A recent poll by UL Medical Solutions revealed that with less than two years until the required transition to the 2016 version of the ISO 13485 standard, respondents are finding themselves unprepared for implementation, required by March 1, 2019, only 23 months away. 

High rates of unpreparedness

A full 29% responded that they were “completely unprepared” for the new standard, while 41% claimed to be Somewhat Prepared. This data correlates with another ISO 13485 IQ test hosted by MedTechIntelligence where over half of the respondents answered a key question “ISO 13485:2016 Requires ISO 14971” incorrectly.

“Implementation of the new requirements in ISO 13485:2016 to an existing ISO 13485:2003 system will take a substantial effort, even for a small manufacturer,” said Mark Leimbeck, Program Manager at UL. “In addition to the quality system, ISO 13485 has the potential to touch every process in the manufacturing and design processes, meaning it will take substantial coordination.”

Waiting until 2018?

According to the ISO data, over 26,000 companies currently have ISO 13485 certification. That means if companies choose to wait until late 2018, they may have to wait and risk missing the transition deadline.

“Oftentimes it’s easier to bring in someone from the outside who has experience with the changes to ISO 13485:2016 and can use that experience to make the process go quicker,” said Linda Chatwin RAC JD, a UL Senior Solutions Consultant. “Not only is it easier, but it reduces the burden on existing staff so they can continue focusing on areas that support the business.”

Linda Chatwin RAC JD Is Senior Customer Solutions Consultant at UL.