Milwaukee Electronics' Portland Facility Completes Transition to ISO 13485:2016


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Milwaukee Electronics' Portland facility completed its audit for the transition to ISO 13485:2016 and recertification to ISO 9001:2015 in October.

"We completed the audit with only three minor findings which were quickly corrected. Our team did a great job supporting this transition," said Bob Willenbring, Milwaukee Electronics' Corporate Quality Director.

The quality team began their transition efforts to ISO 13485 revision in 2017, shortly after the facility completed certification to the latest revision of ISO 9001. While some of the work supporting revision of ISO 9001 quality management system (QMS) procedures did benefit the ISO 13485 revision, the two standards are no longer as closely aligned, which drove some additional procedural modifications. For example, 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.

"Jack Tanz, our Quality Engineer, did a great job updating procedures to comply with the new standard, then working with the Quality team to perform a full internal audit to identify any areas we needed to enhance. They completed over 90% of the work prior to my joining the company. The only area I felt we needed to add was employee training on the intent of the standards," added Willenbring.

While employees were already fully trained on the procedures, the additional training was designed to better ensure they understood the intent of both standards in terms of mitigating risk and driving better understanding of the impact of each employee’s efforts on product quality and overall customer satisfaction.

"Both standards drive more risk analysis across the organization and require employees to understand the specific impact of their roles in process of product realization at a much deeper level than in previous iterations. Our training was designed to
ensure they fully understood that new level of responsibility," said Willenbring. At a corporate level, Willenbring is working to better standardize procedures across the company.

"Our quality procedures vary slightly by facility. While we serve distinctly different customer bases in each facility, we will be focusing on standardizing key processes, such as corrective action, and the look and feel of documentation going forward. While certificates demonstrate third-party oversight of our QMS at each facility, it is equally important that we internally maintain a vision that unifies our approach to quality documentation across our company," said Willenbring.

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