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"Medical devices" required in scope

Ralba

Involved In Discussions
#1
(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.
 
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somashekar

Staff member
Super Moderator
#2
(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.
The scope in the certificate for ISO 13485 has to clearly tell the interested parties what specific family of medical device, services, or associated activity is being certified. This is normal, because the standard is about Medical devices - Quality management system.
it is absolutely fine if you have an integrated quality management system that encompasses both medical devices as well as other products. The focus of the audit will be on the "medical devices" part only.
 

Ralba

Involved In Discussions
#3
Seems reasonable. I am betting they got their wires crossed and the auditor only meant to request the 13485 change.
 
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