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Product Traceability - SERKINDO
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Product Traceability

ISO

Product Traceability

by Serkindo 0 Comment

Fitur Khusus ISO 13485

Beberapa fitur yang membedakan ISO 13485 dari standar mutu umum seperti ISO 9001:

๐Ÿ“„ Dokumentasi teknis wajib
๐Ÿงช Validasi proses kritis (misal: sterilisasi, software embedded)
๐Ÿ” Traceability menyeluruh โ€“ dari bahan baku ke produk akhir
๐Ÿ”Ž Pelaporan kejadian pasca pemasaran (post-market surveillance)
๐Ÿงฉ Manajemen risiko produk (ISO 14971)

 

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Kontak Kami :

  1. Sertifikasi Indonesia

Alamat : Jl. Pembinaan No.36, Lengkong Gudang Tim., Kec. Serpong, Kota Tangerang Selatan, Banten 15310

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