Home About Fapon Biotech Quality Control

Quality Control

From technology platform establishment, experiment design to product verification, quality management is always implemented in the life cycle of each product.
  • 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 Standard, High Quality
  • 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.

    High Demand, High Efficiency

Large-Scale Production & Continuous Improvement of Production Capacity

Stable and high-efficiency supply capacity, emand-based deployment of resources achieves rapid productivity increase.

Professional Production Personnel

Professional production personnels are arranged to manage the production process, ensuring a stable supply of products.

Innovative Production Platform

The production platform has been upgraded into a world-leading standard in meeting the needs of customers for bulk purchase.

Large Single-Batch Production

Large single-batch production with a shorter lead time, less inter-batch variation, higher stability and uniformity in Performance.