We have been continuously improving our quality system to help customers accelerate drug development and clinical declaration processes. The company passed the ISO 9001:2015 quality management system certification for the first time in 2016; passed the ISO 13485: 2016 medical device quality management system certification in 2019; and established a GMP-level product quality management system in 2021; in 2022, SPR testing services passed the CNAS accreditation. A good quality management system will continue to be improved with customer requirements/regulatory requirements/market environment, etc. ACROBiosystems has an experienced and professional quality management team, familiar with the bio-pharmaceutical regulations of different countries and regions around the world, closely following industry trends, and can quickly establish or improve quality management systems according to different product types, different customer application scenarios, and changing regulatory requirements, carry out corresponding product development and production to meet the requirements of different customers and make them compatible with

ACROBiosystems' quality system is based on risk-based thinking and design concepts, and establishes management requirements for each module from six aspects: people (E-Learning online training system), machines (confirmation and verification management system), materials (material and supplier classification management system), methods (four-level file structure), environment (QA monitoring of the production environment and production process), and measurement (more than 20 testing techniques, more than 30 testing steps, four reviews, and three releases). Each module is assigned to a dedicated QA person. During the operation of the ACRO quality management system, various monitoring and measurement methods (daily testing, supplier performance, customer satisfaction surveys, internal audits, management reviews, external audits, etc.) are used to identify problems in the real-time operation of the system and continuously improve to ensure the effectiveness, adequacy, and suitability of the quality management system.