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AS 9100 Rev D - Quality Management Systems – Over ISO 9001:2015 - The Gap Analysis Checklist
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This gap analysis checklist is prepared for use in evaluating a Quality Management System (QMS) against the requirements of the new
Aerospace standard. The AS 9100 Rev D standard includes the requirements of ISO 9001:2015 and specifies additional aviation, space, and
defense (ASD) industry requirements.
In the checklist, each requirement is expressed as a question that the user (auditor / assessor) can use to evaluate your QMS capabilities. You
will need to have copies of the AS 9100 D and ISO 9001:2015 standards to use along with this checklist so that, if required, you can refer to the
requirements and the clarification sections of Annex A.
While the structure of the AS and ISO standards at the same when comparing the contents, the additional ASD requirements are highlighted in
yellow in the relevant sections of the checklist and the intent of the main clauses of the new standard is shown in blue font.
After you have prepared an audit schedule, and assigned responsibility to your auditors for different areas or processes to audit, copy each
section of the checklist for the auditors working with that section. As you work through the checklist take notes on what is in place, and what
needs to be developed.
In the space for ‘currently in place’, list or reference the procedures or other documents, or evidence that you have reviewed and that will provide
information for the new QMS. Take notes on the status of the documents, that is, will they need to be revised for the new system, or can they be
used as is? Also note where processes are in place, but documentation is needed. Focus on what is in place, and what needs to be developed.
While you do want to know if documented information is in place and if procedures and processes are being complied with, compliance is not
your main focus for this audit. Remember that the final outcome of this audit should be a list of things that your company needs to do to comply
with AS 9100 Rev D.
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--- QUALITY MANAGEMENT SYSTEMS Currently Compliant If No - % Items

REQUIREMENTS YES / NO? Completed
in Place Needed

4 CONTEXT OF THE ORGANIZATION

Intend This first clause introduces two sub-clauses relating to the context of the organization, (1) understanding the organization and its
of context and (2) understanding the needs and expectations of interested parties. Together they require that you determine the issues
clause and requirements that can impact on the planning of the Quality Management System (QMS). In addition, the scope of the QMS and
the QMS processes along with their applicability and interactions need to be determined.

4.1 Understanding the organization and its context

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Does your company determine the external and internal

issues that are relevant to your purpose and strategic
direction?

Do you consider the relevant issues that affect your

ability to achieve the intended results of the Quality
Management System (QMS)?

Does your company monitor and review the information

related to the external and internal issues?

4.2 Understanding the needs and expectations of interested parties

With consideration given to their impact or potential

impact on your company’s ability to consistently provide
products and services that meet customer and
applicable statutory and regulatory requirements, do
you determine:

• The interested parties that are relevant to the QMS?

• The requirements of these interested parties that are

relevant to the QMS?

Does your company monitor and review the information

about these interested parties and their relevant
requirements?

4.3 Determining the scope of the quality management system

To establish the scope of the QMS, does your company

determine the boundaries and applicability of the QMS?

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When determining the scope of the QMS, do you

consider the:

• External and internal issues (per 4.1)?

• Requirements of relevant interested parties (per 4.2)?

• The products and services of your company?

When a requirement of AS 9100 D can be applied, is

the requirement applied by your company?

When requirements cannot be applied, and in order to

claim conformity to AS 9100 D, how do you determine if
your ability or responsibility to ensure conformity of
products and services are not affected?

Is the scope of the QMS available and maintained as

documented information?

Does the scope state the products and services

covered by the QMS?

Does your company provide justification for any

instance where a requirement of the standard cannot
be applied?

4.4 Quality management system and its processes

4.4.1 As required by the standard, do you establish,

document, implement, maintain and continually improve
the QMS?

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Does the QMS also address customer and applicable

statutory and regulatory quality management system
requirements?

Does your company determine the processes needed

for the QMS, their interactions and applications
throughout your company?

That is, for the QMS processes do you determine the:

• Inputs required and the outputs expected from the

processes?

• Sequence and interaction of the processes?

• Criteria, methods, including measurements and

related performance indicators needed to ensure the
effective operation, and control of the processes?

• Resources needed and ensure they are available?

• Assignment of the responsibilities and authorities for

these processes?

• Risks and opportunities (per 6.1), and plans to

implement the appropriate actions to address them?
See also Operational risk management (per 8.1.1)

• Methods for monitoring, measuring, and evaluation of

processes and, if needed, the changes to processes
to ensure that they achieve intended results?

• Opportunities for improvement of the processes and

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the QMS?

Does your company maintain the necessary

documented information to support the operation of
processes?

4.4.2 Does your company maintain and retain the necessary

documented information to provide the confidence that
the processes are being carried out as planned?

Does the documented information include:

• General description of relevant interested parties, per

see 4.2 a?

• Scope of the QMS, including boundaries and

applicability, per see 4.3?

• Description of the processes needed for the QMS and

their application throughout the organization?

• Sequence and interaction of the processes?

• Assignment of the responsibilities and authorities for

these processes?

With reference to the Note in section 4.4.2:

• Do you compile the above items of the QMS in a

single source of documented information and referred
to as a quality manual?

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5 LEADERSHIP

Intent This clause requires that your top management demonstrates leadership and commitment with respect to the QMS. In addition, top
of management is required to demonstrate leadership and commitment with respect to customer focus. This section also asks top
clause management to establish, implement and maintain a quality policy that is appropriate to your company and to ensure that the
responsibilities and authorities for relevant roles are assigned, communicated and understood.

5.1 Leadership and commitment

5.1.1 General

Does top management demonstrate leadership and

commitment with respect to the QMS by:

• Taking accountability for the effectiveness of the

QMS?

• Ensuring that the quality policy and quality objectives

are established for the QMS and are compatible with
the strategic direction and the context of the
organization?

• Ensuring that the quality policy is communicated,

understood and applied within the company?

• Ensuring the integration of the QMS requirements into

the company’s business processes?

• Promoting the use of both the process approach and

risk-based thinking?

• Ensuring that the resources needed for the QMS are

available?
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• Communicating the importance of effective quality

management and of conforming to the QMS
requirements?

• Ensuring that the QMS achieves its intended results?

• Engaging, directing and supporting persons to

contribute to the effectiveness of the QMS?

Promoting continual improvement?

• Supporting other relevant management roles to

demonstrate their leadership as it applies to their
areas of responsibility?

5.1.2 Customer focus

Does top management demonstrate leadership and

commitment with respect to customer focus by ensuring
that the:

• Customer requirements and applicable statutory and

regulatory requirements are determined and met?

• Risks and opportunities that can affect conformity of

products and services and the ability to enhance
customer satisfaction are determined and addressed?

• Focus on consistently providing products and

services that meet customer and applicable statutory
and regulatory requirements are maintained?

• Focus on enhancing customer satisfaction is

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maintained?

• Product and service conformity and on-time delivery

performance are measured and action is taken if
planned results are not or will not be achieved?

5.2 Policy

5.2.1 Developing the quality policy

Has your top management established, implemented

and maintained a quality policy that:

• Is appropriate to the purpose and context of the

organization?

• Provides a framework for setting and reviewing

quality objectives?

• Includes a commitment to satisfy applicable

requirements?

• Includes a commitment to continual improvement of

the QMS?

5.2.2 Communicating the quality policy

Is your quality policy:

• Communicated, understood and applied within your

company?

• Available as documented information?

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