Definition Major vs. Minor Non Conformance Definitions

M

Mondo 22

#1
Can anyone tell me the definitions of a major and a minor non conformance as described in ISO 9000

Thanks,
 
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Stijloor

Staff member
Super Moderator
#2
Re: MAjor/Minor Non Conformance Definitions

Minor Nonconformity
The definition of a MINOR nonconformity:
• Failure to conform to a requirement which (based on judgement and experience) is not likely to result in QMS failure
• A single observed lapse or isolated incident
• Minimal risk of nonconforming product or service

Major Nonconformity
The definition of a MAJOR nonconformity:
• Total breakdown of system, control, or procedure
• Absence of an ISO 9001 requirement
• A number of minors related to the same clause
• An nonconformity that would result in probable shipment of nonconforming product
• A condition that may result in the failure or materially reduce the usability of product for intended purpose;
• A nonconformity that experience and judgement indicate will likely result in QMS failure or materially reduce its ability to assure controlled processes and products

More here:

http://Elsmar.com/Forums/showpost.php?p=293329&postcount=2



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Randy

Super Moderator
#5
Re: MAjor/Minor Non Conformance Definitions

Thank you!

Keep in mind that grading of nonconformities is NOT required for internal audits.
Don't waste your time on it. :nope:
On top of the above, there are no official definitions in ISO 9000 because it's of little importance...Just focus on the definition of nonconformity itself and forget the dribble stuff

"nonfulfillment of a requirement"
 
Likes: db
#6
Re: Major/Minor Non Conformance Definitions

Can anyone tell me the definitions of a major and a minor non conformance as described in ISO 9000

Thanks,
I don't believe they are defined in ISO 9000! As has been said, don't waste your time trying to figure out how to grade internal audits. If the content of the audit reports (non-conformity statements) doesn't justify grading, your management will be confused and you may be criticized for "crying wolf"...

Leave grading to the external auditors - it's worth knowing how they grade, but that's all.
 

qusys

Trusted Information Resource
#7
Re: Major/Minor Non Conformance Definitions

Can anyone tell me the definitions of a major and a minor non conformance as described in ISO 9000

Thanks,
Agree with Stijloor.
The definition of minor, major , observation is more relative to registrar audit ( 3rd parties ones).
However, based upon experience, if you as organization decide to rank the grade of non, this could be useful to highlight and raise attention from topo mgmt side also for mgmt review, where results of audits shalle be taken into account.:bigwave:
 

Marcelo

Inactive Registered Visitor
#8
They were created for certification purposes.

They are also theoretically incorrect - there's a non-conformity (non-fulfillment of a requirement), or there is not :)
 
Last edited:

Stijloor

Staff member
Super Moderator
#9
OK Friends,

To add to the discussion. :D

From "Rules for achieving IATF recognition, 3rd Edition."

Page 39.

Major nonconformity
is one or more of the following:
  • The absence of or total breakdown of a system to meet an ISO/TS 16949:2009 requirement. A number of minor nonconformities against one requirement can represent a total breakdown of the system and thus be considered a major nonconformity.
  • Any noncompliance that would result in the probable shipment of nonconforming product. A condition that may result in the failure or materially reduce the usability of the products or services for their intended purpose.
  • A noncompliance that judgment and experience indicate is likely either to result in the failure of the quality management system or to materially reduce its ability to ensure controlled processes and products.

Minor nonconformity
Is a failure to comply with ISO/TS 16949:2009 which based on judgment and experience is not likely to result in the failure of the quality management system or to reduce its ability to ensure controlled processes or products. It may be one of the following:
  • A failure in some part of the client's quality management system relative to ISO/TS 16949:2009.
  • A single observed lapse in following one item of a company's quality management system.
 
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