Like many ISO standards, ISO 13485 (Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes) is currently under revision with the revised standard ISO 13485:2016, expected to be published before the end of March 2016.
“LRQA has an in-depth knowledge and understanding of assessment within the medical device sector and has been active within this arena since 1994,” said Alan To, LRQA Global Strategic Marketing Manager. “To support those organisations to prepare for managing their transition effectively to the new standard, LRQA has launched a brand new course, the ISO 13485:2016 Update Workshop, which has been developed based upon the Final Draft International Standard (FDIS) version of ISO 13485.”
ISO/FDIS 13485:2016 was released on the 23rd September last year and following the commenting period and the positive ISO and CEN voting process, this has now been submitted for publication. “Based on this information we expect the revised standard to be published in the next couple of months. However, the overarching detail contained in the FDIS gives us a good indication of how the revised ISO 13485 is going to look and our courses have been designed to reflect this,” said John Howlett, Technical Manager – Medical Devices.
The Update Workshop is designed to provide delegates with an overview about the new and changed areas of the standard, along with an opportunity to identify how their own organisation’s management systems may need to be adapted to ensure they can successfully complete their transition to ISO 13485:2016.
A key aspect for Global and European stakeholders is that the FDIS will be adopted as both an ISO and EN standard and the process will then commence on harmonising the EN version under the European Medical Device Directives.
Through our extensive range of training and assessment services, LRQA is helping organisations worldwide transition to the new and revised ISO standards. For more information about ISO 13485, email firstname.lastname@example.org or visit www.lrqamea.com.