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AS9100D
– Quality Management Systems –
⇓  Introduction to AS9100D
⇓  What is AS9100D
⇓  Why Implement AS9100D
⇓  How to Implement AS9100D

Introduction to AS9100D
Maintaining superior product quality is always a constant
challenge. Effective quality management requires a robust
quality system. The quality system has to be designed to
ensure not only good internal quality but supplier quality as
well. When the supplier is in a different country or continent
managing product quality can become even more
challenging. To ensure quality of goods, regardless of the
supplier’s home country, there are ISO standards for
developing and maintaining quality systems. However, the risk
of poor quality differs from industry to industry. If a part fails
on a home appliance, in most cases it is likely a mere
inconvenience to the customer. In contrast, if a part fails on a

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piece of equipment in the aviation, space or defense industry

the effect could potentially cause severe injury or loss of life. 
The importance of quality components within these industries
cannot be overstated. To ensure adequate levels of quality and
customer satisfaction in the aviation, space and defense
industries, the SAE AS9100 standard was developed. This
standard defines the quality management system
requirements to be used at all levels of the supply chain by
suppliers from around the globe.

What is AS9100D
The AS9100D standard specifies the Quality Management
System requirements for organizations that design, develop or
manufacture aviation, space, and defense products. The
AS9100 standard is an SAE document developed by the
International Aerospace Quality Group (IAQG). The IAQG is
comprised of representatives from Europe, the Asia Pacific
region and the Americas. The standard is acknowledged
worldwide. While some countries utilize various numbering
practices the standard remains the same around the world.
The AS9100 includes not only the ISO 9001:2015
requirements, but also identifies additional requirements
specifically for the aviation, space and defense industries.
Some of the changes to Revision D of the AS9100 standard
include the addition of information regarding the handling of
counterfeit parts, attention to the human factors of
manufacturing quality, a focus on product safety, ethics
training, and the process approach including SIPOC and PDCA
tools, Risk Based Thinking, and monitoring supplier delivery
performance. Organizations whose Quality Management
System meets the requirements of the AS9100 Rev.D standard
may apply for their AS9100 certificate of compliance.
To support the proper application of the AS9100 Rev. D
standard, the IAQG have produced the 9100:2016 Series
Clarifications publication. This document provides additional
information intended to clear up any confusion or settle any
disputes regarding the application of the standard. The
clarifications publication includes information applicable to
the 9100, 9110 and 9120 standards.

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Why Implement AS9100D

Whether your organization is new to the aviation, space or
defense industries or a long-time manufacturer, gaining
AS9100D certification will benefit your organization.
Achievement of an AS9100D certification indicates to your
current and potential customers that your organization is
devoted to supplying the highest level of quality and product
safety. Maintaining the highest levels of quality in any industry
is fundamental to the survival and growth of an organization.
 In order to not only achieve but also maintain consistent high
quality, an organization needs a robust, well maintained
quality management system QMS.  Implementation of an
AS9100D QMS will produce many benefits including but not
limited to:

Improvement of quality processes and meeting your

customer’s needs
Promoting decision making based upon evidence and
data
Monitoring of processes to improve efficiency, and
productivity
A Reduction in the three forms of waste and scrap costs.
Supporting and encouraging  a culture of continuous
improvement
Active risk assessment of designs and processes and
effective mitigation practices
Consistent compliance to regulatory, safety and reliability
requirements.
Enhancement of your corporate image in the global
marketplace.

In addition to the many benefits to your organization, there is

also the subject of corporate responsibility to consider. These
industries rely heavily on their suppliers to provide material
and components that not only meet their functional
requirements but also safety requirements. Failure to maintain
the highest levels of quality or properly identify and mitigate
risk in the design of a component or assembly could have a
detrimental effect on your organization or worse. Potential
component or system failures could result in injuries or
possible fatalities. Organizations must be diligent in
identification and evaluation of risk in their designs and follow

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through with effective measures to reduce or eliminate that

risk. Development and implementation of an AS9100D
compliant QMS is an important step toward success and can
have a huge effect on your bottom line.

How to Implement AS9100D

Implementation of any new management system requires
dedication of management to the success of the project along
with time and resources to accomplish the goal. It is the same
with the successful development, implementation and
maintenance of an AS9100 D quality management system.  In
this section, we will briefly cover the main requirements of the
QMS requirements. The standard includes the requirements of
ISO 9001:2015 with additional requirements unique to the
aviation, space and defense industries. The standard requires
the process approach based on the PDCA (Plan, Do, Check,
Act) method for product and process improvements and
problem resolution. In addition, the standard advocates the
practice of risk based thinking. Proactive risk identification,
assessment, and mitigation methodology is required.
Addressing of risk is one of many items included in the
previously mentioned clarification document.
The success of the QMS requires a commitment of time and
resources from all levels of the organization. Top management
must lead the effort towards the successful implementation
and continued support of the QMS.  The AS9100D standard
provides a model for the establishment and implementation
of an effective QMS.  The following paragraphs provide brief
descriptions of the main sections that constitute the body of
information within the standard.

Section 4 – Context of the Organization

The AS9100D standard requires evaluation of the internal and
external influences relevant to organization’s purpose or
direction that could affect meeting the requirements and
goals of the QMS.  The organization must also:

Understand and take into account the needs and

expectations of interested parties.
Determine and document the scope of the QMS
Commit to the establishment, maintenance and
continuous improvement of the QMS.
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Section 5 – Leadership
The AS9100D standard requires that all levels of management
within the organization embrace and commit to the success of
the QMS. The leaders of the organization must:

Be accountable for the success and support of the QMS

Integrate the QMS into the organizations regular
business processes
Ensure that all product, safety, and regulatory
requirements are defined and understood.
Promote risk based thinking and use of the process
approach
Establish a quality policy and objectives aligned with
corporate strategy
Ensure that the quality policy is available for review and
maintained
Provide adequate resources for implementation and
continued support of the QMS
Encourage associates to become engaged in the QMS
and contribute to its success
Foster a culture of continual improvement within the
organization.

Organizational Roles Responsibilities and Authority

Top management of the organization must assign
responsibility and authority for supporting, reporting and
maintaining the QMS.  Furthermore, leadership of the
organization is required to assign responsibility and authority
for ensuring that the QMS conforms to AS9100D
requirements and for regularly reporting the QMS
performance results.

Section 6 – Planning
Just like any other endeavor, the development and
implementation of an AS9100 compliant QMS requires proper
planning.  During the planning phase, top management must
consider multiple factors. Management must consider the
context of the organization along with any and all interested
parties. In addition, management must determine the scope of
the quality management system, and take proactive measures
to ensure the QMS is capable of achieving its desired
objectives. Plans must be developed and implemented to

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provide sufficient support and resources necessary to achieve

continual improvement of the QMS. The AS9100 standard
outlines many requirements to be met during the planning
phase including but not limited to the following:

Actions to address Risks and Opportunities

The organization must develop plans for identifying, and
addressing potential risks and opportunities for improvement.
The plan must include methods for addressing risks and
taking full advantage of opportunities for improvement. In
addition, the organization must determine how to properly
integrate these methods into the heart of the QMS.

Addressing Risk
There are multiple options an organization can consider for
addressing risk. Many are spelled out in the standard for
addressing risk. Some examples given are as follows:

Avoiding Risk
Taking a risk in pursuit of an opportunity
Determining and eliminating the cause of the risk
Taking action to change the outcome or lower the
severity of the risk
Making an educated decision to live with the risk

Addressing Opportunities
Opportunities can present themselves in a myriad of ways or
forms. Taking action to seize these opportunities can have a
profound impact on the organization. Stepping up when
opportunity presents itself can lead to:

Adoption of new methods and practices to improve

quality
Development and introduction of new products or
product lines
Increased market share or moving into new markets
Utilizing new technology within the organization

Addressing risks and opportunities can improve the

organizations ability to meet or exceed customer expectations
of performance or quality. In addition, proactively addressing
risk and seizing opportunities for improvement can also have
a positive impact on your organization’s bottom line.

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Establishing Quality Objectives and Plans for achieving

them.

The establishment of quality objectives is vital if your QMS is

going to continually improve. Quality objectives are one type
of KPI (Key process indicator) that can be measured and
monitored throughout the year. The quality objectives must
address what needs improvement. Do your due diligence,
collect and analyze data. Then let data speak for itself, not
opinion or rhetoric. Quality objectives should also align with
your organization’s strategic long term plans. In this section,
we shall be using the terms objective and goal
interchangeably.  When determining the goals or objectives
for the QMS, be certain that they are SMART goals.

Specific – Define the goal as clearly as possible. Cover the

why, what, when, where, and who details when defining
the objective. Make sure everyone is on the same page.
Measurable – Make certain that your goals are expressed
in measurable terms. Define the measurable in the how
many, how much or how often terms. Such as the goal of
reducing customer shortages by 50%. A goal must be
measurable because what you cannot measure you
cannot improve.
Attainable – Ensure that the goal is achievable. Make
certain it is within reach and not unattainable. In
addition, the goal must be accomplished by the person
or persons assigned within their regular responsibilities
and authority.
Relevant – Ask yourself questions such as “Does the goal
fit the organization’s needs?” “Will achievement of this
goal contribute to the short- and long-term strategy of
the organization?” Make sure the goal is relevant to your
business.
Time Based – Goals should have a defined timeline. For
example, achieving a reduction in customer shortages by
50% within the next 12 months. This will instill a sense of
urgency and enable the responsible parties to plan and
manage their time accurately.

Once the goals or objectives have been determined, it is vital

that they are well communicated within the organization. They
are not intended to be a secret plan.  In addition, the
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involvement of each team or individual should be clearly

communicated and understood. If the goal is to reduce
customer shortages by 50% then the shipping department
should be involved from the start. And each associate working
in the shipping department must fully understand their role in
achieving the objective. Associates that are well informed and
actively involved tend to take mental ownership of the process
or objective. Proper communication, employee involvement
and empowerment at all levels of the organization frequently
results in increased employee morale and lower turnover
rates.

Section 7 – Support
Successful development, implementation and continued
improvement of an AS9100D compliant QMS is highly
dependent upon the support received from the management
team of the organization. AS9100D compliance requires top
management within the organization to commit adequate
resources for establishing, implementing, maintaining and
driving continual improvement of the Quality Management
System. The organization must consider the capabilities of and
any constraints of available, qualified internal resources. In the
same manner, the resources that will be acquired from
external sources must be considered as well. Some examples
of the resources management is required to supply are listed
below.  The list is not intended to be fully comprehensive but
includes information relating to the major requirements
needed to meet the standard.

General Requirements – The organization must determine

and meet the personnel requirements mandatory to
implement and manage the QMS, and for the support of
its processes. In addition, management must determine
and provide the proper infrastructure, environment,
monitoring and measurement resources, and
measurement traceability to support a robust QMS.
Competence – The organization must determine the level
of competence required for each position supporting the
QMS including the level of education, training or
experience required. It is not uncommon for AS9100D
compliant organizations to develop and maintain bios for
each of the key personnel responsible for the QMS and
its adherence to the standard.
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Awareness – Management must ensure that the persons

performing work are aware of the quality policy, the
objectives as mentioned in section six of the standard
and roles and responsibilities to the success and
continuous improvement of the Quality Management
system.
Communication – Management of the organization shall
determine and establish the appropriate internal and
external lines of communication required for the success
of the QMS. The organization must also define the
method of communication along with what will be
communicated, when to communicate, whom to
communicate with and how often communication will
take place. Furthermore, communication should include
internal and external feedback pertaining to the Quality
Management System status and its objectives.
Documentation – The organization must develop and
maintain documented information required by AS9100D
standard. Along with any information deemed necessary
by the organization for the success of the QMS. The
required documentation shall have adequate protection
of the content and control revisions ensuring that any
changes or updates are identified and traceable. The
proper documents must be available for use where and
when required. Furthermore, the document control
system must provide for proper access, distribution,
storage, retention and the eventual disposition of
obsolete documents.

Section – 8 Operation
Top management of the organization must plan for the
operation of the Quality Management System. Once the
QMS is developed and implemented, the day to day operation
of the QMS must be managed and monitored to ensure it is
fulfilling its intended purpose and pursuing the appropriate
objectives. The AS9100D standard outlines what the
organization must do to ensure proper operation of the QMS.
In this section, we will briefly touch on the main points
contained within the standard.

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Operational Planning and Control – Plans shall be

developed for the implementation and control of the
processes identifying and addressing operational risk,
product identity, traceability and product safety. One
additional requirement included in the AS9100D
standard addresses the requirements concerning the
control of counterfeit parts. Proper training of personnel
including verification and testing, to identify counterfeit
parts, along with processes for the containment and
disposition of said parts is required by the standard.
Requirements for Products and Services – The
organization is required to implement processes to
ensure that all product and service requirements are met
on a consistent basis. The processes for communication
with customers and the criteria for acceptance of
products and services are among the requirements that
must be defined by the AS9100D standard.
Design and Development of Products and Services –
Compliant organizations are required to establish and
support a robust design and development process to
ensure product and service requirements are met. This
includes but is not limited to design inputs, development
and verification of the design and control of the outputs
such as drawings, part lists, the material and any special
product or process requirements.
Control of Externally Supplied Processes, Products and
Services – Externally sourced parts or services must be
monitored and controlled. The organization should have
a robust supplier quality management process with
regular evaluation of supplier performance. The
organization shall determine and apply the appropriate
criteria for judging the quality of an external supplier’s
parts or products and the supplier’s performance.
Production and Service Provision – Systems must be in
place to effectively monitor and control multiple aspects
of the production processes including but not limited to:
Equipment, Tools and Software used for
automation, monitoring, measuring or controlling
production processes must be validated and
properly maintained.
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Validation of special processes that cannot be

monitored or accurately measured
Material or product traceability when required to
assure the quality and conformity of products or
services.
Control of process changes including
documentation of the review results and the
associates authorizing the change in the process or
processes.
Release of Products and Services – Systems must be in
place to document conformity prior to the release of a
product to the customer. The organization must be able
to produce evidence of compliance including the product
acceptance criteria, the person authorizing the release,
and their qualifications.
Control of Non-Conforming Outputs – The organization
shall develop and maintain systems and procedures for
the containment and control of any non-conforming
process outputs. This would include proper
documentation of the non-conformity along with the
segregation, disposition and prevention of use or
delivery to the customer.

Section – 9 Performance
Organizations pursuing AS9100 certification must develop and
maintain effective procedures for monitoring and evaluating
the performance and effectiveness of their Quality
Management System. If it cannot be measured it cannot be
properly controlled. Therefore, the QMS must include the
proper tools, associate training and sufficient resources to
monitor the progress of the QMS and the achievement of
planned objectives.

Monitoring, Measurement, Analysis, and Evaluation – The

organization shall determine what needs to be
monitored and measured, when it shall be done, and the
method of documentation.
Internal Audit Process – Internal audits are required to be
performed at regular intervals to ensure that the QMS is
meeting internal, customer and any applicable regulatory
requirements. Records of the audit results shall be

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retained as evidence of compliance and shall be available

for review.
Management Reviews – Management shall hold QMS
review meetings at regular intervals. The agenda or
subject matter of the review meetings are the decision of
the organization. The subject matter may include but is
not limited to the following:
Reviewing the status of actions from previous reviews
Changes to any internal or external issues relevant to the
management system
Information about the QMS performance including audit
results and progress of objectives.
Potential risks to the QMS or opportunities for
improvements.
Review of the supplier performance KPIs

Any relevant information resulting from the meetings should

be shared with workers and other interested parties. The
organization shall also retain documented records of the
results of the management reviews.

Section 10 – Improvement
In order for an organization’s Quality Management System to
be most effective, it must continually improve. Organizations
must actively look for opportunities to improve the effectivity
of their QMS. They should continually work toward achieving
the QMS objectives while providing products and services
tailored to their customer requirements.

The AS9100 standard requires that organizations have plans in

place to react to non-conformities. This should include but not
be limited to containment, control, Root Cause Analysis
(RCA) and Corrective Action Preventative Action (CAPA). In
order to prevent the problem from becoming a repeat
problem, the root cause must be identified.

A good example is a weed in your garden. The goal of

your garden is to grow and supply you, the customer,
with high quality fresh produce. Weeds rob the soil of
essential nutrients and moisture interfering or possibly
preventing the garden from achieving the planned
objective. If you merely cut down or pull the weed
without identifying the root, it will be back. The same can

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be said about quality problems. In many cases, we end

up addressing the symptom and not the true root cause.
If the root cause is not determined, the issues may re-
occur within the same process or elsewhere in the
organization. The root cause is the true underlying or
fundamental cause of nonconformity.

An action plan should be developed for implementation of the

appropriate corrective actions and documenting their
effectiveness. The standard also requires that the organization
document the incident including the corrective actions and
their effectiveness. The records must be properly maintained
and available for review by management or during a third
party audit.

In Conclusion
As previously stated, AS9100D incorporates the PDCA cycle
approach towards building, maintaining and improving your
QMS. The PDCA (Plan, Do, Check, Act) cycle includes the Plan
phase that covers the planning phase and beginning stages of
QMS development. The Do cycle deals with QMs
implementation and operation. The Check cycle is the
evaluation of the QMS effectiveness. This includes the
management reviews of the QMS performance. Finally the Act
phase looks at ways to integrate improvements throughout
the organization and ensures the PDCA cycle never ends. Thus
the depiction of the PDCA cycle as a circle and not a straight
line.

The initial development and implementation of an AS9100

compliant Quality Management System may take several
months and a large amount of resources. One key to success
is to have participation and buy-in from all levels of the
organization. Quality is everyone’s responsibility. The QMS
must have adequate resources and constant support from
organizational leadership.
At any time during the planning, implementation or operation
of the QMS questions arise regarding the AS9100 standard. Be
sure to reference the 9100-2016 Series Clarification document
provided by the IAQG. Referencing this document may
provide the information required to clear up any confusion
regarding the application of the standard. In some cases,
further clarification is needed or you may require the

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assistance of experienced, and highly qualified subject matter

experts. When additional resources or subject matter experts
are needed they are close at hand. At Quality-One we can
meet your needs. Therefore, if your organization is in need of
additional resources or would like more information regarding
AS9100D implementation, please contact one of the
professionals at Quality-One.

Learn More About AS9100D

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