Mu rwego rwo kwita ku babyeyi n'ababyeyi ku isi hose, ibyemezo byo gutanga amasoko ku mpapuro zigenga biva mu buryo bwa 'bushingiye ku giciro ' bugana ku cyibanze ku 'kubahiriza no gucunga ibyago. ' By'umwihariko ku masoko yo mu Burayi no muri Amerika, ibyemezo by'impapuro byabaye ibisabwa kugira ngo umuntu yinjire mu nzira yo kugabura, aho kuba icyifuzo.
Dushingiye ku bunararibonye bwacu bufatika mu mishinga yohereza ibicuruzwa hanze ya OEM, twabonye ko mugihe cyambere cyo gusuzuma ibicuruzwa, hejuru ya 60% byabaguzi ba B2B ntibabanza gukuraho abafite ibiciro biri hejuru, ahubwo ni inganda zifite sisitemu zo gutanga ibyemezo bituzuye. Ibi birerekana kandi ko icyemezo cya CE, sisitemu ya ISO, hamwe no kubahiriza FDA byahindutse ibipimo ngenderwaho byo gusuzuma amasoko mpuzamahanga.
Iyi ngingo izasesengura logique ishingiye kumpamyabumenyi ijyanye nimpapuro zabigenewe zifatika, hamwe nuburyo bwingenzi bwo gusuzuma abaguzi bakoresha mubufatanye bwa OEM.
I.Ibikenewe bya Sisitemu Yimpamyabumenyi Yuzuye
1. Ibisabwa mu bucuruzi na manda zigenga
Kurugero, ku isoko ry’ubumwe bw’ibihugu by’Uburayi, icyemezo cya CE ntabwo ari ikirango cyo kwamamaza gusa ahubwo ni itegeko ryemewe. Munsi ya Amabwiriza agenga komisiyo y’ibihugu by’i Burayi , ibicuruzwa bigamije guhura n’umubiri w’umuntu bigomba kuba byujuje ubuziranenge n’ubuzima.
Muri Amerika ,. Ikigo cy’Amerika gishinzwe ibiribwa n’ibiyobyabwenge (FDA) kigenga ibicuruzwa nka OEM impapuro binyuze mu kwiyandikisha no kugenzura.
Impapuro zabugenewe hamwe nibindi bicuruzwa bigenewe guhura nuruhu rwimpinja ntibishobora kwinjira mumasoko rusange yisoko (supermarket, imiyoboro ya e-ubucuruzi, hamwe numuyoboro wubuvuzi) udafite ibyemezo byubahiriza kwerekana umutekano wabo kandi wizewe.
2. Ibyingenzi byimpamyabumenyi: Gutanga urunigi rwo gucunga ibyago
Urebye mu nganda, impamyabumenyi ijyanye nimpapuro zishobora gukoreshwa ntabwo ari imwe gusa '' yerekana ibimenyetso 'ahubwo ni uburyo bwuzuye bwo kubahiriza ibintu byinshi bikurikirana.
Ku bakora umwuga wabigize umwuga bafite uburambe bwigihe kirekire kumasoko yo hanze, impamyabumenyi mpuzamahanga ntabwo ikora nkibisabwa kwinjiza isoko gusa ahubwo ikora no kwerekana imbaraga zubushobozi bwo gukora, sisitemu yo kugenzura ubuziranenge, hamwe ninshingano zabaturage.
Hamwe na hamwe, izi mpamyabumenyi zishyigikira ibikorwa bisanzwe, byubahiriza, kandi buri gihe mubuzima bwibicuruzwa byose - harimo R&D, umusaruro, kurengera ibidukikije, umutekano, ninshingano zabaturage.
Gushiraho no gukora sisitemu yo gucunga neza kugirango habeho umusaruro uhamye, ubuziranenge bwibicuruzwa, hamwe nubushobozi bwo gukomeza gutera imbere.
Igena imicungire y’ibidukikije, igenzura ingaruka z’ibidukikije mu bikorwa by’umusaruro, kandi igateza imbere inganda n’icyatsi n’iterambere rirambye.
Yibanze ku micungire y’ubuzima n’umutekano ku kazi kugira ngo umutekano w’abakozi ukorwe kandi ugabanye ingaruka z’umutekano muke.
Witoze inshingano z’imibereho, ukurikize amahame mpuzamahanga y’umurimo, imyitwarire y’ubucuruzi, hamwe n’ibisabwa kubahiriza amasoko, kandi uzamure kumenyekanisha amasoko ku isi.
Menya neza ko ibicuruzwa bitarimo ibintu byangiza, byemeza umutekano n’ibidukikije byangiza ibidukikije.
Gukemura ibibazo byihariye byubahirizwa hamwe n’ibisabwa by’umutekano mu rwego rw’ibicuruzwa by’isuku kugirango ushimangire isuku y’ibicuruzwa n’umutekano w’umutekano.
Yujuje umutekano uteganijwe, ubuzima, n’ibidukikije ku isoko ry’ibihugu by’Uburayi, bituma isoko ry’amategeko ryinjira mu bihugu by’Uburayi.
Yubahiriza amabwiriza ajyanye n’ubuyobozi bushinzwe ibiryo n’ibiyobyabwenge muri Amerika, kugera ku isoko no kubahiriza amabwiriza muri Amerika ya Ruguru.
Itanga igeragezwa ryibicuruzwa, ubugenzuzi bwuruganda, hamwe no kugenzura ubuziranenge binyuze mumuryango wagatatu wemewe, byongera abakiriya ibyiringiro mubicuruzwa.
Kugenzura niba ibikoresho bishingiye ku biti bikoreshwa mu bicuruzwa, nka pompe no gupakira, biva mu mashyamba acungwa neza, byujuje ibisabwa ku bidukikije ndetse no gukurikirana ibidukikije.
Izi mpamyabumenyi zuzuzanya, zishyiraho uburyo bunoze bwo kugenzura ingaruka no kwangiza ibidukikije mu bice byinshi - birimo imicungire y’ubuziranenge, imicungire y’ibidukikije, umutekano w’akazi, inshingano z’imibereho, umutekano w’ibintu, kubona isoko, kwizerwa n’abandi bantu, hamwe n’amasoko arambye. Bakora kandi nk'ibipimo ngenderwaho byerekana ubushobozi bw'uruganda rukora ibicuruzwa binini, mpuzamahanga, kandi byujuje ibikorwa byohereza ibicuruzwa hanze.
3. Ingaruka Akenshi Zirengagizwa nabaguzi mubufatanye
Ibibazo bikunze kugaragara mubufatanye bwa OEM burimo:
Ibyemezo biremewe ariko ntibikubiyemo ibicuruzwa bigezweho; ( kurugero, barashobora gupfuka gusa impapuro zishobora gukoreshwa ariko ntibakureho impapuro. )
Icyemezo cya CE kirahari, ariko File Technique irabuze.
Impamyabumenyi ya ISO yararangiye cyangwa ntabwo yavuguruwe.
Ibyingenzi:
Impamyabumenyi zonyine ntizemeza kubahiriza; ubunyangamugayo bwa sisitemu yubuyobozi nicyo cyingenzi.
II. CE Icyemezo: Icyangombwa cyingenzi gisabwa impapuro zinjira kugirango zinjire ku isoko ryiburayi
1. Ibisobanuro nyabyo bya CE (Akenshi ntibumva nabi Abaguzi)
Intego yicyemezo cya CE ni:
Uruganda rutangaza ko ibicuruzwa byubahiriza amabwiriza y’ubumwe bw’ibihugu by’Uburayi kandi ko ashinzwe amategeko.
Ntabwo ari 'icyemezo cyiza, ' ahubwo ni 'imenyekanisha ryujuje ibisabwa rishyigikiwe ninyandiko za tekiniki. '
2. Ibyangombwa byingenzi bisabwa kubitabo byigenga munsi ya sisitemu ya CE
Kubicuruzwa byabigenewe, CE yibanze cyane kuri:
Umutekano wibikoresho (kubura imiti itera)
Umutekano wo guhuza uruhu (guhuza dermatologiya)
Kubahiriza ibirango n'amabwiriza
Icyitonderwa kidasanzwe:
Abatanga OEM benshi batanga gusa batanga 'CE ikimenyetso ' ariko ntibashobora gutanga ibyangombwa byuzuye; iki nikimenyetso gikomeye.
3. Inzira isanzwe kubaguzi kugirango bemeze icyemezo cya CE
Birasabwa ko ubona ibi bikurikira mugihe cyo gutanga amasoko:
Itangazo rihuza (DoC)
Idosiye yuzuye ya tekiniki
Raporo yikizamini cya gatatu (urugero, SGS / Intertek)
Ibicuruzwa byacu byabigenewe byose bishyigikiwe na CE yuzuye ya tekiniki iboneka bisabwe.
III. Sisitemu ya ISO: Urufatiro rwo guhuza ubuziranenge muri OEM Diaper
1. Kuki ISO igena kwizerwa k'ubufatanye bw'igihe kirekire?
Mu mishinga yacu nyayo ya OEM, twasanze ko:
Igipimo cyo kurega kubakiriya gifitanye isano cyane no gukura kwa sisitemu ya ISO.
ISO ntabwo ari icyemezo gusa; byerekana ubushobozi bwo kuyobora.
Ukurikije uburambe bufatika bwibikorwa byingenzi byohereza ibicuruzwa mu mahanga OEM, ISO ntabwo ari urutonde rwinyandiko gusa ku mpapuro, ahubwo ni urwego rukomeye rwibipimo bigomba gukurikizwa muburyo bwose - kuva R&D, amasoko, numusaruro kugeza kugenzura neza na serivisi nyuma yo kugurisha. Ni ngombwa cyane cyane kwemeza ibicuruzwa byujuje ubuziranenge, kubahiriza igihe ntarengwa cyo gutanga, gutsinda igenzura ry’abakiriya, no gukomeza kubahiriza amabwiriza yo hanze.
Mu nganda zikuze za OEM zikuze, sisitemu ya ISO (ishingiye kuri sisitemu yo gucunga neza ISO 9001 kandi ihujwe na ISO 14001, ISO 45001, nibindi) yashyizwe mubikorwa byingenzi:
(1) Igenzura ryimikorere ya SAP ikurura ibyingenzi nuburyo bwibanze
Kubyingenzi byibanze byimikorere-polimeri ya super absorbent polymer (SAP) imiterere yimikorere-sisitemu ya ISO isaba gushyiraho ibipimo ngenderwaho bisanzwe hamwe nuburyo bukoreshwa:
Igipimo cya SAP gihamye, gukwirakwiza uburinganire, ubwinshi, hamwe nuburyo bwo guhuza;
Kugenzura ingaruka zingenzi zingirakamaro nko gusibanganya intangiriro, guhuzagurika, gutandukanya ibice, hamwe no guhinduka;
Funga ibipimo byumuvuduko wumusaruro, imyanya yo gufatira hamwe, hamwe no gufunga ibikoresho kugirango wirinde ihindagurika ryimikorere iterwa no guhinduka kwabakozi.
Binyuze mu kugenzura inzira, menya neza ko igipimo cyo kwinjiza, gutembera neza, hamwe n’ubushobozi bwo gufunga amazi bikomeza kuba byiza kuri buri gicuruzwa.
(2) Sisitemu Yibikoresho Byakurikiranwe Sisitemu
ISO itegeka ibisabwa gukurikiranwa, bishyirwa mubikorwa muburyo bwo gutanga impapuro zikurikira:
Ibikoresho byose bibisi-birimo imyenda idoda, SAP, ibiti, ibiti bifata ibyuma bifata ibyuma, ibyuma bya elastike, na firime yinyuma - bigomba gukorerwa igenzura riteganijwe ukihagera, kandi amakuru yicyiciro agomba kwandikwa;
Mugihe cyo gukora, umubare wibikoresho fatizo, guhinduranya umusaruro, nimero yuruhererekane rwibikoresho, nibihe byo gukora birahuzwa;
Gushoboza urunigi rwuzuye rushobora gukurikiranwa kuva 'ibicuruzwa byarangiye → umusaruro wibyiciro → ibikoresho fatizo → utanga. '
Mugihe habaye ikibazo cyabakiriya cyangwa ubuziranenge budasanzwe, urugero rwikibazo rushobora kumenyekana vuba kugirango wirinde ibyago byo kwanduzwa kwinshi. Iki kandi nikintu kigenzurwa mugihe cyubugenzuzi bwuruganda nabakiriya b’abanyaburayi n’abanyamerika.
(3) Icyitegererezo gisanzwe no kurekura uburyo bwibicuruzwa byarangiye
Sisitemu ya ISO ihindura igenzura ryibicuruzwa byarangiye kuva 'urubanza rushingiye kuburambe ' muburyo bugereranywa, busubirwamo, kandi bushobora kugenzurwa:
Sobanura ibintu byo kwipimisha hamwe nibisabwa kugirango ugaragare, ibipimo, kwinjiza amazi, gucengera inyuma, gucengera kuruhande, kumeneka, imbaraga zingana, n'imbaraga zifatika;
Shyira mu bikorwa ibipimo ngenderwaho bya AQL hamwe n'ibipimo ngenderwaho byagenwe, uburyo bwo kugenzura, n'amategeko yo kwakira;
Andika kandi ubike amakuru yubugenzuzi mugihe nyacyo; shimangira byimazeyo kwigunga, gusubiramo, no kongera gukora / gusiba ibicuruzwa bidahuye kugirango wirinde koherezwa.
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ISO ishimangira uruzinduko rwa PDCA no gukomeza gutera imbere, ishyiraho uburyo busanzwe bwo gukemura ibibazo by'abakiriya:
Kwakira ibirego → Gutanga ikibazo → Kugenzura ku rubuga → Isesengura ry'impamvu (Abantu / Imashini / Ibikoresho / Uburyo / Ibidukikije) actions Ibikorwa byo gukosora ver Kugenzura neza → Gukumira ko bitazongera kubaho;
Ibibazo byose byabakiriya bigomba kuba byanditse kandi bigakoreshwa mugutezimbere umusaruro, kugenzura, cyangwa kuyobora;
Isesengura ryibarurishamibare risanzwe ryamakuru rikorwa kugirango rigabanye igipimo cy inenge ku isoko no kuzamura ireme ryigihe kirekire.
Muri rusange, sisitemu ya ISO ituma inganda za OEM zidashobora kuva kure 'umusaruro mwinshi ' no kugera kubikorwa bigenzurwa, ubuziranenge buhamye, ibibazo bikurikiranwa, hamwe niterambere ryashyizwe mubikorwa. Ntabwo ikora nkurwego rwibanze rwo kubahiriza ibyifuzo byabakiriya mpuzamahanga ariko kandi ikora nkingwate yibanze kubikorwa binini binini, bihamye.
IV. Logic Inyuma Yamabwiriza ya FDA: Urufunguzo rwo Kwinjira mumasoko yo muri Amerika hamwe nimpapuro zabigenewe
1. FDA Ntabwo ari 'Icyemezo ' ahubwo ni Sisitemu yo Kugenzura
Abaguzi benshi bibeshya ko FDA ari urwego rwemeza, ariko mubyukuri:
FDA ishimangira kwiyandikisha no gutanga
Ishimangira kubahiriza inzira zinganda
Ishimangira inshingano z'umutekano wibicuruzwa
2. Ibice byingenzi byibanze kuri FDA
Ku mpapuro zabigenewe:
Umutekano wibikoresho (cyane cyane urwego-ruhuza uruhu)
Ibirango
Sisitemu yo gucunga neza uruganda
3. CE na FDA: Itandukaniro ryingenzi Abaguzi bagomba gusobanukirwa
Ingingo |
Andika |
Isoko |
Ingorane |
CE |
Itangazo ryo guhuza |
EU |
Guciriritse |
FDA |
Sisitemu yo kugenzura |
Amerika |
Hejuru |
Inama zinzobere:
Niba abakiriya bawe bagenewe bari kuri Amazone cyangwa mumiyoboro yo muri Amerika ya ruguru, kubahiriza FDA birakomeye kuruta icyemezo cya CE.
V. Nigute ushobora guhitamo OEM Utanga Impapuro Zimpamyabumenyi Yuzuye?
1. Reba Hejuru Yimpamyabumenyi; Suzuma 'Sisitemu '
Turasaba gusuzuma abatanga ibyiciro bitatu:
Urwego 1: Kugenzura ukuri kwimpamyabumenyi
Urwego rwa 2: Menya neza ko ibyemezo bihuye nibicuruzwa (impapuro zabigenewe)
Urwego rwa 3: Suzuma ubushobozi bwabatanga kubungabunga no kuvugurura ibyemezo
2. Bafite Ubushobozi Bwukuri bwo Kwimenyekanisha Kubitabo Byabigenewe?
Uruganda rwose rushobora gukora OEM rugomba gushyigikira:
Guhindura imiterere yimyenda yimyenda
Guhindura sisitemu ya elastike mumapantaro yo gukuramo
Igishushanyo mbonera cyo gukuramo ibisubizo byabakuze
Umwanzuro
Ku baguzi mpuzamahanga, cyane cyane ba nyir'ibicuruzwa n'ababigurisha, urufunguzo ntabwo ari ukugenzura gusa niba utanga isoko 'afite ibyemezo, ' ahubwo ni ukumenya niba ibyo byemezo by’impapuro bifite ishingiro, byuzuye, kandi bikurikizwa ku bicuruzwa nyirizina by’ibicuruzwa urimo gushaka.
Ibibazo
1. Ese impapuro zose zabigenewe zisaba icyemezo cya CE?
Ntabwo impapuro zose zabigenewe zisaba ibyemezo bya CE byemewe , ariko niba uteganya kugurisha mukarere k'ubukungu bw’ibihugu by’Uburayi (EEA), kubahiriza CE ni ngombwa. Nubwo bitaba itegeko, abadandaza n'abacuruzi benshi baracyasaba icyemezo cya CE murwego rwo kwemerera abatanga isoko.
2.Ni ukubera iki ibyemezo byimpapuro ari ngombwa kubirango byabigenewe?
Kubafite ibirango, impapuro zimpapuro zigira ingaruka:
Kwinjira ku isoko (EU, Amerika, Uburasirazuba bwo hagati, Aziya y'Amajyepfo y'Uburasirazuba)
Iyemezwa rya platform (Amazone, iminyururu yo kugurisha)
Icyizere cy'umuguzi no kwizerwa kuranga
Hatariho impamyabushobozi ikwiye, niyo nziza yo mu rwego rwo hejuru irashobora guhura nimbogamizi zemewe nubucuruzi.
3.Ni gute nshobora kugenzura niba ibyemezo by'abatanga impapuro zemewe ari ukuri?
Kugenzura ibyemezo byimpapuro zimpapuro za OEM, ugomba gusaba:
Itangazo ryuzuzanya (Do C) kubyemezo bya CE
Inyandiko yuzuye ya tekiniki (Idosiye ya tekiniki)
Icyemezo cya ISO cyemewe hamwe no gutanga ibisobanuro byumubiri
Raporo yikizamini cya gatatu (urugero, SGS)
Urashobora kandi kunyuranya ninzego zemeza ibyemezo binyuze mububiko bwemewe nkubwa komisiyo yu Burayi.
