AS9100 - 4.3 Configuration Management - Regulatory impositions

Is it acceptable to state that 'configuration management' would be provided only when it is flowed down in the contract/po? Or if that is not permitted could we state that only for aerospace orders it would apply but for non-aerosapce orders it would not?

I am interpreting the configuration mgt clause to mean that the customer desires all changes from the contract point on with regards to the product to be reviewed and approved by them.

we have an ISO9001 certified system and are attempting to get ready for AS9100.

What about your regulatory impositions?

There are Configuration Management implications in the FAA’s ACSEP order. Also, if you are designing and developing TSOA/PMA products, RTCA DO-254 (hardware) and DO-178B (software) have tremendous Configuration Management implications.

We are not an FAA approved repair station so I am not familair with the ACSEP order. I do not know what TSOA/PMA stand for. I assume the RTCA DO-254 and DO-178B are some sort of document specifying requirements?

Would these items you mention be required to achieve AS9100 certification?

Thanks for your help and understanding.

ACSEP is the FAA Order pertaining to production approval holders, not repair stations. It is pertinent because it is a “quality system requirement imposed by an applicable regulatory authority” (see AS9100, 4.2.1).

TSO and PMA are certifications that may pertain to your products. If your products are not TSO or PMA, then the RTCA documents most likely will not apply.

I think, that the scope of your AS9100 certificate will cover only your aerospace products and should be sufficient.

Thanks Al.

So if our 'scope' would only cover aerospace products then our ISO9001 certified system would cover all non-aerospace products.

Assuming that is correct, I have two questions:

1) Could we take it a step further and state that only if an order comes in for an aerospace product and if they call out AS9100 as a requirement on their contract/PO we would then flow down any of the additional requirements such as configuration managament etc (of course making sure that we comply with all the additional 80+ requirements in AS9100) for that order?

2) If the scope is just aerospace products (even though AS9100 fully encompasses ISO 9001:2000) would we not then have to maintain and have a separate audit for the ISO 9001 quality system that is used for the other 60% of our business that is non-aerospace related?

Try having a look at ISO 10007 Guidelines for configuration management. Also, 4.3 Configuration Management is a SHALL, so must be addressed. Is not as complicated as it sounds. I was able to satisfy the requirement with a one page chart.

I have attached an outline chart of Configuration Management activities. I hope this helps in developing a CM system. Remember keep it simple and don't read too much into the standard.

When you go through the outine ask yourself "Why would I not want to do any of these activities?".

Attachement at:
Document Control Project - How to be an effective document control coordinator

thanks Justin.

I guess my confusion lies in that I am not sure if my interpertation of configuration management is correct.

we have an ISO9001 certified QMS already and have procuedures for Engineering change notices that address changes to drawings.

"I am interpreting the configuration mgt clause to mean that the customer desires all changes from the contract point on with regards to the product to be reviewed and approved by them. " (from my original post)

That is what I think I see in ISO 10007 when they talk about in annex A "procedures for the control of changes prior to the establishment of a contractual configuration baseline..."

ddun is correct in that people try to read into the requirement too much.

Basically, everything you do to get your product to the customer is Configuration Management. All one really need do is to show this relationship to your product. I have attached the actual procedure from my AS9100 Rev B & ISO 9001:2000 Quality Manual. It is a one page diagram that shows the interaction of processes, ie Configuration Management.

Hope it helps

View attachment Config Mgmt.doc