Should the requirements FAA/EASA Part 21 be addressed within the QMS and AS9100D quality manual?

DuncanGibbons

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#1
Are the requirements of FAA/EASA Part 21 addressed by the companies AS9100D quality manual or is a separate document required for conformance to the FAA/EASA regulatory requirements?

Additionally, when a company is being certified to AS9100D does the auditor review Part 21 conformance or exclude such requirements from the scope and leave it for the aviation regulatory auditor?
 
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Tagin

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#2
(Disclaimer: from a 9001 perspective) As I understand it, 9100 includes 9001, and 9001 requires that you address "statutory and regulatory requirements". So my first thought, from my 9001 view, would be to refer at the appropriate points in the QMS that the regulatory requirements are being addressed in document XYZ where the FAA requirements are detailed.

However, since the XYZ doc in turn has to likely refer to the actual QMS procedures where the regs are operationalized (incorporated as controls, etc., into the processes), then it seems a better way to do it would be to go ahead and embed all the operationalized regs into the QMS, and then have a separate summary cross-reference doc which says "we address the FAA regs at these steps in these QMS procedures as follows..." and list out the regs and where in the QMS the controls, etc. are implemented.
 

Sidney Vianna

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#3
Are the requirements of FAA/EASA Part 21 addressed by the companies AS9100D quality manual or is a separate document required for conformance to the FAA/EASA regulatory requirements?

Additionally, when a company is being certified to AS9100D does the auditor review Part 21 conformance or exclude such requirements from the scope and leave it for the aviation regulatory auditor?
An AS9100 audit is NOT a regulatory audit, but auditors are expected to have the competence that includes awareness of the relevant regulations applicable to the products being delivered.

If you are not familiar with, yet, peruse

 

Kronos147

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#5
Some organization maintain a business manual that includes everything, rather than (just) a 'quality manual.'

9100 requirements under 4.1, 4.2 and 6.1 should lead the "quality management system" to incorporating those requirements.

I agree with John. Why have separate this and separate that. The HLS (high level structure, alignment of the clauses in different standards) was introduced for just this reason.
 
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