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Ụlọ » Akụkọ » Akụkọ ụlọ ọrụ Joytech na-akwalite ogo yana asambodo ISO 13485 maka akụrụngwa mmepụta ọhụrụ na ngalaba ngwaahịa.

Joytech na-eji Asambodo ISO 13485 kwalite ogo maka akụrụngwa mmepụta ọhụrụ na ụdị ngwaahịa.

Nlele: 0     Odee: Saịtị Editọ Oge mbipụta: 2024-05-28 Mmalite: Saịtị

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Joytech emelitere ISO 13485 anyị asambodo nwere ntọala mmepụta akwadoro ọhụrụ yana ụdị ngwaahịa ọhụrụ.

Nke a pụtara na ihe niile ọhụrụ A na-arụpụta ngwaahịa Joytech na-ere n'okpuru usoro njikwa asambodo ISO 13485.

Kedu ihe bụ ISO 13485?

ISO 13485 bụ ọkọlọtọ mba ụwa ama ama maka sistemụ njikwa ogo akọwapụtara maka ụlọ ọrụ ngwaọrụ ahụike. Emebere ya iji hụ na ngwaọrụ ahụike na-egbo mkpa ndị ahịa yana usoro iwu. Ụkpụrụ ahụ na-ekpuchi akụkụ niile nke usoro ndụ ngwaọrụ ahụike, gụnyere imewe, mmepe, mmepụta, nchekwa, nkesa, ntinye, ọrụ na mkpofu.

Akụkụ bụ isi nke ISO 13485:

Sistemụ Njikwa Ogo (QMS): Na-ewepụta QMS siri ike iji jikwaa usoro yana hụ na ngwaahịa dị mma.

Nrube isi n'usoro iwu: Na-eme ka nrube isi n'usoro iwu chọrọ.

Njikwa ihe egwu: Na-etinye ụkpụrụ njikwa ihe egwu n'oge ndụ ngwaahịa niile.

· Mmepụta ngwaahịa: Na-ekpuchi ọkwa niile site na imewe na mmepe na mmepụta na ọrụ post-ahịa.

· Njikwa usoro: Na-ekwusi ike mkpa ọ dị ịchịkwa usoro iji nọgide na-enwe àgwà ngwaahịa.

· Mmelite na-aga n'ihu: Na-elekwasị anya na nkwalite usoro na sistemụ na-aga n'ihu.

Asambodo sitere na ISO 13485:

Mgbe ụlọ ọrụ nwetara asambodo ISO 13485, ọ pụtara na otu asambodo nọọrọ onwe ya enyochala sistemu njikwa ogo ụlọ ọrụ wee chọpụta na ọ dabara ihe achọrọ nke ọkọlọtọ ISO 13485. Asambodo a na-egosi na ụlọ ọrụ ahụ ewepụtala usoro na njikwa dị irè iji hụ na nchekwa na ịdị irè nke ngwaọrụ ahụike ya.

Nsonaazụ nke ISO 13485 Asambodo:

· Nkwenye usoro iwu: na-enyere aka n'ịmezu ihe iwu chọrọ n'ahịa dị iche iche zuru ụwa ọnụ, nke dị oké mkpa maka ịzụ ahịa ngwaọrụ ọgwụ.

· Ntụkwasị obi nke ndị ahịa: Na-eme ka ntụkwasị obi na ntụkwasị obi dị n'etiti ndị ahịa na ndị na-eme ihe gbasara ịdịmma na nchekwa nke ngwaahịa.

· Ịnweta Ahịa: Na-eme ka ịbanye n'ahịa ọhụrụ ebe asambodo ISO 13485 bụ ihe dị mkpa maka nkwado iwu.

· Ịrụ ọrụ nke ọma: Na-akwalite usoro nhazi na nkwalite na-aga n'ihu, na-eduga n'ịrụ ọrụ.

Njikwa ihe ize ndụ: Gbaa mbọ hụ na a na-ejikọta usoro njikwa ihe egwu nke ọma n'oge ndụ ngwaahịa niile.

Gịnị bụ Ụlọ ọrụ Joytech ọhụrụ sitere na ISO 13485 kwadoro?

Ebe ọhụrụ Joytech dị na No. 502 Shunda Road anọwo na-emepụta kemgbe 2023. 

Na-ekpuchi mpaghara nke 69,000 square mita na ngụkọta arụmọrụ arụnyere n'elu 260,000 square mita, ọhụrụ owuwu na-onwem na akpaghị aka mmepụta, mgbakọ, na nkwakọ ahịrị, nakwa dị ka akpaghị aka ụlọ nkwakọba ihe atọ. A na-emepụta ọtụtụ ngwaahịa Joytech ugbu a n'ụlọ ọrụ ọhụrụ a.


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ISO13485 akwadoro oke ngwaahịa

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