Start New ISO Standard Planning: Consultant
MedTech Review senior consultant John Beasley says that while there is a three-year transition period for the third edition of the international quality standard for medical manufacturing, ISO 13483:2016, which was published 2/24, medical device manufacturers and their suppliers would be wise to start their transition planning now. Writing online for Plastics Today, Beasley says the new standard has a broader scope than previous editions. “It applies to any organization involved in the lifecycle of the medical device,” he writes, “including providers of technical services, component manufacturers, entities involved in regulatory work, such as European Union authorized representatives, even distributors and importers. The scope has opened up a lot, and this is new.”
Beasley also points to the standard’s new emphasis on a risk-based approach. He says that a key change is the requirement to have a written quality agreement between the original equipment manufacturer and the contract injection molders, extruders, or any other suppliers of products and services that describes controls in place that are proportionate to the risks of the devices involved.
Another new clause in the standard involves software and has the potential to create some issues, Beasley says. The clause is similar to an FDA regulation that says that if a company uses software to automate production or any other part of a quality management system, the software has to be validated, he says. Beasley says that although the FDA requirement has been around since 1996, it’s not typically part of an agency inspection and many companies have either weak validation or no validation. “Compliance is expensive,” he writes, “and sometimes companies might wait until they receive a Form 483 Warning Letter before making improvements.”
He cautions that when a company applies for ISO 13485:2016 certification, it’s out of wiggle room and must have a documented procedure for validating application of software used in a quality management system and must have the software validated before it is used and revalidated if changes are made.
However, Beasley says, there is no ISO standard that provides guidance on meeting the requirement and the standard that is under development is not likely to be published until sometime in 2018, the final year of the ISO transition.