Definition Major vs. Minor Non Conformance Definitions

James

Involved In Discussions
#11
Hi all

Just reading through this old post, which is very useful. Is it still safe to assume that grading nonconformity in internal audits is still unnecessary? I'm working to ISO 13485

Thanks

James
 
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Marc

Hunkered Down for the Duration with a Mask on...
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#13
Depends on the nonconformances. If each is in a different process/system, not necessarily. For example, if you have multiple nonconformances in document control it is probably a systemic problem (major). If you have 1 in document control and 1 in internal audits and 1 in design and development, a systematic problem is not indicated, so no major.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#14
Hi all

Just reading through this old post, which is very useful. Is it still safe to assume that grading nonconformity in internal audits is still unnecessary? I'm working to ISO 13485
See Yodon's post below for medical device/ISO 13485 specifics.

In general, pretty much as above. The question is, is the auditor seeing what s/he believes may be a systemic problem. If so, the auditor should take a deeper look. If the problem is identified as systemic, it is a major issue and a corrective action is probably necessary.
 
Last edited:

yodon

Staff member
Super Moderator
#15
The GHTF (Global Harmonization Task Force - morphed into the IMDRF - International Medical Device Regulators Forum) wrote a paper on grading nonconformities. It's not specifically for internal audits nor does anybody require it but (to me at least) it makes sense. It takes the burden off the auditor to classify a finding and enables a risk-based approach to responding to findings.
 

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