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Milwaukee Electronics' Portland, Oregon, facility has become one of the first companies in the EMS industry to be certified to ISO 9001:2015.
"The ISO 9001 standard is continuing to evolve, placing more emphasize on leadership responsibility. The changes are focused on risk-based thinking at all levels of the organization to analyze performance trends and correct issues that would otherwise impact performance objectives," said Paul Satryb, quality manager at Milwaukee Electronics' Portland facility.
In preparation to achieve ISO 9001:2015 certification, the Portland facility's Quality Team conducted a gap analysis beginning in January 2017. The gap analysis included a paragraph audit and consequently, an action item. This provided the direction needed to upgrade the Quality Management System (QMS) to comply with the ISO 9001:2015 standard.
ISO 13485:2003 was revised to version 2016. The facility's QMS will undergo an audit to achieve certification to ISO 13485:2016 in August 2018.