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  6. [ISO Certification] ISO 13485 Medical Device Quality Management System

[ISO Certification] ISO 13485 Medical Device Quality Management System

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last updated:Sep 02, 2020

東北環境技術
東北環境技術
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Improving trust from the market and customers! Introducing the medical device quality management system.

Our company provides consulting services for obtaining ISO certification and improving operations. "ISO 13485" is the international standard for quality management systems for medical devices. Nowadays, many countries, including Canada, Europe, and Australia, require medical device manufacturers to manage their processes in accordance with ISO 13485. By obtaining ISO 13485 certification, companies gain an advantage when entering the medical device industry and when exporting overseas. Please feel free to contact us with any questions, inquiries, or requests for quotes regarding ISO. 【Benefits of ISO 13485】 ■ Provides an advantage when entering the medical device industry and exporting overseas ■ Leads to increased trust from the market and customers ■ Enhances employee awareness and contributes to improving corporate culture ■ Facilitates the succession of operations through standardization and clarification of work ■ Ensures compliance with laws and prepares for risks *For more details, please refer to the related links page or feel free to contact us.

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[ISO Certification] ISO 13485 Medical Device Quality Management System

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  • Related Link - https://www.tkgiso.co.jp/iso/iso13485

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【Consulting Features】 ■ Available 24 hours a day, 365 days a year ■ Reduces the workload for customers ■ No limit on the number of contacts with customers ■ Thoroughly study everything about the customer ■ Create a system that maximizes current operations ■ Free support for inquiries via phone or email even after certification is obtained *For more details, please refer to the related link page or feel free to contact us.

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【Purpose】 ■ISO certification acquisition *For more details, please refer to the related link page or feel free to contact us.

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東北環境技術

東北環境技術

Service Industry

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We will solve your concerns like these! I want to obtain ISO! / I have obtained it, but it has become a burden. / I am not seeing specific results. Our consulting motto is to work together with our clients on-site, seeing the actual situation, understanding the reality, and taking action (tasks/document creation/improvement activities). We create a system where ISO is operated through regular business activities without creating unnecessary tasks limited to ISO activities. If you are considering utilizing ISO for your management, please feel free to consult with us. We can assist in the Tohoku region (Fukushima, Miyagi, Iwate, Aomori, Akita, Yamagata) / Kanto region (Tokyo, Kanagawa, Chiba, Saitama, Ibaraki, Tochigi, Gunma) / and other areas as well.

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