Ngā Whakatutukitanga a AmerikaTiwhikete ISO 13485, he paerewa ā-ao mō ngā taputapu hauora me ngā hua e pā ana.
Mō18 tau, kua whakapau kaha mātou ki te whakarato ratonga tohunga e ai ki ngā paerewa o te ao.
E harikoa ana a Merican ki te whakapuaki kua angitu tana whakatutuki iTiwhikete ISO 13485, te paerewa pūnaha whakahaere kounga e mōhiotia ana i te ao mō ngā taputapu hauora. He tohu tēnei tohu nui mō te whakapau kaha a Merican ki te haumaru hua, te hiranga o te kounga me te tutuki i ngā whakaritenga o te ao, e whakakaha ake ana i te waitohu18 tauo ngā tohungatanga o te ahumahi.
Tēnā koa, ka taea e koe te homai he whakamāramatanga mō te ISO 13485?
ISO 13485He paerewa e mōhiotia ana e te ao whānui e whakaatu ana i ngā whakaritenga mō tētahi pūnaha whakahaere kounga e tika ana mō ngā taputapu hauora. E whakatakoto ana i ngā whakaritenga pakari mō te hoahoa me te whakawhanaketanga hua, te whakahaere mōrearea, te whakahaere whakaputa, te whai i ngā ture, te tuhi tuhinga, me te whakapai tonu.
Ko te whakatutukitanga o tēnei tiwhikete he tohu i te kaha o Merican ki te tuku tonu i ngā hua haumaru, pono, me te kounga teitei e tutuki ai ngā tumanakohanga a ngā ture o te ao me ngā kaihoko.
Kua mōhiotia te kamupene mō te kaha me te pono o tōna waitohu me ngā tohu maha i ngā wā o mua.18 tau.
Mō18 tau, kua whakatapua a Merican ki te umanga taputapu hauora me te whakaora rama. Nā tēnei whakapau kaha kua hua ake he ingoa kaha, i hangaia i runga i te auahatanga, te pono me ngā uara e aro ana ki te kiritaki. I roto i tōna whānui haere o te ao, kua rite tonu a Merican i ana mahi ki ngā paerewa kounga me te haumaru o te ao, ā, kua whiwhi i ngā tiwhikete me ngā whakamanatanga mana maha i roto i te tukanga.
Te whakatutukitanga angitu oISO 13485Ka whakapakari ake i te anga kounga whānui a Merican, me te whakarato taunakitanga pakari mō ōna pūkenga R&D pakari, ngā tukanga hanga paerewa, me ngā pūnaha whakahaere kounga pakari.
E whakapau kaha ana mātou ki te haumi tonu ki te kounga me te hanga.
Hei whakarite i te haumaru me te whai huatanga o ngā hua mō te wā roa, kei te whakapau kaha tonu a Merican ki:
- Kei te kamupene ngā whare hanga hou me ngā raina whakaputa aunoa.
- He pakari ngā pūnaha whakahaere kounga me ngā pūnaha arotake ā-roto a te kamupene.
- E whakahīhī ana tā mātou kamupene ki te whai i ngā tīma R&D ngaio me te whakapūmau kounga.
He mea tino nui te whakarite i te whai i ngā āhuatanga katoa me te whakahaere i ngā mōrearea puta noa i te huringa ora o te hua.
Ko ia āhuatanga o ngā mahi a Merican kua hangaia me te whakaaro ki te kiritaki, kia rite ai te kounga, te whakaiti i te mōrearea, me te pono o te mahi a te hua.
Te titiro whakamua:Te whakapai ake i ngā paerewa hei whakarite i te hiranga
Te whakatutukiISO 13485Ehara te tiwhikete i te mutunga o te tukanga, engari ko te tīmatanga o tētahi tukanga hou. I te heke mai, ka mau tonu a Merican i ngā paerewa kounga hauora, ka whakarei ake i ana pūnaha whakahaere kounga, ka tuku hua e tuku ana i te pono, te haumaru, me te rangimarie o te hinengaro ki ngā kiritaki o te ao katoa.
Mō18 tau, kua arotahi mātou ki te kounga.
He mea whakahīhī ki a mātou te pupuri i ngā tohu maha, e whakapono ana mātou ka whakatupu i te whakapono ki ā mātou ratonga.
E whakapau kaha ana a Merican ki te whakatakoto i ngā paearu teitei ake mō te hiranga i roto i te umanga oranga me ngā taputapu hauora o te ao.
