Why ISO 13485 didn't implement changes and format of ISO 9001:2015 edition?
Why did ISO 13485 not remain in line with the ISO 9001 standard and did not implement the changes and the format of the 9001:2015 edition?
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Until the introduction of the high-level structure in 2015, ISO 9001:2008 and ISO 13485:2003 were very similar standards.
Unfortunately, corrections on the ISO 13485:2003 took too long. The new version of ISO 13485 has been decided to be released in 2016 although it relies on ISO 9001: 2008. So when ISO 9001:2015 was finally released with the new structure, 13485: 2016 was also already ready for release with the ISO 9001: 2008 structure. Then the ISO organization decided to release 13485 with the old structure.
For more information on similarities between ISO 9001 and ISO 13485, see the following article:
- Similarities and differences between ISO 9001:2015 and ISO 13485:2016 https://advisera.com/9001academy/blog/2015/01/21/iso-9001-vs-iso-13485/
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Feb 25, 2021