Can ISO 9001 lead auditor audit ISO 13485?
Am a lead auditor in ISO 9001:2015 can it be difficult for me to audit the ISO 13485
Assign topic to the user
Although basic things are the same between these two standards (like internal audit process, corrective actions, managing documents and records, managing non-conformances), there are certain specifications of the ISO 13485:2016 (mostly from points 6, 7, and 8 depending on the type of the medical device and type of production). If you are an auditor, then you know that auditors should dominate the audit criteria used. I suggest that you study the standard ISO 13485:2016, to specially check the Annex B of the standard where the correspondence between ISO 13485:2016 and ISO 9001:2015 is explained.
For more information on what ISO 13485 is, please see the article on the following link:
- What is ISO 13485? https://advisera.com/13485academy/what-is-iso-13485/
For more information about Similarities and differences between ISO 9001:2015 and ISO 13485:2016, please see the article on the following link: https://advisera.com/9001academy/blog/2015/01/21/iso-9001-vs-iso-13485/
Comment as guest or Sign in
Nov 10, 2020