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Quality management system khusus kepada peralatan kesehatan (ISO 13485:2004). 

ISO 13485:2004 adalah sebuah persyaratan yang di peruntukan bagi perusahaan yang khusus memproduksi alat-alat kesehatan dan bukanlah standard alat kesehatan/ alat medis. Standard ini memastikan persyaratan untuk sistem manajemen mutu di mana organisasi perlu menunjukkan kemampuan untuk menyediakan perangkat medis / perangkat kesehatan dan jasa terkait yang secara konsisten memenuhi persyaratan pelanggan juga memenuhi semua peraturan yang telah di tetapkan. Dengan perangkat medis atau jasa terkait .  Tujuan utamanya adalah memfasilitasi persyaratan perangkat peraturan medis untuk manajemen mutu.

Apa keuntungan kepada perusahaan dalam implementasi ISO 13485:2004?

1. Dengan lulus sertifikasi ini menandakan kemampuan perusahaan untuk mensuplay peralatan medis dan jasa terkait
2. Menjadi salah satu identifikasi serta evaluasi bahwa organisasi dapat memenuhi permintaan pelanggan juga memenuhi semua persyaratan peraturan yang berlaku
3. Di tinjau dari sudut manajemen , menunjukkan bahwa sertifikasi menandakan organisasi telah menjalankan proses bisnis dengan effective dan efesien sesuai dengan standard internasional
4. Menetapkan sistem manajemen yang berorientasi terhadap desain, pengembangan, produksi, dan pemasangan peralatan medis dan jasa terkait.

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• Choose  ISO Consultant firm  with a clear background of business legality. This can be measured by carefully reading or detail of the relevant service provider (usually can be checked at page “About Us, Our Vision, Mission, Contact us, etc.”, about us or Business Profile. It would be better if you put more attention to service providers in the form of a personal rather than company or  individual, because it is legally more secure.

•  It would be better if the company’s Consulting Services ISO  (ISO Consultant),  ISO has been certified ISO 9001 as a basis for a minimum commitment of applying “Quality Management  System” for his own company.

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• Concentrate your choice to the Consultant Services Company of ISO (ISO Consultant firm) that provides detailed information on their website. Services provided to the product so that potential clients to clearly understand the benefits and what benefits they will get.

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• Try carefully carefully Client List / list of customers that include on your site or in the proposal, it is better to do re-confirm, whether the list of those companies actually become a client of the company’s Consulting Services ISO (ISO Consultant) is.  Do-do client list is made a lot of data but only to spit out our fictitious. And it’s good TSB Corporate Consulting Services can be proved by showing its cooperation contract to a client list that he wrote.

•  If you’ve found Consulting Services Company of  ISO (ISO Consultant firm) who has passed the seven (7) above requirements, the last thing you should do is do a test product ordering services. Make reservations by email and wait for how long the response given by the Company’s ISO consultant services to the reservation that you have submitted,  generally  sooner response is  better that’s  means the company of  ISO consulting services provider to understand the concept of “the importance of time in responding to clients’ or prospective clients in the relationship with their business line.

Hopefully helpful …!

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