Setting up a M1003 QA Program for the AAR

M

Mixtrate

Hi there!

I'm have been set in charge of setting up a QA Program specifically the M1003 for the AAR. I'm basically looking for any one who has experience with the AAR or the M1003 QA program to help get our program started and on the right path.

Right now we are in the research phase trying plan for timelines and cost estimates.
We've made a few calls and have been told that the AAR is really backed up.

We had a few more questions and I think you might be able to help us piece them together.

So far we know that we need three things
  • Technical Testing
  • QA Program (M1003)
  • AAR Approval (service trials)

Technical Testing:
I know that we need to do several technical testing for Pressure and materials used.​
  • Do we have to finish our technical testing before we apply for our QA program?

QA Program:
​​We are currently in the starting phases of writing our QA Manual and getting the QA program on its feet.
  • ​What is the relationship of the M1003 and the Semi-Annual meeting (April and October)?

AAR Approval:
From what we know, the AAR meets in April and in October. We should have our design done however the QA will most likely not be approved.
In the "Process for Obtaining AAR Approval" Document it states: "Product designs can be presented to the appropriate committee at semi-annual meetings​"​. Does this mean the following:
  • Can we present in front of the AAR in APRIL without having our QA M1003 certification?
  • Do we have to finish our technical tests before we show our designs to the AAR in their semi annual meetings?
  • Can we get any sort of conditional approval from the AAR without having M1003/Technical Testing done? (I.e. they say "get this stuff done and then you'll be approved for two year trials")
  • Can you tell us a bit more about this process?

Costs:
We received some numbers from various sources about costs.

Application fee: $720
Audit: ~$5000
Technical testing: ~$10,000 - $50,000 (outside of AAR)

I would be greatly appreciate any input on the M1003 regarding these questions or any thing else that can help us.

Thank you!
 
M

Mixtrate

Hey, so we've made a few calls to people in the AAR and some talked to some consultation companies about this and here are some answers that we got back. Maybe this info can help someone in the future.

Question: Can we present in front of the AAR in APRIL without having our QA M1003 certification?
Answer: Yes. However you don't need to present to the AAR committee, you can instead send your application and designs to the AAR anytime and they will approve it. About $250 and a few months.

Question: Do we have to finish our technical tests before we show our designs to the AAR in their semi annual meetings?
Answer: Yes it's recommended that you finish technical testing before hand.

Question: Can we get any sort of conditional approval from the AAR without having M1003/Technical Testing done? (I.e. they say "get this stuff done and then you'll be approved for two year trials")
Answer: Yes. Your device can get approved without your company having an M1003. You can then take your product and start manufacturing it at a certified M1003 manufacturer.
 
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