Claiming exemptions (N/A) in AS9100D - what is the methodology and location?

N

normzone

Trusted Information Resource
#1
#1
Lucky me ... just began with a new outfit that recently transitioned from 9001:2008 to AS9100D.

I'm informed that this make-to-order outfit does not do design, but I don't see any such statement on the certificate.

It's implied in the the scope which only states " Manufacture of blah blah and blah ", and I just heard it stated that the exemption " is on OASIS ", but I'm not feeling it yet.

Any counsel appreciated :(
 
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Pjservan

Pjservan

Involved In Discussions
#2
#2
Approved exceptions, now called exclusions, will be listed in Oasis:
1544039081828.png

More importantly it should be captured in somewhere in your QMS with proper justification. Most commonly in the Quality Manual.
 
Al Rosen

Al Rosen

Leader
Super Moderator
#3
#3
normzone said:
Lucky me ... just began with a new outfit that recently transitioned from 9001:2008 to AS9100D.

I'm informed that this make-to-order outfit does not do design, but I don't see any such statement on the certificate.

It's implied in the the scope which only states " Manufacture of blah blah and blah ", and I just heard it stated that the exemption " is on OASIS ", but I'm not feeling it yet.

Any counsel appreciated :(
Click to expand...
What you need to do is described as part of 4.3 in the standard.

The scope shall state the types of products and services covered, and provide justification for any requirement of this International Standard that the organization determines is not applicable to the scope of its quality management system.
Click to expand...
 
E

EMP

EMP
#4
#4
We just had a 1st stage - auditor was happy with this statement under 4.3

"Non-applicable items under to AS9100D / EN ISO 9001:2015 -
No design or calibration (AS9100D / EN ISO 9001:2015 Requirement 8.3 - Design and Development of Products and Services and 7.1.5.2 – Measurement Traceability Process) are carried out as part of the company processes and is therefore not applicable to the QMS"
 
Al Rosen

Al Rosen

Leader
Super Moderator
#5
#5
EMP said:
We just had a 1st stage - auditor was happy with this statement under 4.3

"Non-applicable items under to AS9100D / EN ISO 9001:2015 -
No design or calibration (AS9100D / EN ISO 9001:2015 Requirement 8.3 - Design and Development of Products and Services and 7.1.5.2 – Measurement Traceability Process) are carried out as part of the company processes and is therefore not applicable to the QMS"
Click to expand...
What do you mean by "are carried out as part of the company processes"? If they are part of the company processes, how are they not applicable to the QMS?
 
Al Rosen

Al Rosen

Leader
Super Moderator
#7
#7
EMP said:
It is
"No design or calibration ... are carried out as part of the company processes"
Click to expand...
I can understand that no design is carried out as part of the company processes, but why no calibration? Is it that no measurement of product is carried out and therefore calibration is not applicable?
 
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