The ISO 13485 standard “Quality management systems. Requirements for regulatory purposes” is used globally by medical device manufacturers as a regulatory pathway to bring their medical devices onto some of largest worlds markets – Europe, Australia, Japan, Canada, South Korea and Brazil, etc.
During the transition (co-existence) period, ISO 13485:2016 will co-exist with ISO13485:2003.
The transition period will last until February, 2019, at which point the 2003 version will be withdrawn
Some of the key changes to ISO 13485 include:
- Inclusion of risk management across all process activities
- Additional requirements for design activities
- Additional requirements for process validation and verification activities
- Improvement in supplier control processes using a risk-based approach
- Increased emphasis on feedback methodologies
- Explicit requirements for quality system software
- For outsourced processes control based on risk and ability to meet specifications and requirements
- Detailed requirements in Technical file
- Management Review frequency determination