TUV USA Inc.

– Transition Towards 9100D

AS9100 Rev. D Requirements

This checklist is designed to be used to identify the requirements of the AS9100 Revision D in comparison (as in gap analysis) to the
requirements of Revision C. It is not a checklist of the entire requirements of AS9100D standard. In the “Additional Requirements” section,
differences between the Rev. C and Rev. D requirements are identified. Since the clauses have been renamed, renumbered and re-
sequenced, it is assumed that an AS9100 Rev. D Quality Manual and associated procedures will undergo a complete revision. Where
there are no additional requirements listed, the requirements between Rev. C and Rev. D are essentially the same, with the exception of
language changes such as “Externally provided processes, products and services” instead of “Purchasing” or “Leadership” instead of
“Management Commitment.”

For an organization that does not intend to perform a complete revision of its Quality Manual and associated procedures, this checklist can
be used as a “compliance matrix.” The intent for a compliance matrix is to identify where in the current QMS documentation the AS 9100D
requirement has already covered—the Quality Manual or procedure reference and paragraph number would be entered into the “Where
Covered” column. If an AS9100D requirement is not met in the current Quality Manual or associated procedure, the expectation is that an
additional procedure or addendum would be created on an interim basis.

AS 9100D Requirement Where Covered Additional Requirements Comments

1 Scope Plan-do-check-act model
Add risk-based thinking

2 Normative References ISO 9001: 2015

3 Terms and Definitions Add product safety and counterfeit

product to standard terms and
definitions

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AS 9100D Requirement Where Covered Additional Requirements Comments

4 Context of the Organization

4.1 Understanding the Organization and Emphasis on defining the QMS and
its Context context of the organization
Exclusions not listed; clauses are
applicable or not applicable with
justification
4.2 Understanding the Needs and
Expectations of Interested Parties
4.3 Determining the Scope of the QMS What the organization does

4.4 Quality Management System and its Include a general description of Basically, a Quality
Processes relevant interested parties Manual with more
Sequence of interactions descriptions
Description of processes needed
for the QMS
5 Leadership
5.1 Leadership and Commitment Top management

5.1.1 General

5.1.2 Customer Focus Statement that if product and

service conformity and OTD are
measured and actions will be taken
if planned results are not achieved.
5.2 Policy

5.2.1 Developing the Quality Policy

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AS 9100D Requirement Where Covered Additional Requirements Comments

5.2.2 Communicating the Quality Policy

5.3 Organizational Roles and

Responsibilities
6. Planning

6.1 Actions to Address Risks and Need to describe how risk is met in A formal risk
Opportunities all contexts, not just in planning or management process
contract review is required to manage
Increases requirements operational risk in
clause 8.1.1

6.2 Quality Objectives and Planning to

Achieve Them
6.3 Planning of Changes

7 Support

7.1 Resources

7.1.1 General

7.1.2 People Add requirements for human

factors
7.1.3 Infrastructure
7.1.4 Environment for the Operation of Suitable environment =
Processes combination of human and physical
factors such as social,
psychological and physical

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AS 9100D Requirement Where Covered Additional Requirements Comments

7.1.5 Monitoring and Measuring Resources Provided resources are suitable Documented
and maintained to ensure Information =
continuing fitness. Records

7.1.5.1 General

7.1.5.2 Measurement Traceability Calibration of

monitoring &
measuring equipment
unchanged

7.1.6 Organization Knowledge Sharing of organizational Can also be from

knowledge and experience. external sources
Results of improvements in (conferences,
standards,
products, processes and services.
customers,
consultants, etc.)
7.2 Competence Consideration for periodic review of
necessary competence

7.3 Awareness Awareness to include QMS

procedures/manual and changes,
contribution to product or service
conformity, safety and importance
of ethical behavior
7.4 Communication Needs to include internal and
external feedback relevant to the
QMS

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AS 9100D Requirement
7.5 Documented Information
7.5.1 General
7.5.2 Creating and Updating
7.5.3 Control of Documented Information
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Where Covered Additional Requirements Comments
Formerly referred to
as internal and
external documents
Approval implies authorized
persons and approval methods
identified (an approval matrix-who
can approve what and how)
Adequate protection from loss of
confidentiality, improper use or loss
of integrity
Electronic date protection—loss,
unauthorized changes, unintended
alteration, corruption and physical
damage
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AS9100 Rev. D Requirements

AS 9100D Requirement Where Covered Additional Requirements Comments

8 Operation
8.1 Operational Planning and Control Determination of requirements to
consider:
Personal & product safety
Producibility & inspectability
Reliability, availability and
maintainability
Suitability of part & materials used
in the product
Selection & development of
embedded software
Product obsolescence
Prevention, detection, removal of
foreign objects
Handling, packaging & preservation
Recycling or final disposal of
product at life end
Use of statistical techniques for
design verification, process control
(key characteristics), critical items,
design of experiments, failure
mode, effects and criticality
analysis
Determine resources for product
conformity and to meet on time
delivery of products and services
Determining the products and services
from external providers
Controls to prevent the delivery of
nonconforming products/services
Planned sequence to meet
requirements of acceptable risk

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AS 9100D Requirement Where Covered Additional Requirements Comments

8.1.1 Operation Risk Management For operational risk management: New clause dedicated
Assign responsibilities to addressing
Define risk criteria operational risk
management
Identify, assess and
communicate risk
Manage risks that exceed
defined risk criteria
Acceptance of remaining risks
8.1.2 Configuration Management Ensure identification & control of Configuration audits
physical and functional attributes no longer required
Control product identity and
traceability, including changes
Records are consistent with
attributes of products and services

8.1.3 Product Safety Plan, implement & control processes

for product safety including:
Assessment of hazards and
associated risks
Mange safety critical items
Analysis and reporting of events
affecting safety
Communication of event
Employee training

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AS 9100D Requirement Where Covered Additional Requirements Comments

8.1.4 Prevention of Counterfeit Products Plan, implement and control processes
to prevent the introduction of CP
including:
Training for awareness and
prevention of CP
Parts obsolescence monitoring
Controls for purchasing from
original or authorized sources
Requirements for assuring
traceability of parts and
components to original or
authorized manufacturers
Verification and testing to detect
CP
Monitoring of CP reporting
Quarantine and reporting of
suspect to detected CP
8.2 Requirements for Products and
Services
8.2.1 Customer Communication Handling or controlling customer
property
Requirements for contingency
actions
8.2.2 Determination of Requirements Special requirements for
Related to Products and Services product/services determined
Operational risks have been
identified

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AS 9100D Requirement Where Covered Additional Requirements Comments

8.2.3 Review of Requirements Related to Review of requirements
Products and Services coordinated with applicable
functions
Negotiate mutual agreements with
customer when requirements
cannot be fully met
8.2.4 Changes to Requirements for
Products and Services
8.3 Design and Development of Products
and Services
8.3.1 General
8.3.2 Design and Development Planning Divide D&D efforts into distinct
activities and define tasks,
resources responsibilities, design
content and inputs/outputs for each
8.3.3 Design and Development Inputs Address potential consequences of
obsolescence
8.3.4 Design and Development Controls Progression to next stage
authorization
Participants include representative
from all functions
Plan control and review tests for
verification and validation
Test procedures describe test
methods, how to perform and how
to record

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AS 9100D Requirement Where Covered Additional Requirements Comments

8.3.4 Design and Development Controls Ensure correct configuration of test
Continued item
Requirements of test plan and test
procedures are observed
Acceptance criteria are met
Control of monitoring/measuring
devices
Reports to demonstrate that the
design meets requirements for all
operational conditions
8.3.5 Design and Development Outputs Outputs include any critical items,
key characteristics and specific
actions for them
Are approved by authorized
persons prior to release
Define data required to allow
product to be identified,
manufactured, verified, used and
maintained
8.3.6 Design and Development Changes Process in place for notifying
customers of changes that could
affect them prior to implementation
Changes controlled IAW
configuration management process
8.4 Control of Externally Provided Formerly Purchasing
Processes, Products and Services process

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AS 9100D Requirement Where Covered Additional Requirements Comments

8.4.1 General Apply appropriate controls to direct and

sub-tier external providers as well as
selection and use of external providers
8.4.2 Type and Extent of Control Verification activities performed Formerly Verification
according to identified risks of Purchased Product
Include inspection or periodic
testing when high risk of Last Bullet is meant
nonconformities and counterfeit for raw material
parts verification when only
certificates of
Review of production part approval conformance are
process data provided. Could
Review of delegations of product include raw material
verification over checks
Define process for pre-release of
product
Evaluate data in test reports to
confirm product meets
requirements
When purchase of raw material is a
significant operations risk,
implement a process to validate the
accuracy of test reports

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AS 9100D Requirement Where Covered Additional Requirements Comments

8.4.3 Information for External Providers Communicate external providers with

information including
Relevant technical data
Design and development
control
Special requirements
Prevent the use of counterfeit
parts
Ensuring that supplier
personnel are aware of their
contribution to product/service
conformity, safety and ethical
behavior

8.5 Production and Service Provision

8.5.1 Control of Production and Service Ensure that documented information
Provision (procedures, work instructions for
monitoring and measurement (M&M)
activity for product acceptance
includes:
Criteria for acceptance and
rejection
Where in sequence verification
operations occur
Measurement results to be retained
Any specific M&M equipment
required and instructions for their
use

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AS 9100D Requirement Where Covered Additional Requirements Comments

8.5.1.1 Control of Production Equipment,

Tools and Software Programs
8.5.1.2 Validation and Control of Special
Processes
8.5.1.3 Production Process Verification
8.5.2 Identification and Traceability
First article inspection records must be
retained
Maintain the identification of the
configuration of products and services
in order to identify any differences
between the actual configuration and
required configuration.

8.5.3 Property Belonging to Customers or

External Providers

8.5.4 Preservation
8.5.5 Post-Delivery Activities Post-delivery activities to include:
control, updating, and provision of
technical documentation relating to
product use, maintenance, repair, and
overhaul
8.5.6 Control of Changes

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AS 9100D Requirement
8.6 Release of Products and Services
8.7 Control of Nonconforming Outputs
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Where Covered Additional Requirements Comments
New sub clause to address the
verification of product/service at
appropriate stages
Retain documented information on
the release of products/services
including evidence of conformity
and traceability to person
authorizing the release
Nonconforming “Product” replaced with
“Output”
Include provisions for defining
corrective actions for
nonconforming products and
services detected after delivery, as
appropriate to their impacts
Dispositions for use-as-is or repair
to include obtaining authorization
for acceptance under concession
by a relevant authority and, when
applicable, by the customer.
After authorization by the
customer, if the nonconformity
results in a departure from the
contract requirements
Counterfeit, or suspect counterfeit,
parts to be controlled to prevent
reentry into the supply chain.
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AS9100 Rev. D Requirements

AS 9100D Requirement Where Covered Additional Requirements Comments

9 Performance evaluation
9.1 Monitoring, Measurement, Analysis and The organization is responsible to
Evaluation determine monitoring, measurement,
analysis and evaluation
9.1.1 General
9.1.2 Customer Satisfaction

9.1.3 Analysis and Evaluation What needs to be monitored &

measured (M&M)
Methods for M&M and evaluation
needed to ensure valid results
When M&M is performed
When results from M&M is
analyzed and evaluated
Records of M&M to be retained as
appropriate

9.2 Internal Audit

9.3 Management Review

9.3.1 General

9.3.2 Management Review Input Inputs to include on time delivery

performance
9.3.3 Management Review Output Outputs to include identified risks

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AS 9100D Requirement Where Covered Additional Requirements Comments

10 Improvement
10.1 General

10.2 Nonconformity and Corrective Action Clause is a combination of
Nonconformity and Corrective action.
When a nonconformity occurs, the
organization shall:
React, take action to control &
correct
Deal with the consequences
Evaluate need for action, review
and analyze the nonconformity
Determine causes, including those
related to human factors
Human factors involve
gathering information
about human abilities,
limitations, and other
characteristics and
applying it to tools,
machines, systems,
tasks, jobs, and
environments to
produce safe,
comfortable, and
effective human use. If
nonconformities occur,
the organization is to
determine if/what
human factors are
involved

10.3 Continual Improvement The organization is responsible to

monitor the implementation of
improvement activities and evaluate
the effectiveness of results

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