AS9100 - What QMS Exclusions are allowed?

inspector625

Involved In Discussions
#1
Hey,

Can someone help me with a question... What if any, of the QMS requirements in AS9100 can be omitted from an organization's Quality management system?:bigwave:
 
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Big Jim

Trusted Information Resource
#2
Anything in section 7 can be excluded if it doesn't apply to your organization and it can be properly justified as not applying.

That said, some things are harder to justify than others.

You cannot exclude because it is outsourced.

You cannot exclude simply because you want to. it needs a good solid justification.
 

dsanabria

Quite Involved in Discussions
#3
Anything in section 7 can be excluded if it doesn't apply to your organization and it can be properly justified as not applying.

That said, some things are harder to justify than others.

You cannot exclude because it is outsourced.

You cannot exclude simply because you want to. it needs a good solid justification.
and here is your authority

and I Quote for AS9100C

1.2 Application
All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.

Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.

Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.
This standard is intended for use by organizations that design, develop and/or produce aviation, space and defense products; and by organizations providing post-delivery support, including the provision of maintenance, spare parts or materials for their own products.

Organizations whose primary business is providing maintenance, repair and overhaul services for aviation commercial and military products; and original equipment manufacturers with maintenance, repair and overhaul operations that operate autonomously, or that are substantially different from their manufacturing/production operations; should use the IAQG-developed 9110 standard (see Bibliography).

Organizations that procure parts, materials and assemblies and resell these products to a customer in the aviation, space and defense industries, including organizations that procure products and split them into smaller quantities for resale, should use the IAQG-developed 9120 standard (see Bibliography)."


End of Quote!
 

dsanabria

Quite Involved in Discussions
#5
Has this changed with 2016 revision D?
Yes

except it is now clause 8 and any exclusion not applicable clause must have a justification as to why it does not apply.

Typical exclusions include 8.3 Design 7 Development and 8.5.1.2 (a,b,c,d,e,f,g,h,i) however the statement "When problems are detected after delivery, the organization shall take appropriate action including investigation and reporting." which takes you to 10.2 - must remain.


A.5 APPLICABILITY

This International Standard does not refer to “exclusions” in relation to the applicability of its requirements to the organization’s quality management system. However, an organization can review the applicability of requirements due to the size or complexity of the organization, the management model it adopts, the range of the organization’s activities, and the nature of the risks and opportunities it encounters.

The requirements for applicability are addressed in 4.3, which defines conditions under which an organization can decide that a requirement cannot be applied to any of the processes within the scope of its quality management system. The organization can only decide that a requirement is not applicable if its decision will not result in failure to achieve conformity of products and services.
 

Big Jim

Trusted Information Resource
#6
Has this changed with 2016 revision D?
As with ISO 9001:2015 exclusions (nonapplicability) may be claimed for ANY portion of the standard as long as it can be justified. That is part of why control of nonconforming product and inspection (old standard 8.3 and 8.2.4) are no longer in the product realization section. They were in section 8 to protect them from being considered for exclusion. Now that they do not need that level of protection they are part of operation (the new product realization) where they always belonged.

One of the comments that came up in training about nonapplicability was good luck on trying to justifying something you could not justify before.
 

dsanabria

Quite Involved in Discussions
#8
In short, nothing has significantly changed...
YEAP!

People made a monster out of AS9100D - but in reality, they just made more business friendly.

This is why I am changing the Quality Management System to a Business Management System.

Nice job in AS9100D to focus on management and the team in achieving a products that meets customer, regulatory and safety requirements.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#9
YEAP!

People made a monster out of AS9100D - but in reality, they just made more business friendly.

This is why I am changing the Quality Management System to a Business Management System. <snip>
That's what I always called my services - My claim was/is to be a "business systems specialist", as it has been for well over 25 years now. Even Elsmar - On home page for years:

The Elsmar Cove Mission
To be a Free Business Standards Compliance and Business Systems Information Resource to Quality Assurance, Engineering and Management Professionals. People Helping Each Other since 1996!
 
#10
Hey,

Can someone help me with a question... What if any, of the QMS requirements in AS9100 can be omitted from an organization's Quality management system?:bigwave:
it depends in the organization, which service he provides to costumer
there are new AS standard that are Adapted to different services and baseness as Vendors cleaning and mor another solution is to implement only part of the standard and be certified only in this part​
 
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