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Supporting Site Quality Manual and References Requirements

S

Sebastian

Trusted Information Resource
#11
#11
I work for company where product design function is performed by remote supporting site. This remote supporting site is part of other manufacturing site quality management system.
This remote supporting site operates according to own procedures not ours. Scope of 3rd party audit of that manufacturing site covers remote supporting site and during audit interfaces between remote supporting site and our manufacturing plant are verified. This support is referenced in our quality manual. So my comment was adequate.

There is also another scenario. US-site can be ISO 9001:2015 certified as standalone organization. Then scope of 3rd party audit of one of manufacturing sites it supports, e.g. China shall include auditing of supporting site. It is obvious, that if ISO 9001:2015 certified site will be audited according to IATF 16949 in future, they need to perform gap analysis and adjust own system to be IATF compliant. Also in this scenario they could have own system and don't care about system of manufacturing site they support.

Everything depends on business relation between manufacturing site and remote supporting site. This has to be recognized during preparation to audit, to properly determine evaluation criteria.
 
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A

Angie

Starting to get Involved
#12
#12
Yes, but it seems now China thinking has changed and they think US should not use their manual? I am surprised the registrar allows this type of thinking? But we will see when we have follow up audit soon. Thank you very much for your response.
 
B

batteryguy

Involved In Discussions
#13
#13
We have a similar situation in that our manufacturing site is in the U.S., but our product and process design occurs at a sister site in Japan. The Japan site has a separate ISO9001 certification from us, but will not pursue IATF certification like we currently are. We do not share a common quality manual, and we do not audit their processes to ensure conformity to the IATF standard. Is it OK for us to outsource the process design function to them under these circumstances?
 
A

Angie

Starting to get Involved
#14
#14
Thank you very much. I thought I was thinking correctly, but sometimes someone can tell you something so many times you begin to think you are wrong.... ha ha I will let you all know how the 3rd party audit goes. If we tell auditor the remote sites does not use manufacturing site manual it could be very short audit! ha ha
 
S

Sebastian

Trusted Information Resource
#15
#15
Batteryguy, if Japan site wont pursue IATF 16949 certification, it would be required to perform 3rd party audit there according to IATF 16949, focused on support you get from them. It will be scheduled before timing of your US site audit and it will be repeated e.g. every year when you are audited annually.
If they want it or not, they will have IATF 16949 audit.
 
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