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Quality Assurance

Sakura strives for continuous quality enhancement as complying with Pharmaceutical Affairs Law and related regulations. A third-party certificate Sakura has certified includes ISO 13485 and ISO 9001 Quality Management System. Sakura products are backed up by long-standing achievements in the manufacture and sale, as well as a consistent quality assurance system in the range extending from R & D, production, sale to maintenance, and assure you of satisfaction and peace of mind.


ISO 13485

ISO 13485, the quality management system for medical devices, is based on ISO 9001 and additional requirements. Conformance to ISO 13485 is required for production and sale of medical devices in many countries including Europe, United States and Japan.


Unit / Division Certified:

Laboratory Unit
Cleaning & Sterilization Unit (excluding Non-medical Cleaning Devices)
Medical Device Sales Unit
Sapporo Office, Sendai Office, Tokyo Office, Kanto Office, Osaka Office, Okayama Office, Hiroshima Office, Fukuoka Office
Marketing, Academic & Scientific Affairs, Purchasing & Logistics
Service & Maintenance Unit
Customer Service
Regulatory Affairs & Control (located in Nerima, Tokyo)

ISO 9001

ISO9001 is the international quality management system which aims to meet market needs with enhanced quality of products and services, and to improve customer satisfaction. Sakura promotes various initiatives for further quality enhancement through ongoing efforts to optimize our system.



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