The latest revision of ISO 13485 (Medical Devices – Quality Management System) has been published.
The standard, which is certified in over 27,000 organisations worldwide, provides a framework that meets the comprehensive requirements for a Medical Devices Quality Management System. It ensures both Manufacturers and Service Providers comply and demonstrate said compliance to regulatory requirements.
As with ISO 9001:2015 (Quality Management), ISO 13485 organisations are able to manage risk, ensure best practice in both Quality and Safety, improve processes internally and importantly provide confidence to patients and those in the industry.
Notable changes to ISO 13485 in the 2016 revision are not dissimilar from those found in the revision of ISO 9001. Alignment of the standard against global regulatory requirements, inclusion of overall risk based thinking throughout the QMS.
The 2016 revision of ISO 13485 strengthens supplier control processes as well as the need to clarify validation, verification and design activities. The standard also covers off the need for validation of software in different applications.
Organisations holding ISO 13485:2003 will have a three year transition period to transition to ISO 13485:2016. IMSM are able to assist organisations to upgrade their Management System to comply with the 2016 revision.