HHAO MEDI Successfully Passes 2026 ISO 13485 and ISO 9001 Audits
Published on October 13, 2026
Audits confirm compliance with ISO 13485:2016 and ISO 9001:2015
Covers quality management systems across design, manufacturing, and post-market surveillance
Reinforces HHAO MEDI’s commitment to patient safety, product quality, and continuous improvement
HHAO MEDI announced today that it has successfully passed its 2026 ISO 13485 and ISO 9001 quality management system audits. The audits were conducted by an accredited certification body and confirmed full compliance with both international standards without any non-conformities. ISO 13485:2016 is the internationally recognized quality management system standard for medical devices, while ISO 9001:2015 provides a process-oriented framework for consistently meeting customer needs and applicable regulatory requirements.
“Quality is the foundation of every medical device we design and manufacture,” said Mr Fanlinmin, the General Manager at HHAO MEDI. “Passing the 2026 ISO 13485 and ISO 9001 audits reflects the dedication of our team and our ongoing commitment to delivering safe, reliable, and effective solutions for clinicians and patients.”
What is the purpose of ISO 13485 and ISO 9001 certification?
ISO 13485 certification helps medical device manufacturers demonstrate compliance with regulatory requirements and maintain effective quality management throughout the product lifecycle. ISO 9001 certification further strengthens operational processes, customer focus, and continual improvement. Together, the standards support consistent product quality, risk management, and readiness for international market access.
How do the certifications support HHAO MEDI’s operations?
The certifications cover key areas including design and development, manufacturing, supplier management, document control, corrective and preventive action (CAPA), and post-market surveillance. For hospitals, distributors, and healthcare providers, these certifications provide confidence that HHAO MEDI products are manufactured under rigorous, internationally recognized quality management systems.
The 2026 ISO 13485 and ISO 9001 audits are part of HHAO MEDI’s ongoing commitment to quality excellence and regulatory compliance. More information can be found at https://www.iafcertsearch.org/.
HHAO MEDI CO LIMITED ( HONG KONG )
Phone # 008613737941709 Fax # 0086 771 3895310
Email:sarah@hhao-tech.com
Webste: www.hhao-tech.com
Sarah
Sarah
