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ISO 13485 Update: Worries About Firms Missing 2019 Deadline; Quality Systems Standard Handbook In The Works; Suppliers Now Eligible For Certs – And More

This article was originally published in The Gray Sheet

Executive Summary

Device manufacturers might be tempted to put off becoming certified to the newly revised ISO 13485 because they've been given three years to conform to the global quality systems standard. But not so fast, says ex-FDA official Kim Trautman, who's worried that ISO's three-year window for companies to comply will "lull people into a false sense of security": "Not every firm has three years, per se, to transition from the 2003 version of ISO 13485 to the 2016 version; some firms might only have one year depending on how their certifications are laid out," she warns. Meanwhile, ISO is authoring a handbook to the revised standard, and Trautman talks about what firms should keep an eye on in the rejiggered standard, including its scope – which now allows vendors to be certified to the standard – and sections on compliant handling, purchasing activities and risk. Also: a podcast interview with Trautman, who talks about her worries that firms will miss ISO's March 2019 deadline.


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