Shanghai IVEN Pharmatech Engineering Co., Ltd.
IVEN Pharmatech Engineering ni ikigo mpuzamahanga cy’ubwubatsi gitanga ibisubizo ku nganda z’ubuvuzi. Dutanga ibisubizo by’ubuhanga bihuriweho ku nganda z’imiti n’uruganda rw’ubuvuzi ku isi yose hakurikijwe ihame rya EU GMP / US FDA cGMP, WHO GMP, PIC/S GMP n’ibindi. Dufite uburambe bw’imyaka myinshi mu nganda z’imiti n’ubuvuzi, twiyemeje gutanga ibisubizo bishimishije ku bakiriya bacu ku isi yose, birimo igishushanyo mbonera cy’imishinga igezweho, ibikoresho byiza, imicungire myiza y’ibikorwa, na serivisi yuzuye mu buzima bwose.
Turi bande?
IVEN yashinzwe mu 2005 kandi ikora cyane mu nganda zikora imiti n'ubuvuzi, twashinze inganda enye zikora imashini zo kuzuza no gupakira imiti, uburyo bwo gutunganya amazi mu miti, uburyo bwo gutwara amazi mu buryo bw'ubwenge no gutunganya ibikoresho. Twatanze ibikoresho ibihumbi byo gukora imiti n'ubuvuzi ndetse n'imishinga y'ingenzi, twakoreye abakiriya amagana baturutse mu bihugu birenga 50, twafashije abakiriya bacu kunoza ubushobozi bwabo bwo gukora imiti n'ubuvuzi, tubona isoko n'izina ryiza ku isoko ryabo.
Icyo dukora?
Dushingiye ku byo abakiriya basaba mu bihugu bitandukanye, duhindura uburyo bwo gukora imashini zikoreshwa mu buhanga mu bijyanye n'imiti iterwa mu nganda, imiti ikomeye, imiti y'ibinyabuzima, uruganda rukoreshwa mu buvuzi, n'uruganda rukora ibikoresho by'ubuvuzi. Uburyo bwacu bwo gukora imashini bugizwe n'ibikoresho by'ubuhanga bugizwe n'icyumba gisukuye, ibikoresho bisukuye, uburyo bwo gutunganya amazi mu miti, uburyo bwo gukora, uburyo bwo gukora imiti mu buryo bwikora, uburyo bwo gupakira, uburyo bw'ikoranabuhanga mu by'ubwiza, uburyo bwo kugenzura ubuziranenge, laboratwari nkuru n'ibindi. Dukurikije ibyo abakiriya bakeneye, IVEN ishobora gutanga serivisi z'umwuga nk'uko bikurikira:
*Ubujyanama ku bijyanye n'imishinga ishoboka
*Igishushanyo mbonera cy'umushinga
*Guhitamo no guhindura icyitegererezo cy'ibikoresho
*Gushyiraho no gukoresha
* Kwemeza ibikoresho n'uburyo bikorwamo
*Ubujyanama ku igenzura ry'ubuziranenge
*Kohereza ikoranabuhanga mu musaruro
* Inyandiko zikomeye kandi zoroshye
*Amahugurwa ku bakozi
*Serivise y'ubuzima bwose nyuma yo kugurisha
*Ubugenzuzi bw'umusaruro
*Kuvugurura serivisi n'ibindi.
Kuki Turi Abayo?
Guha abakiriya agacironi akamaro ko kubaho kwa Iven, ni n'ubuyobozi bw'ibikorwa ku banyamuryango bacu bose ba Iven. Isosiyete yacu imaze imyaka irenga 16 ikorera abakiriya mpuzamahanga, dushobora kumva neza ibyo abakiriya bacu mpuzamahanga bakeneye, kandi duhora dutanga ibikoresho byiza n'umushinga ku bakiriya ku giciro cyiza.
Impuguke zacu mu bya tekiniki zifite uburambe bw'imyaka ibarirwa muri za mirongo mu nganda z'imiti n'ubuvuzi, kandi zizi neza ibisabwa ku rwego mpuzamahanga bya GMP, nka EU GMP / US FDA cGMP, WHO GMP, PIC/S GMP principle n'ibindi.
Itsinda ryacu ry’abahanga rikora cyane kandi rikora neza cyane, rifite uburambe bwinshi mu mishinga itandukanye y’imiti, twubaka umushinga w’ubuziranenge, tudashingiye gusa ku byo umukiriya akeneye ubu, ahubwo tunatekereza ku byo umukiriya azakoresha buri munsi mu kazi ke ka buri munsi no korohereza ubuvuzi, ndetse no kwagura mu gihe kizaza.
Itsinda ryacu ry’abacuruzi rifite ubumenyi buhagije kandi rifite icyerekezo mpuzamahanga n’ubumenyi bujyanye n’imiti, ritanga serivisi nziza kandi inoze ku bakiriya kuva ku rwego rwo kugurisha kugeza ku rwego rwo kugurisha nyuma yo kugurisha, rifite inshingano zikomeye n’inshingano.
Urubanza rw'umushinga
Ese ufite ibibazo bikurikira?
• Ibintu by'ingenzi mu mushinga w'igishushanyo mbonera ntabwo bigaragara cyane, imiterere yacyo ntabwo ikwiye.
• Igishushanyo mbonera cyo kwibandaho ntabwo gisanzwe, ishyirwa mu bikorwa riragoye.
• Iterambere rya gahunda y'igishushanyo mbonera rirarenze urugero, gahunda yo kubaka ntabwo irarangira.
• Ubwiza bw'ibikoresho ntibushobora kumenyekana kugeza igihe bitagishoboye gukora.
• Biragoye kumenya ikiguzi kugeza igihe amafaranga azahomba.
• Namaze igihe kinini nsura abatanga serivisi, mbagezaho igishushanyo mbonera n'imicungire y'ubwubatsi, ngereranya buri kimwe inshuro nyinshi.
Iven itanga igisubizo cy’ubuhanga mu by’imiti n’ubuvuzi ku isi yose, harimo icyumba gisukuye, uburyo bwo kugenzura no kugenzura imikorere y’imiti, uburyo bwo gutunganya amazi mu miti, uburyo bwo gutegura no gutwara imiti, uburyo bwo kuzuza no gupakira, uburyo bwo gutwara ibintu mu buryo bwikora, uburyo bwo kugenzura ubuziranenge n’ubushakashatsi rusange n’ibindi. Dukurikije ibisabwa n’inganda zikora imiti mu bihugu bitandukanye ndetse n’ibyo abakiriya basaba ku giti cyabo, IVEN ihindura witonze ibisubizo by’imishinga y’ubuhanga mu by’imiti kandi igafasha abakiriya bacu kugira izina ryiza n’icyubahiro mu nganda zikora imiti mu gihugu.
Uruganda rwacu
Imashini zikora imiti:
Ubushobozi bwacu bwo gukora ubushakashatsi no guteza imbere imashini zikora imiti mu bijyanye n’ibisubizo bya IV buri ku rwego rwo hejuru mu gihugu no mu rwego rwo hejuru mpuzamahanga. Yasabye patenti zisaga 60 za tekiniki, ishobora gutanga inyandiko zose zemeza ibicuruzwa by’abakiriya ndetse n’icyemezo cya GMP. Isosiyete yacu yagurishije amagana y’imirongo ikora imiti ya IV kugeza mu mpera za 2014, ifite 50% by’isoko; umurongo ukora imiti ya IV mu icupa ry’ikirahure ufite 70% by’isoko mu Bushinwa. Umurongo ukora imiti ya IV mu macupa ya pulasitiki nawo wagurishijwe muri Aziya yo Hagati no muri Aziya y’Amajyepfo y’Amajyepfo n’ahandi. Ihabwa ishimwe risesuye n’abakiriya bose. Isosiyete yacu yubatse ubufatanye bwiza mu bucuruzi n’inganda zikora imiti ya IV zisaga 300 mu Bushinwa, kandi yamenyekanye cyane muri Uzbekistan, Pakisitani, Negeria n’ibindi bihugu 30. Twabaye ikirango gikunzwe cyane mu Bushinwa iyo abakora imiti ya IV ku isi hose bagura. Uruganda rwacu rw’imashini zikora imiti ni rumwe mu bagize ishyirahamwe ry’ibikoresho by’imiti mu Bushinwa, Komite y’Igihugu y’Ubuhanga ku Bikoresho Bishinzwe Ubuziranenge bw’Ibikoresho by’Imiti, n’uruganda rukora imiti mu Bushinwa. Dugenzura cyane ubuziranenge bw'imashini, dushingiye kuri ISO9001: 2008, dukurikiza amahame ya cGMP, GMP y'i Burayi, GMP ya Amerika na WHO GMP n'ibindi.
Twakoze ibikoresho bitandukanye kugira ngo bihuze n'ibikenewe byihariye, nk'umurongo wo gukora umuti wa IV utari PVC Soft Bag/PP cup/glass cup, umurongo wo gukora umuti wa ampoule/vial washing-fill-sealing, umurongo wo gukora umuti wa oral liquid washing-drying-filling-sealing, umurongo wo gukora umuti wa dialysis solution filling-sealing, umurongo wo gukora umuti wa syringe filling-sealing wuzuye mbere n'ibindi.
Ibikoresho byo gusukura amazi:
Ni ikigo cy’ikoranabuhanga rigezweho cyihariye mu bushakashatsi no guteza imbere no gukora ishami rya RO rishinzwe amazi meza, sisitemu yo gukaraba amazi menshi ikoreshwa mu gutera inshinge, moteri itunganya umwuka, sisitemu yo gutegura ibisubizo, ubwoko bwose bw’ikigega cyo kubika amazi n’ibisubizo, hamwe n’uburyo bwo kuyakwirakwiza.
Dutanga igishushanyo mbonera cy’ibikoresho byiza kandi bigakorwa hakurikijwe GMP, USP, FDA GMP, EU GMP n’ibindi.
Sisitemu yo gupakira imodoka n'ububiko n'uruganda rw'ibikoresho:
Nk’ikigo gikomeye mu gukora sisitemu yo guhuza ububiko bw’ibikoresho n’ibikoresho byikora, twibanda ku bushakashatsi n’iterambere ry’ibikoresho byo gupakira no kubika ibikoresho, gushushanya, gukora, ubwubatsi n’amahugurwa.
Ha abakiriya sisitemu yose yo guhuza kuva kuri Auto Packing kugeza kuri Warehouse WMS & WCS engineering ifite ireme kandi serivisi nziza, nko gukoresha imashini ya robotic packing carton, imashini ifunguka mu buryo bwikora, sisitemu yo gutwara ibintu ikora na sisitemu yo kubika ibintu ikora mu buryo bwikora mu buryo butatu n'ibindi.
Hamwe n'ibisubizo bihendutse cyane, imishinga yacu n'ibicuruzwa byacu bikoreshwa cyane mu nganda zikora imiti, ibiribwa, ibikoresho by'ikoranabuhanga n'ibindi.
Uruganda rukora imashini zitwara amaraso mu cyuma gishyushya amaraso:
Twibanze ku bikoresho byo gukora imiyoboro y'amaraso ifite ubuziranenge, ikora neza, ifatika kandi ihamye hamwe na sisitemu ikora yikora. Twakoresheje ikoranabuhanga rigezweho ryo gukora imiyoboro y'amaraso ikoresha umwuka mu buryo bwa vacuum mu myaka 20 ishize, kandi twateje imbere imiyoboro myinshi y'imiyoboro y'amaraso ikoresha umwuka mu buryo bwa vacuum, byateje imbere inganda zikora imiyoboro y'amaraso ikoresha umwuka mu buryo bwa vacuum ku rwego rwo hejuru ku isi.
Dushyira imbaraga nyinshi mu bwiza bw'ibicuruzwa no guhanga udushya mu bya tekiniki, twageze ku ruhushya rurenga 20 rw'ibikoresho byo gukora imiyoboro yo gukusanya amaraso. Dukomeza kunoza urwego rwa tekiniki rw'ibikoresho kandi tuba abayobozi n'abashinze inganda z'ibikoresho byo gukusanya amaraso mu Bushinwa.
Imishinga yo mu mahanga
Kugeza ubu, tumaze gutanga ibikoresho amagana by’imiti n’ibikoresho by’ubuvuzi mu bihugu birenga 60. Hagati aho, twafashije abakiriya bacu kubaka uruganda rw’imiti n’ubuvuzi hamwe n’imishinga ikomeye muri Amerika, Uzbekistan, Tajikistan, Indoneziya, Tayilande, Sawudite, Iraki, Nijeriya, Uganda, Lawosi n’ahandi. Iyi mishinga yose yahesheje abakiriya bacu inkunga ikomeye kandi leta yabo yarabishimiye.
Amerika ya Ruguru
Uruganda rugezweho rw’imiti muri Amerika rwubatswe burundu n’ikigo cy’Abashinwa – Shanghai IVEN Pharmatech Engineering, ni rwo rwa mbere kandi rw’intambwe ikomeye mu nganda z’ubuhanga mu by’imiti mu Bushinwa.
Umurongo w’ibikoresho by’ingufu za IV ukoresha uburyo bwo gucapa, gukora, kuzuza no gufunga. Nyuma y’ibyo, sisitemu yo gukora ubuvuzi bw’ibanze ikora uburyo bwo gushyiramo ibikoresho by’ingufu za IV mu buryo bwikora ikoresheje robots zishyiramo ibikoresho by’ingufu mu buryo bwikora, hanyuma ibikoresho by’ingufu bikinjira kandi bigasohoka muri autoclave. Hanyuma, ibikoresho by’ingufu za IV byakozwe ubuvuzi bw’ibanze bigenzurwa n’imashini ipima amazi afite ingufu nyinshi hamwe n’imashini igenzura amaso, kugira ngo harebwe aho amazi yamenetse, utunyangingo turi imbere n’ibisesenguwe by’ingufu hakoreshejwe uburyo bwizewe.
Aziya yo Hagati
Mu bihugu bitanu byo muri Aziya yo Hagati, imiti myinshi itumizwa mu mahanga, tutibagiwe no gutera imiti mu nganda. Nyuma y'imyaka myinshi dukora cyane, twamaze kubafasha kuva muri iyo ngorane umwe umwe. Muri Kazakisitani, twubatse uruganda runini rw'imiti rugizwe n'imirongo ibiri ikora imiti ya Soft Bag IV-Solution Production Lines n'imirongo ine ikora imiti ya Ampoules Injection Production Lines.
Muri Uzbekistan, twubatse uruganda rwa PP Bottle IV-Solution Pharmaceutical Factory, rushobora gukora amacupa miliyoni 18 buri mwaka. Uruganda ntirubazanira inyungu nyinshi mu bukungu gusa, ahubwo runaha abaturage baho inyungu zifatika mu kuvura imiti.
Afurika
Afurika ifite abaturage benshi, aho inganda zikora imiti zikiri nke, ikeneye kwitabwaho cyane. Muri iki gihe, turimo kubaka uruganda rwa Soft Bag IV-Solution Pharmaceutical Factory muri Nijeriya, rushobora gukora Soft Bag IV buri mwaka. Twakomeza kubaka inganda nyinshi zikora imiti yo mu rwego rwo hejuru muri Afurika, kandi twifuza ko abaturage bo muri Afurika babona inyungu zifatika bakoresheje imiti ikoreshwa mu ngo zabo.
Uburasirazuba bwo Hagati
Ku ruhande rw'Uburasirazuba bwo Hagati, inganda zikora imiti ziracyari mu ntangiriro, ariko bagiye bavuga ko FDA yo muri Amerika ifite igitekerezo gihanitse kandi ikora neza cyane kugira ngo igenzure inganda zayo zikora imiti n'ubuziranenge. Umwe mu bakiriya bacu ukomoka muri Arabiya Sawudite yadutegetse gukora umushinga wose wa Soft Bag IV-Solution Turnkey kuri bo, ushobora gukora Soft Bag IV buri mwaka.
Mu bindi bihugu byo muri Aziya, inganda z’imiti zashyizeho urufatiro, ariko ntibiraborohera kubaka uruganda rwiza rwa IV-Solution. Umwe mu bakiriya bacu bo muri Indoneziya, nyuma yo gutoranya abakiriya bacu, yaduhisemo, dutunganya ibikoresho bikomeye cyane, kubaka uruganda rwo mu rwego rwo hejuru rwa IV-Solution Farumasi mu gihugu cyabo. Twarangije umushinga wabo wa 1 w’amacupa 8000 ku isaha, urimo kugenda neza. Kandi icyiciro cyabo cya 2 cy’amacupa 12000 ku isaha, twarangije gushyiraho kandi turimo gukora.
ITSINDA RYACU
• Nk'ikipe y'abanyamwuga ifite uburambe bw'imyaka irenga 10 n'umutungo mwinshi mu nganda z'imiti, inyinshi mu zigurwa ry'ibicuruzwa ziba nziza, igiciro cyazo ni cyiza, zihendutse kandi zitanga inyungu.
• Dukoresheje uburyo bw’ubugenzuzi bw’umwuga n’ubwiza bw’ubuziranenge, igishushanyo mbonera cyacu n’ubwubatsi byacu byujuje ibisabwa ku buziranenge bwa FAD, GMP, ISO9001 na 14000, Ibikoresho biraramba cyane kandi muri rusange bishobora gukoreshwa imyaka irenga 15. (Ibikoresho by’icyuma kidafunze biraboneka mu gihe kirenga imyaka 20)
• Itsinda ryacu ry’abahanga mu by’ubugeni riyobowe n’inzobere nyinshi zikomeye mu nganda z’imiti zifite ubushobozi budasanzwe mu bya tekiniki, abahanga mu gusesengura no kunoza imiterere y’umushinga, kandi rizemeza neza ko umushinga uzashyirwa mu bikorwa neza.
• Hamwe no kubara neza, gutegura igenamigambi riboneye no gushyiraho uburyo bwihariye bwo kubara ibiciro, gucunga iminzani no kunoza ikiguzi cy'umurimo w'ubwubatsi, bityo ibigo bigira inyungu nziza.
• Hamwe n'itsinda ry'abakora serivisi z'umwuga ritanga ubufasha kuri interineti no hanze ya interineti mu ndimi nyinshi, nko mu Cyongereza, Icyesipanyoli, Igifaransa, n'ibindi, bityo bigatuma serivisi nziza kandi ikora neza.
• Uburambe bw'imyaka irenga 10 mu mishinga ijyanye n'imiti hamwe n'ubuhanga bukomeye mu bya tekiniki mu gushyiraho no kubaka, imishinga yakurikije amabwiriza ya FDA, GMP n'Umuryango w'Ubumwe bw'u Burayi n'ibindi bigenzurwa.
BAMWE MU BUKIRIYA BACU
IBIKORWA BITANGAJE IKIPE YACU YAGIRIYE ABAKIRIYA BACU!
Icyemezo cy'ikigo
CE
FDA
FDA
ISO 9001
Incamake y'Urugero rw'Umushinga
Twohereje ibikoresho amagana mu bihugu birenga 40, tunatanga imishinga irenga icumi yo gucuruza imiti ndetse n'indi mishinga myinshi yo gucuruza imiti. Dukoresheje imbaraga nyinshi igihe cyose, twagiye tubona ibitekerezo byiza by'abakiriya bacu kandi twimakaza izina ryiza ku isoko mpuzamahanga buhoro buhoro.
Ubwitange bwa serivisi
Ubufasha bwa tekiniki mbere yo kugurisha
1. Kugira uruhare mu gutegura umushinga no gutanga inama ku buryo bworoshye igihe umuguzi atangiye gushyira mu bikorwa gahunda y'umushinga n'uburyo bwo guhitamo ibikoresho.
2. Ohereza injeniyeri z’ikoranabuhanga n’abakozi bo kugurisha kugira ngo baganire byimbitse n’umuguzi ku bikoresho bya tekiniki, kandi batange igisubizo cy’ibanze cyo guhitamo ubwoko bw’ibikoresho.
3. Ha umuguzi imbonerahamwe y'ibikorwa, amakuru ya tekiniki n'imiterere y'ibikoresho bifitanye isano kugira ngo akoreshe igishushanyo mbonera cy'inyubako y'uruganda.
4. Tanga urugero rw'ubuhanga bw'ikigo kugira ngo umuguzi arebe uko byagenda mu gihe cyo guhitamo no gushushanya ubwoko bw'ikintu. Tanga kandi ibintu bifitanye isano n'urugero rw'ubuhanga bw'icyo kintu mu ihererekanya ry'ikoranabuhanga.
5. Kugenzura urwego rw'umusaruro n'imigendekere y'ibikorwa by'ikigo. Tanga inyandiko zijyanye na sisitemu yo gucunga ibikoresho n'uburyo bwo kugenzura ubuziranenge.
Imicungire y'imishinga ya II iri kugurishwa
1. Ku bijyanye n'umushinga ufite amasezerano yasinyweho, isosiyete ikora imicungire y'umushinga ikubiyemo inzira rusange kuva ku gusinya amasezerano kugeza ku igenzura rya nyuma no kwemerwa k'umushinga. Intambwe z'ibanze ni izi zikurikira: gusinya amasezerano, kugena imbonerahamwe y'imiterere y'ubutaka, gukora no gutunganya, guteranya no gukosora amakosa, gukosora amakosa ya nyuma yo guteranya, kugenzura ibyo watanze, kohereza ibikoresho, gukosora amakosa ya terminal, kugenzura no kwemera.
2. Isosiyete izashyiraho injeniyeri ufite uburambe bwinshi mu micungire y'imishinga nk'umuntu ushinzwe, uzafata inshingano zose zo gucunga imishinga no kuyihuza. Umuguzi agomba kwemeza ibikoresho byo gupakira hanyuma agasiga icyitegererezo. Umuguzi agomba kandi gutanga ibikoresho byo gukoresha mu gihe cyo guteranya no gukosora amakosa ku mucuruzi ku buntu.
3. Igenzura ry’ibanze n’iyakirwa ry’ibikoresho rishobora gukorerwa mu ruganda rw’umutanga cyangwa uruganda rw’umuguzi. Iyo igenzura n’iyakirwa bikorewe mu ruganda rw’umutanga, umuguzi agomba kohereza abantu ku ruganda rw’umutanga kugira ngo bagenzure kandi bemererwe mu minsi 7 y’akazi nyuma yo kubona imenyesha ry’uko ibikoresho byakozwe n’umutanga. Iyo igenzura n’iyakirwa bikorewe mu ruganda rw’umuguzi, ibikoresho bigomba gupakururwa no gusuzumwa niba hari ibintu bivuye ku mutanga n’umuguzi mu minsi 2 y’akazi nyuma yuko ibikoresho bihageze. Raporo y’igenzura n’iyakirwa nayo igomba kuba yuzuye.
4. Gahunda yo gushyiraho ibikoresho igenwa binyuze mu bwumvikane bw'impande zombi. Abakozi bayo bashinzwe gukemura ibibazo bazayobora ishyirwaho hakurikijwe amasezerano kandi bakorere abakozi bo mu rwego rwo hejuru amahugurwa yo gukoresha no kubungabunga ibikoresho by'umukoresha.
5. Mu gihe umuguzi atanze amazi, amashanyarazi, gazi n'ibikoresho byo gukosora, ashobora kumenyesha umucuruzi mu nyandiko kohereza abakozi bo gukosora ibikoresho. Amafaranga y'amazi, amashanyarazi, gazi n'ibikoresho byo gukosora agomba kwishyurwa n'umuguzi.
6. Gukosora amakosa bikorwa mu byiciro bibiri. Ibikoresho bishyirwaho kandi imiyoboro ishyirwa mu cyiciro cya mbere. Mu cyiciro cya kabiri, gutunganya amakosa no gukora igerageza bikorwa mu gihe icyuma gikonjesha cy'umukoresha gisukuye kandi amazi, amashanyarazi, gazi n'ibikoresho byo gutunganya amakosa bihari.
7. Ku bijyanye n'igenzura rya nyuma n'iyemewe, ikizamini cya nyuma gikorwa hakurikijwe amasezerano n'igitabo cy'amabwiriza y'ibikoresho imbere y'abakozi b'umutanga ibicuruzwa n'umuyobozi w'umuguzi. Isuzuma rya nyuma n'iyemewe byuzuzwa iyo ikizamini cya nyuma kirangiye.
Inyandiko za tekiniki za III zatanzwe
I) Amakuru yerekeye ibisabwa mu gushyiraho (IQ)
1. Icyemezo cy'ubuziranenge, igitabo cy'amabwiriza, urutonde rw'ibipakiye
2. Urutonde rw'ibyoherezwa, urutonde rw'ibice byambarwa, imenyesha ry'uko byakemuwe
3. Imbonerahamwe zo gushyiraho ibikoresho (harimo igishushanyo cy'imiterere y'ibikoresho, igishushanyo cy'aho umuyoboro uhurira, igishushanyo cy'aho inkuta iherereye, igishushanyo cy'amashanyarazi, igishushanyo cy'imodoka itwara imizigo, igitabo cy'amabwiriza yo gushyiraho no kuzamura)
4. Igitabo cy'amabwiriza agenga ibikoresho by'ingenzi byaguzwe
II) Amakuru yerekeye ubushobozi bwo gukora (PQ)
1. Raporo y'igenzura ry'uruganda ku bipimo by'imikorere
2. Icyemezo cyo kwemererwa gukoresha igikoresho
3. Icyemezo cy'ibikoresho by'ingenzi by'imashini nkuru
4. Amahame ngenderwaho y’ubu agenga kwemerwa kw’ibicuruzwa by’ibicuruzwa
III) Amakuru yerekeye imikorere (OQ)
1. Uburyo bwo gupima ibipimo bya tekiniki by'ibikoresho n'ibipimo by'imikorere
2. Uburyo busanzwe bwo gukora, uburyo busanzwe bwo koza
3. Uburyo bwo kubungabunga no gusana
4. Amahame ngenderwaho ku bijyanye n'uko ibikoresho bihoraho
5. Inyandiko y'ibyangombwa byo gushyiraho
6. Inyandiko y'impamyabushobozi zo gukora neza
7. Inyandiko y'impamyabushobozi yo kwiruka ku mupilote
IV) Igenzura ry'imikorere y'ibikoresho
1. Igenzura ry'ibanze ry'imikorere (kugenzura ingano yashyizwemo n'ubusobanuro)
2. Kugenzura imiterere n'ubuhanga bihuye
3. Ikizamini cy'imikorere cy'ibisabwa mu kugenzura byikora
4. Gutanga igisubizo gituma ibikoresho byose bihura n'igenzura rya GMP
Serivisi ya IV Nyuma yo kugurisha
1. Shyiraho dosiye z'ibikoresho by'abakiriya, komeza uruhererekane rw'ibikoresho by'inyongera rudasibangana, kandi utange inama ku bijyanye no kuvugurura no gusimbuza ibikoresho by'abakiriya.
2. Shyiraho uburyo bwo gukurikirana. Sura umukiriya buri gihe iyo gushyiraho no gukosora ibikoresho birangiye kugira ngo umusubize amakuru y'ikoreshwa ryabyo ku gihe kugira ngo umenye neza ko ibikoresho bikora neza, bihamye kandi byizewe kandi bikureho impungenge z'umukiriya.
3. Tanga igisubizo mu masaha 2 nyuma yo kubona imenyesha ry'uko ibikoresho by'umuguzi byangiritse cyangwa serivisi isabwa. Teganya abakozi bashinzwe kubungabunga ibikoresho kugira ngo bagere aho byakorewe mu masaha 24, kandi nibura mu masaha 48.
4. Igihe cy'ingwate y'ubuziranenge: umwaka umwe nyuma yo kwemerwa kw'ibikoresho. "Ingwate eshatu" zakozwe mu gihe cy'ingwate y'ubuziranenge zirimo: garanti yo gusana (ku mashini yuzuye), garanti yo gusimbuza (ku bice byambaye ubusa usibye ibyangiritse byakozwe n'umuntu), na garanti yo gusubizwa amafaranga (ku bice byishyurwa).
5. Gushyiraho uburyo bwo gutanga ibirego kuri serivisi. Intego yacu nyamukuru ni ugukorera abakiriya bacu neza no kwemera ubugenzuzi bw'abakiriya bacu. Tugomba guhagarika byimazeyo ikibazo cy'uko abakozi bacu bashaka kwishyurwa mu gihe cyo gushyiraho ibikoresho, gutunganya ibikoresho no gutanga serivisi za tekiniki.
Gahunda y'amahugurwa ya V ku bijyanye no gukoresha no kubungabunga
1. Ihame rusange ry'amahugurwa ni "ubwinshi bwinshi, ubwiza bwo hejuru, kwihuta no kugabanya ikiguzi". Gahunda y'amahugurwa igomba gufasha umusaruro.
2. Amasomo: Amasomo y’inyigisho n’amasomo ngiro. Amasomo y’inyigisho ashingiye ahanini ku mahame agenga imikorere y’ibikoresho, imiterere, imiterere y’imikorere, urwego rw’imikorere, ingamba zo kubikoresha, nibindi. Uburyo bwo kwigisha bw’umwigishwa bwakoreshejwe mu masomo ngiro butuma abahugurwa bamenya vuba imikorere, kubungabunga buri munsi, gukosora no gukemura ibibazo by’ibikoresho ndetse no gusimbuza no guhindura ibice byagenwe.
3. Abarimu: Igishushanyo mbonera cy'ibicuruzwa n'abatekinisiye b'inararibonye
4. Abahugurwa: Abakozi bakora, abakozi bashinzwe kubungabunga n'abakozi bashinzwe gucunga ibikoresho baturutse ku muguzi.
5. Uburyo bwo guhugura: Gahunda y'amahugurwa ikorerwa aho ikigo gikorera ibikoresho ku nshuro ya mbere, naho gahunda y'amahugurwa ikorerwa aho umukoresha akorera ku nshuro ya kabiri.
6. Igihe cy'amahugurwa: Bitewe n'imiterere y'ibikoresho n'abahugurwa
7. Ikiguzi cy'amahugurwa: Gutanga amakuru y'amahugurwa ku buntu no kwakira abahugurwa ku buntu kandi nta kiguzi cy'amahugurwa cyishyuzwa.