June 1, 2023
NextBeam formally earned its ISO quality system certification as of June 1, 2023. NextBeam’s quality system accreditation covers 3 ISO standards:
- ISO 13485 – Medical device quality management system – debuted in 1996 and was developed as a voluntary standard that outlines quality system expectations and regulatory requirements specific to medical device manufacturing. NextBeam is accredited to the latest revision of the standard (2016.)
- ISO 11137-1 – Radiation Sterilization of Health Care Products – debuted in 1995 and specifies requirements for the development, validation, and routine control of a radiation sterilization process for medical devices. NextBeam is accredited to the latest revision.
- ISO 9001 – Quality Management Systems – first published in 1987 and lays out the broad criteria for a modern quality management system. 9001 is not industry-specific and thus sees broad usage worldwide (over 1 million active certificates). NextBeam is accredited to the latest version (2015).
Nick Brydon, NextBeam founder and Head of Sterilization, led this critical effort for the company, which took months of writing procedures and assembling quality records. Nick commented, “Achieving certification for three ISO standards on our first attempt – with zero critical observations – demonstrates the maturity and strength of our quality system and methodical approach to safe and precise radiation sterilization.”
NextBeam set a goal to achieve this critical milestone early: our most demanding customers require these certifications to integrate seamlessly with their own advanced quality management systems. Compliance with these standards enables us to process the most demanding of medical devices and other customer products at the highest level of quality.