Jan. 08, 2026
At Rollyu Precision, quality is more than a promise — it’s a system backed by internationally recognized standards. As an ISO 9001 and ISO 13485 certified manufacturer, we operate under rigorous quality management frameworks that ensure every part we produce meets the highest levels of consistency, traceability, and performance.
ISO 9001 certification demonstrates our ability to deliver products and services that consistently meet customer and regulatory requirements across industrial sectors. It ensures structured quality management, customer focus, and continuous process improvement.
ISO 13485, tailored specifically for the medical device industry, reinforces our commitment to risk management, regulatory compliance, and product safety. This standard is essential for supporting customers in regulated environments, where documentation, process validation, and patient safety are non-negotiable.
Together, these certifications provide clear benefits:
Enhanced product quality and reliability
Robust risk management practices
Regulatory compliance for global medical markets
Customer assurance and supply chain credibility
A competitive edge in both industrial and medical sectors
Both standards require regular internal and external audits, driving a culture of accountability and continuous improvement. Whether we're machining complex medical enclosures or producing precision sheet metal parts for automation, Rollyu Precision delivers with confidence — certified, documented, and ready for your most demanding applications.
Looking for a certified manufacturing partner you can trust?
Talk to our engineering team about your quality, compliance, and traceability requirements.
