Devices

Move Quickly on ISO Quality Standard, Advisors Say

Medical device companies should move quickly to implement the ISO 13485:2016 quality management standard update, according to consulting firm Emergo. Although the standard has a three-year transition period for compliance with the update, the firm’s online post says that companies would be smart to begin advance planning now.

“The primary reason you should not wait too long is that European notified bodies are busy, really busy,” Emergo says. “Since 2013, notified bodies have been obliged to conduct random compliance audits of manufacturers at least once every three years. This has created a massive amount of additional work…. This has led to some of the weaker notified bodies pulling out of the market and also created a massive resource problem for the notified bodies. They simply do not have enough auditors to do all the work. Unfortunately for device manufacturers, this means you will likely be paying higher prices and waiting longer periods for technical files reviews and certification audits. Thus, if you think you can wait until mid- to late-2018 to get ready and schedule your recertification audit, you will be in a very long line and run a very serious risk of letting your ISO 13485 certification lapse.”

Emergo offers these general guidelines for an effective implementation plan:

identify resources necessary to implement the new standard and update any procedures, training and staffing processes to ensure that the resources are in place;
go over timing and transition requirements and issues with your notified body as soon as possible;
develop a quality plan that contains all activities that need to be completed during the transition period, recognizing that everything takes longer than expected;
ensure that all necessary staff are trained to the updated ISO standard and the firm’s own quality plan;
if necessary, do a gap analysis; and
make sure that all internal quality system audits going forward incorporate changes required by the ISO 13485:2016 update.

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