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ISO 13485: 2016


ISO 9001: 2015

HUI Awarded Medical Device ISO 13485:2003 Certification

Posted by HUI on July 14, 2014

HUI is excited to announce the company has been awarded the medical device International Standards Organization (ISO) 13485:2003 certification. In early 2013 HUI began design and development with a large client that required HUI to modify its quality systems so that raw materials, measuring devices, and finished goods could all be traced back to exact manufacturing dates and manufacturing product lots. The next largest change to HUI’s quality system involved the creation of a detailed risk management procedure which would indicate the risks in different levels of potential product failure and the associated corrective actions to prevent those failures prior to production.

What Does This Mean For Our Customers?

HUI has the ability to set up all raw material part numbers associated to your product and trace them to a particular shop order in our ERP system. Should there ever be a problem with a particular raw material part, HUI has the capability to trace product batch and serial numbers in addition to product ship to locations. By having this capability the need for a potential mass recall is reduced. The same process applies to any measuring device that may be deemed out of calibration that may have qualified a product shipped to a customer.

HUI has been using the Design Failure Mode and Effects Analysis (DFMEA) and Process Failure Mode and Effects Analysis (PFEMA) processes since 2010. These processes aim to identify product failure risks within the customer’s product prior to production. These risks are detailed and reviewed with the customer as part of the ISO 13485:2003 risk management procedure.

For more information about HUI, our cart solutions or our 13485 processes please contact Nick Rolf at nrolf@huimfg.com or you can reach him directly at 920-286-2217.

Topics: ISO Certification

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