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Cross-mapping ISO 13485, ISO 15189 and other accreditation and regulatory Canadian standards
I am trying to cross map ISO 13485, ISO 15189 and other accreditation and regulatory Canadian standards that apply to medical testing labs that develop IVTs. In development of a QMS that will satisfy all of them. Any advice?
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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
Expert
Kristina Zvonar Brkić
Jul 14, 2020
It is really hard work, but I think it is doable. Since both standards are similar to ISO 9001:2008, maybe that is the starting point.
Following articles can be helpful:
- Similarities and differences between ISO 9001:2015 and ISO 13485:2016 https://advisera.com/9001academy/blog/2015/01/21/iso-9001-vs-iso-13485/
- ISO 13485:2016 vs. ISO 13485:2003 matrix - https://info.advisera.com/13485academy/free-download/iso-13485-2016-vs-iso-13485-2003-matrix
- ISO 17025 vs. ISO 9001 – Main differences and similarities - https://advisera.com/17025academy/blog/2019/07/11/iso-17025-vs-iso-9001-main-differences-and-similarities//
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Jul 13, 2020
Jul 14, 2020
Jul 14, 2020