chung nhan ISO 13485

CHỨNG NHẬN ISO 13485 LÀ GÌ?

AIRSEAGLOBAL GROUP

✨ LÀ CHỨNG NHẬN CHO DOANH NGHIỆP SẢN XUẤT HÀNG Y TẾ

– ISO 13485 là một tập hợp các yêu cầu được xác định bởi Tổ chức Tiêu chuẩn hóa Quốc tế.

– Đối tượng áp dụng: áp dụng cho tất cả tổ chức sản xuất kinh doanh thiết bị y tế 

✨Lý do tại sao doanh nghiệp cần đạt chứng nhận ISO 13485??

1. ĐẢM BẢO CHẤT LƯỢNG SẢN PHẨM

Chất lượng sản phẩm sẽ đảm bảo: thích hợp để sử dụng, phù hợp với các yêu cầu. Một doanh nghiệp đạt ISO 13485 sẽ đưa doanh nghiệp tiến tới con đường chất lượng

2. ĐÁP ỨNG CÁC YÊU CẦU CỦA PHÁP LUẬT 

+ Theo quy định tại nghị định 36/2016/NĐ-CP về quản lý trang thiết bị y tế.

+ Nghị định 169/2018/NĐ-CP, ngày 31/12/2018 của Chính phủ về việc sửa đổi bổ sung một số điều của Nghị định 36/2016/NĐ-CP về quản lý trang thiết bị y tế

Thiết bị y tế là một trong những mặt hàng đặc thù, mang tính chất chuyên môn hóa và an toàn cao. ISO 13485 là một ĐIỀU KIỆN BẮT BUỘC của các doanh nghiệp sản xuất và kinh doanh về trang thiết bị y tế cũng như các dịch vụ liên quan.

3. NÂNG CAO THƯƠNG HIỆU VÀ SỰ HÀI LÒNG CỦA KHÁCH HÀNG VỚI SẢN PHẨM

4. ĐẠT ĐƯỢC CHỨNG NHẬN HỆ THỐNG QUẢN LÝ CHẤT LƯỢNG ĐẠT TIÊU CHUẨN QUỐC TẾ

✨ISO 13485 có thời hạn bao lâu? => 3 NĂM

=> Doanh nghiệp liên hệ em Tuyết Minh 0971 460 378 để tiến hành làm ISO 13485 trong thời gian ngắn nhất, chỉ từ 5 ngày

MỌI THẮC MẮC XIN LIÊN HỆ MS TUYẾT MINH AIRSEAGLOBAL – 0971 460 378

Zalo: 0971 460 378

Mobi: 0971 460 378

Email: minhtt@airseaglobalgroup.com.vn

AIRSEAGLOBAL – VUA DỊCH VỤ NHẬP KHẨU THIẾT BỊ Y TẾ

  1. Xử lý GIẤY PHÉP chỉ từ 3-5 ngày:
  • Phân loại (Chỉ từ 200k – Chuẩn vào thầu)
  • Công bố tiêu chuẩn áp dụng đối với TBYT loại A, B
  • Đăng ký Lưu hành thiết bị y tế BCD (Chuẩn vào thầu)
  • Công bố đủ điều kiện mua bán TBYT loại BCD (Chuẩn vào thầu)
  • Công bố đủ điều kiện sản xuất, ISO 13485, ISO 9001, CFS
  1. THÔNG QUAN MỞ TỜ KHAI CHỈ TỪ 700k/tờ khai.
  2. Vận chuyển quốc tế, trucking nội địa giá SIÊU TỐT, SIÊU NHANH

Em Tuyết Minh hoàn tiền 100% nếu hồ sơ thầu ko đạt chuẩn vào thầu; hoàn tiền 100% phí phát sinh hải quan cho khách làm Full dịch vụ từ giấy phép, Hải quan, Vận chuyển Fob/ Exw Air/ Sea với Airseaglobal nếu do lỗi sai giấy phép hoặc soát chứng từ bên em – Bên em thuộc WCA member ID 73213

Update Tuyết Minh

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