo.

• Ngaphezu kwamava ama-10 eminyaka kwiprojekthi ye-turnkey kwintsimi ye-Pharmaceutical enezakhono zobugcisa ezomeleleyo zofakelo kunye nolwakhiwo, iiprojekthi zihambelana ne-FDA, i-GMP kunye ne-European Union kunye nolunye uqinisekiso.

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ABANYE ABATHENGI BETHU

IMISEBENZI OMNYOLISEKILEYO IQELA LETHU ELINIKE IGALELO KUBANTU BETHU!

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Isiqinisekiso seNkampani

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I-FDA证书 Kulungile-1
I-FDA证书 Kulungile-2

CE

I-FDA

I-FDA

umfanekiso weskrini we-ISO

ISO 9001

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Inkcazo yeNkcazo yeProjekthi

Sithumele izixhobo ezingamakhulu kumazwe angaphezu kwama-40, kwaye sanikezela ngeeprojekthi ezingaphezulu kweshumi zamayeza kunye neeprojekthi ezininzi ze-turnkey zonyango. Ngemizamo emikhulu ngalo lonke ixesha, siye safumana izimvo eziphezulu zabathengi bethu kwaye saseka igama elihle kwimarike yamazwe ngamazwe ngokuthe ngcembe.

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Ukuzibophelela ngeNkonzo

I-Pre-sales Technical Support

1. Thatha inxaxheba kumsebenzi wokulungiselela iprojekthi kwaye unike iingcebiso ezibhekiselele ekufikeleleni xa umthengi eqala ukwenza isicwangciso seprojekthi kunye nokukhethwa kohlobo lwezixhobo.
2. Thumela iinjineli zobugcisa ezinxulumene nabasebenzi kunye nabasebenzi bokuthengisa ukuba benze unxibelelwano olunzulu kunye nezinto zobugcisa bomthengi kwaye banike isisombululo sokukhetha isixhobo sokuqala.
3. Ukubonelela ngeflowutshati yenkqubo, idatha yobugcisa kunye noyilo loncedo lwesixhobo esinxulumeneyo kumthengi kuyilo lwakhe lwesakhiwo somzi-mveliso.
4. Ukubonelela ngomzekelo wobunjineli wenkampani kwireferensi yomthengi ngexesha lokukhetha uhlobo kunye noyilo. Kwangaxeshanye ukubonelela ngezinto ezinxulumene nomzekelo wobunjineli kutshintshiselwano lobugcisa.
5. Hlola intsimi yemveliso kunye nokuhamba kwenkqubo yenkampani. Ukubonelela ngamaxwebhu anxulumene nenkqubo yolawulo lolungiselelo kunye nenkqubo yokulawula umgangatho.

II Ulawulo lweeProjekthi ezithengiswayo

1. Ngokumalunga neprojekthi kunye nekhontrakthi esayiniweyo, inkampani iqhuba ulawulo lweprojekthi olubandakanya yonke inkqubo ukusuka ekusayinwe kwikhontrakthi ukuya kwitshekhi yokugqibela kunye nokwamkelwa kweprojekthi. Amanyathelo asisiseko alandelayo: ukusayinwa kwekhontrakthi, ukuzimisela kwegrafu yeplani yomgangatho, ukuveliswa kunye nokulungiswa, ukudibanisa okuncinci kunye nokulungiswa kweempazamo, ukulungiswa kwendibano yokugqibela, ukuhlolwa kokunikezelwa, ukuthunyelwa kwezixhobo, ukutshatyalaliswa kwe-terminal, ukujonga kunye nokwamkelwa.
2. Inkampani iya kuqesha injineli enamava amaninzi kulawulo lweprojekthi njengomntu ophetheyo, oya kuthatha uxanduva olupheleleyo lolawulo lweprojekthi kunye nokunxibelelana. Umthengi kufuneka aqinisekise izinto zokupakisha kwaye ashiye isampuli. Umthengi kufuneka abonelele ngezixhobo zokuqhuba uhambo ngexesha lokudibanisa kunye nokulungiswa kweempazamo kumthengisi simahla.
3. Ukutshekishwa kwangaphambili kunye nokwamkelwa kwesixhobo kunokwenziwa kumzi-mveliso womthengisi okanye kumzi-mveliso womthengi. Ukuba itshekhi kunye nokwamkelwa kuqhutyelwa kumzi-mveliso womthengisi, umthengi kufuneka athumele abantu kumzi-mveliso womthengisi ukuze batshekishwe kwaye bamkelwe phakathi kweentsuku ezi-7 zokusebenza emva kokufumana isaziso sokuveliswa kwezixhobo ezigqityiweyo kumthengisi. Ukuba itshekhi kunye nokwamkelwa kuqhutyelwa kumzi-mveliso womthengi, izixhobo kufuneka zikhutshwe kwaye zihlolwe kunye nobukho bezinto zombini ezivela kumthengisi kunye nomthengi phakathi kweentsuku ezi-2 zokusebenza emva kokuba isixhobo sifikile. Itshekhi kunye nengxelo yokwamkelwa nayo kufuneka igqitywe.
4. Iskim sofakelo lwezixhobo simiselwa ngesivumelwano samaqela omabini. Abasebenzi bayo bokulungisa iimpazamo baya kukhokela ukufakwa ngokwekhontrakthi kwaye baqhube uqeqesho lwabasebenzi bokusebenza kunye nokugcinwa kwabasebenzi.
5. Kwimeko yokuba unikezelo lwamanzi, umbane, igesi kunye nezixhobo zokulungisa zinikezelwa, umthengi unokwazisa kwifom ebhaliweyo umthengisi ukuba athumele abasebenzi ukuba balungise izixhobo. Iindleko zamanzi, umbane, igesi kunye nezinto zokucoca kufuneka zihlawulwe ngumthengi.
6. Ukulungiswa kweempazamo kwenziwa ngezigaba ezibini. Isixhobo sifakwe kwaye imigca ibekwe kwinqanaba lokuqala. Kwinqanaba lesibini, ukulungiswa kwe-debugging kunye nomqhubi we-pilot wenziwa kwimeko yokuba i-air conditioner yomsebenzisi ihlanjululwe kwaye amanzi, umbane, igesi kunye nezinto zokucoca ziyafumaneka.
7. Ngokumalunga netshekhi yokugqibela kunye nokwamkelwa, uvavanyo lokugqibela lwenziwa ngokwemvumelwano kunye nencwadi yemiyalelo yesixhobo phambi kwabasebenzi bomthengisi kunye nomntu ophetheyo womthengi. Itshekhi yokugqibela kunye nengxelo yokwamkelwa izaliswe xa uvavanyo lokugqibela lugqityiwe.

III Amaxwebhu oBuchule aNikiwe

I) Idatha yoFakelo lwesiqinisekiso (IQ)
1. Isatifikethi somgangatho, incwadi yemiyalelo, uluhlu lokupakisha
2. Uluhlu lokuthumela, uluhlu lweendawo zokunxiba, isaziso sokulungiswa kweempazamo
3. Imizobo yokufakela (kubandakanywa umzobo wenkcazo yezixhobo, umzobo wendawo yombhobho wokudibanisa, umzobo wendawo ye-node, i-electric schematic diagram, i-mechanical drive diagram, incwadi yemiyalelo yokufakela kunye nokuphakanyiswa)
4. Incwadana yokusebenza yeendawo ezithengiweyo eziphambili

II) Idatha yesiqinisekiso soMsebenzi (PQ)
1. Ingxelo yokuhlolwa kwefektri kwipharamitha yentsebenzo
2. Isiqinisekiso sokwamkelwa kwesixhobo
3. Isiqinisekiso sezinto ezibalulekileyo zomatshini oyintloko
4. Imigangatho yangoku yemigangatho yokwamkelwa kwemveliso yemveliso

III) Idatha yokufaneleka koMsebenzi (OQ)
1. Indlela yokuvavanya kwisixhobo sobugcisa beparameter kunye nesalathisi sokusebenza
2. Inkqubo yokusebenza esemgangathweni, inkqubo yokucoca eqhelekileyo
3. Iinkqubo zokugcinwa nokulungiswa
4. Imigangatho yokungasebenzi kakuhle kwezixhobo
5. Irekhodi yokufakela isiqinisekiso
6. Irekhodi yesiqinisekiso sokwenziwa komsebenzi
7. Ukuqhuba irekhodi yesiqinisekiso

IV) Ukuqinisekiswa kokusebenza kwezixhobo
1. Ukuqinisekiswa okusisiseko okusebenzayo (jonga ubungakanani obulayishiweyo kunye nokucaca)
2. Qwalasela ukuthotyelwa kwesakhiwo kunye nokwenziwa
3. Uvavanyo olusebenzayo lweemfuno zolawulo oluzenzekelayo
4. Ukubonelela ngesisombululo esenza ukuba iseti epheleleyo yezixhobo zihlangabezane nokuqinisekiswa kwe-GMP

INkonzo ye-IV emva kokuthengisa
1. Ukuseka iifayile zezixhobo zabathengi, gcina ikhonkco lonikezelo olungaphazamisekiyo lwamacandelo angasese, kwaye unike iingcebiso malunga nokuhlaziywa kobugcisa kunye nokutshintshwa.
2. Misela inkqubo yokulandelela. Ndwendwela umthengi ngamaxesha athile xa ukufakwa kwezixhobo kunye nokulungiswa kweempazamo kugqityiwe ukunika umva ulwazi lokusetyenziswa kwangexesha ukuze kuqinisekiswe isandi, ukusebenza okuzinzileyo nokuthembekileyo kwesixhobo kunye nokususa ixhala lomthengi.
3. Yenza impendulo kwiiyure ze-2 emva kokufumana isaziso sokungaphumeleli kwesixhobo somthengi okanye imfuno yenkonzo. Lungiselela abasebenzi bezolondolozo ukuba bafike kwisiza kwiiyure ezingama-24, kunye neeyure ezingama-48 kungekudala.
4. Ixesha lokuqinisekisa umgangatho: Unyaka we-1 emva kokwamkelwa kwezixhobo. "Iziqinisekiso ezintathu" eziqhutywe ngexesha lokuqinisekiswa komgangatho zibandakanya: isiqinisekiso sokulungiswa (kumatshini opheleleyo), isiqinisekiso sokutshintshwa (ukunxiba iinxalenye ngaphandle komonakalo owenziwe ngumntu), kunye nesiqinisekiso sokubuyiselwa imali (kwiindawo ezikhethiweyo).
5. Ukuseka inkqubo yenkonzo yezikhalazo. Yeyona njongo yethu iphambili ukukhonza abathengi bethu ngcono kwaye samkele ukonganyelwa kwabathengi bethu. Kufuneka siphelise ngokuqinileyo into yokuba abasebenzi bethu bafune intlawulo ngexesha lofakelo lwezixhobo, ukulungisa iimpazamo kunye nenkonzo yobugcisa.

V Inkqubo yoQeqesho lokuSebenza noLondolozo
1. Umgaqo-siseko jikelele woqeqesho "ubuninzi obuphezulu, umgangatho ophezulu, ukukhawuleza kunye nokunciphisa iindleko". Inkqubo yoqeqesho kufuneka isebenze kwimveliso.
2. Ikhosi: Ikhosi yethiyori kunye nekhosi yeprakhtikhali. Ikhosi yethiyori ikakhulu imalunga nomgaqo-siseko wokusebenza kwezixhobo, ubume, iimpawu zokusebenza, uluhlu lwezicelo, amanyathelo okhuseleko okusebenza, njl. njl. Indlela yokufundisa yomfundi eyamkelwe kwikhosi yepraktikhali ivumela abaqeqeshwayo ukuba bawuqonde ngokukhawuleza umsebenzi, ukugcinwa kwemihla ngemihla, ukulungisa iimpazamo kunye nokusombulula ingxaki izixhobo kunye nokutshintshwa kunye nohlengahlengiso lwamacandelo athile.
3. Ootitshala: Uyilo olukhulu lwemveliso kunye namagcisa anamava
4. Abaqeqeshwayo: Abasebenzi abasebenzayo, abasebenzi bolondolozo kunye nabasebenzi abanxulumene nolawulo abasuka kumthengi.
5. Imodi yoqeqesho: Inkqubo yoqeqesho iqhutyelwa kwindawo yokwenziwa kwezixhobo zenkampani okokuqala, kwaye inkqubo yoqeqesho iqhutyelwa kwindawo yokuvelisa yomsebenzisi okwesibini.
6. Ixesha loqeqesho: Kuxhomekeke kwimeko yokusebenza yezixhobo kunye nabaqeqeshwayo
7. Iindleko zoqeqesho: Ukubonelela ngedatha yoqeqesho simahla kunye nokuhlalisa abaqeqeshwa simahla kwaye kungahlawulisi mali yoqeqesho.


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