Guidance for Transition from ISO9001:2008 to AS9100C

I

Irvingstark

#1
We are registered to ISO9001:2008 and making the transition to AS9100C. We are very early in the process and I am trying to get my head around the requirements for AS9100C.

I understand the holes where I need now to develop/incorporate Risk Managment and FOD procedures.

My question revolves around which becomes the driving document? Is the documented Procedures/Work Instructions/Forms independent within each quality system (ISO and AS)? So when I revise the ISO document, I need to consider the AS impact and revise those as well (if appropriate)?

Any guidance is appreciated, light a candle, do not curse my darkness.

Thanks in advance!
 
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RCW

Quite Involved in Discussions
#2
It depends on what your game plan is and what works best for your company but....

I'm running 3 QMSs (ISO 9001, ISO 13485, & AS9100) at the same time and I try to use the same forms, procedures, work instructions, etc. as much as possible . I feel the more different paths there are to wander down, the more confusion there will be.
 
#3
We are registered to ISO9001:2008 and making the transition to AS9100C. We are very early in the process and I am trying to get my head around the requirements for AS9100C.

I understand the holes where I need now to develop/incorporate Risk Managment and FOD procedures.

My question revolves around which becomes the driving document? Is the documented Procedures/Work Instructions/Forms independent within each quality system (ISO and AS)? So when I revise the ISO document, I need to consider the AS impact and revise those as well (if appropriate)?

Any guidance is appreciated, light a candle, do not curse my darkness.

Thanks in advance!
I believe you're thinking about this the wrong way - your organization has ONE Quality System. You have, in this case, to meet 2 requirements: ISO 9001 (foundation) and then the "adders" of AS 9100 C.

You shouldn't be thinking of "2 systems". You define and document how your operate your processes and make sure the specifics are catered for. So in the process of dealing with how you control your non-conforming product, you should see in your documented procedure, firstly, the various requirements of identification, segregation, reporting, review, disposition etc (as required by ISO 9001) and then, for aerospace products how you handle the "extra" requirements.

Simples!
 
I

Irvingstark

#4
Do you number then for each QMS or do you keep them the same number and reference them within the different QMS?

Thanks,

Irv.
 
I

Irvingstark

#6
The clouds are starting to part...

So just tailor existing documents to meet each standard whether AS9100 or IS9000. The requirements of the standard will be addressed for each QMS within the particular guiding document for the Quality System Procedure, Work Instruction and Forms. Am I on the right path?

Thanks,

Irv.
 

John Broomfield

Staff member
Super Moderator
#7
Do you number then for each QMS or do you keep them the same number and reference them within the different QMS?

Thanks,

Irv.
Irving,

Instead of coding your organizational management system's documents for the standards, do what others did years ago. Code or uniquely identify them for your organization.

You could assign each of them a random number or you could code them to inform users, at a glance, the doc type, owner and issue status along the lines of:

A-B-C(D)

A = Doc Type
B = Dept of Process Owner
C = 01 to 99 for each unique combination of A and B
D = letter for draft or number for a doc that is approved for use (A indicates first draft - review comments requested and 1 indicates first issue for use and improvement.

No procedure should be called an ISO Procedure or a Quality Procedure come to that.

Name your management system for your company and avoid giving the impression that your management system is primarily for certification purposes.

Good luck,

John
 

John Broomfield

Staff member
Super Moderator
#8
The clouds are starting to part...

So just tailor existing documents to meet each standard whether AS9100 or IS9000. The requirements of the standard will be addressed for each QMS within the particular guiding document for the Quality System Procedure, Work Instruction and Forms. Am I on the right path?

Thanks,

Irv.
Irv,

Most of your procedures should be a result of analyzing the processes needed by your management system for it to be effective. Document these procedures to the extent needed for effective planning, operation and control of these processes and no more.

I take it that you already understand how your organization works as a system and that you have determined the processes needed by your management system for it to be effective.

If not, study clause 4.1 and ask us about any aspect you do not understand.

John
 
R

Reg Morrison

#9
I am in full agreement with Andy's comment. You CANT have multiple quality systems. You have 1 QMS that should be exercised in different ways depending on the contract and program requirements. Organizations that still function with multiple quality manuals are extinct. They might not know that yet, but they belong to the prehistoric world of QC.

Further, much more important than deciding document protocols is to understand the process approach. Documents serve no other purpose than to give definition to processes.

As a suggestion, I would encourage you to take the time and read the numerous threads we have on AS9100 transition. There is a lot of knowledge and wisdom captured in those discussions.

Good luck.
 
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