IATF 16949 8.3 Exclusions

loripltz

Registered
We just went through our Stage 2 IATF 16949 certification audit and were sited with a nonconformance stating: "The scope of the quality management system, including details of and justification for any exclusions per Quality Policy Manual (QM-101) Rev. 3 states exclusion of 8.3 in its entirety which does not meet IATF Requirements for permissible exclusions (clauses related to product design)."

Our scope is written as "Eagle Wings Industries excludes Product design (Section 8.3) since we are not responsible for the design of the products we provide to our customers. We manufacture to our customers’ designs and cannot change the form, fit or function without customer approval so therefore this section is not within the scope of Eagle Wings Inc. ISO 9001/IATF 16949 registered activities."

The auditor is stating the we can not exclude product design input and outputs, and I can not find any where this is noted. I'm not sure if this is a valid finding, if anyone can point me in the right directions, I would greatly appreciated.


Thanks,
 

Howard Atkins

Forum Administrator
Leader
Admin
from the standard
4.3.1 Determining the scope of the quality management system - supplemental
Supporting functions: whether on-site or remote (such as design centres, corporate headquarters, and distribution centres), shall be included in the scope of the Quality Management System (QMS).
The only permitted exclusion for this Automotive QMS Standard relates to the product design and development requirements within ISO 9001, Section 8.3. The exclusion shall be justified and maintained as documented information (see ISO 9001; Section 7.5).
Permitted exclusions do not include manufacturing process design.
 

Ooi Yew Jin

Starting to get Involved
There are 8.3.1 - 8.3.6 clauses in 8.3. Although we did not involve in product design, we still need to compliance some of the clauses when we involving in sample requisition, sample run, submit to customer qualify, customer approve, ready for mass production...
 

aacar

Registered
madde 8.3 ü komple hariç tutamazsınız ürün tasarımınız olmasa da proses tasarımınız devam ettiği için süreç tasarımına girdi olan müşteri şartları, teknik datalar vb. almak ve süreci işletmek en son da ppap dosyası ile müşteriye sunum yapmak durumunuz devam eder. Kalite El kitabınızda kapsamı tanımlarken hariç tutulan maddenin ürün tasarımının neden hariç tutulduğunu da açıkça beyan etmeniz gerekmektedir.

You cannot completely exclude item 8.3. Even if you do not have a product design, your process design continues, so customer requirements, technical data, etc., which are input into the process design. your status continues to receive and run the process, and finally to present to the customer with the ppap file. When defining the scope in your Quality Manual, you must also clearly state why the product design of the excluded item is excluded.

It will be enough to take what you wrote in the explanation into your handbook and carry out your process design studies.
 

John Broomfield

Leader
Super Moderator
We just went through our Stage 2 IATF 16949 certification audit and were sited with a nonconformance stating: "The scope of the quality management system, including details of and justification for any exclusions per Quality Policy Manual (QM-101) Rev. 3 states exclusion of 8.3 in its entirety which does not meet IATF Requirements for permissible exclusions (clauses related to product design)."

Our scope is written as "Eagle Wings Industries excludes Product design (Section 8.3) since we are not responsible for the design of the products we provide to our customers. We manufacture to our customers’ designs and cannot change the form, fit or function without customer approval so therefore this section is not within the scope of Eagle Wings Inc. ISO 9001/IATF 16949 registered activities."

The auditor is stating the we can not exclude product design input and outputs, and I can not find any where this is noted. I'm not sure if this is a valid finding, if anyone can point me in the right directions, I would greatly appreciated.


Thanks,

Your organization remains responsible for the design of its manufacturing processes.

It may also be responsible for the design of its services to its customers.
 
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