ISO13485 mea lapaʻau ʻōnaehana hoʻokele maikaʻi ʻōnaehana hōʻoia

Nā pae huahana pili e pili ana i ka palapala hōʻoia ISO13485:

Hoʻokaʻawale ʻia nā huahana pili i uhi ʻia e ka ISO13485 certification i 7 mau ʻenehana loea

1. ʻO nā mea lapaʻau non-active
2. ʻO nā mea lapaʻau ikaika (non-implantable).
3. ʻO nā mea lapaʻau hoʻoikaika (implantable).
4. In vitro diagnostic lāʻau lapaʻau
5. Nā ʻano hana sterilization o nā mea lapaʻau
6. Nā lāʻau lapaʻau i loaʻa a hoʻohana i nā mea kikoʻī / ʻenehana
7. Nā lawelawe pili i ka lāʻau lapaʻau

Nā kūlana no ke noi ʻana no ka palapala hōʻoia ISO13485:

Pono nā mea noi e loaʻa ke kūlana kānāwai

Pono nā mea noi e loaʻa nā palapala laikini kūpono

1. No nā ʻoihana hana, pono nā huahana papa I e hāʻawi i nā palapala hoʻopaʻa inoa huahana a me nā palapala hoʻopaʻa inoa hana; Pono nā huahana papa II a me III e hāʻawi i nā palapala hoʻopaʻa inoa huahana lāʻau lapaʻau a me nā laikini ʻoihana hana lāʻau lapaʻau;

2. No nā ʻoihana hana, pono e hāʻawi ka poʻe e hana nei i nā huahana Class II i kahi palapala hoʻopaʻa inoa ʻoihana e hana ana i nā lāʻau lapaʻau; pono e hāʻawi ka poʻe lawelawe i nā huahana Class III i kahi laikini ʻoihana hana lāʻau lapaʻau;

3. No nā ʻoihana e lawe wale aku ana, e like me nā palapala i hoʻopuka ʻia e ka Ministry of Commerce, Customs and Food and Drug Administration i ka lā Malaki 31, pono e loaʻa nā mea hoʻopuka i nā mea lapaʻau a me ka pale ʻana i ka maʻi maʻi i nā palapala hoʻopaʻa inoa / palapala hoʻopaʻa palapala ma ka home. kumu o ka hoʻokō ʻana i nā koi o ka ʻāina lawe mai. A me ka laikini ʻoihana hana lāʻau lapaʻau / palapala hoʻopaʻa palapala;

Ua hoʻokumu ka mea noi i kahi ʻōnaehana hoʻokele palapala e like me nā kūlana (me ka manual quality, nā palapala kaʻina hana, nā mea loiloi kūloko, nā mea loiloi hoʻokele a me nā ʻano ʻē aʻe e pili ana i koi ʻia e nā palapala kaʻina hana)

Ma mua o ka noi ʻana no ka hōʻoia, ma ke kumu, ua hana maikaʻi ka ʻōnaehana hoʻokele o ka auditee no ka liʻiliʻi o ʻekolu mahina a ua hana i kahi loiloi kūloko a me ka loiloi hoʻokele piha (no ka hana ʻana i nā huahana lāʻau lapaʻau implantable, ua hana ka ʻōnaehana no ka liʻiliʻi 6 mahina, a no nā huahana ʻē aʻe Ua holo ka ʻōnaehana hoʻokele no ka liʻiliʻi 3 mahina)

ʻO ke koʻikoʻi o ka palapala hōʻoia ISO13485:

1. E noʻonoʻo i ka manaʻo o ka hui e hoʻokō i nā kānāwai a me nā lula pili
2. E kōkua i nā hui e hoʻomaikaʻi i ko lākou pae hoʻokele a me ka hana o ka hana, a hāʻawi i ka hilinaʻi i ka lehulehu a me nā keʻena hoʻoponopono
3. Hoʻokūpaʻa ka maʻamau i nā koi o ka hoʻokele pilikia e kōkua i nā hui e hōʻemi i ka hopena o nā pōʻino maikaʻi a i ʻole nā ​​hanana pōʻino ma o ka hoʻokele waiwai kūpono.