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Has anyone had experience in moving from multiple single-site certifications to a single multi-site certification with ISO 13485? My company is in the process of consolidating 10+ single certificates into 1 multiple-site certificate, but I need some feedback from others who have completed this process.
1. Did your NB require a re-audit of each site prior to adding to your multiple site certificate?
2. Do you certify your EU sales offices?
3. As all of our sites are currently certified, our plan is to allow them to continue to run their QMS systems as they are with the exception of requiring documented reporting to Corporate of internal audits, CAPAs, complaints, and mgmt rvw. We have corporate wide stds, which are general enough in nature to allow each site to tailor to their needs, but are we missing other important items?
4. Do each of your sites maintain their own quality manual or do you have an overall corporate quality manual covering all sites? We will have an overall corporate manual, but have not decided if each site will keep their own manuals.
Thank you for your feedback,
Greg
1. Did your NB require a re-audit of each site prior to adding to your multiple site certificate?
2. Do you certify your EU sales offices?
3. As all of our sites are currently certified, our plan is to allow them to continue to run their QMS systems as they are with the exception of requiring documented reporting to Corporate of internal audits, CAPAs, complaints, and mgmt rvw. We have corporate wide stds, which are general enough in nature to allow each site to tailor to their needs, but are we missing other important items?
4. Do each of your sites maintain their own quality manual or do you have an overall corporate quality manual covering all sites? We will have an overall corporate manual, but have not decided if each site will keep their own manuals.
Thank you for your feedback,
Greg