Chii chinonzi ISO13485 standard?
Iyo ISO13485 yakajairwa chiyero chehutongi hwemhando inoshanda kune zvekurapa zvinodzora nharaunda. Zita rayo rakazara ndi "Medical Device Quality Management System ye Regulatory Requirements." Iyo inotora iyo yakakodzera pfungwa yakavakirwa paPDCA mune ISO9001 chiyero. Kuenzaniswa neiyo ISO9001 chiyero, iyo inoshanda kumarudzi ese emasangano, ISO13485 ine hunyanzvi uye inotarisa padhizaini nekusimudzira, kugadzira, kuchengetedza uye kutenderera, kuisirwa, sevhisi uye kubviswa kwekupedzisira kwemidziyo yekurapa. uye kuraswa uye mamwe masangano eindasitiri ane hukama. Parizvino, masangano anogona kutanga masisitimu kana kutsvaga certification zvichibva pane ISO13485:2016 standard.
ISO13485: Zvikamu zvakakosha zveiyo 2016 standard
1. Iyi chiyero inotora zvinodiwa zvekutonga semutsetse mukuru uye inosimbisa basa guru remabhizinesi kusangana nezvinodiwa zvekutonga;
2. Iyi chiyero inosimbisa nzira yakatarisana nenjodzi kune manejimendi maitiro uye inosimbisa kushandiswa kwesangano kwengozi-yakatarisana nemaitiro kune akakodzera maitiro anodiwa kudzora hunhu hwekutonga hurongwa;
3. Iyi chiyero inosimbisa zvinodiwa pakutaurirana uye kushuma nemasangano anodzora;
4. Zvichienderana neISO9001, mwero uyu unoisa zvakanyanya kusimba pane zvinodiwa pakunyorwa uye kurekodha.
Mhando dzebhizinesi dzinoshanda
Marudzi makuru emasangano ane chekuita nechitupa cheISO13485 anosanganisira: vagadziri nevagadziri vezvishandiso zvekurapa, vashandi vemidziyo yekurapa, vanopa masevhisi emidziyo yekurapa, software yemuchina wezvokurapa uye vanogadzira Hardware, uye zvikamu zvemidziyo yekurapa.
Zvigadzirwa zvinoenderana nemhando dzinoshanda kune ISO13485 certification:
Zvigadzirwa zvinoenderana zvakafukidzwa ne ISO13485 certification zvakakamurwa kuita 7 tekinoroji minda
1. Michina yekurapa isingashande
2. Midziyo yekurapa inoshanda (isina-implantable).
3. Active (implantable) mishonga yezvokurapa
4. In vitro diagnostic medical devices
5. Sterilization nzira dzemishonga yezvokurapa
6. Zvishandiso zvekurapa zvine / kushandisa chaiyo zvinhu / tekinoroji
7. Zvishandiso zvine chekuita nemishonga yekurapa
Mamiriro ekunyorera ISO13485 chitupa:
Vanyoreri vanofanira kunge vaine chimiro chepamutemo chakajeka
Vanyoreri vanofanirwa kunge vaine marezinesi anoenderana
1. Kumabhizinesi ekugadzira, Zvigadzirwa zveKirasi I zvinoda kupa zvitupa zvekunyoreswa kwechigadzirwa chechigadzirwa uye zvitupa zvekunyoresa kugadzira; Zvigadzirwa zveKirasi II uye III zvinoda kupa zvitupa zvekunyoreswa kwechigadzirwa chechigadzirwa uye marezinesi ebhizinesi rekugadzira mudziyo wekurapa;
2. Kune mabhizinesi anoshanda, ayo anoshanda eClass II zvigadzirwa zvinoda kupa mudziyo wekurapa unoshanda bhizinesi rekunyoresa chitupa; avo vanoshandisa zvigadzirwa zveKirasi III vanofanirwa kupa mudziyo wekurapa unoshanda bhizinesi rezinesi;
3. Kumabhizinesi anongoendesa kunze kwenyika, maererano nemagwaro akapihwa neBazi reCommerce, Customs neChikafu neDrug Administration musi wa31 Kurume, kutengeswa kunze kwenyika zvinhu zvekurapa nekudzivirira denda zvinofanirwawo kuwana zvitupa zvekunyoresa chigadzirwa chemidziyo yekurapa / zvitupa zvekurekodha pa mamiriro ekuzadzikisa zvinodiwa nenyika inotenga kunze kwenyika. Uye yekurapa mudziyo kugadzira bhizinesi rezinesi / rekodhi chitupa;
Munyoreri akagadzira yakanyorwa manejimendi system zvinoenderana nezviyero (kusanganisira mhando yemanyorero, magwaro ekuita, zvemukati zvekuongorora zvemukati, manejimendi ekuongorora zvinhu uye mamwe mafomu ane hukama anodiwa nemagwaro ekuita)
Usati wanyorera chitupa, musimboti, manejimendi yeaudie yanga ichishanda zvinobudirira kweinenge mwedzi mitatu uye yakaita ongororo yakazara yemukati uye manejimendi ongororo (yekugadzirwa kwezvinhu zvinoisirwa mishonga yemuchina wekurapa, sisitimu yanga ichishanda ingangoita 6. mwedzi, uye kune zvimwe zvigadzirwa Iyo manejimendi system yanga ichimhanya kweinenge 3 mwedzi)
Iko kukosha kwe ISO13485 certification:
1. Ratidza kuzvipira kwesangano kuzadzisa mitemo nemirau yakakodzera
2. Masangano anobatsira kuvandudza manejimendi awo uye mashandiro emashandiro awo, uye anopa chivimbo kuruzhinji nemasangano anodzora.
3. Chiyero chinosimbisa zvinodikanwa zvekutarisira njodzi kubatsira masangano kuderedza mukana wenjodzi yemhando yetsaona kana zviitiko zvakashata kuburikidza nekutonga kwengozi kunoshanda.
Nguva yekutumira: Jan-04-2024