9100 revision 2016

Changes presentation
clause-by-clause

IAQG 9100 Team

October 2016

The IAQG is a legally incorporated international not for profit association

(INPA) with membership from the Americas, Europe and the Asia Pacific Region
 9100 revision 2016

INTRODUCTION
In September 2016, a revision of the 9100 standard has been published
by the IAQG (International Aerospace Quality Group)
The 9100 standard is based on the ISO 9001 standard, with specific
requirements for the Aviation, Space and Defense Industry. Its revision
includes the ISO 9001 content published in September 2015.

A key changes presentation from the 9100:2009 to the 9100:2016

is available on the IAQG web site. It provides general information about the
main changes introduced in the ISO 9001 content and in the 9100
additions.
This presentation complements the previous one. It is organized clause by
clause and is more intended for experts.

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 9100 revision 2016

The ISO 9001 needed to change, to:

Adapt to a changing world
Enhance an organization's ability to satisfy its customers
Provide a consistent foundation for the future
Reflect the increasingly complex environments in which
organizations operate
Ensure the new standard reflects the needs of all interested
parties
Integrate with other management systems

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 9100 revision 2016

The 9100 needs to change, to:

Incorporate changes made by ISO TC176 to
the ISO 9001:2015 requirements
(ISO liaison organized to collaborate with the IAQG 9100 team and to
obtain consideration for IAQG requirements)

Consider Aviation, Space and Defense stakeholders needs

identified since the last revision
(web survey performed in 2013)

Consider clarifications to 9100 series requests issued by IAQG

since the last revision
(requirements clarified or notes added)

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 What is 9100?
ISO 9001:2015 Baseline Text

9100 Series
International Aviation,
Space and Defense
Quality Requirements
ADDITIONAL REQUIREMENTS
ISO 9001
- Operations Risk Management Quality Management System
- Product Safety
- Special Requirements
- Critical Items
- Configuration Management
- On Time Delivery
- Counterfeit Parts
- Expanded requirements for production
and external providers

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 9100 revision 2016

In the following slides, the changes are identified by:

ISO 9001 >>>>>>>
9100 additions >>
(specific to AS&D: Aviation, Space & Defense)

Additional slides provide more information on topics identified with

Interested parties Risk management
Scope of a QMS Product safety
Quality manual Prevention of counterfeit parts
Organizational knowledge Evaluation of test reports
Awareness Human factors
Documented information

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 9100 revision 2016
Summary of changes - clause by clause

Foreword, Revision summary/Rationale, Intended application

Introduction
0.1 General
Includes verbal significations of
0.2 Quality management principles shall, should, may, can
0.3 Process approach
Plan-Do-Check-Act cycle 7 principles to consider
Risk-based thinking
0.4 Relationship with other Schematic representations of:
management system standards - a process
Requirements - the standard (with a PDCA approach)
1. Scope
2. Normative references
3. Terms and definitions
Special requirements
Critical items
Key characteristic
Counterfeit part Definition added
Product safety Definition added

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Summary of changes - clause by clause

4. Context of the organization Determine relevant external issues (legal,

technological, competitive, market, cultural, social,
and economic environments)
and internal issues (values, culture, knowledge, and
4.1 Understanding the organization performance of the organization)
and its context

4.2 Understanding the needs Determine relevant interested parties and their
and expectations of interested parties requirements (such as customers, partners,
authorities)

4.3 Determining the scope of the quality

management system Document the scope of the QMS and justification for
any case where a requirement cannot be applied
(exclusion)
4.4 Quality management system
and its processes
Define the documented information to be maintained
or to be retained to the extent necessary

Explicit requirement for a documented

information maintained with content defined
(can be called quality manual) (not required by ISO)

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Interested parties
Definition (ISO 9000)
stakeholder
person or organization that can affect, be affected by, or perceive itself to be
affected by a decision or activity

Examples of interested parties:

employees, management, organization owners, unions
suppliers, customers, partners
regulatory authorities (Aviation, Space, Defense)
certification organizations,

Criteria to determine interested parties relevancy, requirements and clause

applicability:
Tier level in the supply chain: Original Equipment Manufacturers, Production
Approval Holders / Design Organization Approval / Production Organization
Approval, Systems integrators
Product families: raw materials, components, assemblies
Activity: distribution, design, maintenance, manufacturing, service
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Scope of the QMS

9100:2016 no longer refers to exclusions in relation to the applicability of its
requirements to the organizations quality management system.

The applicability of each requirement of the standard depends on:

the size or complexity of the organization
the management model of the organization
the range of the organizations activities
the nature of the risks and opportunities for the organization

The organization can decide that a requirement is not applicable,

only if this decision will not result in failure to achieve:
conformity of products and services
enhancement of customer satisfaction
Justifications must be provided for non applicability
For AS&D, non applicability outside clause 8 (Operation) would be unusual

The negative word exclusion is not used

The positive word applicability is preferred
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Quality Manual
The 9100 requires to establish and maintain documented information
describing: Interested Parties; QMS Scope; Process Description, Sequence &
Interactions; and Responsibilities and Authorities.
The requirement can be met in different ways: document, webpages, CD Rom,
electronic document management system, etc.
The intent of the AS&D note The above description of the quality management system can be
compiled into a single source of documented information and referred to as a quality manual. is

to convey the practicality to maintain the required information in a centralized location

for ease of audit and availability for customers and other interested parties
to highlight that this documented information may or not, be called a quality manual.
(terms management handbook or company management manual are often used).
NOTE: A document called quality manual may be required for the organization by relevant
interested parties

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Summary of changes - clause by clause

Leadership instead of only management of

5. Leadership responsibilities (management to demonstrate their
leadership)
5.1 Leadership and commitment
Top management to ensure integration of QMS into
5.2 Policy business processes (now explicit)
5.3 Organizational roles,
Policy aligned with organization strategic direction
responsibilities and authorities

A management representative required as focal

point for QM issues (removed from ISO 9001:2015)

6. Planning
6.1 Actions to address risks and Determine risks and opportunities, considering the
issues raised and requirements identified.
opportunities
Plan appropriate actions to reduce undesired effects
6.2 Quality objectives and on the QMS and evaluate effectiveness
planning to achieve them
Planning the achievement of objectives more
6.3 Planning of changes prescriptive and includes the evaluation of results

Changes to the QMS to be carried out in a planned

manner
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7. Support
Environment includes human and physical
7.1 Resources factors
7.1.1 General
7.1.2 People Determine necessary knowledge gained from
experience, lessons learned, success,
7.1.3 Infrastructure failures, conferences,
7.1.4 Environment for the operation of
processes Added the requirement for persons to be
aware of:
7.1.5 Monitoring and measuring resources their contribution to product or service conformity
7.1.6 Organizational knowledge their contribution to product safety
the importance of ethical behavior
7.2 Competence
Determine the external communications relevant
7.3 Awareness to the QMS
7.4 Communication
New terminology (replacing documents and
7.5 Documented information records)
7.5.1 General No requirement for 6 mandated procedures, but
7.5.2 Creating and updating still a requirement to identify the documented
information & processes needed for the QMS
7.5.3 Control of documented information
Added the requirement to define data
protection processes for documented
information managed electronically 13
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Organizational knowledge
Knowledge specific to the organization is gained by experience.
Rationale:
To safeguard the organization from loss of knowledge, e.g.,
through staff turnover
failure to capture and share information
To encourage the organization to acquire (e.g., learning from experience,
benchmarking ...) and share knowledge (e.g. mentoring of newcomers);

Implementation consideration
Activities to benefit from lessons learned, e.g., database, communications,
incorporation of lessons learned in processes and procedures
Identification of experts able to transfer knowledge, on job training, tutorial
sessions
Implement succession planning activities

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Awareness
The 9100:2016 requires the employees aware of:
their contribution to product or service conformity
their contribution to product safety
the importance of ethical behavior
Awareness activities can be performed in different ways:
direct communication of expectations between managers and employees
communication campaigns on dedicated topics, e.g., posters, pamphlets,
fliers, newsletters, videos
identification of focal points with responsibility for communication and
promotion
formal training

What is expected:
individuals should be able to explain their own role, how they contribute to
quality
quality basics (follow instructions, report events, maintain records )
individuals know the use of the products and potential impact of failures
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importance of ethical behavior

Organizations should make their own determination of what is
important to communicate to their employees in regard to ethics
Below some examples:
Establishing a culture where employees understand their responsibilities
Managers listening to employees and effectively recognizing their work (in
addition it can help boost productivity)
Reporting and not passing on defects or non conformances (e.g., line
stoppage as appropriate, recalling delivered non conforming product, ..)
A culture allowing unethical behavior can breed all manner of damaging
and even criminal activity
Respect the laws, regulations, internal rules, regarding e.g. : conflict of
interests, export compliance regulations, intellectual property agreements,
acceptance or proposals of gifts, invitations or favors with customers and
suppliers

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Documented information
There is no longer a requirement for six mandatory documented procedures in
the ISO 9001:2015, howeverthe extent of the documentation that is needed will
depend on the business context.
It is the responsibility of the organization to maintain documented information
to support the operation of its processes:
Topics to be documented:
Interested parties; QMS scope; Process description, sequence & interactions;
Responsibilities and authorities
Quality Policy and Objectives
AS&D requires maintained documented information regarding
nonconformity and corrective action management processes
as it is a key process for aerospace.
Various methods can be used to meet the requirement
(e.g., procedures, process flow diagrams, videos, graphic instructions, screen
shots, etc.)

It is the responsibility of the organization to retain the documented information

necessary to have confidence that the processes are being carried out as
planned. 17
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Summary of changes - clause by clause

Project Management (9100:2009 clause 7.1.1) and

8. Operation Control of Work Transfers (9100:2009 clause 7.1.4)
no more separated clauses but incorporated in
clause 8.1 (with risk concept introduced for work
8.1 Operational planning and control transfer) and clarified

Reinforce the planning and control activities

8.1.1 Operation risk management with dispositions
to ensure On-Quality and On-Time delivery
of products or services
8.1.2 Configuration management
to prevent delivery of nonconforming
products and services
8.1.3 Product safety to ensure involvement of representatives
from all functions

8.1.4 Prevention of counterfeit parts

Promoting in a note the implementation of
integrated phased processes as a method to
achieve operational planning and control

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 9100 revision 2016
Summary of changes - clause by clause

8. Operation

Based on the requirements of 9100:2009 (7.1.1)

8.1 Operational planning and control this clause is related to risks in operational
processes defined in clause 8 (no major change)
while 6.1 is related to risks in QMS of the
organization
8.1.1 Operation risk management

Based on the requirements of 9100:2009 (7.1.3),

8.1.2 Configuration management revised to clarify stakeholders expectations

8.1.3 Product safety

Added new requirements to address product
safety considerations throughout the product
8.1.4 Prevention of counterfeit parts lifecycle

Added new requirements to prevent the use of

counterfeit or suspect counterfeit parts

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Risk management
Clause 6.1 is related to risks in QMS of the organization:
Manage risks at organization / processes level
(such as: new customers, new market, company partnerships, business
localizations, )

Clause 8.1.1 is related to the risks in Operational Processes

defined in clause 8:
Implement a formal process to manage risks
Adapt the process to the organization and the product
(e.g. quantitative requirements and probabilistic risk analysis may be required in
some cases ; determine people involved in this activity)
Deploy the risks analysis within the operation activities
(such as : contract review and signature, new technologies
introduction, external providers selection, )

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Risk management
Annex A.4 ISO 9001
Risk-based thinking the organization to understand its context and
determine risks as a basis for planning
Key purpose of QMS is to act as a preventive tool, hence no separate
clause on preventive action
Risk-based thinking has enabled some reduction in prescriptive
requirements and greater flexibility
There is no requirement for formal methods for risk management

Annex A.4 9100 additions

Within Aviation, Space, and Defense (AS&D) , risk is expressed as a
combination of severity and likelihood of having a potential negative
impact to processes, products, services, customer, or end users.
Due to the complexity of AS&D processes, products, and services, and
the severity of the potential consequences of failures, a formal process
to manage operational risks is required

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Addition Product safety

New clause (8.1.3) on Product Safety, including requirements to address
product safety considerations throughout the product lifecycle (use the NOTE as
guidance) + revision for consistency of other clauses related to safety 7.3, 8.1, 8.4.3 & 8.5.4

A full Safety Management System (SMS) as defined by ICAO (International

Civil Aviation Organization) is not required by 9100, but the introduction of this
new clause contributes to the SMS approach

Rationale
Industry acknowledgement of the importance of increasing safety
Recognition of the 9100 certifications by authorities is part of IAQG strategy

Definition
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

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Product safety
Examples of activities to consider:
Assessment of hazards and mitigation of associated risks:
Implement FMEA relating to product (DFMEA) and process (PFMEA)
Perform safety analysis
Identify and mitigate risks relating to the organization and its personnel
(human factors, management of responsibilities)

Management of safety critical items:

Define and implement a monitoring control plan for critical items identified
through FMEA and safety analysis

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Product safety
Examples of activities to consider (cont.)
Analysis and reporting of occurred events affecting safety:
Organize the collection of potential and occurred events, and analyze
their impacts with specialists
Organize the internal escalation process and external reporting to
interested parties
Analyze the adverse trends of products in service reliability and define
appropriate actions

Communication of these events and training of personnel:

Promote safety culture and lessons learned from occurred events
(impacts of the parts delivered by the organization on the final product safety)

Prevent occurrence of safety issues by taking into account industry

experience (including occurrences on other products with similar functions or based on
same technologies or components)

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Addition Counterfeit parts prevention

New clause (8.1.4) including requirements for prevention of counterfeit parts
and a note giving examples of the associated processes
+ revision of affected clauses: 8.4.2 ; 8.4.3 (external provisions) & 8.7 (nonconformities)

Rationale
Mitigate effects of growing threat of counterfeit / fraudulent product
Recognize the emerging counterfeit/fraudulent statutory/regulatory
requirements on QMS processes
Definition
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.

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Counterfeit parts prevention

Processes to consider:
Training in the awareness and prevention of counterfeit parts
Procurement personnel in trusted source selection and requirements
Inspection personnel for prevention of counterfeit items (visual/test)
Design personnel in obsolescence management
Obsolescence monitoring design decisions and parts selections to be
appropriate for service life of product

Controls for acquiring parts from original manufacturers, authorized

distributors, or other approved sources

Assuring traceability of parts and components to their original manufacturers :

Original Equipment Manufacturer (OEM) or
Authorized manufacturer (e.g., in case of PMA, direct delivery authorizations)

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Counterfeit parts prevention

Processes to consider:
Verification and test methodologies to detect counterfeit parts:
Parts identification or marking
Tests or chemical analysis
Counterfeit parts reporting
Monitoring reporting from external sources (access to databases,
information letters from OEMs)
Quarantine and reporting of internal incidences in appropriate
government and industry reporting systems
(determine the responsibilities in the escalation process, the process to follow to
report to authorities / customers)

Requirement regarding non conformance control:

Segregate and control suspected or known counterfeit products
Ensure these products are not re-introduced into the supply chain

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Summary of changes - clause by clause

8. Operation
8.2 Requirements for products and services
Extended to requirements regarding
contingency actions
8.2.1 Customer communication

8.2.2 Determining the requirements related Added consideration for the organization to
to products and services meet the claims for products and services

8.2.3 Review of the requirements related Added requirement that review shall be
to products and services coordinated with applicable functions of
the organization
8.2.4 Changes to requirements for products
and services Added requirement for actions in case of
not meeting some customer requirements

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8. Operation
Clause re-structured to allow for a more
8.3 Design and development process orientated approach
of products and services Requirement to maintain a process

Clear flexibility (nature, duration and complexity ) in

8.3.1 General
determining stages and controls
8.3.2 Design and development planning
Consider documented information needed for
demonstration of compliance to requirements
8.3.3 Design and development inputs
Added requirement to take account of
8.3.4 Design and development controls
handling obsolescence, where applicable

8.3.5 Design and development outputs

Ensure monitoring and measuring devices
used for testing are properly controlled
8.3.6 Design and development changes

Outputs shall be approved by authorized

person(s) prior to release

Added requirement for a process and

criteria for notifying customers, about
changes that affect customer requirements
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Summary of changes - clause by clause
New terminology. Clause covering the previous
purchases and outsourcing
8. Operation Externally provided processes include outsourced
processes (processes needed for the QMS, for
8.4 Control of externally provided which 4.4 applies in addition to 8.4).
processes, products and services
Explicit requirement for external providers to
apply appropriate controls to their direct and
8.4.1 General sub-tier external providers, to ensure the
consistency in the whole supply chain
NB: a sub-tier external provider means the
8.4.2 Type and extent of control external providers of a direct external provider of
an organization.
8.4.3 Information for external providers
Added evaluation of data on test reports
provided, to confirm the results comply with
requirements

Added validation process of tests reports

accuracy for raw materials identified as a
significant operational risk

More explicit topics to be considered to

communicate requirements to external
providers
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Requirements added back-in from previous 9100 version

Evaluation of data on test reports
Rationale
Avoid non compliance of test reports results with the requirements
Implementation
Determine the products for which test reports will be required
At receiving, check the test results are compliant before accepting the parts

Validation process of tests reports accuracy for raw materials

Rationale
Inaccurate, incomplete or unduly altered test reports for raw materials have
introduced undue risks on critical applications
Implementation
Determine the critical raw material for which this clause will apply (according to
customers requirements or as design outputs, safety analysis outputs)
Define the process to be applied (e.g. periodic scheduled retests performed on
samples)
Apply the process and take necessary actions
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8. Operation This clause considers monitoring and

measurement activities will ensure the control of
8.5 Production and service provision processes and outputs, and that acceptance
criteria for products and services are met.
8.5.1 Control of production and service
provision Review structure of sub-clauses:
8.5.1.1 Control of equipment, tools and software
programs
8.5.2 Identification and traceability 8.5.1.2 Validation and control of special processes
8.5.1.3 Production process verification
8.5.3 Property belonging to customers or
external providers New ISO clause (as per 9100:2009)
8.5.4 Preservation Clarified that when problems are detected after
delivery the organization shall take appropriate
8.5.5 Post-delivery activities actions
8.5.6 Control of changes New ISO clause to emphasize on this topic

New ISO clause to verify that all activities have

8.6 Release of products and services been carried out before release and delivery by
authorized persons

8.7 Control of nonconforming outputs Outputs including products and services

Maintained the requirement for a procedure

to define the NC process and responsibilities
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9. Performance evaluation
9.1 Monitoring, measurement, analysis and Specific requirements for analysis and
evaluation evaluation when using results as inputs to
management review
9.1.1 General
Outputs from the analysis are clearer
9.1.2 Customer satisfaction
9.1.3 Analysis and evaluation Explicit topics to consider for the internal audit
programme(s)
9.2 Internal audit
Added on-time delivery performance as
9.3 Management review input
10. Improvement
Added requirement to evaluate the need for
10.1 General action based on human factors to ensure
10.2 Nonconformity and corrective action nonconformities do not recur
10.3 Continual improvement
Nonconformity and corrective action
Annex (informative) procedure added back-in from ISO
A. Clarification of new structure, terminology
and concepts
For risk management, added the 9100
B. Standards developed by ISO/TC 176 clarification
C. Standards developed by IAQG
Bibliography Full list of IAQG standards available

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Human factors
Addition
Requirement to include the human factors considerations in the
root causes analysis of nonconformities
Definition
The understanding of the interactions between people, machines and each
other and their impact on human performance.
Example: Recognition that
persons performing tasks are
affected by physical fitness,
physiological characteristics,
personality, stress, fatigue,
distraction, communication and
attitude in order to ensure a safe
interface between the persons and
all other environmental elements
such as other persons, equipment,
facilities, procedures and data.

34
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Human factors
Rationale
To reinforce the controls linked to clause 7.1.4 (environment for the operation
of processes) and clause 8.5.1 g (prevention of human errors)
Recognize the importance of human factors in the origin of nonconformities

Implementation considerations
Determine the human factors to be considered according to the products,
workplaces, equipment and people of the organization
Include the elements to be reviewed during the root causes analysis of
nonconformities
Capitalize with lessons learned on occurred human errors

35
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High Level Summary of Changes
Implementation benefits

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9100 Changes - High Level Summary

No Requirements
New process model When planning the QMS, determine the
Clause 1 Added a PDCA model Clause 6 actions needed to address
Added Risk-based thinking Planning for opportunities and risks (prevention)
Scope Emphasis on defining the QMS and Increases requirements for planning of
the QMS
context of the organization changes

Clause 2 ISO 9000:2015 referenced Determine knowledge management

Normative ref Clause 7 requirements
Support Awareness on product conformity,
ISO 9001 terms and definitions moved product safety, ethical behavior
Clause 3
to ISO 9000
Terms and Added 9100 product safety, Planning for product obsolescence
definitions counterfeit part Plan activities needed to assure
Clause 8 product safety
Prevention of counterfeit parts
Maintained documented information is Operation Process to validate test reports for raw
Clause 4 required, can be named Quality Manual material based on risks
Context of Justified exclusions not limited to Release of products and services
the Realization/Operations processes
organization QMS processes have performance Assess performance of QMS
indicators Clause 9
processes
Performance Added Note to evaluate performance
QMS compatible with strategic direction evaluation indicators on internal audits
Clause 5 QMS requirements integrated into
business processes
Leadership Processes deliver their intended Clause 10 Consider human factors in
outputs Improvement nonconformity / corrective action

All ISO MS standards will now have this common 10 clause structure
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Implementation Benefits
When implemented and managed well:
Produce and continually improve safe and reliable products
Meet or exceed customer and regulatory requirements to ensure
satisfaction
Processes necessary to conduct day-to-day business are defined
where necessary and managed
Improved integration with business operations and strategy
Documentation accurately reflects the work to be performed and
actions to be taken
Focus on the complete supply chain and stakeholders
Fewer customer unique documents
Recognized by Regulatory Authorities

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The IAQG is a legally incorporated international not for profit association October 2016
(INPA) with membership from the Americas, Europe and the Asia Pacific Region
 9100 Revision 2016

Deployment Support Material

Where to find it ?

39
The IAQG is a legally incorporated international not for profit association October 2016
(INPA) with membership from the Americas, Europe and the Asia Pacific Region
 Path through the IAQG web site

www.iaqg.org

40
The IAQG is a legally incorporated international not for profit association October 2016
(INPA) with membership from the Americas, Europe and the Asia Pacific Region
 9100 Deployment Support Material

41
The IAQG is a legally incorporated international not for profit association October 2016
(INPA) with membership from the Americas, Europe and the Asia Pacific Region
 Questions

42
The IAQG is a legally incorporated international not for profit association October 2016
(INPA) with membership from the Americas, Europe and the Asia Pacific Region