Clause-by-clause explanation
of AS9100 Rev D
WHITE PAPER
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Table of Contents
Executive summary ....................................................................................................................................... 3
Introduction .................................................................................................................................................. 3
1. Process approach ...................................................................................................................................... 4
2. Plan-Do-Check-Act cycle ........................................................................................................................... 5
3. Terms and definitions ............................................................................................................................... 6
4. Context of the organization ...................................................................................................................... 8
5. Leadership................................................................................................................................................. 9
6. Planning .................................................................................................................................................. 10
7. Support ................................................................................................................................................... 11
8. Operations .............................................................................................................................................. 13
9. Performance evaluation ......................................................................................................................... 17
10. Improvements....................................................................................................................................... 19
Conclusion................................................................................................................................................... 20
Sample of documentation templates ......................................................................................................... 20
References .................................................................................................................................................. 20
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Executive summary
Providing products and services that meet customer needs and enhance customer satisfaction is the
goal of any Quality Management System (QMS), and AS9100 Rev D provides a framework to do this in
the aviation, space, and defense industry (often called the aerospace industry). This white paper is
designed to help you in the first step of implementation—understanding what the requirements of the
standard mean—and to clear up any misconceptions regarding the standard’s requirements.
In this document, you will find each clause of AS9100 Rev D explained in plain English to help you better
understand the requirements of the standard. To make this easy, the clauses will be laid out in the same
order and assigned the same numbering designation as the clauses in AS9100 Rev D, and there will be
links to additional learning materials included as well.
Introduction
Some people see a management system as an administrative burden with limited benefit to the
company, but why is this the case? This could be due to the thinking of some individuals that the
management system is something separate from the way they do their “business,” but this line of
thinking limits their ability to go beyond simply documenting everything in the management system to
the point where they can benefit from the improvements that a management system can bring.
Please note that this white paper is not a replacement for the AS9100 Rev D requirements. You can get
the requirements from the http://standards.sae.org/as9100d/ website.
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1. Process approach
Using the process approach is a key step in implementing an effective Quality Management System.
When you identify all of the processes within your system, including details of all the necessary inputs,
resources, activities, documents, and outputs of each, you can then see how they interact—with the
outputs of some processes becoming the inputs for others. This allows you to monitor and measure the
important indicators of your processes so that you know they are functioning correctly. This is why the
standard explains the process approach before going into the requirements for a Quality Management
System.
The basic concept of the process approach is that you look at the activities in your entire organization as
a series of processes—activities that take inputs and perform actions to make outputs. You can then
determine the sequence and interactions of your processes, which allows you to determine what
processes need to happen before others can start, what resources you need for each process, and what
results are expected and needed from each process. In addition, identifying the interactions between
processes can give you insight into potential problems and waste, where outputs are not adequate or
remain unused.
The best approach is to start your implementation by creating a process map that includes all of your
processes and how they are interconnected. For instance, your purchasing process needs input from
your contract process to determine what to buy, so it cannot start until your contract process has
created this output. Likewise, your production process cannot start until your purchasing process has
acquired the correct raw materials. Your global process map, which identifies all of the processes and
how they link together, will then allow you to define the processes in terms of inputs needed, controls
to be applied, and outputs expected. This process map can then be reviewed and updated throughout
the implementation process.
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2. Plan-Do-Check-Act cycle
The Plan-Do-Check-Act cycle has been an integral part of quality assurance for many years, and it is a
core concept in this standard. In order to ensure the effectiveness of the Quality Management System,
it is important to make sure that the first step is Planning. This step includes defining polices, objectives,
procedures and processes, controls, and necessary monitoring and measurement. The next step is the
Do phase when the plans are realized, policies and procedures are communicated and applied,
processes are performed, and records of activities are produced. The Check phase comes next, where
the monitoring and measurement results captured in the Do phase are analyzed and assessed for
acceptable results against the planned arrangements. This phase includes audits and management
review in the assessment. Finally, the Act phase occurs, where the organization will take action on any
problems found or needed improvements identified in the Check phase. This PDCA cycle becomes an
ongoing process that is used to drive continual improvement in the organization.
To find out more, see this article: PDCA cycle in AS9100 Rev D.
Quality Management System
Organization
and its
context
Support
and
Operation
(4)
Plan
(7,8)
Customer
satisfaction
Do
Customer
requirements
Planning
Leadership
(6)
(5)
Act
Needs and
expectations
of interested
parties
Performance
Evaluation
(9)
Check
Improvement
Products and
services
(10)
(4)
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3. Terms and definitions
Apart from five aerospace-specific terms, the main terms and definitions used in AS9100 Rev D can be
found in a related document, ISO 9000:2015, but this involves purchasing yet another standard just to
understand what the terms mean. Understanding the terms is important before you start implementing,
so that you can ensure that you apply the requirements to the correct areas of your organization. Here
are some of the most important terms and definitions used throughout AS9100 Rev D:
Top Management – The individual or group who controls and coordinates the organization at the
highest level. When the scope of the management system covers only part of an organization, this term
refers to the individuals who direct that part of the organization.
Organization – A person or group who has their own functions with responsibility and authority to
achieve objectives.
Context of the organization – The combination of internal and external factors that affect the ability of
the organization to achieve their stated purpose, objectives, performance, and sustainability with
respect to the management system. This can include internal factors such as values and knowledge, as
well as external factors such as competitiveness and economic environment.
Interested party – A person or organization who is involved in, or perceives itself to be affected by, the
activities of the organization. Interested parties can include customers, suppliers, government, local
communities, employees, etc.
Process – Any set of activities that takes inputs to deliver an intended result, or output. For example:
the production process takes inputs (raw materials, work instructions, product specifications, etc.) and
performs several steps in an appropriate sequence. The outputs are the product, quality check reports,
etc.
Procedure – A defined way to perform a process or activity. Procedures can be documented or
undocumented.
Quality – Quality is the difference between a customer’s expectations and the perception of how well
these expectations were met upon receipt of the products and services.
Nonconformity – Failure to meet a requirement.
Risk – Risk is “the effect of uncertainty on objectives,” and is seen as a positive or negative deviation
from what is expected. In the aerospace community, risk is generally expressed in terms of the
likelihood of occurrence and the severity of the consequences.
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Effectiveness – The level of success in achieving a desired result. For example: the purchasing process is
effective if the required products and services that are procured arrive on time and conforming to
requirements.
Documented information – The information that is required to be maintained by an organization, for
example, the documented policies, procedures, and records required to achieve results within the
organization.
Five aerospace-specific terms are defined within AS9100 Rev D: counterfeit part, critical items, key
characteristic, product safety, and special requirements. For more information on these aerospacespecific terms, see this article: Five special aerospace terms in AS9100 Rev D.
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4. Context of the organization
4.1 Understanding the organization and its context
This clause includes a new requirement for the organization to identify the internal and external issues
that are relevant for the organization to meet the objectives of the QMS. These issues need to include
all elements that are, or may be, capable of effecting the QMS objectives and future outcomes.
Tip: For more information, see this article: AS9100: Understanding the requirements of context of the
organization.
4.2 Understanding needs and expectations of interested parties
Because interested parties can affect the organization’s products and services, customer satisfaction,
and statutory and regulatory requirements, it is critical to determine who the relevant interested parties
are and what their needs and expectations include.
Tip: For more information, see this article: Identifying interesting parties and their requirements
according to AS9100 Rev D.
4.3 Determining the scope of the Quality Management System
The scope of the QMS defines what is included within the QMS and, as such, is the first critical
milestone in implementation. The scope is defined considering the organizational context, the needs
and expectations of interested parties, and applicable legal and regulatory compliance obligations.
Additional factors to consider are the products, services, organizational size, and complexity. The scope
and any justified exclusions must be maintained as documented information.
For more information, see this 9001Academy article: How to define the scope of the QMS according to
ISO 9001:2015.
4.4 The Quality Management System and its processes
As an organization you need to establish, implement, maintain, and continually improve your QMS,
including the definition of the processes needed and their interactions, in accordance with the
requirements of AS9100 Rev D. This is where you will use the process approach to determine the inputs
and outputs of your processes, the sequence and interactions between them, the resources needed,
and the responsibilities required to ensure that the processes are effective.
Additionally, you will need to maintain any necessary documented information to support the processes
you have identified and to provide evidence that the processes were carried out as planned. The
necessary descriptions of the QMS and its processes, as well as other information gathered, can be
collected into a single document and called a quality manual.
Tip: For more information, see this article: The future of the quality manual in AS9100.
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5. Leadership
5.1 Leadership and commitment
In order for a QMS to be efficient and effective, it is important that top management is committed to
the outcome of the QMS. The commitment must be demonstrated through communicating the
importance of meeting customer requirements, compliance with legal and other requirements,
establishing and communicating the quality policy and objectives, conducting management reviews, and
addressing resource needs. A focus on customers, including measuring product and service conformity
and on-time delivery, demonstrates this commitment in a concrete way when action is taken in the
event planned results are not achieved.
5.2 Policy
The quality policy is the overall goal and commitment that top management intends to be met by the
QMS—the high-level document stating the QMS direction, including commitment to quality and
customer satisfaction. Some key factors include providing a framework for quality objectives, meeting
compliance and regulatory obligations, and providing a commitment to the continual improvement of
the QMS. Critically, the quality policy must be maintained as documented information (possibly in the
quality manual mentioned above), be communicated and understood throughout the organization, and
available to interested parties.
5.3 Organizational roles, responsibilities, and authorities
For the QMS to work, it is necessary to define the roles, responsibilities, and authorities for all activities:
who needs to do what, and who can authorize which activities. This becomes critical in specific
situations, such as emergency plans, and especially the responsibilities of temporarily employed
workers. There is also a requirement for a management representative who is responsible for the QMS
and has the organizational freedom to resolve quality issues.
Tip: For more information, see this article: Is the management representative still required in AS9100
Rev D?
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6. Planning
6.1 Action to address risks and opportunities
When planning the QMS, it is critical that you understand the risks and opportunities that exist and
could affect the QMS. This is done by considering the context of the organization and the needs and
expectations of interested parties in order to determine the risks that need to be addressed. The
purpose for identifying and addressing risks and opportunities is to ensure that the QMS will achieve the
expected results and achieve improvements, and that desirable effects will be enhanced. These planned
actions will later be evaluated for effectiveness.
6.2 Quality objectives and planning to achieve them
In line with the quality policy, top management is expected to establish quality objectives—measurable,
quantitative, and time-based objectives to promote improvement in the QMS. These objectives need to
be implemented at appropriate functions in the organization and plans made to achieve the objectives,
including activities to review progress and react to objectives that are not met.
Tip: For more information, see this article: How to define quality objectives in AS9100.
6.3 Planning changes
When you determine that a change is needed in your QMS, you don’t just make the change and hope it
will be ok—you need to plan the change. Do this by considering the purpose of the change,
consequences of the change, integrity of the QMS, necessary resources, and allocation of
responsibilities and authorities.
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7. Support
7.1 Resources
In order to establish, implement, maintain, and continually improve your QMS, you will need to assign
and manage the resources required to do so. This includes the people, infrastructure, environment for
operating processes, monitoring and measurement resources, and organizational knowledge that is
necessary to ensure that your processes are performed correctly. You will need to take into account the
capabilities and constraints of your existing internal resources, as well as the need to obtain additional
resources from external providers.
7.2 Competence
You will need to identify the competence required to properly perform the processes of the QMS such
that adequate outputs are obtained. This competence can be based on appropriate education, training,
or experience, and you must then ensure that employees performing the processes have the necessary
competence. This means your process will need to not only identify what competence is required, but
also what competence is missing for employees and how you will ensure that they obtain this
competence for the work to be performed.
7.3 Awareness
Awareness is closely associated with competence; however, it deals with what the employees must
understand to perform their work. Employees must be aware of the quality policy and objectives,
current and future impacts that affect the tasks they perform, and what their personal performance
means in the QMS, including how bad performance could affect the QMS. The information on personal
performance needs to include how they affect product and service conformity, product safety, and the
importance of ethical behavior.
7.4 Communication
In order for your QMS to be effectively relayed to your employees, you will need to establish processes
for internal and external communication. What do you need to communicate? When do you need to
communicate? How will you communicate? Who will you communicate to? Who will do the
communication? You will need to have some communication plans in place for when something
happens in your QMS that you need to relay to interested parties.
7.5 Documented information
QMS documentation includes all of the procedures and records required by the AS9100 Rev D standard,
as well as any documents that you have identified as necessary to ensure and demonstrate that your
QMS processes are correctly performed. Many factors affect documentation, including complexity of
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the processes, size of the organization, media used for the information, and the competence of
employees.
The standard requires that the documented information you need for your QMS is properly identified
and described, adequately protected, stored and preserved to maintain legibility, distributed and
retrieved to ensure appropriate use, and controlled when changes are made. Documented information
must be adequately reviewed and approved prior to use to ensure that the information is fit for the
intended purpose.
Another important note is that you must have controls in place to prevent the unintended use of
obsolete information.
Tip: For more information, see this article: A new approach to document and record control in AS9100.
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8. Operations
8.1 Operational planning and control
In order to meet the requirements that are set out for your products and services, your organization will
need to plan, implement, and control the processes necessary to deliver on these requirements. You
will first need to determine which requirements are applicable to your products and services so that you
can identify what features you will need to include to meet these requirements.
You will then need to define the processes needed to produce the necessary product and service
features, as well as what criteria the products and services need to meet to be accepted for release. You
will then need to identify the resources required in order to ensure that these processes function, as
well as the records needed to show that they were carried out as planned.
For adequate planning of operational control, you will also need to put in place the processes needed to
address operational risk management, configuration management, product safety, and the prevention
of counterfeit parts.
Tip: For more information, see these articles: 5 key elements of risk management in AS9100 Rev D and
Understanding configuration management in AS9100 Rev D.
8.2 Requirements for products and services
In order to determine the requirements necessary for your products and services, you will need to
ensure good customer communication. You will need to have processes in place for collecting
information about customer needs for your products and services, handling inquiries, contracts and
orders, customer feedback, handling and controlling customer property and, if necessary, establishing
requirements for contingency actions.
There are certain activities that need to happen before offering your products and services to the
customer; requirements need to be defined, such as applicable legal requirements and those your
organization deems necessary, and you will need to ensure that you can deliver to these requirements.
After you receive the order, and prior to delivery, your organization must review the requirements
related to the products and services and keep records of this review. When a customer changes the
requirements, you must ensure that all necessary documented information is amended with the new
information and all relevant persons are aware of the change. In addition, special requirements of the
products and services need to be determined and any operational risks need to be identified.
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8.3 Design and development of products and services
Design and development is the process that takes you from the initial idea for a product or service to
the final acceptance of the product or service for production. Although the terms ‘”design” and
“development” are often used interchangeably, they define different parts of the same process and
therefore must be used together.
The first step in design and development is planning, where all phases must be defined with appropriate
activities including review, verification, and validation for each phase. Design and development inputs
related to products and services include:




Functional requirements and performance requirements
Legal and regulatory requirements
Information from previous related designs
Other requirements that are deemed relevant to the design and development, such as
customer requirements, market information, etc.
Design and development outputs are to be in a format suitable for verifying that they meet the design
inputs. They must be approved before acceptance, and can be in any form necessary for the product or
service, such as drawings, parts lists, plans, packaging information, etc.
Review is an important part of design and development, and review activities must be defined and
controlled to ensure that the process proceeds in the intended direction. The review can identify
problems during design and development and suggest actions to resolve these problems, and the
review must be documented. When tests are necessary for the purpose of verification and validation,
these tests must be planned, controlled, reviewed, and documented.
The last step in design and development is to identify, review, and control changes during the design
and development of products and services. Documented information is required regarding these
changes, the results of reviews, authorization for change, and actions taken to prevent adverse effects.
8.4 Control of externally provided processes, products and services
This long title refers to purchasing, including outsourced processes as well as products and services you
acquire from suppliers. Your organization will need to establish and document the criteria for selecting
suppliers, which will include an assessment of how critical the outsourced product or service is to the
quality of your product or service. Records of this evaluation must be kept, including a register of
external providers.
You will also need to establish controls to ensure that externally provided processes, products, and
services do not adversely affect your products and services. These controls need to be communicated to
external providers, and may include:
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





Approval of methods, processes, and equipment
Processes, products, and services to be provided
Competence requirements to be met
What verification or validation activities you intend to perform
Special requirements, critical items, or key characteristics
Provider contribution to product and service conformity, product safety, and the importance of
ethical behavior
Your organization retains responsibility for the conformity of all externally provided processes,
products, and services, and must manage the risks identified for external providers.
8.5 Production and service provision
Provision of products and services must be performed under controlled conditions such that the
conformity of products and services is maintained. This can include documented information to
maintain the processes, work instructions, monitoring and measurement equipment, infrastructure, etc.
Criteria for acceptance must be maintained, including criteria for workmanship, and provisions included
for the prevention, detection, and removal of foreign objects. Control must be maintained of
equipment, tools, and software programs, and special processes must be validated and controlled.
Outputs must be identified by suitable means to ensure product and service conformance is identifiable.
When traceability is required, your organization needs to control the outputs by unique identification
and, where necessary, maintain documented information. When property belonging to customers or
external providers is used, the organization must identify, verify, protect, and safeguard this property,
including reporting on lost or damaged property.
Outputs must be preserved to maintain product and service conformity, and post-delivery activities that
are required for the products and services must be identified and planned. These post-delivery activities
may be determined through statutory and regulatory requirements, customer requirements, customer
feedback, analysis of in-service data, etc.
When changes in the product and service provision processes are required, they must be reviewed and
controlled in order to ensure conformity to requirements. Persons authorized to approve product or
service provision changes shall be identified.
8.6 Release of products and services
Products and services must not be released until they are determined to meet all requirements, and all
planned arrangements have been met. This can be done by documenting evidence of product and
service conformance, including the criteria for acceptance and information about who authorized the
release of the product or service. At the delivery of the product or service, the organization must ensure
that all required documented information is present to accompany the products and services.
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8.7 Control of nonconforming outputs
The requirements state that nonconforming outputs must be prevented from unintended use or
delivery, so your organization must identify and control any nonconforming outputs that derive from
your processes during any phase of the product and service provision. Depending on the nature of the
nonconformity, one of the following actions can be taken:




Correction
Segregation, containment, return, or suspension
Informing the customer
Obtaining authorized acceptance by relevant authority, and when acceptable to the customer
When you disposition nonconforming products as use-as-is or repair, you can only implement the
disposition after approval by an authorized design authority, and customer approval when the
nonconformity results in a departure from contract requirements. Product that is scrap must be marked
or controlled until physically rendered unusable, and counterfeit or suspected counterfeit parts must be
controlled to prevent unintended use. When a nonconformity is corrected, the conformity to
requirements must be verified prior to use.
Documented information must be kept that describes the nonconformity, actions taken, concessions
obtained, and the authority deciding on the actions to be taken.
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9. Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
This requirement should not be confused with clause 7.1.5, which deals with managing the equipment
necessary for monitoring and measurement—this is about a wider aspect of monitoring and
measurement within your QMS. The information you derive from monitoring and measurement will
become an important input to your processes for improvement and management review.
The first step is to determine what needs to be monitored and measured, how, and when, as well as
when data will be evaluated and analyzed. Monitoring and measurement should include effectiveness
of the QMS as well as how well you met customer requirements (including on-time delivery) and how
satisfied customers are. This can be done by many forms including interviews, questionnaires, direct
contact, etc.
Data analysis is to be performed to evaluate:







Product and service conformity
Degree of customer satisfaction
QMS performance and effectiveness
Effectiveness of planning implementation
Effectiveness of actions taken for risks and opportunities
Performance of external providers
Need for QMS improvements
9.2 Internal audit
The goal of the internal audit is to verify conformity by checking if your QMS:


Complies with the AS9100 Rev D requirements
Is effectively implemented and maintained
At the conclusion of an audit you will present audit results collected from the review of data during the
audit. These results will include observations of positive outcomes, opportunities for improvement, and
non-conformities to the processes. When corrective action is taken for a non-conformity, and
verification of the action is needed, a follow-up audit may be necessary.
Tip: For more information, see these articles: 6 Main steps in the internal audit according to AS9100 Rev
D and Developing an internal audit checklist for AS9100 Rev D.
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9.3 Management review
Top management must review the QMS on a routine basis to assess:




How appropriate the QMS is to its purpose
How adequate the QMS is for meeting standard requirements
How applicable the QMS is to the business needs
How effective the QMS is towards achieving planned results
The review must evaluate the status of previous actions, changes in internal and external issues,
customer satisfaction, quality policy and objectives, process performance, nonconformities and
corrective actions, monitoring and measurement results, audit results, external provider performance,
on-time delivery performance, adequacy of resources, effectiveness of actions for risks and
opportunities, and opportunities for improvement.
The output of the management review includes decisions on opportunities for improvement, changes to
the QMS, resource needs,and risks identified. Results of the management review must be maintained as
documented information.
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10. Improvements
10.1 General
One goal of a QMS is continual improvement, and to this end your organization must determine and
select opportunities for improvement for which you will plan actions to achieve. This activity is
necessary to meet customer requirements and enhance customer satisfaction, and can be in the form of
corrective action, innovation, training, reducing undesired effects, etc.
10.2 Nonconformity and corrective action
Any nonconformity identified in the system must be corrected to deal with the consequences of the
problem. Once the correction for the problem has been addressed, an assessment of the need for
corrective action to find and correct the root cause of the nonconformity is triggered, and when
necessary, the root cause is addressed to prevent recurrence. Actions taken for corrective action must
be documented and evaluated for effectiveness.
When necessary, corrective actions must also be flowed down to external providers when it is
determined that the responsibility lies with them. Specific actions must be taken when timely and
effective corrective actions are not achieved.
Tip: For more information, see this article: Corrective actions vs. continual improvement in AS9100.
10.3 Continual improvement
Continual improvement is a key guiding principle of the QMS, so it is critical that this occurs to achieve
and maintain the suitability, adequacy, and effectiveness of the QMS regarding the organization’s
objectives.
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Conclusion
The AS9100 Rev D standard provides your organization with guidance on implementing a QMS that will
focus on providing products and services that will meet customer requirements and enhance customer
satisfaction. Successfully understanding and implementing all requirements of the standard can provide
benefits for your company, and start you on the road to sustained continual improvement. Certification
to the standard can be a successful marketing tool that brings improved reputation and motivation to
your company through better efficiency, increased quality of products and services, and improvement in
your supply chain. All of the elements of AS9100 Rev D are closely related to the ability of your
organization to deliver satisfaction to your customers and satisfy the needs and expectations of your
stakeholders.
With this in mind, can you afford NOT to implement AS9100 Rev S within your organization?
Tip: For more information, see these articles: 7 Key benefits of AS9100 implementation and 13
Implementation steps for AS9100 Rev D.
Sample of documentation templates
You can also download a free preview of the AS9100 Rev D Documentation toolkit. This will allow you to
see samples of policies and procedures used in the implementation of AS9100 Rev D.
References
9100Academy
AS9100 Rev D, SAE International: http://standards.sae.org/as9100d/
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