Conley Carey Receives ISO 13485:2016 Re-certification
Our quality management system has successfully passed the ISO 13485:2016 triennial re-certification audit, confirming our ongoing commitment to medical device quality standards.
Shanghai — Conley Carey Biomedical Co., Ltd. is pleased to announce the successful completion of its ISO 13485:2016 triennial re-certification audit, conducted by SGS Group at our Pudong manufacturing facility on June 12–14, 2025.
The audit covered all aspects of our quality management system, including design and development controls, production process validation, post-market surveillance, and complaint handling procedures. The SGS lead auditor noted that Conley Carey's documented quality system and the live implementation matched closely, with no major non-conformances raised across the three-day review.
ISO 13485:2016 is the internationally recognised standard for quality management systems in the design and manufacture of medical devices. It is a prerequisite for CE marking in the European Union and is recognised by regulatory bodies in over 100 countries.
"This re-certification affirms that our processes meet the rigorous expectations of global healthcare regulators," said Dr. Wei Liang, CEO. "It gives our international partners the documented assurance that every product leaving our facility has been manufactured under verifiable quality controls."
The certificate is valid until June 2028 and covers the full scope of Conley Carey's product portfolio — ophthalmic, nasal, oral, and contact lens care product lines.
