The ISO Working Committee has recently completed its revision exercise for ISO13485 started since April 2012. The new ISO13485:2016 standard has been published on 1st March 2016.
Summary of the key changes
The most important change in the revision is the application of a risk-based approach in the development of most aspects of a quality management system.
Other major changes include:
- Validation of the application of computer software used in the quality management system
- Establishment and maintenance of technical medical device files and design development files
- New requirements for complaint handling procedures
- Validation of processes for sterile barrier systems as well as sterilisation
- Clarifications of existing requirements regarding top management responsibility
- Definition of skills and experience required for personnel involved in quality management and documentation of training and assessment of effectiveness of training.
The revision of ISO 13485 does not adopt the so-called high-level structure for management system standards detailed in Annex SL of the ISO Directive. As a result, there are important structural differences between the revised ISO 13485 and the recently published ISO 9001:2015.
Timeline for the transition
The published version of ISO 13485 will provide a three year transition period for device manufacturers and other organisations certified to ISO 13485:2003. Given the extent of the anticipated changes, as well as the structural differences between the revised ISO 13485 and ISO 9001:2015, transitioning to the new requirements is likely to require a considerable investment of time and resources. Medical device manufacturers and other ISO 13485 certified organisations are advised to promptly begin the process of evaluating the application of the standard’s new requirements to their existing quality management system, in order to determine the scope of required changes and the time required to implement them.
For more information about the changes, click here [ PDF 503 kB ].