Can ISO 9001 lead auditor audit ISO 13485?

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/