Founded in 1901 and awarded its Royal Charter in 1929, BSI became the world's first national standards body and was one of the founding members of the International Organization for Standardization (ISO), which has grown to become the world's leading commercial standards service organization. At present, 49% of the world's top 500 companies use BSI certification services. The certification issued by BSI has an authoritative reputation and extensive international recognition effect in the international market, and is known as the "source of standards" in the industry.
All along, Sun Trine attaches great importance to the construction of quality management system, as early as the establishment of the 100,000 dust-free workshop, and passed the ISO9001, ISO13485, GMP and other system certification.
Compared with the previous ISO13485 certification, the BSI audit is more stringent, and puts forward higher requirements for product design and development, production process control, and enterprise quality management. In addition, the audit included the company's sterile products in the audit scope and optimized the product line.
The certificate marks that Sun Trine fully meets the requirements of ISO13485:2016 medical device quality management system in all aspects of product development, production and sales, and reaches the corresponding international standard, which is a major upgrade and breakthrough of Sun Trine in the construction of quality management system, and helps Sun Trine to further expand the overseas market.