(To the moderators, this is not a direct repeat of the question I posted to ISO9001 and specific to the 13485 portion of our cert)
Our auditor for our ISO13485 put in his renewal of our certification that we must have "for medical devices" in our scope for our ISO13485 certification. The audit was not done exclusively over our medical projects, and our QMS does NOT separate our standards, but instead mentions which standards are covered by each of our SOPs.
Is this normal and kosher? The fact the audit was not done over our medical customers only and that we apply the controls outside of the medical field seems redundant since it is a medical standard already.
Our auditor for our ISO13485 put in his renewal of our certification that we must have "for medical devices" in our scope for our ISO13485 certification. The audit was not done exclusively over our medical projects, and our QMS does NOT separate our standards, but instead mentions which standards are covered by each of our SOPs.
Is this normal and kosher? The fact the audit was not done over our medical customers only and that we apply the controls outside of the medical field seems redundant since it is a medical standard already.