ExoLytic, Inc.
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AS 9100
AS9100 is
published by SAE. It includes all of the requirements of
ISO 9001 and adds requirements specific to the Aerospace industry. Like
ISO 9001, AS9100 is intended to apply to all companies regardless of
size, product, or location. However, companies seeking AS9100 registration
will in general have products which end up on an aircraft or spacecraft
since it is the manufacturers of these crafts which require or at least
prefer companies which are registered to AS9100.
For companies who distribute, but do not produce aerospace products AS9120 was developed.
AS9100 — Aerospace Companies
Quality Management System
AS 9100
The additions, and therefore challenges, to
AS9100 over
ISO 9001 are focused primarily around three basic concepts: control,
traceability, and regulatory compliance.
For control, AS9100 requires additional management
over such activities as product development, process changes, purchasing
documentation, and testing documentation. The overriding theme is that
assumptions are not allowed. Therefore in an AS9100 Quality Management
System, there will typically be more procedural details and work
instructions. Little can be left to pure "on-the-job training" since quality
and ultimately safety are paramount with aerospace products.
Traceability is another large theme. AS9100 requires
that you can trace both products and processes, as well as any related
changes. This means that it must be possible to trace the component
materials back to their source so that in the case of a recall it can be
positively identified as to where the suspect material came from and where
all of the product went to. Traceability also extends to product development
and configuration management so that companies must be able to trace
design/configuration changes through development and implementation so it is
clear exactly what products were produced under which configuration.
Regulatory compliance can either be a small or large
component of a company’s efforts to achieve registration to AS9100. While
AS9100's requirements are not "product based", but "system based", it does
require that products meet any applicable regulations. For some products
there are few, if any requirements, and for others the requirements are
significant. From a QMS perspective appropriate ties must be made to notify
regulatory agencies, perform appropriate testing, etc, but these are
generally not significant issues to address. The larger hurdle is to address
any product design regulations if those regulations have not already been
evaluated and addressed.
With the additional requirements of control,
traceability, and regulatory compliance it is even more important that
companies be careful about how they document their Quality Management
System. There is often a tendency to over-document requirements to gain
additional controls and traceability, but if a company is not careful it can
create documentation that is difficult to use or be in compliance with.
Careful reading and interpretation of AS9100 will show that there is a
finite group of areas within the QMS that need extra detail over
ISO 9001. Even within these areas, the extra documentation and/or detail
does not need to be burdensome if it is written carefully and provides the
right amount of control, tempered with flexibility.
ExoLytic's consulting program is specifically designed to
manage this balance and to provide a Quality Management system that is not
only compliance, but also useful and manageable.
