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ISO 13485 sistem manajemen mutu alat kesehatan - SERKINDO
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ISO 13485 sistem manajemen mutu alat kesehatan

ISO

ISO 13485 sistem manajemen mutu alat kesehatan

by Serkindo 0 Comment

Peran ISO 13485 dalam Menjamin Mutu Produk Alkes

ISO 13485 adalah standar internasional yang dirancang untuk memastikan sistem manajemen mutu dalam industri alat kesehatan berjalan efektif. Standar ini mencakup semua tahapan siklus hidup alat kesehatan, mulai dari desain, produksi, instalasi, hingga layanan purna jual. Dengan menerapkan ISO 13485, perusahaan menunjukkan bahwa mereka memiliki kontrol kualitas yang ketat, dokumentasi yang tertelusur, dan proses yang terdokumentasi dengan baik—yang semuanya mendukung keamanan dan keandalan produk.

 

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