Umbiko Wonyaka Wobuqotho Bekhwalithi ka-2021

uFebhuwari 2022

Mayelana nalombiko

1. Imiyalelo yokuhlanganisa

Umbiko wobuqotho bekhwalithi okhishwe yinkampani ubhalwa ngokuhambisana nemithetho yekhwalithi kazwelonke efanele, imithethonqubo, imithetho kanye nezindinganiso zekhwalithi zemboni ezifanele. Ubuqotho bekhwalithi yenkampani kanye nokuphathwa kwekhwalithi embikweni kuwukubonakaliswa kwangempela kwesimo samanje senkampani. Inkampani inesibopho sokuqonda okuqukethwe kombiko kanye nobuqiniso kanye nobuchwepheshe bezitatimende neziphetho ezifanele.

2. Ububanzi bombiko

Lo mbiko uthatha i-Anji Hongde Medical Supplies Co., Ltd. njengomzimba oyinhloko, futhi uchaza okuqukethwe kokusebenza kwenkampani kwekhwalithi nobuqotho ngo-2021.

3. Incazelo yesibizo

Ukuze kube lula ukuveza imizwa, umbiko ubhekisela ku-"Anji Hongde Medical Products Co., Ltd." ngokuthi "i-Hongde" kanye "neNkampani" ngamafuphi.

4. Isikhathi sokubika kanye nobuningi

Isikhathi sokubika: Kusukela ngoJanuwari 1, 2021 kuya kuDisemba 31, 2021, idatha ethile nokuqukethwe kungaphezu kobubanzi obungenhla.

Umjikelezo wokukhishwa kombiko: Lo mbiko wonyaka ungowesibili wokukhishwa, futhi uzokhishwa minyaka yonke kusukela ngo-2020.

5. Uhlobo lokukhishwa kombiko

Lo mbiko ushicilelwe njengombhalo we-elekthronikhi, otholakala ku-http://e990.goodao.net/ iwebhusayithi ongayilandafuthi ngifunde.

Iphrofayela Yenkampani

Yasungulwa ngo-2006, le nkampani itholakala e-Bamboo Industry Science and Technology Entrepreneurship Center, eXiaofeng Town, e-Anji, eZhejiang, enenhloko-dolobha ebhalisiwe engu-1.6 million yuan, indawo engamahektare angu-25, indawo yokwakha engamamitha-skwele angu-23,000, kanye nempahla iyonke engu-66.54 million. Iwucwaningo nentuthuko, ukuklama, ukukhiqiza, ukuthengisa kanye nensizakalo njengomunye wabakhiqizi bemikhiqizo yokugqoka yezokwelapha.

Imikhiqizo eyinhloko amabhandeji e-viscose plaster, amabhandeji e-elastic, ama-plaster pad, amabhandeji aqinile e-polymer, ama-polymer splints ezokwelapha, ama-tongue depressors, amabhandeji e-elastic, i-vaseline gauze, imaski yezokwelapha elahlwayo kanye neminye imikhiqizo ithengiswa ngaphakathi ezweni futhi ithunyelwe eYurophu nase-United States, eMpumalanga Ephakathi naseNingizimu-mpumalanga ye-Asia nakwamanye amazwe nezifunda.

Le nkampani iwine ikhaya labakhubazekile elinezinkanyezi ezinhlanu eSifundazweni saseZhejiang, i-Independent Innovation Award ka-2019, ibhizinisi lobuchwepheshe elincane neliphakathi nendawo, isikhungo se-R&D esisezingeni lesifunda, indawo yamamodeli yokwenza umqondo "wezintaba ezimbili" ngo-2019, iqembu elithuthukile labafundi bemodeli, kanye nesifunda ngo-2020. I-Government Quality Award kanye nezinye izincomo.

irekhodi eliqondiwe

Isahluko Sokuqala Umqondo Wekhwalithi

1.1 Umsebenzi Wenkampani

1.2 Umbono Wenkampani

1.3 Izindinganiso Zenkampani

1.4 Isiko Lebhizinisi

1.5 Inqubomgomo Yokuphatha Ikhwalithi, Imvelo, Impilo Nokuphepha Emsebenzini

1.6 Imibono eqondisayo

1.7 Ukuzibophezela Kobuqotho Bekhwalithi

Isahluko sesibili Ukuphathwa Kwekhwalithi Yebhizinisi

2.1 Inhlangano yokuphatha ikhwalithi

2.2 Uhlelo lokuphatha ikhwalithi

2.3 Ukuphathwa kwezingozi zekhwalithi nokuphepha

isahluko sesithathu Ubuqotho Bekhwalithi

3.1 Ukuzibophezela Kwekhwalithi

3.2 Ukuphathwa Kokusebenza

3.3 Ukuphathwa Kokumaketha

Isahluko Sesine Isisekelo Sekhwalithi

4.1 Ukuphathwa okujwayelekile

4.2 Ukuphathwa kokulinganisa

.3 Ukuphathwa Kwesitifiketi

4.4 Ukuhlolwa nokuphathwa kokuhlolwa

isahluko sesihlanu Umthwalo Wemfanelo Wekhwalithi Yomkhiqizo

5.1 Izinga Lekhwalithi Yomkhiqizo

5.2 Umthwalo wemfanelo womkhiqizo ngemva kokuthengiswa

5.3 Umthwalo Wemfanelo Wenkampani Kwezenhlalo

5.4 Irekhodi lesikweletu elisezingeni eliphezulu

Ulimi lwefindo

Isahluko Sokuqala Umqondo Wekhwalithi

1.1Umsebenzi Wenkampani

Yakha uphawu olusezingeni eliphezulu bese udala uphawu lokulinganisa imboni.

1.2Umbono Wenkampani

Hola abakhubazekile ukuthi bahambise impilo yabantu emhlabeni jikelele.

1.3Izindinganiso Zenkampani

Ubuqotho, ukusebenza ngendlela efanele, ukusungula izinto ezintsha, ukuzinikela kanye nokunakekela abakhubazekile.

1.4Isiko Lebhizinisi

Eminyakeni yokusebenza kwentuthuko, uHongde ubelokhu ebheka isiko lenkampani njengendawo yokusekela kanye nembono eqondisayo yentuthuko, futhi kancane kancane uye wakha isiko lenkampani eliyingqayizivele maqondana nomsebenzi wenkampani, umbono, kanye nezindinganiso ezizungeze intuthuko nokukhula kwenkampani. Njengomthombo ongokomoya, isiko lenkampani lihlala liqhuba inkampani ukuthi iqhubekele phambili.

Le nkampani ithatha “ukwakha uphawu olusezingeni eliphezulu nokudala izilinganiso zemboni” njengomgomo wayo wenkampani, “ukuhola abakhubazekile ukuba bahambisane nempilo yabantu yomhlaba wonke” njengombono wayo wenkampani, inamathela emqondweni oyinhloko “wokuqhubekisela phambili umoya wobuntu nokuthuthukisa imbangela yabantu abakhubazekile”, futhi ilwela ukwakha isiko lebhizinisi laseHongde.

1.5Ikhwalithi, Imvelo, Impilo Nokuphepha Emsebenzini Inqubomgomo Yokuphatha

UHongde ulandela ngokuqinile “uMthetho Wekhwalithi Yomkhiqizo”, “uMthetho Wokuphepha Kwemishini Ekhethekile” kanye neminye imithetho nemigomo kazwelonke kanye nezidingo zezindinganiso eziphoqelekile zikazwelonke zokukhiqiza nokuthengisa imikhiqizo. Ukuze kwenziwe ukuphathwa kwebhizinisi kube sezingeni elifanayo futhi kuthuthukiswe ikhwalithi yomkhiqizo, inkampani iyaqhubeka nokuthuthukisa izinga lohlelo lokuphatha ikhwalithi, ukuze izinga lokuphathwa kwekhwalithi kanye nekhwalithi yomkhiqizo weHongde kuthuthukiswe kakhulu.

Ngaphansi kwesiqinisekiso sekhwalithi yomkhiqizo efanelekile, sizoqhubeka nokuthuthukisa ikhwalithi yomkhiqizo ukuze sihlangabezane nezidingo zamakhasimende. Endaweni yokukhiqiza yasendaweni yebhizinisi, i-6S "yokuhlela, ukulungisa, ukuhlanza, ukuhlanza, ukufunda nokubhala, kanye nokuphepha" isetshenziselwa ukuphatha ngempumelelo izici zokukhiqiza ezifana nabasebenzi, imishini, izinto zokwakha, kanye nezindlela endaweni yokukhiqiza, futhi inikeze abasebenzi indawo enempilo nephephile yomsebenzi nokuphila. . Abaholi benkampani bayabanakekela abasebenzi, bahlonipha amalungelo abo bonke abasebenzi okuhlela ngokuzithandela nokujoyina izinhlangano zabasebenzi kanye nokwenza izingxoxo ezihlangene, ukuhlela abasebenzi njalo ukuthi bahlolwe ngokomzimba, kanye nokwenza umsebenzi omuhle ekuvimbeleni nasekwelapheni izifo zomsebenzi. Ukwakha ngaphandle "Incwadi Yekhwalithi" ehambisanayo evela ku-R&D, ukuthengwa, ukukhiqiza, ukuthengisa, inqubo yokugcinwa kwekhwalithi ngemuva kokuthengisa ukuqinisekisa ukuthi amakhasimende anikezwa imikhiqizo ephephile, esebenza kahle futhi efanelekile.

1.5.1Inqubomgomo Yekhwalithi:

Inqubomgomo yekhwalithi yenkampani ithi:

Sungula ibhizinisi elinobungcweti futhi uwine ngekhwalithi.

Ngokuphathelene nekhwalithi, kubalulekile ukwanelisa amakhasimende kanye nabanye abantu abathintekayo ngobuchwepheshe obuthuthukisiwe, imikhiqizo esezingeni eliphezulu, insizakalo yobungcweti kanye nokuphathwa kwekilasi eliphezulu ngokusebenzisa ubuchwepheshe obusha obuqhubekayo, ukuze kuhlangatshezwane nezidingo zamakhasimende kanye nezidingo zomthetho nezokulawula, kanye nokuthuthukisa ukusebenza kahle kohlelo.

1.5.2Inqubomgomo Yobuqotho Bekhwalithi:

Ikhwalithi iyimpande, ubuntu buyisisekelo, umklamo omusha, ukukhiqiza okuhle

1.6Imibono eqondisayo

Abaholi benkampani banaka ukwakhiwa kohlelo lokuphatha ikhwalithi, baqoka abasebenzi abakhethekile abazobhekana nokuphathwa kwekhwalithi, baphakamisa ukuqinisa imodi "yokulwa" (umoya, uhlelo, isikhuthazo), bathuthukise indlela yokusebenza futhi bathuthukise ukwakhiwa kwamakhono, futhi bacacise umbono oqondisayo wokuthi "ikhwalithi idala inani, insizakalo idala ikhwalithi".

1.7Ukuzibophezela Kobuqotho Bekhwalithi

UHongde unaka ukwakhiwa kwesiko lenkampani, uhlakulela ikhwalithi yokuziphatha yabasebenzi abakhuthele, abazinikele, nabanesibopho, futhi usemise iqembu labasebenzi abasezingeni eliphezulu abanomthwalo wemfanelo futhi abangochwepheshe. Ngaphansi kwesisekelo sokuthobela imithetho nemigomo, inkampani ithatha izidingo zamakhasimende njengesikhungo, yenza imisebenzi yokukhiqiza nokusebenza ngemikhiqizo nezinsizakalo ezisezingeni eliphezulu, ifaka umqondo wokukhiqiza imikhiqizo esezingeni eliphezulu emicabangweni yabo bonke abasebenzi benkampani, futhi iqinisa njalo ubumbano lwenkampani futhi ithuthukise isithombe senkampani, ukuze kufezwe intuthuko esimeme yebhizinisi. Ngemikhiqizo enezinkinga zekhwalithi, ngokwesimo sangempela senkinga, inkampani iyazilungisa ngamazinga ahlukahlukene.

Ngaphansi kwezimo ezijwayelekile zokuthuthwa, ukugcinwa kanye nokusetshenziswa komkhiqizo, zingakapheli izinyanga ezingama-24 zokugcinwa endaweni eyomile, uma kunenkinga yesikhunta, umenzi kufanele awushintshe. Bese usetha umugqa wesevisi yamakhasimende, uphendule ezidingweni zesevisi yamakhasimende zingakapheli amahora angama-48, bese uphakamisa izixazululo ngesikhathi esifanele.

Isahluko sesibili Ukuphathwa Kwekhwalithi Yebhizinisi

2.1Inhlangano yokuphatha ikhwalithi

2.1.1Ishadi Lenhlangano

Ngokwezidingo "zoMthetho Wenkampani" kanye "ne-Articles of Association", inkampani isungula isakhiwo senhlangano futhi isebenzisa uhlelo lomthwalo wemfanelo lomphathi jikelele. Ngokombono webhizinisi nowamasu okhona, kuneminyango eyisithupha esebenzayo: uMnyango Wezobuchwepheshe Bokukhiqiza, uMnyango Wezobuchwepheshe Bekhwalithi, uMnyango Wokubhida Nokuthenga, uMnyango Wokuphatha Okuvamile, uMnyango Wentuthuko Yangaphandle, kanye noMnyango Wokuhlela Nezezimali. Umphathi jikelele wenkampani uqinisekisa ukuthi imithwalo yemfanelo kanye namagunya eminyango eshiwo ngenhla kanye nezikhundla ezihlobene nayo ziyachazwa, futhi umnyango ngamunye wenza imisebenzi yawo futhi ubambisana ukuze kusetshenziswe ngokugcwele ukwabiwa kwezinsizakusebenza zabantu, ukutshalwa kwezimali, ingqalasizinda, imishini, njll. ukuqinisekisa ukusebenza kahle kohlelo lokuphatha.

2.1.2Abameleli bokuphatha

Uqokwe futhi wagunyazwa ngumphathi jikelele wenkampani ukuthi aqondise futhi alawule ukusebenza kohlelo ohlelweni lokuphathwa kwekhwalithi. Unesibopho sokukhuthaza ukusetshenziswa okuqondile kwenqubomgomo yekhwalithi yenkampani, izinhloso zekhwalithi, kanye nesu lekhwalithi, kanye nokuhlola nokuzithuthukisa. Imithwalo yemfanelo ethile ifaka:
a) Ngokusho kwe-EN ISO 13485:2016 (IDT ISO 13485:2016), YY/T0287:2017), Umkhuba Omuhle Wokukhiqiza Wamadivayisi Ezokwelapha (No. 64) kanye ne-MDD93/42/EEC njengoba kushintshiwe ngezimfuneko zika-2007/47 /EC zokuqinisekisa ukusungulwa, ukusetshenziswa kanye nokugcinwa kohlelo lokuphathwa kwekhwalithi yenkampani; b) obhekene nomphathi jikelele; c) obhekene nokusungula, ukusebenzisa kanye nokugcina uhlelo lokuphathwa kwekhwalithi ngokuhambisana nezidingo zemithethonqubo nezindinganiso, kuhlanganiswe nesimo sangempela senkampani; d) ukubika kumphathi jikelele Umphathi ubika ngokusebenza kohlelo lokuphathwa kwekhwalithi kanye nezidingo zokuthuthukisa; e) obhekene nokuxhumanisa ukusebenza kohlelo ukuqinisekisa ukusebenza okuvamile kanye nokusetshenziswa okuphumelelayo kohlelo lokuphathwa kwekhwalithi; f) oqinisekisa ukuthi ukuqwashisa ngokuhlangabezana nezidingo zomthetho ezisebenzayo kanye nezidingo zohlelo lokuphathwa kwekhwalithi kuphakanyiswa kuyo yonke inkampani; g) Obhekene nokuhlela ukubuyekezwa kanye nokulahlwa kwemikhiqizo emikhulu engahambisani; h) Unesibopho sokusungula nokufeza ukuxhumana kwangaphandle kanye nokuxhumana ngezindaba eziphathelene nohlelo lokuphathwa kwekhwalithi;
i) Unesibopho sokubuyekeza incwadi yekhwalithi kanye nokugunyazwa kwemibhalo yenqubo.
2.1.3 Ubuchwepheshe Bekhwalithi
UMnyango Njengomnyango oyisisekelo wokulawula ikhwalithi yomkhiqizo, uMnyango Wezobuchwepheshe Bekhwalithi uphinde ube umnyango wokuphatha ophakathi ohlelweni lokuphathwa kwekhwalithi yenkampani, futhi udlala indima ebalulekile ekwakhiweni kokuphathwa kwekhwalithi. Ngesikhathi esifanayo, kunemithwalo yemfanelo eminingi kanye nezibopho enkambisweni yokuphatha, kanje: j) Unomthwalo wemfanelo wokuhlola nokuhlola imikhiqizo (kufaka phakathi izinto zokusetshenziswa, imikhiqizo eqediwe kancane kanye nemikhiqizo eqediwe), ukugcinwa nokukhululwa; k) Unomthwalo wemfanelo wokuqapha nokulinganisa amaphuzu okulawula ikhwalithi, unomthwalo wemfanelo ebalulekile l) Unomthwalo wemfanelo wokuqoqwa nokuhlaziywa kolwazi lwekhwalithi yomkhiqizo (idatha); m) Hlela ukubuyekezwa okungafanele, ukuphakamisa nokusebenzisa izindlela zokulahla, kanye nokwenza ukuqapha nokuqinisekisa;
n) Unesibopho sokucutshungulwa kwemikhiqizo engafaneleki kanye nokuqapha izinqubo;
o) Unomthwalo wemfanelo wokuphathwa kwemishini yokuhlola, ukusungula amafayela emishini yokuhlola, nokuqondisa umsebenzi wokuhlola; p) Ukwakha imiyalelo yokuhlola umkhiqizo nokuqondisa ukuqaliswa kwayo; q) Ukusiza ekusingatheni izinkinga zekhwalithi yemikhiqizo ekhiqiziwe; r) Ukwenza umsebenzi omuhle ekuhlolweni nasekuhlolweni komkhiqizo Ukuhlonza isimo; s) Ukwakha nokuqinisekisa amazinga obuchwepheshe afanele kanye nemininingwane yemikhiqizo; t) Ukwenza ucwaningo nokuthuthukiswa kwemikhiqizo emisha, njll. u) Ukubambisana nezinkinga zobuchwepheshe enkonzweni yangemva kokuthengisa komkhiqizo; v) Ukusiza abameleli bokuphatha ukusebenzisa imisebenzi yokuhlolwa kwangaphakathi; Ukucubungula isiqondiso sobuchwepheshe.

2.2Uhlelo lokuphatha ikhwalithi

I-Hongde ithola ukwaneliseka kwamakhasimende ngemikhiqizo yayo ngesimo somkhiqizo wekhwalithi ephezulu kanye nesimo sesevisi, futhi ihlala yenza intuthuko yamasu enqubomgomo yekhwalithi kanye nemigomo yekhwalithi ukuze ivumelane nentuthuko yenkampani. Ngokwezinga le-ISO 13485, inkampani isungule uhlelo lokuphatha ikhwalithi oluhlanganisa ukuklama, ukuthuthukiswa, ukukhiqiza, ukuthengisa kanye nensizakalo, futhi imikhiqizo iphumelele isitifiketi se-CE. Ukuze kuhlangatshezwane nezidingo zentuthuko esheshayo yenkampani, kuqiniswe njalo umsebenzi wokuphatha ikhwalithi, futhi kuthuthukiswe isithombe somkhiqizo wekhwalithi ephezulu, inkampani iqhubekile nokwenza umsebenzi wokushintsha uhlelo lokuphatha ikhwalithi. Ngokukhuthaza umkhiqizo, inkampani ithuthukise kakhulu ukuthandwa komkhiqizo we-Hongde kulo mkhakha, futhi yaphakamisa umkhiqizo we-Hongde emakethe yamazwe ngamazwe.

Le nkampani isebenzisa ukuthuthukiswa okuqhubekayo kohlelo ngokuhlolwa kwangaphakathi kwaminyaka yonke, ukubuyekezwa kokuphathwa kanye nokuphathwa kwangaphandle kanye nokuhlolwa ukuqinisekisa ukusebenza kahle kohlelo lokuphathwa kwekhwalithi, ngaleyo ndlela kuqinisekiswe ikhwalithi yomkhiqizo. Ngokwezidingo ze-ISO 13485 standard, inkampani iqhuba ukuphathwa okujwayelekile nokujwayelekile kwenkampani ngokusebenzisa "i-Quality Manual", imibhalo yenqubo kanye nemibhalo yezinga lesithathu ukuqinisekisa ukufezwa kwekhwalithi yenkampani, imvelo, izinqubomgomo zempilo nokuphepha emsebenzini kanye nemigomo yekhwalithi, ukuze amakhasimende kanye nabantu abahlobene nabo bathole insizakalo eyanelisayo.

2.2.1Imfundo Yobuqotho Esezingeni Eliphezulu

Umgomo wokuthuthukiswa okusimeme nokunempilo kokusebenza okulalela umthetho, ukwethembeka nokuthembeka, i-Hongde isungule futhi yaqalisa izinhlelo zokuqeqesha zemfundo yekhwalithi nobuqotho ngokusebenzisa "Izinqubo Zokulawula Abasebenzi" kanye "Nezinqubo Zokulawula Ukuqeqeshwa" ukuhlola ukuthi kungenzeka yini izinhlelo zemfundo nokuqeqesha zekhwalithi nobuqotho. Ukusakazwa kwenkampani yonke kanye nokukhuthazwa komoya wobuqotho bekhwalithi. Kusukela kubaphathi kuya kubasebenzi abaphambili, i-Hongde ihlala igcizelela ikhwalithi yomkhiqizo kuqala, futhi ibheka ikhwalithi nobuqotho njengesihluthulelo sokuvula umnyango wemakethe. Ukulawulwa kwekhwalithi; ngesikhathi esifanayo, ukuhlela ukwakhiwa, ukusakazwa kanye nemisebenzi yesiko lobuqotho benkampani; ukuhlela ukuthi abasebenzi baqhube ukuqeqeshwa okuhlelekile mayelana nemvelo kanye nokuphepha emsebenzini kanye nempilo. Imfundo yekhwalithi nobuqotho ingamandla angokwemvelo okwenza umsebenzi omuhle ekuphathweni kwekhwalithi nobuqotho. Kungumsebenzi wesikhathi eside ukusungula nokuhlanganisa izindinganiso eziyinhloko zebhizinisi. I-Hongde yenza imizamo engapheli ngenxa yalokhu.

2.2.2Ubuqotho nokuzithiba

I-Hongde ibilokhu ibeka ukubaluleka okukhulu ekwakhiweni kwekhwalithi nobuqotho bebhizinisi ngenkathi ukuqwashisa ngomkhiqizo wayo kuthuthukiswa njalo. Isungule izindinganiso zenkampani "zobuqotho, ukusebenza kahle, ukusungula izinto ezintsha, ukuzinikela, nokunakekela abakhubazekile". Le nkampani ilandela ngokuqinile imithetho nemigomo kazwelonke neyendawo, izindinganiso ezifanele zezwe, zendawo nezezimboni zomthwalo wemfanelo wezenhlalo, futhi iveza imithetho nemigomo yenkampani ngendlela eyiqiniso, enembile, ngesikhathi esifanele futhi ephelele.

2.2.3Izinhloso zokuphatha

Ohlelweni lokuphatha lokuthuthukisa ikhwalithi, uHongde ubhekene nezingcindezi zemvelo zangaphakathi nezangaphandle kanye nezinguquko eziqhubekayo ezidingweni zezinhlangano ezihlobene, kanye nezixazululo zenkampani ezingozini namathuba. Kwakhiwa izinhloso zokuphatha zomnyango ngamunye futhi kwakhiwa izinhloso zokuphatha ikhwalithi zomnyango ngamunye.

Umphathi jikelele wenkampani uyaqonda ngokucacile ukuthi ukuncintisana emakethe ekugcineni kuwukuncintisana kwamathalente, futhi uqinisa imizamo yabasebenzi emfundweni yekhwalithi yomkhiqizo kanye nokuqeqeshwa kwamakhono ebhizinisi ngendlela ebanzi, unamathela esimisweni sokuhlanganisa ukuqeqeshwa nokuhlolwa, futhi wamukela inhlanganisela yezindlela zokuqeqesha zangaphakathi nezangaphandle. Ukuthuthukisa njalo uhlelo lokuphatha imfundo nokuqeqeshwa. Kusukela ezicini ezimbili zezidingo zabasebenzi kanye nokuthuthukiswa kwenkampani, okuqukethwe kokuqeqeshwa kuhlelwe ngokucophelela nangokufanele, futhi ukuqeqeshwa kwamazinga amaningi, kwezinhlobo eziningi, kwezindlela eziningi kanye nokuhlukanisiwe kwenziwa ukuze kucebiswe amakhono abasebenzi emakhonweni ebhizinisi angaphakathi, emakhonweni okuphatha ikhwalithi kanye nezinye izici. Ngokuqeqeshwa okuqhubekayo nokulungiswa, amathalente okuphatha enkampani akhona kanye namathalente obuchwepheshe ahlukile, futhi isikhundla ngasinye somsebenzi sinezinga elihle lokudlulisela, elibeke isisekelo sabasebenzi sokuthuthukiswa okunempilo kokuphathwa kwekhwalithi.

2.2.4Izinhloso zekhwalithi

a) Ngokwezidingo ze-EN ISO 13485:2016 (IDT ISO 13485:2016), YY/T0287:2017), Umkhuba Omuhle Wokukhiqiza Wamadivayisi Ezokwelapha (No. 64) kanye ne-MDD93/42/EEC njengoba kushintshiwe ngo-2007/47/EC Qinisekisa ukusungulwa, ukusetshenziswa kanye nokugcinwa kohlelo lokuphatha ikhwalithi yenkampani;

b) Unesibopho kumphathi jikelele;

c) Unesibopho sokusungula, ukusebenzisa nokugcina uhlelo lokuphatha ikhwalithi ngokuhambisana nezidingo zemithethonqubo nezindinganiso kanye nesimo sangempela senkampani;

d) Bika ukusebenza kohlelo lokuphatha ikhwalithi kanye nezidingo zokuthuthukisa kumphathi jikelele;

e) Unesibopho sokuxhumanisa ukusebenza kohlelo ukuqinisekisa ukusebenza okuvamile kanye nokuqaliswa okuphumelelayo kohlelo lokuphatha ikhwalithi;

f) ukuqinisekisa ukuthi ulwazi luyaphakanyiswa kuyo yonke inkampani ukuze kuhlangatshezwane nezidingo zomthetho ezisebenzayo kanye nezidingo zohlelo lokuphatha ikhwalithi;

g) Unesibopho sokuhlela ukubuyekezwa nokulahlwa kwemikhiqizo emikhulu engahambisani nemithetho;

h) Ukuba nesibopho sokusungula nokufeza ukuxhumana kwangaphandle kanye nokuxhumana ngezindaba eziphathelene nohlelo lokuphathwa kwekhwalithi;

i) Unomthwalo wemfanelo wokubuyekeza incwadi yemiyalelo yekhwalithi kanye nokugunyazwa kwemibhalo yenqubo.

2.1.3UMnyango Wezobuchwepheshe Bekhwalithi

Njengomnyango oyisisekelo wokulawula ikhwalithi yomkhiqizo, umnyango wezobuchwepheshe bekhwalithi uphinde ube umnyango wokuphatha ophakathi ohlelweni lokuphathwa kwekhwalithi yenkampani, futhi udlala indima ebalulekile ekwakhiweni kokuphathwa kwekhwalithi nekhwalithi. Ngesikhathi esifanayo, kunemithwalo yemfanelo eminingi kanye nezibopho enkambisweni yokuphatha, kanje:

j) Unesibopho sokuhlola nokuhlola imikhiqizo (kufaka phakathi izinto zokusetshenziswa, imikhiqizo eqediwe kancane kanye nemikhiqizo eqediwe), ukugcinwa nokukhululwa;

k) Unesibopho sokuqapha nokulinganisa amaphuzu okulawula ikhwalithi, futhi unesibopho sokuqapha izinqubo ezibalulekile ngokuzulazula;

l) Unesibopho sokuqoqwa nokuhlaziywa kolwazi lwekhwalithi yomkhiqizo (idatha);

m) Ukuhlela ukubuyekezwa kokungalandeli imithetho, ukuphakamisa nokusebenzisa izindlela zokulahla, kanye nokuqhuba ukuqapha nokuqinisekisa;

n) Unesibopho sokuphathwa kwemikhiqizo engahambisani nokuqapha izinqubo;

o) Unesibopho sokuphathwa kwemishini yokuhlola, ukusungula amafayela emishini yokuhlola, nokuqondisa umsebenzi wokuhlola;

p) Ukwakha imiyalelo yokuhlola umkhiqizo nokuqapha ukusetshenziswa kwawo;

q) Ukusiza ekubhekaneni nezinkinga zekhwalithi yemikhiqizo ekhiqiziwe;

r) Yenza umsebenzi omuhle wokuhlola umkhiqizo kanye nokuhlonza isimo sokuhlola;

s) Ukwakha nokuqinisekisa amazinga obuchwepheshe afanele kanye nezincazelo zemikhiqizo;

t) Yenza ucwaningo kanye nokuthuthukiswa kwemikhiqizo emisha, njll.

u) Ukubambisana ekubhekaneni nezinkinga zobuchwepheshe enkonzweni yangemva kokuthengisa yemikhiqizo;

v) Ukusiza abameleli babaphathi ekuqalisweni kwemisebenzi yokuhlolwa kwangaphakathi;

w) Nikeza isiqondiso sobuchwepheshe kule nqubo.

Enkambisweni yokuthuthukiswa okuqhubekayo nokuthuthukiswa, umkhiqizo uchazwa ngokwezinga eliphezulu kanye nezidingo eziphakeme zokunemba nokusebenza kahle, ukuncintisana kwemboni yenkampani kuyathuthuka, futhi imigomo yekhwalithi enzima iyabekwa. Imigomo yekhwalithi yenkampani iboniswe ku-“Quality Objective Decomposition Table”, kanti eminye yemigomo yilena elandelayo:
a. Izinga elifanelekile lokuhlolwa kwemikhiqizo kanye kuphela lifinyelela ku-96%. b. Izinga lesikhalazo somkhiqizo alidluli ku-2%; C. Ingozi yokuphepha komkhiqizo ingu-zero.

Isibalo 2 Ithebula lezibalo mayelana nokuqedwa kwemigomo yekhwalithi ngo-2021

2.2.5Inhloso yokulinganisa

Ngokusekelwa kwamathuluzi okuhlola anembile kanye nezindlela zokuhlola ezijwayelekile, imishini ihlelwa njalo ukuqinisekisa ukuthi izinga lokuhlola lemishini yokuhlola lifinyelela ku-100%, futhi ukuqeqeshwa nokuhlolwa kwabasebenzi abafanele bokuhlola kudinga izinga lokupasa elingu-100% labasebenzi enqubweni yokulinganisa ebalulekile.

2.2.6Imithethonqubo yekhwalithi

Ukuze kuqiniswe ukubhekwa nokuphathwa kwekhwalithi yemikhiqizo, kuthuthukiswe izinga lekhwalithi yomkhiqizo, kucaciswe imithwalo yemfanelo yekhwalithi yomkhiqizo, futhi kuvikelwe amalungelo nezintshisekelo ezisemthethweni zamakhasimende, sihlonza ngokukhethekile imithetho nemigomo yekhwalithi, njengokuthi “Umthetho Wekhwalithi Yomkhiqizo WeRiphabhulikhi Yabantu BaseShayina” kanye “Nohlelo Lokuphathwa Kwekhwalithi Yedivayisi Yezokwelapha”. Izidingo Zemithethonqubo “, “Umkhuba Wokuphathwa Kwekhwalithi Wokukhiqiza Amadivayisi Ezokwelapha”, “Imithethonqubo Yokugadwa Nokuphathwa Kwamadivayisi Ezokwelapha”, “Imithetho Yokuhlukaniswa Kwamadivayisi Ezokwelapha”, “Imiyalelo Yedivayisi Yezokwelapha Nemithethonqubo Yokuphathwa Kokulebula”, “Imithetho Yokuqanjwa Kwamagama Edivayisi Yezokwelapha Ejwayelekile”, “ISO13485 : 2016″” MDD 93/42/EEC (2007/47/EC) “, njll., idinga ukukhiqizwa kwemikhiqizo esezingeni eliphezulu endaweni efanelekile kanye nophawu lwe-Hongde endaweni ethobela umthetho.

2.2.7Uhlelo lokuphatha ikhwalithi

UHongde usungule “Inqubo Yokulawula Ikhwalithi”, “Inqubo Yokulawula Ukuqinisekisa” kanye “Nenqubo Yokulawula Umkhiqizo Ongajwayelekile” ekuphathweni kwekhwalithi. Kusukela ezintweni zokusetshenziswa, inqubo yokucubungula umsebenzi ifakwe imishini yokuhlola yomqhubi ngamunye ukuze aqalise ukuzihlola, futhi kuhlelwa ukuhlolwa kwansuku zonke. Yenza ukuhlolwa kwekhwalithi yemikhiqizo yenqubo, abahloli bahlola ngokugcwele ngaphambi kokushiya ifektri, balawule ngokuqinile ikhwalithi yomkhiqizo, futhi bafeze ukulethwa okufanelekile okungu-100%. Le nkampani isungule “Izinqubo Zokulawula Ukuthenga” kanye “Nezinqubo Zokulawula Ikhwalithi” zezinqubo zokuphatha ibhizinisi ezifana nenqubo yokuphatha ukumaketha, inqubo yokuphatha ukuklama nokuthuthukiswa, inqubo yokuphatha ukuthengwa kwempahla, inqubo yokuphatha ukukhiqiza, inqubo yokuphatha ukuhlolwa, ukupakisha, inqubo yokuphatha ezokuthutha, inqubo yokuphatha ukuthunyelwa kwamanye amazwe kanye nokuphathwa kwempahla yokugcina impahla. 》 kanye nezinye izinhlelo ezihlobene ukulandelela, ukuqapha nokuphatha yonke inqubo yemikhiqizo ukuze kufezwe umphumela wokuvimbela izinkinga ngaphambi kokuba zenzeke, ukuze kuqinisekiswe futhi kuthuthukisweikhwalithi yomkhiqizo.

Njalo ngeviki, inkampani ihlanganisa umnyango wokukhiqiza kanye nomnyango wezobuchwepheshe bekhwalithi ukuze ibambe imihlangano ejwayelekile ukuze kuxoxwe ngezinkinga ezikhona empendulweni yekhwalithi yomkhiqizo evela kumakhasimende, kuxoxwe ngokubambisana ngezixazululo ezinengqondo ezivela emcabangweni wokuqeda izinkinga zekhwalithi, futhi kuqoshwe izinkinga zekhwalithi ezibikwe ngamakhasimende ukuze kuqashwe. Thuthukisa futhi uthuthukise uhlelo lokuphatha ikhwalithi ukuze luhlangabezane nezidingo zokuphatha kanye nezidingo zemakethe.

2.2.8Isinxephezelo semfanelo yekhwalithi

Ikhwalithi iyisisekelo seHongde. Ukuze ulawule kancane kancane ikhwalithi yemikhiqizo evela emthonjeni, isinyathelo sokuqala ukulawula ikhwalithi yezinto zokusetshenziswa ezingenayo. Izinto zokusetshenziswa ezithengwa ezimbonini zangaphandle zidinga ukuhlolwa ngabahloli abangochwepheshe ukuze kuhlangatshezwane nazo zonke izakhiwo zezinto ezidingekayo yinkampani ngaphambi kokuba zamukelwe. Inkampani yezinto zokwakha kudingeka ibe nomnyango okhethekile wokuxoxisana ukuze unikeze imithwalo yemfanelo eyengeziwe kumhlinzeki ukuze ahlinzeke ngokuhlolwa kwezimo ezimbi. Isixazululo esithile sincike enkingeni yekhwalithi. Isinyathelo sesibili, ukulawula inqubo okuqinile, njengoba igama lisho, ukulawula ukukhiqiza nokucubungula efektri. Inkampani inemigqa yokukhiqiza evuthiwe nemishini yokukhiqiza kanye nabaqhubi abanolwazi, baklama imidwebo yokucubungula umkhiqizo ngokwezidingo zamakhasimende, futhi bakhe izindlela zobuchwepheshe bokucubungula ezifanele. Ukukhiqiza nokucubungula kuhambisana ngokuqinile. Inqubo idinga ukusebenza, abaqhubi enqubweni ngayinye bayazihlola, futhi kukhona abahloli abafanele ekuxhumaneni ngakunye kokuqhuba ukuhlolwa. Ukuhlolwa kokugcina kuhlelwa imikhiqizo eqediwe ngemuva kokucubungula, futhi ukuhlolwa okuphelele okungu-100% kwenziwa emikhiqizweni. Isinyathelo sesithathu ukuhlinzeka ngensizakalo ephezulu ngemuva kokuthengisa kwemikhiqizo yangaphambili efektri. Kungakhathaliseki ukuthi kwenzekani phakathi nesikhathi sewaranti yomkhiqizo, inkampani izothatha isinyathelo sokuthatha umthwalo wemfanelo futhi inikeze izixazululo kanye nokusekelwa kobuchwepheshe ezinkingeni zekhwalithi ukuze kufezwe ukwaneliseka kwamakhasimende.

Le nkampani ithuthukisa ikhwalithi yomkhiqizo futhi inciphisa izindleko zokukhiqiza ngokuphathwa kwekhwalithi ephelele. Ngokwezidingo zenkampani zokuthuthukiswa, nangokuhambisana nomgomo wokuxhumanisa ikhwalithi yomkhiqizo wenkampani kanye nezinzuzo eziphelele nezintshisekelo zabasebenzi, kuye kwaklanywa izinhlelo ezifanele. Ukuze kugwenywe ukwenzeka njalo kwezingozi zekhwalithi, sungula indlela yokulandelela izinkinga, uxazulule izimbangela bese uthatha izixazululo. Ngesikhathi esifanayo, ukuze kuqinisekiswe amalungelo nezintshisekelo ezisemthethweni zamakhasimende, inkampani ihlala inikeza amakhasimende imikhiqizo efanelekile enesiqinisekiso sekhwalithi. Umnyango wokuhlela wakha izinqubomgomo zokuthengisa ezifanele, uphatha izikhalazo zamakhasimende kanye nokubuyiselwa kwemali, ukhuthaza ukuthuthukiswa kwangaphakathi kwenkampani, futhi uhlole abantu abanomthwalo wemfanelo abafanele.

2.3Ukuphathwa kwezingozi zekhwalithi nokuphepha

2.3.1Izikhalazo zekhwalithi

UHongde uhlala enaka izidingo zamakhasimende, esebenzisa isimiso "sokukhonza ngenhliziyo nangokuthuthuka ngokwesayensi", ebheka ukwaneliseka kwamakhasimende njengomgomo wethu waphakade, futhi efaka ukwaneliseka kwamakhasimende njengomgomo wekhwalithi yenkampani. Ukuze kube lula izikhalazo zamakhasimende, inkampani isungule umuntu okhethekile obhekene nokwamukela izikhalazo. Inkampani yakhe izinhlelo ezifana "nezinqubo zokwanelisa amakhasimende kanye nokulawula impendulo", "izinqubo zokuqapha imicimbi emibi kanye nokuhlola kabusha", kanye "nezinqubo zokuqapha nokulawula ngemuva kokuthengisa" ukuze ziphathe kahle ubudlelwano namakhasimende. Chaza ngokucacile umnyango obhekene nokusingatha izikhalazo zamakhasimende, ukuxazulula izinkinga zamakhasimende okokuqala, kanye nokufeza impendulo esheshayo.

Ishadi 3 Inqubo Yokusingatha Izikhalazo Zamakhasimende

2.3.2Ukuqapha Ingozi Yekhwalithi

2.3.2.1Amaphuzu Okulawula Ikhwalithi

UHongde wenza ukuhlolwa okubalulekile ngezingozi ezikhona ezimfanelweni ezibalulekile, ezingxenyeni ezibalulekile kanye nezixhumanisi ezibuthakathaka zekhwalithi yomkhiqizo, futhi wakha uhlelo lokuphatha inqubo ukuze aluphathe. Setha umuntu okhethekile ophethe ukulawula isixhumanisi ngasinye. Umuntu ophethe unekhono elithile lokuhlela, ukuhlela imishini, ukuhlela izinto, ukuhlela imiyalelo yokusebenza, ukuhlela imvelo, ukuhlela ukuhlola kanye namanye amakhono okuxhumanisa, futhi usebenzisa ukulawula amaphuzu okulawula ikhwalithi. Wenza izingozi ezikhona ezimfanelweni ezibalulekile, ezingxenyeni ezibalulekile kanye nezixhumanisi ezibuthakathaka zekhwalithi yomkhiqizo zilawulwe.

2.3.2.2Ukuqapha Nokuhlola Ikhwalithi

UHongde usemise umnyango wezobuchwepheshe bekhwalithi, uchwepheshe wokuhlola ikhwalithi ukuhlola nokuqondisa inqubo yokukhiqiza yochungechunge ngalunye lwemikhiqizo, kanye nochwepheshe wokuphatha izinqubo ukuqondisa ukuqaliswa kwendawo ngayinye yokukhiqiza kanye nesiyalo senqubo. Ngokusho kohlelo lokuhlola isikhuthazo sekhwalithi kanye nokuphathwa kwenqubo oluhlelwe yinkampani, izinkinga ezitholakala ekuqapheni nasekuhloleni ikhwalithi kanye nesimo esibi esitholwe ngabaqhubi enqubweni yokukhiqiza ziyalungiswa futhi ziqondiswe ngokwesimo sangempela sokukhiqiza.

2.3.3Ukuphathwa kwezimo eziphuthumayo zezehlakalo ezisezingeni eliphezulu

Le nkampani isungula futhi igcina indlela yokulungiselela izimo eziphuthumayo zesikweletu kanye nokuphendula ukuze yenze izimpendulo ezisheshayo nezisheshayo ezenzakalweni ezingase zibe khona ezingathembekile noma eziphuthumayo noma eziphuthumayo. Le nkampani isungule inethiwekhi ephelele yesevisi yangemuva kokuthengisa, yasungula izingcingo zesevisi yamakhasimende ukuze yamukele izikhalazo zamakhasimende, futhi yahlela abasebenzi besevisi yangemuva kokuthengisa ukuze banikeze isevisi yangemuva kokuthengisa kanye nokusingatha izikhalazo zamakhasimende. "Izinqubo Zokuqapha Nokulawula Ngemva Kokuthengisa" zenzelwe abasebenzi bangemuva kokuthengisa, futhi inqubo yokusingatha izikhalazo zamakhasimende isisunguliwe. Uma inkinga efanayo yekhwalithi isixazululiwe izikhathi ezintathu ngesikhathi sewaranti futhi ingakaxazululwa, inkampani izothatha indawo yayo. UMnyango Wokuhlela uzolandela futhi ubuyele ekusingatheni kwezikhalazo ngakunye ukuqinisekisa ukuthi isikhalazo sivaliwe futhi ikhasimende liyaneliseka. Kuze kube manje inkampani ayikaze ibe nomcimbi owodwa wokuvezwa kwezindaba.

isahluko sesithathu Ubuqotho Bekhwalithi

3.1Ukuzibophezela Kwekhwalithi

UHongde uthembisa umphakathi wonke kanye nokuzithiba:

1. Yiba nesibopho kubasebenzi futhi usungule imfundo yekhwalithi nobuqotho kanye nohlelo lomvuzo nokujezisa. Yakha imithethonqubo yekhwalithi nobuqotho, uhlele abasebenzi njalo ukuze bafunde izindinganiso zekhwalithi nobuqotho, uqinise ukuqwashisa ngekhwalithi nobuqotho, futhi udinge amarekhodi afanele; sebenzisa imithwalo yemfanelo yobuqotho bekhwalithi kanye nemithwalo yemfanelo yomsebenzi wabasebenzi, usungule ukuhlolwa kokusebenza kobuqotho bekhwalithi kanye nezindlela zomvuzo nokujezisa, futhi ukhuthaze abasebenzi ukuthi bahlanganyele ngenkuthalo ekhwalithini yenkampani. Ukwakhiwa kobuqotho.

2. Yiba nesibopho senkampani futhi usungule uhlelo lokuhlola ubuqotho bekhwalithi. Ngokuhambisana nemithethonqubo efanele, imishini yokuhlola nokuhlola esetshenziswayo kufanele iqinisekiswe noma ilinganiswe njalo ukuqinisekisa ukuthi imishini yokuhlola nokuhlola ihlangabezana nezidingo zezindinganiso zikazwelonke; ngaphansi kwesimo semishini yokuhlola ejwayelekile enembile, abahloli abafanelekayo noma abanekhono elifanayo bazohlinzekwa ukuhlola izinto zokusetshenziswa kanye nemikhiqizo ekhishwe ngaphandle. , izingxenye ezikhishwe ngaphandle zihlolwa noma ziqinisekiswe ngokuqinile, futhi amarekhodi okuhlola noma okuqinisekisa afanele agcinwa njengoba kudingeka; imishini yokuhlola efektri edingekayo ifakwe, futhi umkhiqizo wokugcina uhlolwa futhi ulawulwe ngokuqinile ngokuhambisana nezidingo ezijwayelekile, ukuze imikhiqizo engafaneleki ingaphumi efektri. izidingo, futhi bagcine amarekhodi okuhlolwa efektri emikhiqizo efanelekile ngokwemithethonqubo;

3. Unesibopho ngamakhasimende, usungula abasebenzi abaphatha izikhalazo kanye nohlelo lwenkonzo yangemva kokuthengisa. Imikhiqizo ethengiselwa amakhasimende ihambisana nezitifiketi zokuhlola, futhi inikeze amakhasimende imiyalelo yomkhiqizo; faka futhi uhlukanise amakhasimende ukuze kukhunjulwe izidingo ezikhethekile zamakhasimende akhethekile ngemikhiqizo; sungula ithimba lokwamukela izikhalazo kanye nenethiwekhi yesevisi yangemva kokuthengisa, ngaphakathi kwesikhathi esithembisiwe. Siza amakhasimende ukuxazulula izinkinga ahlangabezana nazo ngesikhathi sokusetshenziswa komkhiqizo, aphathe kahle izikhalazo zamakhasimende kanye nezikhalazo mayelana nekhwalithi yomkhiqizo, futhi alwele ukwenza amakhasimende aneliseke; enze ucwaningo lokwaneliseka kwamakhasimende, aqonde izidingo zamakhasimende, futhi athuthukise njalo ikhwalithi yomkhiqizo.

4. Yiba nesibopho emphakathini futhi usungule uhlelo oluphelele lokulandelela umkhiqizo. Imikhiqizo etholakale inephutha ingabuyiswa ngesikhathi; izingozi zekhwalithi yomkhiqizo ezenzekile zingaphathwa kahle ngesikhathi, futhi abantu abafanelekile abanesibopho bazobhekana nesibopho, futhi uhlelo lokuthuthukisa luzokwakhiwa futhi lusetshenziswe, kanye nobuqotho bekhwalithi kanye nokuziphatha kokuzithiba kokusebenzisa ama-logo ukukhombisa ubunikazi bemikhiqizo. Veza noma wenze izibopho zomphakathi futhi ube nesibopho ngezici zezinto zokusetshenziswa ezisetshenziswa emkhiqizweni, inqubo yokumboza umkhiqizo noma ukusebenza komkhiqizo okubonisa ikhwalithi yomkhiqizo.

Uma inkinga yekhwalithi yemikhiqizo yenkampani iholela ekwazisweni kwasekhaya nakwamanye amazwe, ekubuyiselweni noma ekubhujisweni, inkampani iyamukela ngokuzithandela ukuphathwa okufanele okwenziwa umbuso kanye nezivumelwano ezifanele ngokuhambisana nemithethonqubo.

3.2Ukuphathwa Kokusebenza

3.2.1Thuthukisa uhlelo lwekhwalithi futhi uqinise ukuphathwa kwekhwalithi

Eminyakeni edlule, iHongde ibilokhu inamathela ezidingweni zamakhasimende njengokugxila, futhi ithuthukisa njalo umsebenzi wokuphatha ikhwalithi ngokuya ngezidingo zekhwalithi yomkhiqizo. Ngaphansi kwemingcele yezindinganiso zikazwelonke kanye nezindinganiso zemboni, iHongde ibilokhu ithuthukisa izinqubo zokukhiqiza, ithuthukisa ukucushwa kwemishini, futhi ikhiqize imikhiqizo esebenza kahle futhi eyonga amandla. Umkhiqizo osezingeni eliphezulu. Ukusebenza kahle kohlelo lokuphatha ikhwalithi, uhlelo lokuphatha imvelo, uhlelo lokuphatha impilo nokuphepha emsebenzini kanye nezinye izinhlelo ngaphakathi kwebhizinisi kukhuthaze kakhulu ukuthuthukiswa kwekhwalithi yomsebenzi kanye nekhwalithi yomkhiqizo, futhi kwakhuthaza intuthuko esheshayo yomkhiqizo weHongde.

3.2.2Ukulawulwa okuqinile kwama-node kanye nokugcizelela ukuphathwa kwenqubo

Ngokusho kokulawulwa kwekhwalithi kwezinto zokusetshenziswa, imikhiqizo eqediwe kancane kanye nemikhiqizo eqediwe, umnyango wezobuchwepheshe bekhwalithi wenkampani uqaphela uhlelo lokuphatha oluhlanganisa zonke izinto zokuhlola futhi luhlole inqubo yokukhiqiza kuwo wonke amazinga. Sebenzisa uchungechunge lokuphathwa kwenqubo okuphumelelayo, njengokubeka izikhundla kanye nemithwalo yemfanelo, ukuhlolwa kwenqubo, ukuhlolwa kwekhwalithi, ukuzibophezela, ukulandelelwa kwekhwalithi, ukuhlaziywa kwezibalo zedatha, njll., ukuze kuqondiswe ukulawula okubalulekile kwezinqubo ezibalulekile kanye nokusebenza okujwayelekile kwezinqubo ezivamile. Umnyango wezobuchwepheshe bekhwalithi uqinisekisa ikhwalithi yomkhiqizo ngokulawula okuphelele kwenqubo yokukhiqiza kanye nokuqapha okusebenzayo kwama-node ayisihluthulelo.

Ishadi 4 Inqubo yokuhlola ikhwalithi

3.2.3Misa indlela yokuphatha bese usebenzisa ukuphathwa kwemithwalo yemfanelo

Le nkampani ihlukanisa iqembu ngalinye lokuphatha ukukhiqiza futhi inquma umuntu onesibopho sesifunda ozoqapha futhi ahlole ikhwalithi yeqembu ngalinye lokukhiqiza. UMnyango Wezobuchwepheshe Bekhwalithi kanye namaqembu ahlobene nawo aphendula ngokushesha ezikhalweni zamakhasimende mayelana nekhwalithi yomkhiqizo, asebenzise ngenkuthalo izidingo zezikhalazo zamakhasimende futhi aqaphe ukuthuthukiswa kwenqubekela phambili yokucubungula umkhiqizo. Ithimba lezikhalazo zamakhasimende kanye nomuntu onesibopho.

3.2.4Khuthaza ukubamba iqhaza kwabo bonke abasebenzi ukuze kuthuthukiswe ikhwalithi

Le nkampani ibheka ukubaluleka okukhulu ekwakhiweni kwesiko lekhwalithi, futhi ibheka ubuntu njengento ebalulekile yokuqeqeshwa kwekhwalithi kanye nemfundo. Qondisa bonke abasebenzi ukuthi bahlanganyele ekuphathweni kwekhwalithi. Ngezinyathelo eziqhubekayo nezijulile njengokwakhiwa kokucabanga, iziphakamiso zokuthuthukisa ikhwalithi, kanye nokuthuthukiswa kokuzenzakalela kwemishini, iningi labasebenzi lingahlanganyela ngokugcwele kuzo zonke izixhumanisi zokuthuthukisa ikhwalithi. Ngesikhathi esifanayo, abasebenzi kudingeka bazihlole futhi bazihlole ngokubambisana. , ukuze bathuthukise ikhwalithi yomkhiqizo ngokubambisana futhi babelane ngemiphumela yokuthuthukisa ikhwalithi.

3.2.5Thuthukisa ukudluliswa kolwazi futhi uqinise ukuqapha izinkomba

Ngokwesisekelo sezidingo zenqubomgomo yekhwalithi, uHongde uhlela izinhloso zekhwalithi zonyaka olandelayo minyaka yonke, futhi uhlukanisa izinhloso eziphelele zibe yiminyango ehlukahlukene esebenzayo. Phakathi naleso sikhathi, uhlelo lokuqalisa luzohlolwa futhi lulandelwe, futhi amaphutha azotholakala ngenkuthalo futhi athuthukiswe ngesikhathi ukuze kuhlangatshezwane nezinhloso zekhwalithi nezidingo zenkampani. Ukuze kuthuthukiswe ukunemba kanye nesikhathi sokudluliselwa kolwazi lwekhwalithi, inkampani ithuthukise uhlelo lolwazi lwekhwalithi. Ukudluliselwa kolwazi ngesikhathi sangempela kanye nezibalo ezisheshayo nezinembile kufezwa ngohlelo lokwabelana ngolwazi.

3.3Ukuphathwa Kokumaketha

Le nkampani yakha uhlelo lokumaketha minyaka yonke, futhi iluhlukanise lube imisebenzi yedijithali yanyanga zonke kanye nabathengisi abahambisanayo, futhi ihlukanise abathengisi abanomthwalo wemfanelo wesifunda. Le nkampani yenza ukuhlolwa kwefektri kuyo yonke imikhiqizo yaseHongde ethengiswayo, futhi inganikeza idatha yenkomba yokuhlola ehambisanayo. Imikhiqizo yenkampani ithengiswa kulo lonke izwe futhi iba ngumlingani webhizinisi okhethwayo wamakhasimende. Le nkampani yenza imisebenzi yokukhulisa imakethe ngendlela eqondiwe, iqinisa njalo isithombe somkhiqizo futhi ithinta amakhasimende angaba khona. Abaphathi abaphezulu benkampani kanye namakhasimende asezingeni eliphezulu amaqhinga akhe ubuhlobo obuhle bokubambisana ngamasu ngokuvakasha okuvamile kanye nemihlangano phakathi kwabaphathi abaphezulu nezinye izindlela. Umthengisi usungula futhi agcine ubuhlobo obuhle bokubambisana namakhasimende ngokusebenzisa ukuvakasha okuvamile nokuxhumana ngocingo. Futhi "ekusingathweni kwezinkinga zekhwalithi namakhasimende", sekusungulwe indlela ephelele yokukhalaza kwamakhasimende. Ingamukela futhi iphathe izikhalazo zamakhasimende ngesikhathi ukuze ithuthukise ukwaneliseka kwamakhasimende nenkampani.

Thuthukisa indlela yokumaketha, wandise ithimba lokumaketha, uqinise abaphathi, thembeka ebhizinisini, futhi uthuthukise indlela yokuncintisana kwesikhuthazo, ngemigomo nemithwalo yemfanelo ecacile, futhi ulinganisele ukusatshalaliswa kokusebenza kubantu. Thuthukisa futhi ulinganisele inethiwekhi yokumaketha, usungule amafayela amakhasimende, uqhubeke nokuthuthukisa amafasitela okumaketha asekhaya nakwamanye amazwe, futhi usebenzise umthwalo wemfanelo ohlobene nokusebenza kubantu. Yakha inethiwekhi enhle yenkampani, ukhiphe ulwazi lomkhiqizo ngesikhathi esifanele, futhi ukhulise ngenkuthalo ukumaketha okuku-inthanethi.

Isahluko Sesine Isisekelo Sekhwalithi

4.1Ukuphathwa okujwayelekile

Le nkampani ibilokhu ilandela ukuphathwa okujwayelekile, futhi yakhe uchungechunge lweziqondiso zemibhalo ezijwayelekile ezintathu: amazinga okuphatha, amazinga obuchwepheshe, kanye nezindinganiso zomsebenzi.

Le nkampani isekelwe kakhulu kumphathi jikelele futhi isekelwa yizinhloko zeminyango eyahlukene. Ihlela futhi iqondise ukwakhiwa kwamasu okuthuthukisa ikhwalithi yebhizinisi, izinhlelo zomsebenzi zekhwalithi zonyaka, kanye nezinyathelo zokuqinisekisa ukuphepha kwekhwalithi. Imihlangano ejwayelekile ibanjwa ukuze kuxoxwe ngezinqubomgomo zokuphatha ezingcono futhi kwakhiwe incwadi enkampanini. Le nkampani ihlangabezana nezidingo zamakhasimende zemikhiqizo, futhi ngesikhathi esifanayo, enkambisweni yokuklama nokukhiqiza, inkampani yamukela ngenkuthalo amazinga omhlaba wonke okulinganisa (ISO), amazinga kazwelonke (GB), amazinga embonini kanye nezinye izindinganiso zikazwelonke ukuze kuhlolwe ikhwalithi yomkhiqizo, okuthuthukisa kakhulu ikhwalithi yomkhiqizo. Ikhwalithi ikhuthaze ukuthuthukiswa komkhiqizo wenkampani ezimakethe zasekhaya nezangaphandle. Umnyango wokuphatha jikelele wenkampani usungula imithwalo yemisebenzi yesikhundla ngasinye, usungula izindinganiso zomsebenzi ezinemininingwane zezinga lokwenza izinqumo zenkampani kanye nesikhundla ngasinye somsebenzi, wakha incazelo yomsebenzi yomnyango ngamunye, futhi uchaza ngokucacile imithwalo yemisebenzi yesikhundla ngasinye.

4.2Ukuphathwa kokulinganisa

UHongde usemise inqubomgomo yokuphatha ukulinganisa ephumelelayo ngokuhambisana nemithetho nemigomo kazwelonke, futhi usemise ilabhorethri ekhethekile yokuhlela nokuphatha imishini yokulinganisa. Setha abasebenzi bokulinganisa besikhathi esigcwele, abanomthwalo wokuphathwa kwemishini yokulinganisa yenkampani. Eminyakeni yamuva nje, inkampani yethule imishini yokuhlola yasekhaya ethuthukisiwe, eye yaxazulula ngempumelelo ubunzima bokuhlola futhi yanikeza isiqinisekiso esinamandla sokwenziwa kwemikhiqizo esezingeni eliphezulu. Idatha yokulinganisa ephumelelayo nethembekile itholwa yimishini yokulinganisa ejwayelekile ukulawula nokuqondisa ukukhiqizwa, futhi ithole izinzuzo ezinhle kwezomnotho nakwezenhlalo.

4.3Ukuphathwa Kwesitifiketi

Le nkampani ikhiqiza imikhiqizo esezingeni eliphezulu ehlangabezana nezidingo zamakhasimende ngaphansi kombandela wokuthi ukuphathwa kwemvelo kuhambisana nemithetho nemigomo kazwelonke, futhi ikhiqiza, ithengise futhi isebenze ngokusemthethweni ngaphansi kwelayisensi yokukhiqiza amadivayisi ezokwelapha ekhishwe yi-Zhejiang Provincial Drug Administration. Ngokuhambisana nezidingo zokuthuthukiswa kwenkampani, indlela yokukhiqiza ithuthukiswe njalo futhi ithuthukisiwe. Le nkampani iphumelele ngempumelelo isitifiketi sokuphathwa kwekhwalithi ye-ISO 13485, kanti imikhiqizo iphumelele isitifiketi se-CE, esiqinisekisa ukukhiqizwa kwemikhiqizo esezingeni eliphezulu futhi siqinisekisa imigomo nezindinganiso zemisebenzi ehlukahlukene yokukhiqiza nokusebenza. , Intuthuko engcono.

4.4Ukuhlolwa nokuphathwa kokuhlolwa

Ngomgomo wokwakha i-"Hongde" ibe yibhizinisi elihamba phambili emkhakheni wezindleko nokukhuthaza uhlobo lomhlaba, inkampani iqhubeka nokwandisa ithimba lokuhlola, iqinisa ikhono lobuchwepheshe labahloli, futhi ithuthukise ikhwalithi yomkhiqizo ngempumelelo enkulu. Ngokwendlela yenqubo yokukhiqiza enikezwe yinkampani ngokwezincazelo nezinhlobo, ithimba lokuhlola lontanga lihlelwe ukwenza ukuhlolwa emazingeni ahlukahlukene. Le nkampani ibeka incwadi yokuhlola imishini, futhi ihlinzeka ngemishini kanye nokusekelwa kobuchwepheshe kokugcinwa njalo kwemishini yokuhlola kanye nemishini, kanye nokuhlolwa okuphathiswe amakhasimende.

Abahloli bekhwalithi bemishini yokuhlola baqeqeshwe ngobungcweti futhi bangathatha izikhundla zabo kuphela ngemva kokuphumelela ukuhlolwa. Hlela njalo abahloli bekhwalithi ukuze bashintshane ngezinkinga ezahlukahlukene abahlangabezana nazo ekuhlolweni, futhi bakhe izinyathelo zokulungisa ngesikhathi ukuze bathuthukise izinga lokuhlola kanye nekhwalithi yomsebenzi wabahloli bekhwalithi. Enkambisweni yokuhlola nokuphatha, izinhlelo ezahlukene, imithwalo yemfanelo yomsebenzi, izinqubo zokusebenza kwemishini, umqondo ojwayelekile wokuphepha, izinyathelo zokuphepha, njll. konke kusezindongeni ukuze kube lula ukuyisebenzisa.

isahluko sesihlanu Umthwalo Wemfanelo Wekhwalithi Yomkhiqizo

5.1Izinga Lekhwalithi Yomkhiqizo

Ukukhiqizwa nokucutshungulwa komkhiqizo ngamunye wenkampani kunenqubo yokukhiqiza ephelele nevuthiwe, ehlonyiswe ngemishini yokucubungula ethuthukisiwe kanye nabasebenzi abangochwepheshe nabachwepheshe abanolwazi, ukuze kuqondwe ikhwalithi yomkhiqizo kusukela ekuqaleni kokukhiqiza. Zonke izinhlobo zemikhiqizo ekhiqizwa yinkampani zinezinga lokuphasa elingaphezu kuka-9.8% ekuhlolweni kokugcina nsuku zonke. Ngesikhathi senqubo yokuhlola ikhwalithi, asiwamukeli, asikhiqizi, futhi asikhiphi imikhiqizo esezingeni eliphansi. Siqoqa idatha yezibalo ngemikhiqizo enephutha njalo ngenyanga futhi senza ukuhlaziywa kokuguquguquka. , Xazulula izinkinga ezithinta ikhwalithi kusukela embangeni oyinhloko, ngokusebenzisa inqubomgomo yokuphatha ikhwalithi, izinga lezinkinga zomkhiqizo wenkampani liye lancishiswa kancane kancane, izici ezibalulekile nezibalulekile zomkhiqizo zifanelekile ngo-100% ngaphambi kokulethwa kumakhasimende, futhi imikhiqizo ilethwa kumakhasimende kuphela ngemva kokuba ifanelekile.

Ngo-2021, imikhiqizo yenkampani izothunyelwa eZhejiang Medical Device Inspection Institute ukuze ihlolwe ngamaqoqo amabili, futhi imiphumela yokuhlolwa ihlangabezana nezindinganiso zekhwalithi.

Ishadi 5 Umbiko wokuhlolwa komkhiqizo

Ishadi 6 Ukuqhathaniswa kwezinkomba zobuchwepheshe zomkhiqizo wenkampani nezinkomba zobuchwepheshe ezithuthukisiwe ekhaya nakwamanye amazwe

Umfanekiso 7 Umkhiqizo webhandeji le-viscose plaster kanye nokusebenza kwesevisi

5.2Umthwalo wemfanelo womkhiqizo ngemva kokuthengiswa

I-Hongde inethimba lochwepheshe lenkonzo yangemva kokuthengisa elihlinzeka ngensizakalo yangemva kokuthengisa esezingeni eliphezulu. Le nkampani yakhe “Izinqubo Zokuqapha Nokulawula Ngemva Kokuthengisa” kanye “Nezinqubo Zokulawula Ukukhumbula Amadivayisi Ezokwelapha”. Uma kunezinkinga zekhwalithi emikhiqizweni yangaphambili kanye nokwehluleka kokusetshenziswa ngesikhathi sewaranti, inkampani ingalandelela ngokushesha futhi ibuyise kanye nezinye izindlela zokucubungula ukuqinisekisa ukusebenza kahle kwemikhiqizo enekhwalithi embi. Ukukhumbula okunembile kanye nokwelashwa okuphumelelayo, ukuze kuthuthukiswe ukwaneliseka kwamakhasimende nenkampani, umnyango wangemva kokuthengisa unikeza usizo olulandelayo:

1. Usekelo lobuchwepheshe, khetha isakhiwo somkhiqizo esifanelekile kanye nezinto ezibonakalayo ngokwezinto zokwakha nezinqubo ezahlukene;

2. Hlaziya futhi uphendule izimo zomkhiqizo endaweni bese unikeza iziphakamiso zokuzithethelela;

Enkambisweni yesevisi yomkhiqizo, senza ngobuqotho imithwalo yemfanelo kanye nezibopho zethu ngokuhambisana ngokuqinile nemithethonqubo kanye nezinkontileka ezifanele, futhi imikhiqizo enikeziwe iqinisekisiwe ukuthi ihlangabezana nezidingo zobuningi, ikhwalithi, imininingwane kanye nokusebenza okuchazwe enkontilekeni. UHongde unethemba lokuthola ukwesekwa nokuqashelwa kwamakhasimende ethu ngokuklama kobungcweti, ukucubungula, ukuhlola kanye nokuthengisa ngemuva kokuthengisa.

5.3Umthwalo Wemfanelo Wezenhlalo Wenkampani

I-Hongde ingafinyelela izimpumelelo futhi ithuthuke ibe yisilinganiso sayo samanje, esingenakuhlukaniswa nokusekelwa kwezinqubomgomo zikazwelonke, usizo lwabalingani kanye nokusebenza kanzima nokuzinikela kwabasebenzi base-Hongde. I-Hongde ibilokhu inamathela emthwalweni wemfanelo wezenhlalo wezinga ezintathu "wemithetho, izintshisekelo, nokuziphatha", futhi ithuthukisa njalo indlela yokusebenza yenkampani.

Ezingeni lokulawula, selokhu yasungulwa, inkampani ilandele ngokuqinile imithetho nemigomo yentela kazwelonke ehlukahlukene, futhi yakhe izinhlelo nezinqubo zezimali ezifanele zezinhlobo ezahlukene zokumenyezelwa kwezindleko, ukuvunywa, kanye nokubuyiselwa kwemali kwenkampani, futhi ilawula njalo ukuphathwa kwentela futhi ithuthukisa ukuphathwa kwezezimali. Khokha intela ngokuhambisana nemithetho nemigomo, khokha intela ngokugcwele nangesikhathi, uphathe umsebenzi wentela ngabasebenzi abakhethekile, uqeqeshe abasebenzi bezezimali, uthuthukise ukuqwashisa ngentela, ikhwalithi yobungcweti kanye nezinga lokuphatha, futhi uqinisekise ukuthi umsebenzi wentela wenziwa ngendlela ehlelekile nesemthethweni. Ukunciphisa ukukhishwa komoya, ukuvikelwa kwemvelo "njengomthwalo wayo, ukwenza ngcono ubuchwepheshe bokukhiqiza, ukuthuthukisa ubuchwepheshe bokukhiqiza kanye nemishini, ukufeza ukuthuthukiswa nokulungiswa komkhiqizo, ukunciphisa ukukhishwa komoya ongcolile, kanye nokwakha ngenkuthalo ibhizinisi elonga izinsiza nelinobungane nemvelo.

Izinga lenzalo, selokhu kwasungulwa inkampani, ithembele ekutholeni amasiko ekhaya lesisebenzi, kuhlangene nesimo sangempela senkampani, iye yalwela ukunikeza abasebenzi ukwesekwa kwezidingo zomuntu ngamunye emazingeni ahlukene. Njalo ngonyaka, ihlela njalo ukuhlolwa kwezokwelapha kwabasebenzi, isabalalise izinzuzo zeholide nezinto, ukuvakasha kanye nokududuza abasebenzi asebethathe umhlalaphansi futhi inikeze usizo lwezezimali kwabaswele, njll. ukuze ibuyisele kubasebenzi kuzo zonke izici. Inkampani inaka ukwakhiwa okuhlanganisiwe kochungechunge lokuhlinzeka, ithuthukisa njalo inqubo yokuthenga amakhasimende kanye nendlela yokusebenza, isungula uhlelo lokuhlola olufanele nolungakhethi, futhi idala ikhambi elihle kakhulu kumakhasimende. Yakha ubudlelwano bokubambisana obuhlelekile namakhasimende abalulekile, ikhuthaza ukuthuthukiswa kanye nokuguqulwa kwamakhasimende noma abahlinzeki ngokwesiqinisekiso sokuhlinzeka, ikhwalithi, intengo kanye nensizakalo, iyavumelana nokuphathwa kanye nezinqubo zikaHongde kusukela embonweni, yakha ukuvumelana, igcwalisa izinzuzo zomunye nomunye, futhi yabelana ngezinzuzo. Inkampani isungula futhi isebenzise "Izinqubo Zokulawula Ukuthengwa", ilawula futhi ivimbele inqubo yokuthenga kanye nokuphathwa kwamakhasimende noma abahlinzeki, futhi isayina izivumelwano zokubambisana ezifanele zamazwe amabili kanye nezivumelwano zamasu namakhasimende noma abahlinzeki. Inkampani yethu ilandela ngokuqinile imibandela esenkontilekeni esayiniwe, ivumelanisa ama-akhawunti namakhasimende noma abaphakeli ngesikhathi esifanele, iqede umsebenzi wokukhokha, futhi isungula ipulatifomu yokubambisana eqotho yamakhasimende noma abaphakeli.

Ezingeni lokuziphatha, i-Hongde isabela ngenkuthalo ezinkombeni ezahlukahlukene zomphakathi nezokuziphatha ezikhishwa uhulumeni, futhi iphoqa abasebenzi ukuba babambisane futhi balandele ngenkuthalo. Inkampani iyaqhubeka nokukhula nokuthuthuka, ingakhohlwa ukubuyisela emphakathini, ithembele ezinsizeni eziphelele ze-Hongde, isekela iminikelo yokusiza, ukwakhiwa okusha kwezindawo zasemakhaya, usizo kanye neminye imisebenzi yezenhlalakahle yomphakathi, kanye nokufeza imithwalo yemfanelo yomphakathi.

5.4Irekhodi lesikweletu lekhwalithi

Ngenxa yekhwalithi yayo enhle kakhulu, ithembekile. Le nkampani ayikaze ithole ukudalulwa emakethe, futhi ayikaze ithole izingxabano ezivela kumakhasimende mayelana nekhwalithi, futhi ayikaze ithole isijeziso esivela emnyangweni wokuqapha nokuphatha imakethe. Eminyakeni yamuva nje, iHongde ifinyelele izimpumelelo eziningi ezinhle kakhulu, futhi inconywe futhi yaklonyeliswa yiminyango kahulumeni kuzo zonke izigaba izikhathi eziningi, futhi ikhredithi yayo yekhwalithi iqinisekiswe yizo zonke izinhlaka zomphakathi.

Ulimi lwefindo

Ikhwalithi iyisisekelo sokusinda kwebhizinisi, futhi izinga lekhwalithi liyisisekelo esibalulekile sokukhombisa amandla aphelele ebhizinisi. Uma ibhizinisi lifuna ukuba sesimweni esingenakunqotshwa emncintiswaneni onamandla, kufanele linake kakhulu ikhwalithi futhi lithuthukise njalo izinga lalo lokuphathwa kwekhwalithi.

Ekulondolozeni ukuphathwa kwekhwalithi yokuqala, i-Hongde icwaninga njalo futhi ithuthukise imikhiqizo emisha nezinqubo ezintsha, ngemikhiqizo engcono kanye nezindlela zokusebenza ezilula nezisebenza kahle, ukuze inkampani iqhubeke nokugcina izinga eliphambili kanye nesikhundla embonini. I-Hongde ihlala ilandela inqubomgomo yekhwalithi "yokusungula ibhizinisi ngokunemba, iwine ngekhwalithi", futhi ilawula ikhwalithi yemikhiqizo evela ezintweni zokusetshenziswa, imikhiqizo eqediwe kancane kanye nemikhiqizo eqediwe ngaphakathi, futhi iqinisekisa ikhwalithi yomkhiqizo efanelekile engu-100% ngaphambi kokulethwa kumakhasimende. Ngesikhathi esifanayo, ukuqeqeshwa okuvamile kanye nokuphathwa kokuhlola kwenziwa kubahloli abafanele ukuqinisekisa ukuthi ulwazi lokuhlola lwabahloli luyathuthukiswa futhi lubuyekezwa ukuze luvumelane nomthelela wezidingo zekhwalithi ezahlukahlukene ezilethwa yintuthuko yenkampani.

Ukwakhiwa kohlelo lobuqotho bekhwalithi kuwumsebenzi wesikhathi eside nohlelekile. Ukunamathela esimisweni sokuphathwa kwekhwalithi sokuthi “ukungamukeli imikhiqizo enephutha, ukungakhiqizi imikhiqizo enephutha, nokungakhiphi imikhiqizo enephutha”, ukulawula ngokuqinile umkhawulo wekhwalithi, nokukhuthaza ukwakhiwa kwesiko lekhwalithi, ukuze “Umgomo we-“Made in Zhejiang” uhole kakhulu ezweni futhi usezingeni lomhlaba, futhi sizoqhubeka nokusebenza kanzima!