Milwaukee Electronics' Portland facility has completed its audit for the transition to ISO 13485:2016 and re-certification to ISO 9001:2015.
"Our internal team did a great job in supporting the transition to latest revision of ISO 13485. While the preparation done last year for the transition to ISO 9001:2015 helped, the two standards are no longer as closely aligned so there was still a significant level of effort required to ensure compliance with the standard’s requirements," said Bob Willenbring, Milwaukee Electronics’ Corporate Quality Director.
The Portland facility was audited early in October and recommended for certification. There were three minor findings which have been corrected and will be submitted to the facility's Registrar shortly.
The transition to the new standard more closely aligns the facility’s processes with FDA requirements in the areas of complaint handling, process validation and risk management.