TS 16949 Exclusions outside of clause 7.3

cubix rube

Involved In Discussions
#1
I am a bit confused by the language in 1.2, where it says, "...these exclusions are limited to requirements within Clause 7...", but then, right below that box, in BOLD print, it says "The only permitted exclusions for this technical specification relate to 7.3, where the organization is not responsible for product design and development."

Does this mean that we cannot take exclusions to 7.5.1.7, and 7.5.1.8, where we do NOT have any service agreements with anybody? What about 6.2.2.1, "product design skills", since we do NOT design ANY products?

I did search this forum for similar questions but didn't find anything. Thanks in advance.
 
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Howard Atkins

Forum Administrator
Staff member
Admin
#2
The point of exclusions should be removed from the standard, it is a total waste of energy and in ISO 9001 has been taken to absurds.

If you do not do something then it cannot be audited wether it is excluded or not
If you have no customer property then I cannot audit 7.5.4 whether it is excluded or not!

No one ever asks about this

7.5.1.7

states in the note "NOTE The intent of the addition of “service concerns” to this subclause is to ensure that the organization is aware of nonconformities that occur outside of its organization. "

Surley every company should want to know about these issues

7.5.1.8 starts "When there is a service agreement"-- if there isn't there isn't!!!


The whole exclusion came to essentially distinguish between 9001 and 9002 in 2000.
It is now passe
 

somashekar

Staff member
Super Moderator
#3
Learning from the ISO 13485, where it says Exclusion and Non applicability.
7.3 in particular can be excluded if you are not design responsible.
Other sub clauses only in clause 7 can be non applicable to the nature of your organization product / process., and therefore need not be included in the QMS
Both the Exclusion and Non applicability can be detailed in the manual.
 

charanjit singh

Involved In Discussions
#4
There is no need to mention 'exclusion' of clause 6.2.2.1 (design skills...) if a non-design organisation has exclusion of clause 7.3. One can simply mark "not applicable" against clause 6.2.2.1
 
C

Cheryl K

#5
Refer to CQI-16, ISO/TS-16949 Guidance Manual pg 69. No organization is fully exempt from 7.3. This applies to the Product Realization Process so you may not design the component but this also applies to designing the Manufacturing Processes. During the audit if you design the machines, cell layouts, special handling processes etc. they can be audited from cradle to grave.
 

qusys

Trusted Information Resource
#6
I am a bit confused by the language in 1.2, where it says, "...these exclusions are limited to requirements within Clause 7...", but then, right below that box, in BOLD print, it says "The only permitted exclusions for this technical specification relate to 7.3, where the organization is not responsible for product design and development."

Does this mean that we cannot take exclusions to 7.5.1.7, and 7.5.1.8, where we do NOT have any service agreements with anybody? What about 6.2.2.1, "product design skills", since we do NOT design ANY products?

I did search this forum for similar questions but didn't find anything. Thanks in advance.
The interpretation is related to "not applicable" clauses.
 

charanjit singh

Involved In Discussions
#7
If a company is manufacturing established products (no new designs) and thus the production processes have been pre-designed (with process capability checked periodically), does the process design clause still apply?
 
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