Hello all,
We're a medical device manufacturer holding QMS based on ISO 9001:2015 and ISO 13485:2012. Our QMS was based on ISO 13485:2012 integrated with ISO 9001. But now the introduction of ISO 13485:2016 states on clause 0.4 Relationship with ISO 9001 that "this is a stand-alone standard". Even though our company activity is in medical field, there are many tenders also requiring ISO 9001 certificate as well so we have to keep QMS according to both ISO 9001 and ISO 13485.
Now my question is that because ISO 13485:2016 is a stand-alone standard, we cannot build it over ISO 9001:2015. But can we build ISO 9001:2015 over ISO 13485:2016? I reivewed the ISO 9001:2015 standard but couldn't see any clause stating that it is a stand-alone standard.
-Hatice
We're a medical device manufacturer holding QMS based on ISO 9001:2015 and ISO 13485:2012. Our QMS was based on ISO 13485:2012 integrated with ISO 9001. But now the introduction of ISO 13485:2016 states on clause 0.4 Relationship with ISO 9001 that "this is a stand-alone standard". Even though our company activity is in medical field, there are many tenders also requiring ISO 9001 certificate as well so we have to keep QMS according to both ISO 9001 and ISO 13485.
Now my question is that because ISO 13485:2016 is a stand-alone standard, we cannot build it over ISO 9001:2015. But can we build ISO 9001:2015 over ISO 13485:2016? I reivewed the ISO 9001:2015 standard but couldn't see any clause stating that it is a stand-alone standard.
-Hatice