Implementing an AS9100 Aerospace Quality System

[Jeff Frost]

Develop your QMS to meet AS9100 and you automatically meet all the requirements of ISO 9001 and when you go for registration you should have your CB issue their certification listing both.

Trying to maintain two "different systems" is very easy from the standpoint for your organization. You exceed the requirements of ISO 9001 and meet the requirements of AS9100 all while managing your AS9100 based QMS. You may find, as my organization has, that many times when a customers PO adds additional requirements to those contained in ISO 9001 you already have their requirement in place.

[RCW]

I am currently backed into a corner, or run into a dead end, or any other overused metaphor out there.

I am trying to combine and implement the AS9100C requirements into my current quality system, which address ISO9001:2008, ISO13485, 21CFR820, and a few additional customer quality requirements.

When I initially setup my ISO9001 system, I had the 'help' of a consultant. Looking out at the information available regarding ISO9001, there is a TON of information and books. When I added the ISO13485 to my system, the amount of available information was greatly reduced, but the ISO14969 spec really helped to explain what was meant in ISO13485.

Now I am at AS9100C's doorstep, and I am hardly finding any information. By that I mean 1) books - nothing available and the two I have for the Rev B spec were basically worthless even by Rev B standards. 2) Magazine articles - Yes, they go over the Rev C highlights but not in any detail to understand what the AS9100C spec truly requires. 3) It looks like there are no industry guideline specs similar to ISO14969 for medical devices. I've seen references to ISO10006 and ISO10007 but they all seemed directed to developing major operations or towards large companies.

I've tried to do a Gap Analysis but I can't analyze that which I don't understand. I've done a lot of searching here at the Cove, which has helped some, but I still have a lot of questions to go with a lot of confusion. I do want to understand what the requirements are versus buying pre-packaged procedures. (I've already been down that road before.) There seems to be more complexity with AS9100 requirements than there was with ISO13485. By that, I mean the additional AS9100 requirements above and beyond ISO9001.

I've been told to implement AS9100 by upper management (most of us have heard that one before) and I've also been told no funds are available for a consultant.

Am I just whining? Maybe but I guess I am looking for words of wisdom or a finger pointing me in a direction somewhere.

[Neil V.]

In Reply to Parent Post by RCW

I've been told to implement AS9100 by upper management (most of us have heard that one before) and I've also been told no funds are available for a consultant.

Probably no funds to get training for yourself either?

I'm in similar situation right now as far as working on implementation of AS. I appreciate that if you are lost reading the standard this won't help too much just yet, but for what it's worth.... The best piece of advice on here, for me, when paralysis started to set in was to just use the standard for your gap analysis. You don't need anything fancy. Using that approach I was able to come up with some action items that I have confidence in.

[Hunter36]

In Reply to Parent Post by RCW

I am currently backed into a corner, or run into a dead end, or any other overused metaphor out there....

I've been told to implement AS9100 by upper management (most of us have heard that one before) and I've also been told no funds are available for a consultant.

Am I just whining? Maybe but I guess I am looking for words of wisdom or a finger pointing me in a direction somewhere.

I know this isn't much for my first post, but I want you to know I am in a very similar situation such as yourself. However there is a source of information that has proved very useful to me.

I requested quotes from over 15 different registrar companies. Of course this resulted in endless phonecalls and e-mails trying to solicit my business, however, almost all of these agents are incredibly useful sources of information.

Several have been very helpful in pointing me in the right direction and providing me with solid ideas for further implementing our QMS systems without crossing the "consultation" line which is typically unacceptable from potential registrars.

[Kiartys]

Can I add my my woes to yours ?. My small engineering company is in the process of the upgrade to 9100C. Unfortunately being the quality manager and writing the new procedures to include the changes, I am finding it a nightmare. I'm afraid of ending up with procedures that are far too cumbersome for our processes.

There must be some generic procedures that just need tweeking that would cover a lot of small engineering shops that manufacture to customer specs and exclude design and service in their QMS.

This is my first post so I hope I am not standing on anyones toes ?

[RCW]

In Reply to Parent Post by Kiartys

There must be some generic procedures that just need tweeking that would cover a lot of small engineering shops that manufacture to customer specs and exclude design and service in their QMS.

A word of caution about using generic procedures, they tend to back you into a corner. Before you know it, your forcing your company to perform tasks that are not practical to your company just to meet the generic procedure's author's view of the requirement. This is from personal experience.

One book that I have found somewhat useful is "The AS9100C Handbook" by Paton Professional (ISBN 978-1-932828-32-0). If you are converting from AS9100B to AS9100C it does a pretty good job of explaining the changes. Where is falls short is when you are trying to develop an AS9100C from the ground up.

Note: I do not work for Paton Profesional and I do not receive any gratuities from them for endorsing their product.

[Kiartys]

Thanks for the reply. I am aware of the problems following other peoples work. I am 60 % thru my procedures and need to check I am going in the right direction. Many thanks again

[howste]

In Reply to Parent Post by Kiartys

Can I add my my woes to yours ?. My small engineering company is in the process of the upgrade to 9100C. Unfortunately being the quality manager and writing the new procedures to include the changes, I am finding it a nightmare. I'm afraid of ending up with procedures that are far too cumbersome for our processes.

There shouldn't be a need to rewrite all of your procedures to meet the requirements of AS9100 Rev C. I would expect most of your procedures to be unaffected by the changes. If you make the procedures too cumbersome, then it's probably not from AS9100 requirements, it's probably from internal requirements.

Are you familiar with all of the changes? The one addition I would expect to have the most impact is Risk Management. Most of the other changes might just involve minor tweaks to your system.