After being certified with "ISO 9001:2015", recently, Bio-Link Phas have been certified with "ISO 13485:2016" successfully after a strict and detailed review by the third-party testing and certification body. This heavyweight achievement marks the establishment of the quality management system of "clear responsibilities, standardized procedures, pragmatic and efficient, fully controlled" of Bio-Link covering the whole life cycle of the products, and also marks that the company's quality management has proceeded into a new stage of systematization, standardization, and normalization.
Bio-Link is a high-tech enterprise established by famous scientists from the industry and outstanding managers, which is dedicated to the research, development, and manufacture of biopharmaceutical equipment and consumables. Since its establishment, Bio-Link has developed rapidly. Drawing on its strengths in R&D and production, Bio-Link has launched a series of domestic bioprocessing products, including single-use mixing bags, storage bags, sampling bags, freeze/thaw bags, ultrafiltration systems, mixing and storage systems, chromatography resins, chromatography equipment, filtration (clarification, sterilization, virus removal) products, software control systems, etc.
With the development concept of "quality makes excellence", Bio-Link has been focusing on product quality and service, and has been certified with "ISO 9001:2015" last July. The "ISO 13485:2016" is an international common standard for the medical device industry based on medical device regulations. Its full name is "Medical Device — Quality Management System — Requirements for Regulatory", which is an independent standard based on ISO 9001 and dedicated to the medical device industry. The implementation of ISO 13485 is conducive to improving product quality, protecting the interests of customers, and improving the credibility of product quality; improving enterprise management capabilities, promoting continuous improvement, and enhancing the ability of the enterprise to continuously meet the needs and expectations of customers; and improving international trade and eliminating technical barriers.
Dr. Chen Lin, General Manager of Bio-Link, notes that currently, Bio-Link's products are not medical devices, and the company is not a medical device supplier. The certification of ISO 13485:2016 means that the company will voluntarily comply with the relevant quality management requirements, which reflects the company's commitment to fulfilling the relevant regulations and laws. Also, Bio-Link will take this as the starting point to continuously improve the effectiveness of the system operation by applying risk-based thinking, continuing to provide customers with better products and services, and bringing more value to customers in the industry of biopharmaceutical equipment and consumables. What's more, Bio-Link is actively laying out the development of cell and gene therapy bioprocessing business in advance, hoping to provide customers with products, services, and solutions of higher quality.
ISO 9001 Certification
ISO 9001 is an international standard for quality management systems. The certified company has achieved international standards in the integration of various management systems, indicating that the company can continuously and steadily provide customers with qualified products that meet their expectations.
ISO 13485 Certification
ISO 13485 is a quality management system standard applicable to the medical device industry, which focuses on the safety and effectiveness of medical devices. This standard emphasizes that the medical device provided by companies should meet customer and applicable regulatory requirements, which plays a positive role in promoting the quality of medical devices to achieve safety and effectiveness.