High Standard, High Quality

Quality Control System Management

Implementation of ISO 13485:2016 & 9001:2015

>The ISO 9001 is the international core standard, while ISO 13485:2016 is established based on the requirements of the ISO 9001 and added with specific requirements for the medical device industry

>First in the industry within China to be certified by the ISO 9001:2015, followed by the ISO 13485:2016 certification granted in 2020, Fapon Biotech carries out product production and verification under the same quality inspection system as customers to assure product adaptability.

>With a relentless pursuit of product quality, Fapon implements dual quality management systems, control the entire process of product development, production and distribution strictly under SOPs. We are committed to providing products with small inter-batch variation and high stability to customers by maintaining high quality control standards.

High Demand, High Efficiency

Training

Training is provided to product-related R&D, production and QC personnel to promote QC awareness.

Quality Management

Strict management is performed on supplier selection and consumable procurement and regulations. Quality control is carried over the production process to ensure product stability and uniformity.

Equipment Commissioning

Regular maintenance and calibration of equipment and tools related to R&D, production, and quality testing are performed.

Continuous Improvement

Feedback from customers on products is followed up and handled promptly. Corresponding measures for R&D, production, and quality are taken after analyzing causes to achieve continuous improvement.

Fapon Biotech - Model MD030-K-XI/XII/XIII -Molecular Diagnosis Isothermal Amplification