For 9001:2015 and 13485:2016, are IMS audits subject to IAF MD 11? Or as before, 13485 audit time is used if both certification scopes are the same since 13485 is based on 9001 structure?
But, these two standards now seem to have different structures. In previous version, ISO EN 13485:2013 (2012) states additional requirements to 9001:2008 in blue italic sentences. However, new version is not like that and also 13485:2016 is not on the basis of HLS. Therefore, there are some differences between these two standards. Should we follow same approach as above?
March 2019
According to the definition of an integrated management system given in IAF MD11:2019, the provisions of the particular MD are applicable for management standards / specifications regardless whether these standards follow the high-level structure (HLS) or not.
The audit time of an integrated management system based on the requirements of ISO 9001:2015 and ISO 13485:2016 should be calculated taking into consideration the sum of the audit times derived from IAF MD5 and IAF MD9, respectively, as a starting point.
Moreover, IAF MD9 makes an explicit reference to the application of IAF MD11 in the case of integrated management systems. According to IAF MD9, in case of certification of both ISO 9001:2015 and ISO 13485:2016 standards, the audit time should be sufficient for an effective review of all requirements of both certification standards.