Raporo y'Ubwiza ngarukamwaka ya 2021

Gashyantare 2022

Ibyerekeye iyi raporo

1. Amabwiriza yo gukusanya

Raporo y’ubuziranenge bw’ubuziranenge itangwa n’isosiyete yanditswe hakurikijwe amategeko y’igihugu agenga ubuziranenge, amabwiriza, amategeko n’amahame ngenderwaho agenga ubuziranenge bw’inganda. Ubuziranenge bw’ubuziranenge bw’isosiyete n’imicungire y’ubuziranenge muri raporo ni ikimenyetso nyacyo cy’uko isosiyete ihagaze ubu. Isosiyete ifite inshingano zo kugenzura ibikubiye muri raporo mu buryo butabogamye no kugaragaza ukuri n’ubuhanga bw’ibyavuzwe n’imyanzuro bifatika.

2. Ingano ya raporo

Iyi raporo ifata Anji Hongde Medical Supplies Co., Ltd. nk'urwego rw'ingenzi, kandi isobanura ibikubiye mu mikorere y'isosiyete mu bwiza no mu bunyangamugayo mu 2021.

3. Ibisobanuro by'inyito

Kugira ngo byorohereze abantu kubivuga, raporo ivuga ko "Anji Hongde Medical Products Co., Ltd." ari "Hongde" na "Company" mu magambo ahinnye.

4. Igihe n'inshuro zo gutanga raporo

Igihe cyo gutanga raporo: Kuva ku ya 1 Mutarama 2021 kugeza ku ya 31 Ukuboza 2021, amakuru amwe n'amwe n'ibikubiye muri raporo biri hejuru y'urugero rwavuzwe haruguru.

Uruhererekane rwo gusohora raporo: Iyi raporo ngarukamwaka ni yo ya kabiri isohoka, kandi izasohoka buri mwaka guhera mu 2020.

5. Imiterere y'itangazwa rya raporo

Iyi raporo yasohotse nk'inyandiko y'ikoranabuhanga, iboneka kurihttp://e990.goodao.net/ urubuga rwo gukuramokandi usome.

Umwirondoro w'ikigo

Iyi sosiyete yashinzwe mu 2006, iherereye mu kigo cy’ubucuruzi bw’abahanga mu by’imiti cya Bamboo Industry Science and Technology Entrepreneurship Center, Xiaofeng Town, Anji, muri Zhejiang, ifite imari shingiro ya miliyoni 1.6 z’amayuan, ubuso bwa hegitari 25, ubuso bw’ubwubatsi bwa metero kare 23.000, n’umutungo wose hamwe wa miliyoni 66.54. Ni ikigo cy’ubushakashatsi n’iterambere, igishushanyo mbonera, umusaruro, kugurisha na serivisi nk’imwe mu nganda zikora ibikoresho byo gusiga imyenda yo kwa muganga.

Ibicuruzwa by'ingenzi ni ibitambaro bya viscose plaster, ibitambaro bya elastic, plaster pads, ibitambaro bya polymer fixed, ibitambaro bya polymer polimer, ibikoresho byo kugabanya ururimi, ibitambaro bya elastic, gauze ya vaseline, udupfukamunwa two kwa muganga dukoreshwa rimwe n'ibindi bicuruzwa bigurishwa mu gihugu imbere bikajyanwa mu Burayi na Leta Zunze Ubumwe za Amerika, mu Burasirazuba bwo Hagati no mu Majyepfo y'Amajyepfo ya Aziya n'ibindi bihugu n'uturere.

Iyi sosiyete yegukanye inzu y’inyenyeri eshanu y’abafite ubumuga mu Ntara ya Zhejiang, igihembo cy’ubuhanga bwigenga cya 2019, ikigo gito n’igiciriritse cy’ikoranabuhanga, ikigo cy’ubushakashatsi n’iterambere ku rwego rw’akarere, ahantu ho gukorera icyitegererezo mu buryo bw’igitekerezo cy’ “imisozi ibiri” mu 2019, itsinda ry’abanyeshuri b’icyitegererezo bateye imbere, n’akarere mu 2020. Igihembo cy’ubuziranenge bwa Guverinoma n’ibindi bihembo.

amateka y'intego

Igice cya Mbere Igitekerezo cy'Ubuziranenge

1.1 Intego y'ikigo

1.2 Icyerekezo cy'ikigo

1.3 Indangagaciro z'ikigo

1.4 Umuco w'ibigo

1.5 Politiki y'Ubuziranenge, Ibidukikije, Ubuzima n'Umutekano mu Kazi

1.6 Ingengabitekerezo iyobora

1.7 Indangagaciro z'Ubuziranenge

Igice cya kabiri Imicungire y'Ubuziranenge bw'Ibigo

2.1 Ikigo gishinzwe gucunga ubuziranenge

2.2 Sisitemu yo gucunga ubuziranenge

2.3 Gucunga ingaruka z'ubuziranenge n'umutekano

Igice cya gatatu Ubunyangamugayo mu by'Ubwiza

3.1 Ubwitange mu by'Ubuziranenge

3.2 Imicungire y'Imikorere

3.3 Imicungire y'Isoko

Igice cya Kane Ishingiro ry'Ubuziranenge

4.1 Ubuyobozi busanzwe

4.2 Gucunga ibipimo

.3 Ubuyobozi bw'Impamyabumenyi

4.4 Gucunga no kugenzura ibizamini

Igice cya Gatanu Inshingano z'Ubuziranenge bw'Ibicuruzwa

5.1 Urwego rw'Ubwiza bw'Igicuruzwa

5.2 Inshingano zo kugurisha ibicuruzwa nyuma yo kugurisha

5.3 Inshingano z'ikigo mu by'imibereho myiza

5.4 Rekodi nziza y'inguzanyo

Ururimi rw'amapfundo

Igice cya Mbere Igitekerezo cy'Ubuziranenge

1.1Intego y'ikigo

Hubaka ikirango cy’icyiciro cya mbere kandi ushyireho urugero rw’inganda.

1.2Icyerekezo cy'ikigo

Kuyobora abafite ubumuga kugira ngo baherekeze ubuzima bw'abantu ku isi.

1.3Indangagaciro z'ikigo

Ubunyangamugayo, gushyira mu bikorwa ibikorwa bifatika, guhanga udushya, ubwitange no kwita ku bafite ubumuga.

1.4Umuco w'ibigo

Mu myaka y’iterambere, Hongde yahoraga abona umuco w’ibigo nk’inkunga n’ingengabitekerezo y’iterambere, kandi yagiye yubaka umuco wihariye w’ibigo mu bijyanye n’intego z’ibigo, icyerekezo, n’indangagaciro zijyanye n’iterambere n’iterambere ry’ikigo. Nk’umutungo w’umwuka, umuco w’ibigo uhora utera ikigo gutera imbere.

Isosiyete ifata "kubaka ikirango cyo ku rwego rwo hejuru no gushyiraho ibipimo ngenderwaho by'inganda" nk'intego yayo y'ikigo, "guyobora abafite ubumuga mu guherekeza ubuzima bw'abantu ku isi" nk'icyerekezo cy'ikigo, ikurikiza igitekerezo cy'ingenzi cyo "guteza imbere umwuka w'ubugiraneza no guteza imbere intego y'abafite ubumuga", kandi iharanira kubaka umuco wa Hongde.

1.5Politiki yo gucunga Ubuzima n'Umutekano mu kazi, Ireme, Ibidukikije

Hongde yubahiriza cyane "Itegeko ry'Ubuziranenge bw'Ibicuruzwa", "Itegeko ryihariye ry'Umutekano w'Ibikoresho" n'andi mategeko n'amabwiriza y'igihugu ndetse n'ibisabwa n'amahame ngenderwaho y'igihugu yo gukora no kugurisha ibicuruzwa. Kugira ngo ikigo gishyireho uburyo buhamye bwo gucunga ibigo no kunoza ubuziranenge bw'ibicuruzwa, gikomeje kunoza no kunoza urwego rw'imicungire y'ubuziranenge, ku buryo urwego rw'imicungire y'ubuziranenge n'ubuziranenge bw'ibicuruzwa bya Hongde byazamuwe cyane.

Dukurikije garanti y’ubwiza bw’ibicuruzwa, tuzakomeza kunoza ubwiza bw’ibicuruzwa kugira ngo duhuze n’ibyo abakiriya bakeneye. Mu rwego rwo gukora ibikorwa by’ikigo, gahunda ya 6S ivuga ku “gutegura, gukosora, gusukura, gusukura, gusoma no kwandika, n’umutekano” ikoreshwa mu gucunga neza ibintu bikorerwa mu nganda nk’abakozi, imashini, ibikoresho, n’uburyo bwo gukora mu nganda, no guha abakozi ibidukikije byiza kandi bitekanye ku kazi no mu buzima. Abayobozi b’ikigo bita ku bakozi, bubaha uburenganzira bw’abakozi bose bwo kwiyandikisha no kwinjira mu mashyirahamwe y’abakozi ku bushake no gukora ibiganiro rusange, gutegura abakozi buri gihe kugira ngo bakore ibizamini by’umubiri, no gukora akazi keza mu gukumira no kuvura indwara zikomoka ku kazi. Gutegura hanze “Inyandiko z’ubuziranenge” zijyanye n’ubushakashatsi n’iterambere, gutanga amasoko, gukora, kugurisha, no kubungabunga nyuma yo kugurisha inyandiko zo gucunga ubuziranenge kugira ngo abakiriya babone ibicuruzwa bizewe, binoze kandi bikwiye.

1.5.1Politiki y'ubuziranenge:

Politiki y'ubuziranenge bw'ikigo ni iyi:

Shinga ubucuruzi bufite ubuziranenge kandi utsinde ufite ireme.

Ku bijyanye n'ubuziranenge, ni ngombwa guhaza abakiriya n'abandi bantu bireba ikoranabuhanga rigezweho, ibicuruzwa byiza, serivisi z'umwuga n'ubuyobozi bwiza binyuze mu guhanga udushya mu ikoranabuhanga, kugira ngo huzuzwe ibisabwa n'abakiriya n'amategeko n'amabwiriza, kandi hakorwe kunoza imikorere y'uburyo bwo guhuza ibitsina.

1.5.2Politiki y'ubunyangamugayo mu by'ubuziranenge:

Ubwiza ni wo muzi, imiterere ni wo shingiro, igishushanyo mbonera gishya, inganda nziza

1.6Ingengabitekerezo iyobora

Abayobozi b'ikigo bita ku iyubakwa ry'uburyo bwo gucunga ubuziranenge, bagashyiraho abakozi bihariye bashinzwe imicungire myiza, bagatanga igitekerezo cyo gushimangira uburyo bwo "kurwanya" (umwuka, gahunda, gushishikariza), kunoza uburyo no kongera ubushobozi, no gusobanura ingengabitekerezo iyobora "ubuziranenge butanga agaciro, serivisi zitanga ubuziranenge".

1.7Ubwitange bw'ubunyangamugayo mu by'ubuziranenge

Hongde yita ku kubaka umuco w’ikigo, agateza imbere imyitwarire myiza y’abakozi bakorana umwete, bitanga kandi bashinzwe inshingano, kandi yashinze itsinda ry’abakozi beza kandi bashinzwe inshingano kandi b’abanyamwuga. Dushingiye ku kubahiriza amategeko n’amabwiriza, ikigo gifata ibyo abakiriya bakeneye nk’ishingiro, gikora ibikorwa by’umusaruro n’imikorere binyuze mu bicuruzwa na serivisi byiza, gishyira mu bikorwa igitekerezo cyo gukora ibicuruzwa byiza mu bitekerezo by’abakozi bose b’ikigo, kandi gikomeza gukomeza ubumwe bw’ikigo no kunoza isura y’ikigo, kugira ngo kigere ku iterambere rirambye ry’ikigo. Ku bicuruzwa bifite ibibazo by’ubuziranenge, bitewe n’imimerere nyayo y’ikibazo, ikigo kibyishyura ku rugero rutandukanye.

Mu gihe gisanzwe cyo gutwara, kubika no gukoresha ibicuruzwa, mu mezi 24 uhereye igihe bibitswe ahantu humutse, niba hari ikibazo cy'ibihumyo, uwabikoze agomba kubisimbuza. Hamwe no gushyiraho umurongo wa serivisi ku bakiliya, gusubiza ibisabwa ku bakiliya mu masaha 48, no gutanga ibisubizo ku gihe.

Igice cya kabiri Imicungire y'Ubuziranenge bw'Ibigo

2.1Ikigo gishinzwe gucunga ubuziranenge

2.1.1Imbonerahamwe y'Ikigo

Dukurikije ibisabwa n'"Itegeko ry'Isosiyete" n'"Ingingo z'Ishyirahamwe", isosiyete ishyiraho imiterere y'ikigo kandi igashyira mu bikorwa sisitemu y'inshingano z'umuyobozi mukuru. Dukurikije icyerekezo cy'ubucuruzi n'ingamba zihari, hari amashami atandatu y'imikorere: Ishami rishinzwe ikoranabuhanga mu musaruro, Ishami rishinzwe ikoranabuhanga rigezweho, Ishami rishinzwe gutanga amasoko no kugura, Ishami rishinzwe imicungire rusange, Ishami rishinzwe iterambere ry'inyuma, n'Ishami rishinzwe igenamigambi n'imari. Umuyobozi mukuru w'isosiyete agenzura ko inshingano n'ububasha by'amashami yavuzwe haruguru n'imirimo ijyanye nayo byagenwe, kandi buri shami rigakora inshingano zaryo kandi rigafatanya gukoresha neza ingengo y'imari itangwa n'abakozi, ishoramari, ibikorwa remezo, ibikoresho, n'ibindi kugira ngo sisitemu y'imicungire ikore neza.

2.1.2Abahagarariye ubuyobozi

Ashyirwaho kandi agahabwa uburenganzira n'umuyobozi mukuru w'ikigo kugira ngo ayobore kandi agenzure imikorere ya sisitemu muri sisitemu yo gucunga ubuziranenge. Ashinzwe guteza imbere ishyirwa mu bikorwa ryihariye rya politiki y'ubuziranenge bw'ikigo, intego z'ubuziranenge, n'ingamba z'ubuziranenge, ndetse no kubisuzuma no kubinoza. Inshingano zihariye zirimo:
a) Dukurikije EN ISO 13485:2016 (IDT ISO 13485:2016), YY/T0287:2017), Uburyo bwiza bwo gukora ibikoresho by’ubuvuzi (Nomero 64) na MDD93/42/EEC nk’uko byavuguruwe n’ibisabwa mu 2007/47 /EC kugira ngo harebwe ishyirwaho, ishyirwa mu bikorwa n’ibungabungwa rya sisitemu yo gucunga ubuziranenge bw’ikigo; b) ushinzwe umuyobozi mukuru; c) ushinzwe gushyiraho, gushyira mu bikorwa no kubungabunga sisitemu yo gucunga ubuziranenge hakurikijwe ibisabwa n’amabwiriza n’amahame ngenderwaho, hamwe n’imiterere nyayo y’ikigo; d) gutanga raporo ku muyobozi mukuru Umuyobozi atanga raporo ku mikorere ya sisitemu yo gucunga ubuziranenge n’ibikenewe kunozwa; e) ashinzwe guhuza imikorere ya sisitemu kugira ngo harebwe imikorere isanzwe n’ishyirwa mu bikorwa neza rya sisitemu yo gucunga ubuziranenge; f) agenzura ko ubumenyi bwujuje ibisabwa n’amabwiriza n’ibisabwa na sisitemu yo gucunga ubuziranenge bukwirakwira mu kigo cyose; g) Ashinzwe gutegura isuzuma n’ishyirwa mu bikorwa ry’ibicuruzwa by’ingenzi bidahuye n’ibyo bisabwa; h) Ashinzwe gushyiraho no gushyira mu bikorwa itumanaho n'itumanaho byo hanze ku bibazo bifitanye isano n'uburyo bwo gucunga ubuziranenge;
i) Ashinzwe gusuzuma igitabo cy’amabwiriza agenga ubuziranenge no kwemeza inyandiko z’amabwiriza agenga imigendekere y’ibikorwa.
2.1.3 Ikoranabuhanga ry'Ubwiza
Ishami Nk'ishami ry'ibanze rigenzura ubuziranenge bw'ibicuruzwa, Ishami ry'Ikoranabuhanga ry'Ubwiza ni naryo ishami rishinzwe imicungire y'ubuziranenge bw'ikigo, kandi rigira uruhare runini mu kubaka imicungire y'ubuziranenge. Muri icyo gihe, hari inshingano nyinshi mu micungire, nk'izi zikurikira: j) Rishinzwe kugenzura no gupima ibicuruzwa (harimo ibikoresho fatizo, ibicuruzwa byarangiye neza n'ibicuruzwa byarangiye), kubika no gusohora; k) Rishinzwe gukurikirana no gupima ahantu ho kugenzura ubuziranenge, rishinzwe iby'ingenzi l) Rishinzwe gukusanya no gusesengura amakuru y'ubuziranenge bw'ibicuruzwa (amakuru); m) Gutegura isuzuma ridafite ishingiro, gutanga ibitekerezo no gushyira mu bikorwa uburyo bwo kujugunya, no kugenzura no kugenzura;
n) Ashinzwe gutunganya ibicuruzwa bidafite ishingiro no gukurikirana ibikorwa;
o) Ashinzwe gucunga ibikoresho byo gupima, gushyiraho amadosiye y'ibikoresho byo gupima, no kugenzura imirimo yo gupima; p) Gutegura amabwiriza yo kugenzura ibicuruzwa no kugenzura ishyirwa mu bikorwa; q) Gufasha mu gukemura ibibazo by'ubuziranenge bw'ibicuruzwa byakozwe; r) Gukora akazi keza mu kugenzura no gupima ibicuruzwa Kumenya aho bigeze; s) Gutegura no kwemeza amahame ngenderwaho ya tekiniki n'ibipimo ngenderwaho by'ibicuruzwa; t) Gukora ubushakashatsi no guteza imbere ibicuruzwa bishya, nibindi. u) Gufatanya n'ibibazo bya tekiniki muri serivisi nyuma yo kugurisha ibicuruzwa; v) Gufasha abahagarariye ubuyobozi gushyira mu bikorwa ibikorwa by'igenzura ry'imbere mu gihugu; Gutunganya ubuyobozi bwa tekiniki.

2.2Sisitemu yo gucunga ubuziranenge

Hongde inyurwa n'ibicuruzwa byayo ifite imiterere myiza n'imyitwarire myiza ya serivisi, kandi ihora ikora ingamba zo kunoza politiki y'ubuziranenge n'intego z'ubuziranenge kugira ngo bihuze n'iterambere ry'ikigo. Dukurikije amahame ya ISO 13485, isosiyete yashyizeho uburyo bwo gucunga ubuziranenge buhuza igishushanyo, iterambere, umusaruro, kugurisha na serivisi, kandi ibicuruzwa byatsinze icyemezo cya CE. Kugira ngo ihuze n'ibyo isosiyete ikeneye mu iterambere ryihuse, ikomeze gukomeza imirimo yo gucunga ubuziranenge, kandi inoze ishusho nziza y'ubuziranenge bw'ibicuruzwa, isosiyete yakomeje gukora akazi ko guhindura uburyo bwo gucunga ubuziranenge. Binyuze mu kwamamaza ikirango, isosiyete yazamuye cyane uburyo ikirango cya Hongde gikunzwe muri uru rwego, kandi yanazamuye ikirango cya Hongde ku isoko mpuzamahanga.

Isosiyete ishyira mu bikorwa kunoza buri gihe uburyo bw'imikorere binyuze mu igenzura ry'imbere n'igenzura rya buri mwaka, isuzuma ry'imicungire n'igenzura rikorwa n'abantu bo hanze kugira ngo harebwe ko uburyo bw'imikorere y'ubuziranenge bukora neza, bityo habeho ireme ry'umusaruro. Dukurikije ibisabwa n'amahame ya ISO 13485, isosiyete ikora imicungire y'imikorere y'ikigo ikurikije amategeko kandi ikurikije amategeko binyuze mu gushyira mu bikorwa "Inyandiko y'amabwiriza agenga ubuziranenge", inyandiko z'imikorere n'inyandiko zo ku rwego rwa gatatu kugira ngo harebwe ko ireme ry'ikigo, ibidukikije, politiki y'ubuzima n'umutekano mu kazi n'intego z'ubuziranenge, kugira ngo abakiriya n'abafitanye isano babone serivisi ishimishije.

2.2.1Uburezi bw'Ubunyangamugayo bufite Ireme

Ihame ry’iterambere rirambye kandi rirambye ry’imikorere ishingiye ku mategeko, ubunyangamugayo no kwizerwa, Hongde yateguye kandi ishyira mu bikorwa gahunda z’amahugurwa ku burezi bufite ireme n’ubunyangamugayo binyuze mu "Uburyo bwo Kugenzura Abakozi" na "Uburyo bwo Kugenzura Amahugurwa" kugira ngo igerageze uburyo bwo kwigisha no guhugura bufite ireme n’ubunyangamugayo. Kwamamaza no guteza imbere umwuka w’ubunyangamugayo mu kigo cyose. Kuva ku bayobozi kugeza ku bakozi bari imbere, Hongde ahora ashimangira ko umusaruro ukwiriye mbere na mbere, kandi agafata ubunyangamugayo n’ubunyangamugayo nk’urufunguzo rwo gufungura amarembo ku isoko. Kugenzura ubuziranenge; icyarimwe, gutegura ubwubatsi, kwamamaza no gukora ibikorwa by’umuco w’ubunyangamugayo mu kigo; gutegura abakozi gukora amahugurwa ahamye ku bidukikije n’umutekano n’ubuzima mu kazi. Uburezi bufite ireme n’ubunyangamugayo ni imbaraga nyamukuru zo gukora akazi keza mu gucunga ubunyangamugayo no ubunyangamugayo. Ni akazi k’igihe kirekire ko gushyiraho no gushimangira indangagaciro z’ingenzi z’ikigo. Hongde ikora ibishoboka byose kugira ngo ikore neza.

2.2.2Ubunyangamugayo no kwifata neza

Hongde yahoraga iha agaciro gakomeye kubaka ireme n'ubunyangamugayo bw'ikigo mu gihe ubumenyi bw'ikirango cyacyo bwakomeje kunozwa. Yashyizeho indangagaciro z'ikigo nk' "ubunyangamugayo, imikorere, guhanga udushya, ubwitange, no kwita ku bafite ubumuga". Isosiyete ikurikiza amategeko n'amabwiriza y'igihugu n'ay'ibanze, amahame y'igihugu, ay'ibanze n'ay'inganda, kandi ikerekana amategeko n'amabwiriza y'ikigo mu buryo bw'ukuri, butunganye, bujyanye n'igihe kandi bwuzuye.

2.2.3Intego z'ubuyobozi

Muri gahunda y’imicungire yo kunoza ubuziranenge, Hongde ihura n’ibibazo by’ibidukikije imbere mu gihugu no hanze yacyo ndetse n’impinduka zihoraho mu byo ibyifuzo by’impande zifitanye isano, ndetse n’ibisubizo by’ikigo ku byago n’amahirwe. Intego z’ubuyobozi za buri shami zirashyirwaho kandi intego z’imicungire y’ubuziranenge za buri shami zirashyirwaho.

Umuyobozi mukuru w’ikigo asobanukiwe neza ko irushanwa ku isoko ari irushanwa ry’impano, kandi ashimangira imbaraga z’abakozi mu burezi bw’ibicuruzwa n’amahugurwa ku bushobozi bw’ubucuruzi mu buryo bwose, akurikiza ihame ryo guhuza amahugurwa n’isuzumabumenyi, kandi agakoresha uburyo bwo guhuriza hamwe amahugurwa y’imbere n’ayo hanze. Gukomeza kunoza sisitemu y’uburezi n’amahugurwa. Kuva ku ngingo ebyiri z’ibyo abakozi bakeneye n’iterambere ry’ikigo, ibikubiye mu mahugurwa bitegurwa neza kandi mu buryo bukwiye, kandi amahugurwa y’urwego runini, y’ibyiciro byinshi, y’imihanda myinshi n’itandukanye akorwa kugira ngo yongere ubushobozi bw’abakozi mu bushobozi bw’imbere mu kigo, ubushobozi bwo gucunga ireme n’ibindi bice. Binyuze mu mahugurwa ahoraho no kuvugurura, impano z’ubuyobozi bw’ikigo n’impano za tekiniki ziratandukanye, kandi buri mwanya w’akazi ufite urwego rwiza rwo kwimura abakozi, byashyizeho urufatiro rwiza rw’abakozi mu iterambere ryiza ry’imicungire ireme.

2.2.4Intego z'ubuziranenge

a) Dukurikije ibisabwa na EN ISO 13485:2016 (IDT ISO 13485:2016), YY/T0287:2017), Uburyo bwiza bwo gukora ibikoresho by’ubuvuzi (Nomero 64) na MDD93/42/EEC nk’uko byavuguruwe kugeza 2007/47/EC Kureba ishyirwaho, ishyirwa mu bikorwa n’ibungabungwa rya sisitemu yo gucunga ubuziranenge bw’ikigo;

b) Ashinzwe umuyobozi mukuru;

c) Ashinzwe gushyiraho, gushyira mu bikorwa no kubungabunga uburyo bwo gucunga ubuziranenge hakurikijwe ibisabwa n'amabwiriza n'amahame ngenderwaho kandi hakurikijwe uko ikigo gihagaze mu buryo nyabwo;

d) Gutanga raporo ku muyobozi mukuru ku mikorere ya sisitemu yo gucunga ubuziranenge n'ibikenewe mu kunoza;

e) Ashinzwe guhuza imikorere ya sisitemu kugira ngo arebe ko imikorere isanzwe n'ishyirwa mu bikorwa neza rya sisitemu yo gucunga ubuziranenge;

f) kugenzura ko ubukangurambaga bukomeje kwiyongera mu kigo cyose kugira ngo huzuzwe ibisabwa n'amategeko n'ibisabwa mu micungire myiza y'ubuziranenge;

g) Ashinzwe gutegura isuzuma n'ishyirwa mu bikorwa ry'ibicuruzwa by'ingenzi bidahuye n'ibyo bicuruzwa;

h) Kugira inshingano zo gushyiraho no gushyira mu bikorwa itumanaho n'itumanaho byo hanze ku bibazo bifitanye isano n'uburyo bwo gucunga ubuziranenge;

i) Ashinzwe gusuzuma igitabo cy’amabwiriza agenga ubuziranenge no kwemeza inyandiko z’amabwiriza agenga imigendekere y’ibikorwa.

2.1.3Ishami ry'Ikoranabuhanga Rinoze

Nk'ishami ry'ibanze rigenzura ubuziranenge bw'ibicuruzwa, ishami ry'ikoranabuhanga ry'ubuziranenge ni naryo rishinzwe imicungire y'ubuziranenge bw'ikigo, kandi rigira uruhare runini mu kubaka ubuziranenge n'imicungire y'ubuziranenge. Muri icyo gihe, hari inshingano nyinshi n'inshingano mu micungire, nk'ibi bikurikira:

j) Ashinzwe kugenzura no gupima ibicuruzwa (harimo ibikoresho fatizo, ibicuruzwa byarangiye neza n'ibicuruzwa byarangiye), kubika no kurekura ibicuruzwa;

k) Ashinzwe gukurikirana no gupima ahantu ho kugenzura ubuziranenge, kandi ashinzwe gukurikirana ibikorwa by'ingenzi;

l) Ashinzwe gukusanya no gusesengura amakuru y’ubuziranenge bw’ibicuruzwa (amakuru);

m) Gutegura isuzuma ry’ibidakurikije amategeko, gutanga no gushyira mu bikorwa uburyo bwo gutatanya, no gukurikirana no kugenzura;

n) Ashinzwe gutunganya ibicuruzwa bidafite aho bihuriye n'ibyo bicuruzwa no gukurikirana ibikorwa byabyo;

o) Ashinzwe gucunga ibikoresho byo gupima, gushyiraho amadosiye y'ibikoresho byo gupima, no kugenzura imirimo yo gupima;

p) Gutegura amabwiriza yo kugenzura ibicuruzwa no kugenzura ishyirwa mu bikorwa ryabyo;

q) Gufasha mu gukemura ibibazo by’ubuziranenge bw’ibicuruzwa byakozwe;

r) Gukora akazi keza ko kugenzura ibicuruzwa no kumenya uko bihagaze mu isuzuma;

s) Gutegura no kwemeza amahame ngenderwaho y’ikoranabuhanga n’ibipimo ngenderwaho by’ibicuruzwa;

t) Gukora ubushakashatsi no guteza imbere ibicuruzwa bishya, n'ibindi.

u) Gufatanya gukemura ibibazo bya tekiniki muri serivisi y'ibicuruzwa nyuma yo kugurisha;

v) Gufasha abahagarariye ubuyobozi mu gushyira mu bikorwa ibikorwa by'igenzura ry'imbere mu kigo;

w) Gutanga ubuyobozi bwa tekiniki kuri gahunda.

Mu gihe cyo kunoza no guteza imbere ibikorwa, ibicuruzwa bigenwa mu cyerekezo cy’ubwiza hamwe n’ibisabwa byo hejuru kugira ngo bigire ubuziranenge n’imikorere myiza, ubushobozi bw’ikigo mu guhangana n’inganda burarushaho kunozwa, kandi intego z’ubwiza zigashyirwaho. Intego z’ubwiza bw’ikigo zigaragara muri “Imbonerahamwe yo Gusesa Intego z’Ubwiza”, kandi zimwe mu ntego ni izi zikurikira:
a. Igipimo cyemewe cyo kugenzura ibicuruzwa inshuro imwe kigera kuri 96%. b. Igipimo cy'ibirego ku bicuruzwa ntikirenza 2%; C. Impanuka y'umutekano w'umusaruro ni zeru.

Ishusho ya 2 Imbonerahamwe y'ibarurishamibare ku irangizwa ry'intego z'ubuziranenge mu 2021

2.2.5Intego yo gupima

Bitewe n'ibikoresho by'igenzura bifatika n'uburyo busanzwe bwo kugenzura, ibikoresho bihora bigenzurwa kugira ngo igipimo cy'igenzura ry'ibikoresho bigenzurwa kigere ku kigero cya 100%, kandi amahugurwa n'isuzuma ry'abakozi bashinzwe igenzura bisaba ko abakozi batsinda 100% mu gikorwa cy'ingenzi cyo gupima.

2.2.6Amabwiriza agenga ubuziranenge

Kugira ngo twongere ubugenzuzi n'imicungire y'ubuziranenge bw'ibicuruzwa, kunoza urwego rw'ubuziranenge bw'ibicuruzwa, gusobanura inshingano z'ubuziranenge bw'ibicuruzwa, no kurengera uburenganzira n'inyungu byemewe by'abakiriya, dushyira mu bikorwa by'umwihariko amategeko n'amabwiriza agenga ubuziranenge, nka "Itegeko ry'Ubuziranenge bw'Ibicuruzwa rya Repubulika y'Abaturage y'Ubushinwa" na "Sisitemu yo Gucunga Ubuziranenge bw'Ibikoresho by'Ubuvuzi". Ibisabwa ku Mabwiriza ", "Uburyo bwo Gucunga Ubuziranenge mu Gukora Ibikoresho by'Ubuvuzi", "Amabwiriza agenga Ubugenzuzi n'Imicungire y'Ibikoresho by'Ubuvuzi", "Amategeko yo Gushyira mu Bice Ibikoresho by'Ubuvuzi", "Amabwiriza agenga Ibikoresho by'Ubuvuzi n'Amabwiriza agenga Imicungire y'Ibikoresho by'Ubuvuzi", "Amategeko agenga Izina ry'Ibikoresho by'Ubuvuzi", "ISO13485: 2016″" MDD 93/42/EEC (2007/47/EC)", n'ibindi, bisaba ko ibicuruzwa byujuje ubuziranenge bikorwa ahantu hakwiye kandi ikirango cya Hongde kigakomeza kubahiriza amategeko.

2.2.7Sisitemu yo gucunga ubuziranenge

Hongde yashyizeho "Inzira yo Kugenzura Ubwiza", "Inzira yo Kugenzura Igenzura" na "Inzira yo Kugenzura Ibicuruzwa Bidafite Ubuziranenge" mu gucunga ubuziranenge. Guhera ku bikoresho fatizo, inzira yo gutunganya imikorere ifite ibikoresho byo gupima buri mukozi kugira ngo yigenzure, kandi hagategurwa igenzura rya buri munsi. Gukora isuzuma ry'ubuziranenge bw'ibicuruzwa bikorerwa mu buryo bugezweho, abagenzuzi bagenzura neza mbere yo kuva mu ruganda, kugenzura neza ubuziranenge bw'ibicuruzwa, no kugera ku 100% byujuje ibisabwa. Isosiyete yashyizeho "Inzira zo Kugenzura Ibiciro" na "Inzira zo Kugenzura Ubwiza" ku micungire y'ubucuruzi nko gucunga iyamamazabikorwa, gutegura no guteza imbere imiterere, gucunga amasoko, inzira yo gucunga umusaruro, inzira yo kugenzura, gupakira, inzira yo gucunga ubwikorezi, inzira yo gucunga abakozi bo hanze no gucunga ububiko. "n'izindi nzira zijyanye nazo zo gukurikirana, gukurikirana no gucunga inzira yose y'ibicuruzwa kugira ngo hagerwe ku ngaruka zo gukumira ibibazo mbere yuko bibaho, kugira ngo harebwe kandi binoze.ireme ry'ibicuruzwa.

Buri cyumweru, ikigo gihuza ishami rishinzwe umusaruro n'ishami rishinzwe ikoranabuhanga rijyanye n'ubuziranenge kugira ngo bagire inama zihoraho zo kuganira ku bibazo biri mu bitekerezo by'ubuziranenge bw'ibicuruzwa bitangwa n'abakiriya, baganire hamwe ku bisubizo bifatika bivuye mu gitekerezo cyo kurandura ibibazo by'ubuziranenge, no kwandika ibibazo by'ubuziranenge byatangajwe n'abakiriya kugira ngo babe maso. Kunoza no kunoza uburyo bwo gucunga ubuziranenge kugira ngo buhuze n'ibisabwa n'ubuyobozi n'ibikenewe ku isoko.

2.2.8Indishyi ku nshingano z'ubuziranenge

Ubwiza ni ryo shingiro rya Hongde. Kugira ngo hagenzurwe buhoro buhoro ubuziranenge bw'ibicuruzwa biva aho bituruka, intambwe ya mbere ni ukugenzura ubuziranenge bw'ibikoresho fatizo byinjira. Ibikoresho fatizo bigurwa mu nganda zo hanze bigomba kugeragezwa n'abagenzuzi b'inzobere kugira ngo byuzuze imiterere yose y'ibikoresho bisabwa n'isosiyete mbere yuko byemerwa. Isosiyete y'ibikoresho isabwa kugira ishami ryihariye ry'ibiganiro kugira ngo ritange inshingano z'inyongera ku mucuruzi kugira ngo rikore igenzura ry'imiterere mibi. Igisubizo cyihariye giterwa n'ikibazo cy'ubuziranenge. Intambwe ya kabiri, kugenzura neza inzira, nk'uko izina ribisobanura, ni kugenzura umusaruro n'uburyo utunganywa mu ruganda. Isosiyete ifite imirongo y'ibikorwa n'ibikoresho bigezweho hamwe n'abakora ibikoresho b'inararibonye, ​​ishushanya imbonerahamwe yo gutunganya ibicuruzwa hakurikijwe ibyo abakiriya bakeneye, kandi igashyiraho inzira z'ikoranabuhanga rikwiye ryo gutunganya. Gukora no gutunganya ibicuruzwa bihuye neza n'ibisabwa. Ibikorwa bisaba gukora, abakora muri buri gikorwa bigenzura ubwabo, kandi hari abagenzuzi bajyanye muri buri sano kugira ngo bakore igenzura. Igenzura rya nyuma rishyirwaho ku bicuruzwa byarangiye nyuma yo gutunganywa, kandi igenzura ryuzuye 100% rikorwa ku bicuruzwa. Intambwe ya gatatu ni ugutanga serivisi nziza nyuma yo kugurisha ku bicuruzwa byahoze ari uruganda. Uko byagenda kose mu gihe cy’ingwate y’ibicuruzwa, ikigo kizafata iya mbere mu gufata inshingano no gutanga ibisubizo n’ubufasha mu bya tekiniki ku bibazo by’ubuziranenge kugira ngo abakiriya banyurwe.

Isosiyete irushaho kunoza ubwiza bw'ibicuruzwa kandi ikagabanya ikiguzi cy'umusaruro binyuze mu gucunga ubuziranenge bwose. Dukurikije ibisabwa mu iterambere rusange ry'isosiyete, kandi hakurikijwe ihame ryo guhuza ubuziranenge bw'ibicuruzwa by'isosiyete n'inyungu rusange n'inyungu z'abakozi, hashyizweho uburyo bujyanye nabyo. Kugira ngo hirindwe impanuka zikunze kubaho, hashyirwaho uburyo bwo gukurikirana ibibazo, hakemurwa impamvu kandi hagashakishwa ibisubizo. Muri icyo gihe, kugira ngo hamenyekane uburenganzira n'inyungu byemewe by'abakiriya, isosiyete ihora itanga ibicuruzwa byujuje ibisabwa bifite ubuziranenge. Ishami rishinzwe igenamigambi rishyiraho politiki zijyanye n'ubucuruzi, ricunga ibirego by'abakiriya n'ibyishyurwa, riteza imbere iterambere ry'isosiyete, kandi rigasuzuma abantu babishinzwe.

2.3Gucunga ingaruka z'ubuziranenge n'umutekano

2.3.1Ibirego by'ubuziranenge

Hongde ahora yita ku byo abakiriya bakeneye, agashyira mu bikorwa amahame yo "gukorera mu buryo bw'umutima no guteza imbere ubumenyi", agafata kunyurwa kw'abakiriya nk'intego yacu ihoraho, kandi agashyiramo kunyurwa kw'abakiriya nk'intego nziza y'ikigo. Kugira ngo yorohereze ibirego by'abakiriya, ikigo cyashyizeho umuntu wihariye ushinzwe kwakira ibirego. Isosiyete yashyizeho uburyo nka "Uburyo bwo Kunyurwa kw'Abakiriya no Kugenzura Ibitekerezo", "Uburyo bwo Gukurikirana Ibihe Bibi no Kuvugurura Isuzuma", na "Uburyo bwo Gukurikirana no Kugenzura Nyuma yo Kugurisha" kugira ngo ijyane neza n'imibanire y'abakiriya. Sobanura neza ishami rishinzwe gukemura ibirego by'abakiriya, gukemura ibibazo by'abakiriya ku nshuro ya mbere, no kugera ku gisubizo cyihuse.

Imbonerahamwe ya 3 Uburyo bwo Gukemura Ibibazo by'Abakiriya

2.3.2Gukurikirana Ingaruka z'Ubuziranenge

2.3.2.1Ingingo zo kugenzura ubuziranenge

Hongde akora isuzuma ry'ingenzi ku ngaruka ziri mu biranga by'ingenzi, ibice by'ingenzi n'isano ridafite imbaraga mu bwiza bw'umusaruro, kandi agashyiraho uburyo bwo gucunga inzira kugira ngo abicunge. Gushyiraho umuntu wihariye ushinzwe kugenzura buri sano. Umuntu ushinzwe afite ubushobozi bwo gutegura, gutegura ibikoresho, gutegura ibikoresho, gutegura inyigisho z'imikorere, gutegura ibidukikije, gutegura isuzuma n'ubundi bushobozi bwo guhuza ibikorwa, kandi agakoresha uburyo bwo kugenzura ahantu ho kugenzura ubuziranenge. Atuma ingaruka ziri mu biranga by'ingenzi, ibice by'ingenzi n'isano ridafite imbaraga mu bwiza bw'umusaruro zigenzurwa.

2.3.2.2Igenzura ry'Ubuziranenge n'Igenzura

Hongde yashyizeho ishami rishinzwe ikoranabuhanga ry’ubuziranenge, inzobere mu kugenzura ubuziranenge kugira ngo igenzure kandi igenzure uburyo buri ruhererekane rw’ibicuruzwa rukorwa, n’inzobere mu gucunga ibikorwa kugira ngo igenzure ishyirwa mu bikorwa rya buri hantu hakorerwa ibikorwa n’icyiciro cy’ibikorwa. Dukurikije uburyo bwo gusuzuma ubuziranenge n’imicungire y’ibikorwa byakozwe n’isosiyete, ibibazo biboneka mu kugenzura ubuziranenge n’igenzura ry’imiterere n’imimerere mibi abakora ibikorwa bahura na yo mu gikorwa cyo gukora ibintu birakosorwa kandi bigakurikiranwa hakurikijwe uko ibintu bimeze mu buryo nyabwo.

2.3.3Gucunga neza impanuka zihutirwa

Isosiyete ishyiraho kandi ikomeza uburyo bwiza bwo kwitegura no gusubiza ibibazo byihutirwa ku nguzanyo kugira ngo itange ibisubizo byihuse kandi ku gihe ku bibazo bishobora kuba bidafite ireme cyangwa ibibazo byihutirwa. Isosiyete yashyizeho umuyoboro wuzuye wa serivisi nyuma yo kugurisha, ishyiraho telefoni zitanga serivisi ku bakiriya kugira ngo zakire ibirego by'abakiriya, kandi yashyizeho abakozi batanga serivisi nyuma yo kugurisha kugira ngo batange serivisi nyuma yo kugurisha no gukemura ibirego by'abakiriya. "Uburyo bwo kugenzura no kugenzura nyuma yo kugurisha" bwateguwe ku bakozi bashinzwe nyuma yo kugurisha, kandi hashyizweho uburyo bwo gukemura ibirego by'abakiriya. Niba ikibazo kimwe cy'ubuziranenge cyakemuwe inshuro 3 mu gihe cy'ingwate kandi kitarakemuka, isosiyete izasimbuza. Ishami rishinzwe igenamigambi rizakurikirana kandi rigarure kuri buri kibazo kugira ngo rirebe ko ikirego gifunze kandi umukiriya anyuzwe. Kugeza ubu nta gikorwa na kimwe isosiyete yari yakora cyo gutangaza amakuru.

Igice cya gatatu Ubunyangamugayo mu by'Ubwiza

3.1Ubwitange mu Ireme

Hongde asezeranya umuryango wose n'ukwishyira ukizana mu buryo bweruye:

1. Kuba inyangamugayo ku bakozi no gushyiraho uburyo bwo kwigisha ubuziranenge n'ubunyangamugayo, gahunda yo gutanga ibihembo n'ibihano. Gushyiraho amabwiriza agenga ubuziranenge n'ubunyangamugayo, gutegura buri gihe abakozi kugira ngo bige amahame agenga ubuziranenge n'ubunyangamugayo, gushimangira ubumenyi ku buziranenge n'ubunyangamugayo, no gusaba inyandiko zijyanye nabyo; gushyira mu bikorwa inshingano z'ubunyangamugayo hamwe n'inshingano z'akazi k'abakozi, gushyiraho isuzuma ry'ubuziranenge n'uburyo bwo gutanga ibihembo n'ibihano, no guteza imbere abakozi kugira uruhare rugaragara mu ireme ry'ikigo. Kubaka ubunyangamugayo.

2. Kuba ushinzwe ikigo no gushyiraho uburyo bwo kugenzura ubuziranenge bw'ubuziranenge. Dukurikije amabwiriza abigenga, ibikoresho byo kugenzura no gupima bikoreshwa bigomba gusuzumwa buri gihe cyangwa gupimwa kugira ngo harebwe ko ibikoresho byo kugenzura no gupima byujuje ibisabwa n'amahame ngenderwaho y'igihugu; hashingiwe ku bikoresho byo gupima bisanzwe, hagomba gutangwa abagenzuzi babishoboye cyangwa babishoboye kugira ngo bagenzure ibikoresho fatizo n'ibicuruzwa byatanzwe hanze. Ibice byatanzwe hanze bigenzurwa cyangwa byemejwe neza, kandi inyandiko z'igenzura cyangwa igenzura zigomba kubikwa uko bikenewe; ibikoresho by'igenzura by'uruganda bikenewe bifite ibikoresho, kandi umusaruro wa nyuma ugenzurwa neza kandi ukagenzurwa hakurikijwe ibisabwa bisanzwe, kugira ngo ibicuruzwa bidafite ibyangombwa bidasohoka mu ruganda. ibisabwa, kandi hagashyirwaho inyandiko z'igenzura ry'uruganda rw'ibicuruzwa byujuje ibisabwa hakurikijwe amabwiriza;

3. Ushinzwe abakiriya, gushyiraho abakozi bashinzwe kwakira ibirego na serivisi nyuma yo kugurisha. Ibicuruzwa bigurishwa abakiriya biherekezwa n'ibyemezo byo kugenzura, kandi bigaha abakiriya amabwiriza yo kugenzura ibicuruzwa; gutondeka no kugabanya abakiriya kugira ngo bibuke ibisabwa byihariye ku bakiriya bihariye ku bicuruzwa; gushyiraho itsinda rishinzwe kwakira ibirego n'urusobe rwa serivisi nyuma yo kugurisha, mu gihe cyasezeranijwe. Gufasha abakiriya gukemura ibibazo bahura nabyo mu gihe cyo gukoresha ibicuruzwa, gukemura neza ibirego by'abakiriya n'ibirego ku bwiza bw'ibicuruzwa, no guharanira gutuma abakiriya banyurwa; gukora ubushakashatsi ku kunyurwa kw'abakiriya, gusobanukirwa ibyo abakiriya bakeneye, no gukomeza kunoza ubwiza bw'ibicuruzwa.

4. Kuba ushinzwe sosiyete no gushyiraho uburyo bwuzuye bwo gukurikirana ibicuruzwa. Ibicuruzwa byagaragaye ko bifite inenge bishobora kwimurirwa ku gihe; impanuka z’ubuziranenge bw’ibicuruzwa zishobora kwitabwaho ku gihe, kandi abantu babishinzwe bagomba kubibazwa, kandi hagashyirwaho gahunda yo kunoza no gushyira mu bikorwa, kandi hagashyirwaho ubuziranenge n’imyitwarire yo kwitwara neza mu gukoresha ibirango bigaragaza ko ibicuruzwa ari ibyawe. Kugaragaza cyangwa gutanga amasezerano rusange no kuba ushinzwe imiterere y’ibikoresho fatizo byakoreshejwe mu gusiga ibicuruzwa, gusiga ibicuruzwa cyangwa imikorere y’ibicuruzwa igaragaza ubuziranenge bw’ibicuruzwa.

Iyo ikibazo cy’ubuziranenge bw’ibicuruzwa by’isosiyete gitumye bitangazwa mu gihugu no mu mahanga, bigasubizwa cyangwa bigasenywa, isosiyete yemera ku bushake uburyo bukwiye bwo kubyakira butangwa na leta n’amasezerano ajyanye na byo hakurikijwe amabwiriza.

3.2Ubuyobozi bw'Imikorere

3.2.1Kunoza uburyo bwiza bwo gucunga no gushimangira imicungire myiza

Mu myaka yashize, Hongde yakomeje kubahiriza ibyo abakiriya bakeneye nk'insanganyamatsiko, kandi ikomeza kunoza imicungire myiza y'ibicuruzwa hakurikijwe ibisabwa mu rwego rw'ubuziranenge bw'ibicuruzwa. Bitewe n'amahame ngenderwaho y'igihugu n'amahame ngenderwaho y'inganda, Hongde yakomeje kunoza uburyo bwo gukora, kunoza imiterere y'ibikoresho, no gukora ibicuruzwa byiza kandi bizigama ingufu. Ibicuruzwa byiza cyane. Imikorere myiza ya sisitemu yo gucunga ubuziranenge, sisitemu yo gucunga ibidukikije, sisitemu yo gucunga ubuzima n'umutekano mu kazi n'izindi sisitemu mu kigo byateje imbere cyane ireme ry'akazi n'ubuziranenge bw'ibicuruzwa, kandi byateje imbere iterambere ryihuse ry'ikirango cya Hongde.

3.2.2Kugenzura cyane no gushyira imbaraga mu micungire y'ibikorwa

Dukurikije igenzura ry’ubuziranenge bw’ibikoresho fatizo, ibicuruzwa birangiye neza n’ibicuruzwa birangiye, ishami ry’ikoranabuhanga ry’ubuziranenge ry’ikigo rishyiraho uburyo bwo gucunga bukubiyemo ibintu byose bigenzura kandi bugagenzura inzira yo gukora kuri buri rwego. Gushyiraho uburyo bwo gucunga neza ibikorwa, nko gushyiraho imyanya n’inshingano, kugenzura ibikorwa, gusuzuma ubuziranenge, kubazwa, gukurikirana ubuziranenge, gusesengura imibare, nibindi, kugira ngo hagenzurwe uburyo bw’ingenzi bwo kugenzura ibikorwa by’ingenzi n’imikorere isanzwe y’ibikorwa rusange. Ishami ry’ikoranabuhanga ry’ubuziranenge rigenzura ubuziranenge bw’ibicuruzwa binyuze mu kugenzura neza inzira yo gukora no kugenzura neza utuzu tw’ingenzi.

Imbonerahamwe ya 4 Inzira yo kugenzura ubuziranenge

3.2.3Gushyiraho uburyo bwo kugenzura no gushyira mu bikorwa imicungire y'inshingano

Isosiyete igabanya buri tsinda rishinzwe gucunga umusaruro, ikagena umuntu ushinzwe akarere ushinzwe kugenzura no kugenzura ubuziranenge bwa buri tsinda rishinzwe umusaruro. Ishami rishinzwe Ikoranabuhanga Rinoze n'amatsinda afitanye isano basubiza vuba ibibazo by'abakiriya ku birebana n'ubuziranenge bw'umusaruro, bagashyira mu bikorwa ibisabwa n'ibirego by'abakiriya kandi bagakurikirana iterambere ry'imitunganyirize y'umusaruro. Itsinda rishinzwe ibibazo by'abakiriya n'umuntu ushinzwe inshingano.

3.2.4Gushishikariza abakozi bose kwitabira kugira ngo bagere ku kunoza ireme

Iyi sosiyete iha agaciro gakomeye kubaka umuco mwiza, kandi ifata imico nk'ishingiro ry'amahugurwa n'uburezi bwiza. Iyobora abakozi bose kugira uruhare mu micungire myiza. Binyuze mu ngamba zihoraho kandi zirambuye nko kubaka ibintu mu buryo bwumvikana, gutanga ibitekerezo ku kunoza ubuziranenge, no kunoza imikorere y'ibikoresho, abakozi benshi bashobora kugira uruhare rusesuye muri buri sano ryo kunoza ubuziranenge. Muri icyo gihe, abakozi basabwa kwigenzura ubwabo no kugenzurana, kugira ngo bahurize hamwe kunoza ubuziranenge bw'ibicuruzwa no gusangira umusaruro w'ubuziranenge.

3.2.5Kuzamura ihererekanyamakuru no kongera imbaraga mu kugenzura ibipimo

Hashingiwe ku bisabwa muri politiki y’ubuziranenge, Hongde iteganya intego z’ubuziranenge z’umwaka utaha buri mwaka, kandi igashyira intego rusange mu mashami atandukanye y’imikorere. Muri icyo gihe, gahunda yo gushyira mu bikorwa izageragezwa kandi ikurikiranwe, kandi inenge zizavumburwa kandi zinozwe mu gihe kugira ngo zihuze n’intego z’ubuziranenge n’ibisabwa n’ikigo. Kugira ngo inoze uburyo bwo kohereza amakuru meza no kuyatanga ku gihe, ikigo cyavuguruye sisitemu y’amakuru meza. Kohereza amakuru mu buryo nyabwo n’imibare yihuse kandi nyayo bigerwaho binyuze muri sisitemu yo gusangira amakuru.

3.3Ubuyobozi bw'Iyamamazabikorwa

Isosiyete ishyiraho gahunda yo kwamamaza buri mwaka, ikayigabanyamo imirimo ya buri kwezi yo gukoresha ikoranabuhanga n'abacuruzi bajyanye nayo, kandi igatandukanya abacuruzi bashinzwe akarere. Isosiyete ikora igenzura ry'uruganda ku bicuruzwa byose bya Hongde bigurishwa, kandi ishobora gutanga amakuru ajyanye n'ibipimo by'igenzura. Ibicuruzwa by'isosiyete bigurishwa hirya no hino mu gihugu kandi bikaba umufatanyabikorwa w'ubucuruzi w'abakiriya. Isosiyete ikora ibikorwa byo kwagura isoko mu buryo bugamije inyungu, ikomeza gukomeza isura y'ikirango kandi igakoresha abakiriya bashobora kuba abakiriya. Abayobozi bakuru b'isosiyete n'abakiriya beza b'ingamba bashyizeho umubano mwiza w'ubufatanye binyuze mu gusurana buri gihe no guhura hagati y'abayobozi bakuru n'ubundi buryo. Umucuruzi ashyiraho kandi agakomeza umubano mwiza w'ubufatanye n'abakiriya binyuze mu gusurana buri gihe no gutumanaho kuri telefoni. Kandi mu "gukemura ibibazo by'ubuziranenge n'abakiriya", hashyizweho uburyo bwuzuye bwo kwakira no gukemura ibibazo by'abakiriya. Ishobora kwakira no gukemura ibibazo by'abakiriya ku gihe kugira ngo yongere kunyurwa n'abakiriya n'isosiyete.

Guhanga udushya mu bijyanye no kwamamaza, kwagura itsinda rishinzwe kwamamaza, gushimangira imicungire, kuba indahemuka ku kigo, no kunoza uburyo bwo guhatana mu guhatanira inyungu, ufite intego n'inshingano bisobanutse, kandi ugereranye imikorere ku bantu. Kunoza no gushyiraho uburyo busanzwe bwo kwamamaza, gushyiraho dosiye z'abakiriya, gukomeza guteza imbere inzira zo kwamamaza imbere mu gihugu no mu mahanga, no gushyira mu bikorwa inshingano zijyanye n'imikorere ku bantu. Kubaka ihuriro ryiza ry'ibigo, gutangaza amakuru ku bicuruzwa ku gihe, no kwagura ubucuruzi kuri interineti.

Igice cya Kane Ishingiro ry'Ubuziranenge

4.1Ubuyobozi busanzwe

Isosiyete yahoraga ikurikiza amabwiriza agenga imicungire, kandi yashyizeho imirongo itatu y’amabwiriza agenga inyandiko: amahame agenga imicungire, amahame ya tekiniki, n’amahame agenga akazi.

Iyi sosiyete ishingiye ahanini ku muyobozi mukuru kandi ikongerwamo abayobozi b'amashami atandukanye. Iteganya kandi ikayobora ishyirwaho ry'ingamba zo guteza imbere ubuziranenge bw'ibigo, gahunda z'akazi ngarukamwaka, n'ingamba zo kugenzura ubuziranenge bw'ubuziranenge. Inama zisanzwe zibera kugira ngo ziganire kuri politiki nziza zo gucunga no kwandika igitabo muri iyo sosiyete. Ishyirwa mu bikorwa muri iyo sosiyete. Iyi sosiyete irimo kuzuza ibisabwa n'abakiriya ku bicuruzwa, kandi icyarimwe, mu gihe cyo gushushanya no gukora, sosiyete ikoresha cyane amahame mpuzamahanga yo kugenzura (ISO), amahame y'igihugu (GB), amahame y'inganda n'andi mahame y'igihugu kugira ngo igerageze ubuziranenge bw'ibicuruzwa, ibyo bikaba binoza cyane ubuziranenge bw'ibicuruzwa. Ubuziranenge bwateje imbere iterambere ry'ikirango cy'isosiyete ku masoko yo mu gihugu no mu mahanga. Ishami rishinzwe imicungire rusange y'isosiyete rishyiraho inshingano z'akazi za buri mwanya, rishyiraho amahame arambuye y'akazi ku rwego rwo gufata ibyemezo by'isosiyete na buri mwanya w'akazi, rishyiraho ibisobanuro by'imikorere ya buri shami, kandi rikanasobanura neza inshingano z'akazi za buri mwanya.

4.2Gucunga ibipimo

Hongde yashyizeho politiki yo gucunga neza ibipimo hakurikijwe amategeko n'amabwiriza y'igihugu, anashyiraho laboratwari yihariye yo gutegura no gucunga ibikoresho byo gupima. Yashyizeho abakozi basanzwe bapima, bashinzwe gucunga ibikoresho byo gupima by'ikigo. Mu myaka ya vuba aha, isosiyete yatangije ibikoresho byo gupima mu gihugu, byakemuye neza ingorane zo gupima kandi bitanga icyizere gikomeye cyo gukora ibicuruzwa byiza. Amakuru y'ibipimo meza kandi yizewe agaragazwa n'ibikoresho bisanzwe byo gupima kugira ngo bigenzure kandi biyobore umusaruro, kandi byagize inyungu nziza mu bukungu no mu mibereho myiza.

4.3Ubuyobozi bw'Impamyabumenyi

Iyi sosiyete ikora ibicuruzwa byiza cyane kandi byujuje ibisabwa n'abakiriya mu gihe imicungire y'ibidukikije yubahiriza amategeko n'amabwiriza y'igihugu, kandi igatanga, ikagurisha kandi igakora hakurikijwe uruhushya rwo gukora ibikoresho by'ubuvuzi rutangwa n'Ikigo gishinzwe imiti mu Ntara ya Zhejiang. Hakurikijwe ibisabwa mu iterambere ry'iyi sosiyete, uburyo bwo gukora bwakomeje kunozwa no kunozwa. Iyi sosiyete yatsinze neza icyemezo cya sisitemu yo gucunga ubuziranenge ya ISO 13485, kandi ibicuruzwa byatsinze icyemezo cya CE, gihamya ko ibicuruzwa byiza bitangwa kandi kikanagenzura amahame n'amahame agenga ibikorwa bitandukanye byo gukora no gukora. , Iterambere ryiza kurushaho.

4.4Gucunga no kugenzura ibizamini

Intego yo kubaka "Hongde" ikaba ikigo gikomeye mu bijyanye n'ibiciro no kwamamaza ikirango ku isi, ikigo gikomeza kwagura itsinda ry'abagenzuzi, gikomeza ubushobozi bw'abagenzuzi mu by'umwuga, kandi kikanoza ireme ry'ibicuruzwa mu buryo bunoze. Dukurikije inzira ikorwamo n'ikigo hakurikijwe ibipimo n'ubwoko bwabyo, hashyizweho itsinda rishinzwe kugenzura ibikoresho bitandukanye kugira ngo rikore igenzura ku nzego zitandukanye. Ikigo gishyiraho ikaye y'ibikoresho byo gupima, kandi gitanga ibikoresho n'ubufasha bwa tekiniki mu kubungabunga ibikoresho n'ibikoresho byo gupima buri gihe, ndetse no gupima abakiriya.

Abagenzuzi b'ubuziranenge bw'ibikoresho by'igenzura bahawe amahugurwa y'umwuga kandi bashobora gutangira imirimo yabo gusa nyuma yo gutsinda isuzuma. Gutegura buri gihe abagenzuzi b'ubuziranenge kugira ngo bahanahane ibibazo bitandukanye bahura nabyo mu isuzuma, no gushyiraho ingamba zo gukosora ku gihe kugira ngo bongere urwego rw'igenzura n'ireme ry'akazi k'abagenzuzi b'ubuziranenge. Mu igenzura n'imicungire, sisitemu zitandukanye, inshingano z'akazi, inzira zo gukoresha ibikoresho, ubushishozi mu by'umutekano, ingamba zo kwirinda, n'ibindi byose biri ku rukuta kugira ngo byoroshye gushyira mu bikorwa.

Igice cya Gatanu Inshingano z'Ubuziranenge bw'Ibicuruzwa

5.1Urwego rw'Ubwiza bw'Igicuruzwa

Gutunganya no gutunganya buri gicuruzwa cy’ikigo bifite inzira yuzuye kandi igezweho yo gukora, bifite ibikoresho bigezweho byo gutunganya n’abakozi b’inzobere n’abahanga mu bya tekiniki, kugira ngo bamenye ubuziranenge bw’igicuruzwa kuva bagitangira gukora. Ubwoko bwose bw’ibicuruzwa bikorwa n’ikigo bufite igipimo cyo gutsinda kirenga 9.8% mu igenzura rya nyuma buri munsi. Mu gihe cyo kugenzura ubuziranenge, ntitwemera, ntidukora, kandi ntidusohora ibicuruzwa bitujuje ubuziranenge. Dukusanya amakuru y’ibarurishamibare ku bicuruzwa bifite inenge buri kwezi kandi dukora isesengura ry’impinduka. , Gukemura ibibazo bigira ingaruka ku buziranenge uhereye ku mpamvu nyamukuru, binyuze mu gushyira mu bikorwa politiki yo gucunga ubuziranenge, igipimo cy’impinduka z’ibicuruzwa by’ikigo cyagabanutse buhoro buhoro, imiterere y’ingenzi n’ingenzi y’igicuruzwa iba yujuje ubuziranenge 100% mbere yo kugezwa ku bakiriya, kandi ibicuruzwa bigezwa ku bakiriya gusa nyuma yo kubigezwaho ubuziranenge.

Mu 2021, ibicuruzwa by'iyi sosiyete bizoherezwa mu kigo cy’ubuvuzi cya Zhejiang Medical Device Inspection Institute kugira ngo bipimwe mu byiciro bibiri, kandi ibisubizo by'ibizamini byujuje ibisabwa by’ubuziranenge.

Imbonerahamwe ya 5 Raporo y'igenzura ry'ibicuruzwa

Imbonerahamwe ya 6 Igereranya ry'ibipimo bya tekiniki by'ibicuruzwa by'ikigo n'ibipimo bya tekiniki bigezweho mu gihugu no mu mahanga

Ishusho ya 7 Igicuruzwa cya Viscose plaster bandeji n'imikorere ya serivisi

5.2Inshingano zo kugurisha ibicuruzwa nyuma yo kugurisha

Hongde ifite itsinda ry’inzobere mu gutanga serivisi nyuma yo kugurisha kugira ngo ritange serivisi nziza nyuma yo kugurisha. Isosiyete yashyizeho "Ubugenzuzi n’Ubugenzuzi Nyuma yo kugurisha" na "Uburyo bwo Kugenzura Ibikoresho by’Ubuvuzi". Iyo hari ibibazo by’ubuziranenge mu bicuruzwa byahoze ari uruganda ndetse n’ibyangiritse mu gihe cy’ingwate, isosiyete ishobora gukurikirana no gusubiza vuba no gutunganya ibindi bikoresho kugira ngo ikore neza ibicuruzwa bifite ubuziranenge budahagije. Gusubiza neza no kuvura neza, kugira ngo abakiriya banyurwe n’isosiyete, ishami rishinzwe kugurisha nyuma yo kugurisha ritanga ubufasha bukurikira:

1. Inkunga ya tekiniki, hitamo imiterere n'ibikoresho by'umusaruro bifatika hakurikijwe ibikoresho n'inzira zitandukanye;

2. Gusesengura no gusubiza imiterere y'ibicuruzwa biri aho hantu no gutanga ibitekerezo byo kubisobanura;

Mu gihe cyo gutanga serivisi ku bicuruzwa, dusohoza inshingano zacu n'inshingano zacu dukurikije amabwiriza n'amasezerano bireba, kandi ibicuruzwa bitangwa byemejwe ko byujuje ibisabwa mu bwinshi, ubwiza, ibisobanuro n'imikorere bivugwa mu masezerano. Hongde yizeye gushyigikirwa no kwemerwa n'abakiriya bacu binyuze mu gushushanya, gutunganya, gupima no kugurisha by'umwuga.

5.3Inshingano z'ikigo mu by'imibereho myiza

Hongde ishobora kugera ku byo yagezeho no gutera imbere kugeza ku rwego rwayo rw'ubu, rudatandukana n'inkunga ya politiki z'igihugu, ubufasha bw'abafatanyabikorwa ndetse n'umuhati n'ubwitange by'abakozi ba Hongde. Hongde yahoraga yubaha inshingano z'imibereho myiza z'inzego eshatu z'ibanze, ari zo "amategeko, inyungu, n'amahame mbwirizamuco", kandi ihora inoza imikorere y'ikigo.

Ku rwego rw’amategeko, kuva yashingwa, isosiyete yubahiriza amategeko n’amabwiriza atandukanye y’imisoro y’igihugu, kandi yashyizeho uburyo n’amabwiriza ajyanye n’imari n’uburyo butandukanye bwo gutangaza amafaranga, kwemeza no kwishyura isosiyete, kandi ihora igenzura imicungire y’imisoro no kunoza imicungire y’imari. Yishyura imisoro hakurikijwe amategeko n’amabwiriza, yishyura imisoro yose kandi ku gihe, icunga imirimo y’imisoro ikorwa n’abakozi badasanzwe, ihugura abakozi b’imari, inoza ubumenyi ku misoro, ireme ry’umwuga n’urwego rw’imicungire, kandi igenzura ko imirimo y’imisoro ikorwa mu buryo bunoze kandi bwemewe n’amategeko. Kugabanya imyuka ihumanya ikirere, kurengera ibidukikije nk’inshingano zayo bwite, kunoza ikoranabuhanga mu gukora, kuvugurura ikoranabuhanga mu gukora n’ibikoresho, kugera ku kuvugurura no gutunganya ibicuruzwa, kugabanya imyuka ihumanya ikirere, no kubaka ikigo kizigama umutungo kandi kirengera ibidukikije.

Urwego rw'inyungu, kuva aho ikigo gishingiwe, gishingiye ku muco w'inzu y'umukozi, hamwe n'imimerere nyayo y'ikigo, cyaharaniye guha abakozi inkunga y'ibyo bakeneye ku rwego rutandukanye. Buri mwaka, gitegura ibizamini by'ubuvuzi ku bakozi, gitanga imfashanyo n'ibikoresho by'iminsi mikuru, gusura no kwihanganisha abakozi bageze mu zabukuru kandi gitanga ubufasha bw'amafaranga ku bakene, nibindi kugira ngo gisubize abakozi mu buryo bwose. Ikigo cyibanda ku kubaka uruhererekane rw'ibicuruzwa, gikomeza kunoza inzira n'uburyo bwo gutanga amasoko ku bakiliya, gishyiraho uburyo bwo gusuzuma buboneye kandi butabogamye, kandi gishyiraho igisubizo cyiza cyiza ku bakiriya. Gishyiraho imikoranire myiza n'abakiriya bakomeye, giteza imbere kunoza no guhindura abakiriya cyangwa abatanga serivisi mu bijyanye n'ingwate y'ibicuruzwa, ubwiza, igiciro na serivisi, cyumvikana n'ubuyobozi bwa Hongde n'uburyo bukoreshwa mu gitekerezo, kigakora ubwumvikane, cyuzuzanya n'inyungu za buri wese, kandi kigasangira inyungu. Ikigo gishyiraho kandi gishyira mu bikorwa "Inzira zo Kugenzura Itangwa ry'Amasoko", kigenzura kandi kigabanya inzira yo gutanga amasoko n'imicungire y'abakiriya cyangwa abatanga serivisi, kandi gisinya amasezerano y'ubufatanye hagati y'ibihugu byombi n'amasezerano y'ingamba n'abakiriya cyangwa abatanga serivisi. Isosiyete yacu ikurikiza amabwiriza ari mu masezerano yasinywe, igahuza konti n'abakiriya cyangwa abatanga serivisi ku gihe, irangiza akazi ko kwishyura, kandi igashyiraho urubuga rw'ubufatanye buzira umuze ku bakiriya cyangwa abatanga serivisi.

Ku rwego rw'umuco, Hongde isubiza mu buryo bugaragara ibimenyetso bitandukanye by'imibereho myiza n'amahame mbwirizamuco bitangwa na leta, kandi igategeka abakozi gukorana no kububahiriza. Isosiyete ikomeje gukura no gutera imbere, ntiyibagirwa gutanga umusanzu ku muryango, yishingikiriza ku bushobozi bwa Hongde, ishyigikira impano z'abagiraneza, kubaka icyaro gishya, ubufasha n'indi mirimo igamije imibereho myiza ya rubanda, no gusohoza inshingano zayo mu mibereho myiza.

5.4Rekodi y'inguzanyo nziza

Kubera ubwiza bwayo bwiza, ni ikigo cyizewe. Iyi sosiyete ntiyigeze imenyekana ku isoko, nta n'amakimbirane yigeze ihabwa n'abakiriya ku bijyanye n'ubuziranenge, nta n'igihano yigeze ihabwa n'ishami rishinzwe kugenzura no gucunga isoko. Mu myaka ya vuba aha, Hongde yageze ku bikorwa byinshi by'indashyikirwa, kandi yashimiwe kandi ihabwa ibihembo n'inzego za leta ku nzego zose inshuro nyinshi, kandi ubwiza bwayo bwagiye bwemezwa n'inzego zose z'imibereho.

Ururimi rw'amapfundo

Ubwiza ni ishingiro ry'ubuzima bw'ikigo, kandi urwego rw'ubuziranenge ni ishingiro ry'ingenzi ryo kugaragaza imbaraga zuzuye z'ikigo. Niba ikigo gishaka kuba mu mwanya udashobora gutsindwa mu irushanwa rikomeye, kigomba kwita cyane ku bwiza no kunoza urwego rwacyo rwo gucunga ubuziranenge buri gihe.

Mu kubungabunga umuco w’ubuziranenge bw’umwimerere, Hongde ihora ikora ubushakashatsi kandi igateza imbere ibicuruzwa bishya n’imikorere mishya, hamwe n’ibicuruzwa byiza n’uburyo bworoshye kandi bunoze bwo gukora, kugira ngo ikigo gikomeze kugumana urwego n’umwanya mu nganda. Hongde ihora ikurikiza politiki y’ubuziranenge yo “gushinga ubucuruzi mu buryo bunoze, igatsinda mu buryo bwiza”, kandi ikagenzura ubuziranenge bw’ibicuruzwa bivuye mu bikoresho fatizo, ibicuruzwa byarangiye neza n’ibicuruzwa byarangiye imbere, kandi ikemeza 100% by’ubuziranenge bw’ibicuruzwa mbere yo kubigeza ku bakiriya. Muri icyo gihe, hakorwa amahugurwa ahoraho n’imicungire y’isuzuma ku bagenzuzi babishinzwe kugira ngo barebe ko ubumenyi bw’abagenzuzi mu igenzura bunozwa kandi buvugururwa kugira ngo buhuze n’ingaruka z’ibisabwa mu buziranenge butandukanye buterwa n’iterambere ry’ikigo.

Kubaka uburyo bwo kugenzura ubuziranenge ni igikorwa cy’igihe kirekire kandi giteganyijwe. Gukurikiza ihame ryo gucunga ubuziranenge ryo "kwakira ibicuruzwa bifite inenge, kudakora ibicuruzwa bifite inenge, no kudasohora ibicuruzwa bifite inenge", kugenzura neza urwego rw’ubuziranenge, no guteza imbere iyubakwa ry’umuco w’ubuziranenge, kugira ngo "Intego ya "Made in Zhejiang" ibe iya mbere mu gihugu no ku rwego rw’isi, kandi tuzakomeza gukora cyane!