Jan. 18, 2024
From January 2nd to 4th, under the guidance of three SGS auditors, we had a three-day annual audit for ISO 13485 Medical Devices Quality Management System. Since 2005, Genteel has strictly adhered to this quality system for in-house production operations and has gained achievements in quality control.
During this audit, the auditors conducted thorough audits of the production department, human resources department, finance department, research and development department and the sales department. Through on-site inspections and review of various forms and documents, they expressed their satisfactions to our work in recent years. At the same time, they proposed improvement plans for some issues.
With the continuous development of the rehabilitation medical supplies industry, manufacturers face increasing challenges to ensure product quality and safety. Implementing the ISO 13485 international standard is a crucial step for Genteel in ensuring its products meet high-quality standards. Below are the main reasons that we keep this quality standard as guidance.
1. Improved Quality Management:
ISO 13485 emphasizes the establishment and maintenance of a quality management system. Through process control, monitoring, and documentation, Genteel can better ensure the consistency and reliability of products.
2. Risk Management and Compliance:
ISO 13485 requires us to have comprehensive risk management to make sure products complying with regulations and safety standards throughout their lifecycle.
3. Transparency and Traceability:
ISO 13485 emphasizes record-keeping and document control, ensuring transparency throughout the production process. Detailed record-keeping and documentation help in product traceability, reducing the risk of potential recalls and enhancing the ability of production process control.
4. Customer Satisfaction and Trust:
ISO 13485 requires us to focus on customer needs and take measures to guarantee product quality and safety. High-quality management enhances customers satisfactions and builds trust in Genteel.
ISO 13485 quality system contributes to elevate Genteel's quality standards, regulatory compliance, and strengthening our position in the fierce rehabilitation medical devices market. In the future, we will continue to strictly adhere to this standard, bring more high-quality products to customers and contribute to help provide a more convenient and comfortable life for the elderly.
Finally, we would like to appreciate the supervision and guidance from the SGS auditors. Thank you so much.
