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Kuohai Medical Technology has passed ISO9001 and ISO13485 certifications

时间:2024-04-28


Kuohai has passed ISO9001 and ISO13485 international quality management system certification!


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Kuohai Medical Technology has passed ISO9001 system certification


At present, some domestic companies only recognize their ISO9001 and ISO13485 certificates domestically, while the certification of Kuohai Medical is not only recognized by China, but also by more than 30 countries such as the United States and Europe. Of course, it also imposes stricter requirements on the company's quality management system.


The certification certificate of Kuaohai Medical Technology includes symbols such as "IAF", "ANAB", and "IAS", indicating that the certification has been recognized by the three major institutions mentioned above (if there is no such symbol, it indicates that it has not been recognized by these institutions).


Among them, "IAF" is the abbreviation of the International Accreditation Forum, which covers more than 30 member countries, mainly including the European Organization for Accreditation and Accreditation (EAC) and the Pacific Accreditation Cooperation (PAC).


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Kuohai Medical Technology has passed ISO13485 certification


"ANAB" is the abbreviation of the American National Standards Institute - American Society for Quality Accreditation Board (ANSI-ASQ National Accreditation Board). Its certification has authority and credibility in multiple countries such as the United States, mainly focusing on the health industry such as food, medical devices, and cosmetics.


IAS (International Accreditation Service) is one of the three major accreditation bodies in the United States, and its certification has both US and international accreditation.


ISO9001 is an international quality management system standard developed by the International Organization for Standardization (ISO) and adopted by more than 100 countries and regions worldwide, especially developed countries. ISO13485 is a standard for the quality management system of medical devices, aimed at ensuring that medical devices meet relevant regulatory requirements in design, production, service, and other aspects.