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sertifikasi iso 13485 di indonesia - SERKINDO
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sertifikasi iso 13485 di indonesia

ISO

sertifikasi iso 13485 di indonesia

by Serkindo 0 Comment

Bagaimana Cara Mendapatkan Sertifikasi ISO 13485 di Indonesia?

Isi Artikel:
Untuk mendapatkan sertifikasi ISO 13485 di Indonesia, organisasi harus bekerja sama dengan lembaga sertifikasi yang diakreditasi oleh Komite Akreditasi Nasional (KAN). Proses diawali dengan audit awal (gap analysis), kemudian pembentukan sistem mutu sesuai standar ISO 13485.

Perusahaan harus menyiapkan dokumentasi lengkap seperti manual mutu, prosedur kerja, rekaman uji produk, hingga pelatihan staf. Setelah semua sistem berjalan minimal 3 bulan, audit sertifikasi dapat dilakukan dalam dua tahap: audit dokumen dan audit implementasi di lapangan.

Jika lolos audit, sertifikasi akan diterbitkan dan berlaku selama tiga tahun dengan pengawasan tahunan. Dengan proses ini, organisasi akan memiliki sistem mutu yang kuat dan terpercaya.

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