In today’s competitive industrial landscape, maintaining high standards is no longer optional—it’s essential. ISO 9001 compliance plays a central role in ensuring consistent quality in manufacturing ...

Lithoz, a high-performance ceramic materials and 3D printing technology company, has certified its quality management system to ISO 13485 standards ... This achievement builds on Lithoz‘s existing ISO ...

The ISO 13485 certification is internationally recognised as the gold standard for quality management in medical device manufacturing. This achievement builds on Lithoz’s existing ISO 9001 ...

ISO 13485 is an internationally recognized standard ... safety and effectiveness of medical devices. It builds on the ISO 9001 standard with additional regulatory requirements specific to medical ...

Most PCB designers follow IPC standards for design and ISO 9001 for quality. However, ISO 13485 is the international standard for medical device quality management systems (QMS). Organizations ...

“Earning ISO 13485 certification means customers can count on the fact we’ve developed and implemented processes that adhere to QMS standard.” Based on the ISO 9001 process approach to quality ...

ISO 9001:2015 is the globally recognized standard for quality management systems, and ISO 13485:2016 sets the bar for quality management specifically within the medical device sector. Achieving ...

Based on ISO 9001:2008, ISO 13485:2016 is a standard unique to the development and production of medical devices. The Food and Drug Administration (FDA) is anticipated to implement this standard in ...

South African Health Products Regulatory Agency (Sahpra) has indicated that ISO 13485 certification is a prerequisite for the application or renewal of a medical-device license, with effect from 1 ...