ISO – International Organization for Standardization
We have manufactured and sold reagents since 2010, and we worked with d-ROMs / BAP manufacturer in Italy to create a system and facilities in order to assure the quality standards.
With the aim to improve quality and safety in the process, we acquired ISO13485, an international standard for medical device quality assurance, in September 2011, and have established a manufacturing system that complies with international standards.
GMP – Good Manufacturing Practice
GMP specifies that our products are made “safely” with a “constant quality” in every step of the process from receiving raw materials to manufacturing, and shipping finished products. This represents an international standard for manufacturing control and quality control.
In February 2015, we were certified as a GMP factory. In addition, d-ROMs test and BAP test are treated as Class 2 in vitro diagnostics in Korea with compliance to the Pharmaceutical Affairs Law of South Korea.
GMP is known to be as strict as the FDA in the United States, and Wismerll having the certification of GMP gives an objective reputation for manufacturing and quality control.