International – ISO 13485 : ISO board seeks feedback on quality systems standard

Executive Summary

Device firms don’t have to conform to the latest version of ISO 13485 until March 2019, yet the International Organization for Standardization (ISO) Technical Management Board is champing at the bit to open up the quality systems standard for a rewrite. In response, ISO Technical Committee 210 has developed a survey to determine how changing the standard will affect device-makers and other stakeholders. TC210 wants to « gather opinions from the users [of ISO 13485] to justify why no immediate revision is desired, especially in light of all the regulatory changes that are coming, » TC210 delegate Kim Trautman says. The survey closes Nov. 9.

Despite the most recent version of ISO 13485 not even going into effect for another four months, the International Organization for Standardization (ISO) Technical Management Board is already looking to open up the standard for a rewrite.

The three-year transition period for ISO 13485:2016 ends on March 1, 2019. That’s when firms that use the international quality systems standard (and are audited to it) must be certified to the new version.

ISO 13485:2016 is unusually structured for a newer ISO standard. When it was being developed, ISO Technical Committee 210, Working Group 1 – a subcommittee that oversees ISO 13485 revisions – received a waiver from the ISO technical board to not write the standard in a so-called « high-level » format