Quality Management System - Requirements for Aviation, Space and Defence Organizations

AS 9100 REV
D EMPLOYEE POCKET GUIDE
 WHAT IS AS 9100 AEROSPACE
QUALITY MANAGMENT SYSTEM ?
The Aerospace Standards are a series of standards based on ISO 9001 and
developed by the International Aerospace Quality Group (IAQG). They provide
international consistency and address the specific regulatory, safety and reliability
requirements demanded by the aerospace sector.

Industry has established the International Aerospace Quality Group (IAQG), with
representatives from aviation, space, and defense companies in the Americas,
Asia/Pacific, and Europe, to implement initiatives that make significant improvements in
quality and reductions in cost throughout the value stream. The 9100 standard has
been prepared by the IAQG. It was published by SAE as AS9100, EN as EN9100
and JIS as JISQ 9100.

AS 9100 standard is intended for use by organizations that design, develop, or

provide aviation, space, and defense products and services; and by organizations
providing post- delivery activities, including the provision of maintenance, spare parts, or
materials for their own products and services.

Organizations whose primary business is providing maintenance or continuing

airworthiness management services for civil or military aviation articles and products;
and original equipment manufacturers with maintenance, repair, and overhaul
operations that are operated autonomously, or that are substantially different from their
production operations; should use the IAQG-developed 9110 standard.

Organizations that procure parts, materials, and assemblies and resells these
products to a customer in the aviation, space, and defense industry should use the
IAQG-developed 9120 standard. This includes organizations that procure products and
split them into smaller quantities, as well as those that coordinate a customer or
regulatory controlled process on the product.

The current version of ISO 9001 is ISO 9001:2015 and AS9100 Rev D or 9100:2016.
 QUALITY MANAGEMENT
PRINCIPLES
AS 9100 and ISO 9001 Standards are based on the quality management principles
described in ISO 9000.

The quality management principles are:

customer focus;

leadership;

engagement of people;

process approach;

improvement;

evidence-based decision

making; relationship

management
 PROCESS APPROACH
AS 9100 and ISO 9001 promotes the adoption of a process approach when
developing, implementing, and improving the effectiveness of a quality management
system, to enhance customer satisfaction by meeting customer requirements.

The process approach involves the systematic definition and management of

processes, and their interactions, so as to achieve the intended results in accordance
with the quality policy and strategic direction of the organization.

Management of the processes and the system as a whole can be achieved using the
PDCA cycle with an overall focus on risk-based thinking aimed at taking advantage of
opportunities and preventing undesirable results.

The application of the process approach in a quality management system enables:

understanding and consistency in meeting requirements;

the consideration of processes in terms of added value;

the achievement of effective process performance;

improvement of processes based on evaluation of data and information.

The PDCA cycle can be briefly described as follows:

Plan: establish the objectives of the system and its processes, and the resources

needed to deliver results in accordance with customers’ requirements and the

organization’s policies, and identify and address risks and opportunities;

Do: implement what was planned;

Check: monitor and (where applicable) measure processes and the resulting

products and services against policies, objectives, requirements, and planned

activities, and report the results;

Act: take actions to improve performance, as necessary.

 Process Approach (Turtle Approach)

Risk-Based Thinking

Risk based thinking is essential for achieving an effective quality management system.

The concept of risk based thinking is not new, for example, carrying out preventive
action
to eliminate potential nonconformities, analyzing any nonconformities that do occur, and

taking action to prevent recurrence that is appropriate for the effects of the

nonconformity.

To conform to the requirements of this International Standard, an organization needs

to plan and implement actions to address risks and opportunities. Addressing both risks

and opportunities establishes a basis for increasing the effectiveness of the quality

management system, achieving improved results, and preventing negative effects.

Opportunities can arise as a result of a situation favorable to achieving an intended

result, for example, a set of circumstances that allow the organization to attract

customers, develop new products and services, reduce waste, or improve productivity.

REQUIREMENTS OF AS 9100 REV D

Requirements of AS 9100 Rev D:
1. Scope

2. Normative References

3. Terms and Definitions

4. Context of the Organization

5. Leadership

6. Planning

7. Support

8. Operation

9. Performance Evaluation

10. Improvement
 REQUIREMENTS OF AS 9100 REV D
1.SCOPE
Scope of the Quality Management System

• This Standard includes ISO 9001:2015 requirements

• It is emphasized that the requirements specified in this standard are complementary

(not alternative) to customer and applicable statutory and regulatory requirements

• If there is a conflict between the requirements of this standard and customer or

applicable statutory or regulatory requirements, the latter shall take precedence.

• needs to demonstrate its ability to consistently provide products and services that
meet customer and applicable statutory and regulatory requirements

• aims to enhance customer satisfaction through the effective application of the system,

including processes for improvement of the system and the assurance of conformity

to customer and applicable statutory and regulatory requirements.

 REQUIREMENTS OF AS 9100 REV D
2.NORMATIVE REFERENCE
The following documents, in whole or in part, are normatively referenced in this

document and are indispensable for its application. For dated references, only the

edition cited applies. For undated references, the latest edition of the referenced

document (including any amendments) applies.

• ISO 9000:2015 Quality management systems – Fundamentals and vocabulary

• ISO 9001:2015 Quality management systems – Requirements

REQUIREMENTS OF AS 9100 REV

D 3.TERMS AND DEFENITIONS
• Terms and Definitions in ISO 9001:2015 applies

• Counterfeit Part - An unauthorized copy, imitation, substitute, or modified part (e.g.,

material, part, component), which is knowingly misrepresented as a specified

genuine part of an original or authorized manufacturer. NOTE: Examples of a

counterfeit part can include, but are not limited to, the false identification of marking

or labeling, grade, serial number, date code, documentation, or performance

characteristics.

• Critical Items - Those items (e.g., functions, parts, software, characteristics, processes)

having significant effect on the provision and use of the products and services;

including safety, performance, form, fit, function, producibility, service life, etc.;
 that require specific actions to ensure they are adequately managed. Examples of

critical items include safety critical items, fracture critical items, mission critical items,

key characteristics, etc.

• Key Characteristic - An attribute or feature whose variation has a significant effect

on product fit, form, function, performance, service life, or producibility, that requires

specific actions for the purpose of controlling variation.

• Product Safety - The state in which a product is able to perform to its designed or
intended purpose without causing unacceptable risk of harm to persons or
damage

to property.

• Special Requirements - Those requirements identified by the customer, or

determined by the organization, which have high risks of not being met, thus
requiring their

inclusion in the operational risk management process. Factors used in the

determination of special requirements include product or process complexity, past

experience, and product or process maturity. Examples of special requirements

include performance requirements imposed by the customer that are at the limit of

the industry’s capability, or requirements determined by the organization to be at the

limit of its technical or process capabilities.

NOTE: Special requirements and critical items , along with key characteristics, are

interrelated. Special requirements are identified when determining and reviewing

requirements related to the product. Special requirements can require the identification

of critical items. Some critical items will be further classified as key characteristics

because their variation needs to be controlled.

 REQUIREMENTS OF AS 9100 REV
D
4. CONTEXT OF THE
ORGANISATION
4.1 Understanding the Organization and its context

• Determine the internal and external issues that are relevant to

• Purpose of the organization

• Organization strategic direction

• Intended results of QMS

• Monitor and review these internal and external issues

4.2 Understanding the Needs and Expectations of Interested Parties

• Due to their effect or potential effect on the organization’s ability to consistently

provide products and services that meet customer and applicable statutory and

regulatory requirements,

• Determine the interested parties that are relevant to the quality management
system;

• the requirements of these interested parties that are relevant to the quality
management system.

• Monitor and review these internal and external issues

4.3 Determining the Scope of the Quality Management System

• Determine the scope and boundary

• Consider the Issues, Interested Parties requirements, Products and Services

• Document the scope and the non applicability with justification

4.4 Quality Management System and Its Processes

• Establish, implement, maintain, and continually improve a quality management

system, including the processes needed and their
interactions, in accordance with the

requirements of AS 9100 Rev D

• The organization’s quality management system shall also address customer and
applicable statutory and regulatory quality management system requirements.

• Determine the processes needed for the quality management system.

• Ensure these processes are based on PDCA, Risk Based Thinking and Turtle
Approach (Process Approach)

• To the extent necessary maintain and retain the documented information’s.

REQUIREMENTS OF AS 9100 REV

D
5. LEADERSHIP
• Top Management shall demonstrate leadership and commitment with respect to
QMS.

• Top Management ensures that the product and service conformity and on-time
delivery performance are measured and appropriate action is taken if planned
results

are not, or will not be, achieved.

• Establishing the Quality Policy in line with the purpose and context of the
organization and supports its strategic direction; Document,
Communicate Apply and make

available to the relevant interested parties.

• Appoint MR and define roles, responsibilities and authorities for all people.
 REQUIREMENTS OF AS 9100 REV
D
6. PLANNING
• When planning for the quality management system, consider the issues and the
requirements of interested parties and determine the risks and opportunities.

• Plan actions to address these risks and opportunities.

• Integrate and implement the actions into its quality management system
processes and evaluate the effectiveness of these actions.

• Establish quality objectives at relevant functions, levels, and processes needed for
the quality management system.

• When the organization determines the need for changes to the quality management
system, the changes shall be carried out in a planned manner.

REQUIREMENTS OF AS 9100 REV

D
7. SUPPORT
• Determine and provide the resources needed for the establishment, implementation,
maintenance, and continual improvement of the quality management system.

• Determine and provide the persons necessary for the effective implementation of its
quality management system and for the operation and control of its processes

• Determine, provide, and maintain the infrastructure necessary for the operation of
its processes and to achieve conformity of products and services.
• Determine, provide, and maintain the environment necessary for the operation of its
processes and to achieve conformity of products and services.
• Determine and provide the resources needed to ensure valid and reliable results
when
monitoring or measuring is used to verify the conformity of products and services to

requirements.

• Ensure that the resources provided are suitable for the specific type of monitoring
and measurement activities being undertaken and are maintained to ensure their
continuing

fitness for their purpose.

• When measurement traceability is a requirement, or is considered by the

organization to be an essential part of providing confidence in the validity of
measurement results,

measuring equipment shall be calibrated or verified, or both, at specified intervals, or

prior to use, against measurement standards traceable to international or national

measurement standards.

• Identified in order to determine their status and safeguarded from adjustments,

damage, or deterioration that would invalidate the calibration status and
subsequent

measurement results.

• Determine the knowledge necessary for the operation of its processes and to
achieve conformity of products and services.

• Maintain - Preserve - Protect - Acquire - Update the knowledge.

• Determine the necessary competence of person and ensure that these persons are
competent on the basis of appropriate education, training, or experience;

• Where applicable, take actions to acquire the necessary competence, and evaluate
the effectiveness of the actions taken;

• Ensure that persons doing work under the organization’s control are aware of the
policy, objectives, their contribution to the effectiveness of the quality management

system, including the benefits of improved performance, their contribution to the

product conformity and product safety, the implications of not conforming with the
 quality management system requirements; relevant quality management system

documented information and changes thereto, the importance of ethical behavior.

• Determine the internal and external communications relevant to the quality

management system.

• Documented information required by the quality management system shall be

controlled.

• When documented information is managed electronically, data protection

processes shall be defined (e.g., protection from loss,
unauthorized changes, unintended

alteration, corruption, physical damage).

REQUIREMENTS OF AS 9100 REV

D
8. OPERATION
8.1 Operational Planning and Control

• Plan, implement, and control the processes needed to meet the requirements for
the
provision of products and services, and to implement the actions determined in

QMS planning.

• Plan and manage product and service provision in a structured and controlled
manner
to meet requirements at acceptable risk, within resource and schedule constraints.

• Establish, implement, and maintain a process to plan and control the temporary or
permanent transfer of work.
• Plan, implement, and control a process for managing operational risks to the
achievement of applicable requirements.
• Plan, implement, and control a process for configuration management as
appropriate
to the organization and its products and services in order to ensure the identification

and control of physical and functional attributes throughout the product lifecycle.

• Plan, implement, and control the processes needed to assure product safety during
the entire product life cycle.

• Plan, implement, and control processes, appropriate to the organization and the

product, for the prevention of counterfeit or suspect counterfeit part use and their

inclusion in product(s) delivered to the customer

•
•
8.2 Requirements for Products and Services

• Before submitting the quote, before accepting the order and order amendments do
the review with Cross Functional Team to ensure

• The requirements, special requirements, operational risks are determined

• The organization has the ability to meet the requirements for products and
services to be offered to customers.

• If upon review the organization determines that some customer requirements cannot
be met or can only partially be met, negotiate a mutually acceptable requirement
with

the customer

• Ensure that relevant documented information is amended, and that relevant persons

are made aware of the changed requirements, when the requirements for products
and services are changed
8.3 Design and Development of Products and Services

• Establish, implement, and maintain a design and development process that is

appropriate to ensure the subsequent provision of products and services

• Design and development planning shall consider the ability to provide, verify, test
and maintain products and services.

• When appropriate, divide the design and development effort into distinct activities
and,
for each activity, define the tasks, necessary resources, responsibilities, design

content, and inputs and outputs.

• Determine the Design and development input requirements essential for the
specific types of products and services to be designed and developed.

• Apply controls to the design and development process. Controls includes review,
verification and validation.

• Participants in design and development reviews shall include representatives of

functions concerned with the design and development stage(s) being reviewed.

• When tests are necessary for verification and validation, these tests shall be
planned, controlled, reviewed, and documented.

• At the completion of design and development, ensure that reports, calculations, test
results, etc., are able to demonstrate that the design for the product or service meets

the specification requirements for all identified operational conditions

• The Design and Development out put specify, as applicable, any critical items,
including any key characteristics, and specific actions to be taken for these items;

• Identify, review, and control changes made during, or subsequent to, the design and
development of products and services, to the extent necessary to ensure that there
is

no adverse impact on conformity to requirements

• Implement a process with criteria for notifying its customer, prior to implementation,
about changes that affect customer requirements

8.4 Control of Externally Provided Processes, Products, and Services

• Ensure that externally provided processes, products, and services conform to

requirements

• Responsible for the conformity of all externally provided processes, products, and
services, including from sources defined by the customer.

• Ensure, when required, that customer-designated or approved external providers,

including process sources (e.g., special processes), are used.

• Identify and manage the risks associated with the external provision of processes,
products, and services, as well as the selection and use of external providers.

• Require that external providers apply appropriate controls to their direct and sub-tier
external providers, to ensure that requirements are met.
• Determine the controls to be applied to externally provided processes, products, and
services.

• Determine and apply criteria for the evaluation, selection, monitoring of performance,

and re-evaluation of external providers, based on their ability to provide processes or

products and services in accordance with requirements.

• Ensure that externally provided processes, products, and services do not adversely

affect the organization’s ability to consistently deliver conforming products and

services to its customers.

• Verification activities of externally provided processes, products, and services shall

be performed according to the risks identified by the organization. These shall
include

inspection or periodic testing, as applicable, when there is high risk of

nonconformities including counterfeit parts.

• When external provider test reports are utilized to verify externally provided products,

implement a process to evaluate the data in the test reports to confirm that the

product meets requirements. When a customer or organization has identified raw

material as a significant operational risk (e.g., critical items), implement a process

to validate the accuracy of test reports.

• Ensure the adequacy of requirements prior to their communication to the external

provider.

• PO shall have detailed QMS requirements

8.5 Production and Service Provision

• Implement production and service provision under controlled conditions.

• Controlled conditions shall include, as applicable:

• the availability of documented information that defines: the characteristics of

the products to be produced, the services to be provided, or the activities to

be performed; the results to be achieved;

• the availability and use of suitable monitoring and measuring resources

• the implementation of monitoring and measurement activities at appropriate

stages to verify that criteria for control of processes or outputs, and

acceptance criteria for products and services, have been met;

• ensuring that documented information for monitoring and measurement activity

for product acceptance includes : criteria for acceptance and rejection, where in

the sequence verification operations are to be performed, measurement results

to be retained (at a minimum an indication of acceptance or rejection), any

specific monitoring and measurement equipment required and instructions

associated with their use

• Use customer approved / recognized sampling plan

• the use of suitable infrastructure and environment for the operation of

processes

• the appointment of competent persons, including any required qualification;

• Special process validation

• the implementation of actions to prevent human error

• the implementation of release, delivery, and post-delivery activities

 • the establishment of criteria for workmanship (e.g., written standards,
representative samples, illustrations

• the accountability for all products during production (e.g., parts quantities,
split orders, nonconforming product);

• the control and monitoring of identified critical items, including key

characteristics, in accordance with established processes

• the identification of in-process inspection/verification points when adequate

verification of conformity cannot be performed at later stages

• the provision for the prevention, detection, and removal of foreign objects

• the control and monitoring of utilities and supplies (e.g., water, compressed
air,
electricity, chemical products) to the extent they affect conformity to product

requirements

• the identification and recording of products released for subsequent

production use pending completion of all required measuring and
monitoring activities, to

allow recall and replacement if it is later found that the product does not meet

requirements

• Equipment, tools, and software programs used to automate, control, monitor, or

measure production processes shall be validated prior to final release for

production and shall be maintained.
• Storage requirements shall be defined for production equipment or tooling in
storage including any necessary periodic preservation or condition checks

• Implement production process verification activities to ensure the production

process is able to produce products that meet requirements.

• Use a representative item from the first production run of a new part or
assembly to verify that the production processes, production documentation,
and tooling

are able to produce parts and assemblies that meet requirements

• This activity can be referred to as First Article Inspection

• Use suitable means to identify outputs when it is necessary to ensure the

conformity of products and services

• Maintain the identification of the configuration of the products and services in

order to identify any differences between the actual configuration and the

required configuration

• Identify the status of outputs with respect to monitoring and measurement

requirements throughout production and service provision.

• When acceptance authority media are used (e.g., stamps, electronic

signatures, passwords), establish controls for the media

• Control the unique identification of the outputs when traceability is a

requirement, and shall retain the documented information necessary to enable

traceability.

• Identify, verify, protect, and safeguard customers’ or external providers’

property provided for use or incorporation into the products and services.

• Preserve the outputs during production and service provision, to the extent
necessary to ensure conformity to requirements

• Meet requirements for post-delivery activities associated with the products and
services.
 • Review and control changes for production or service provision, to the
extent necessary to ensure continuing conformity with requirements.

• Persons authorized to approve production or service provision changes shall

be identified.

•
8.6 Release of Products and Services

• Implement planned arrangements, at appropriate stages, to verify that the

product and service requirements have been met.

• The release of products and services to the customer shall not proceed until
the planned arrangements have been satisfactorily completed, unless
otherwise

approved by a relevant authority and, as applicable, by the customer.

• When required to demonstrate product qualification, ensure that retained

documented information provides evidence that the products and services meet

the defined requirements

• Ensure that all documented information required to accompany the products

and services are present at delivery

•
8.6 Control of Nonconforming Outputs

• Ensure that outputs that do not conform to their requirements are identified and
controlled to prevent their unintended use or delivery

• Take appropriate action based on the nature of the nonconformity and its effect
on the conformity of products and services. This shall also apply to
nonconforming

products and services detected after delivery of products, during or after the

provision of services. This may includes containment, return rework,

replacement, concession acceptance, scarp etc

• Counterfeit, or suspect counterfeit, parts shall be controlled to prevent reentry

into the supply chain.

• Define the responsibility and authority for the review and disposition of
nonconforming outputs and the process for approving persons making these

decisions.
• Obtaining authorization for acceptance under concession by a relevant
authority and, when applicable, by the customer.

• Dispositions of use-as-is or repair for the acceptance of nonconforming

products only done after approval of customer.

• Product dispositioned for scrap shall be conspicuously and permanently

marked, or positively controlled, until physically rendered unusable
REQUIREMENTS OF AS 9100 REV
D
9. PERFORMANCE EVALUATION
• Determine

• what needs to be monitored and measured;

• the methods for monitoring, measurement, analysis, and evaluation needed

to ensure valid results , when the monitoring and measuring shall be
performed,

• when the results from monitoring and measurement shall be analyzed and
evaluated

• Determine the methods for obtaining, monitoring, and reviewing the customer
satisfaction

• Measure product and service conformity, on-time delivery performance,

customer complaints, and corrective action requests.

• Develop and implement plans for customer satisfaction improvement that

address
deficiencies identified by these evaluations, and assess the effectiveness of the

results.

• Analyze and evaluate appropriate data and information arising from monitoring
and measurement.

• Conduct internal audits at planned intervals to provide information on whether

the quality management system.

• Verify the conformity and effectiveness of the QMS

• Top management shall review the organization's quality management system, at

planned intervals, to ensure its continuing suitability, adequacy, effectiveness,

and alignment with the strategic direction of the organization.

REQUIREMENTS OF AS 9100 REV
D
10. IMPROVEMENT
• Determine and select opportunities for improvement and implement any
necessary actions to meet customer requirements and enhance customer

satisfaction

• When a nonconformity occurs, react to the nonconformity (segregation,

containment, return rework, replacement, concession acceptance, scarp)

• Evaluate the need for action to eliminate the cause(s) of the nonconformity, in
order that it does not recur or occur elsewhere.

• Determining the causes of the nonconformity, including, as applicable, those

related to human factors

• Flow down corrective action requirements to an external provider when it is

determined that the external provider is responsible for the nonconformity.

• Take specific actions when timely and effective corrective actions are not
achieved.

• Continually improve the suitability, adequacy, and effectiveness of the quality

management system.

• Consider the results of analysis and evaluation, and the outputs from
management review, to determine if there are needs or opportunities that shall
be addressed as

part of continual improvement

• Monitor the implementation of improvement activities and evaluate the

effectiveness of the results
KNOW YOUR
YOU ARE RESPONSIBLE FOR