NADCAP Meeting - AS9100 Future R1

AS9100:2016
Change
NADCAP Technical Symposium
September 21, 2016
Areas of Focus
Introductions
IAQG Overview
Changes to the ISO 9001 & AS9100 Standards
Who is Certified to ISO 9001 or AS/EN/JIS 9100?
Goals of Presentation
Understanding of Individual Requirements
Emphasis on
Special Process Based Companies
Requirement Threads
Introductions
Kevin Beard
President NQA
AAQG/IAQG Member
Space & Defense Forums

OPMT/RMC Certification Implementation
AAQSC Standards Committee Member
AS9100 Writing Team AAQG
G19 Counterfeit Parts Avoidance
Aviation, Space & Defense Industry Certification Experience

NASA & Raytheon Certification Project Manager
ESA, JPL, Johns Hopkins APL, Draper, Etc.
Raytheon, Lockheed Martin, L-3, etc.
www.nt s . co m
Service Division Overview

Managed
Services
Testing
Supply
Chain
Manageme
nt
Certificat
ion
Industries We Serve .. And A Variety other Global Markets

Aerospace
Defense
Telecom
Commercial
Transportation
Energy
www.nt s . co m
GLOBAL INTEGRITY AND EXPERTISE
NQA India, 2000

OVER 27 YEARS OF TECHNICAL INTEGRITY
More than 36,000 Customers Worldwide
Serving Customers for Industry Success
Top 5% of Global Certification Bodies

500 Full Time Employees
400 Contract Auditors
Leading Aerospace Industry Registrar
Providing certification for full spectrum of ISO

certifications including AS9100, AS9120 and AS9110
Local audit resources world-wide
Experienced auditors including salaried lead auditors

for AS 9100
Head office in Bengaluru

Regional Locations
Ghaziabad
Hyderabad
Chennai
Mumbai
International Accreditations
ANAB ANSI ASQ Accreditation Board- US
UKAS United Kingdom Accreditation Service
IATF International Automotive Task Force
itSMF/APMG IT Service Management Forum
& Others..
www.nt s . co m
GLOBAL PRESENCE
Londo
n
Bosto
n
Shangh
ai
Bangalor
e
CB Leadership in Focused Industries

AEROSPACE
7% global market share
1,000 clients of 17,000
sites
Long term IAQG Member
AUTOMOTIVE
9% global Market Share
5,100 clients of 57,000
organizations
Ranked #1 in China/6th
Globally
TELECOM
~7% of Global Market
150 Clients of 2000 global
Certifications
15 Year QuEST Member
Certify ~ 20% of QuEST
Forum Members
www.nt s . co m
TRUSTED PARTNER
www.nt s . co m
Focus On Solutions
- NQA Support of AAQG/IAQG UNDERSTANDING
Industry Challenges & End User Needs
Regulatory Changes
Customer & Supply Chain Impacts
CONTRIBUTION
Standards Writing Committees
SCMH Educational Material Development
Industry Auditor Education & Training
CERTIFICATION INTEGRITY
Integrity Focused Processes
Evolve Processes, Practices & People
NQA Customer Awareness & Education
www.nt s . co m
GLOBAL SOLUTIONS
AEROSPACE SERVICES
AS 9100/9110/9120 & ISO 9001
quality management systems
AS 5553 / AS 6081 Counterfeit
electronic parts avoidance
Risk & Continuity Management
ISO 27001 Information security
ISO 28001 Supply chain security
ISO 22301 Business Continuity
and many more
AEROSPACE INDUSTRY ENGAGEMENT
IAQG Space/Defense Forum,

AAQG AS9100 Writing Team, RMC
AAQSC Voting Member
SAE G19 Counterfeit Parts
IAQG/AAQG/AAQSC
Document Management
International Aerospace Quality Group
IAQG General Assembly
AAQG
(Americas)
AAQSC
EAQG
(Europe)
Technical
Committee G-14
APAQG
(Asia & Pacific)
Standards
Development &
Publication
Whose mission is to:

Achieve significant performance improvements in Quality, Delivery, and
consequently Cost, on all products and services throughout the value
stream
IAQG is a trademark the International Aerospace Quality Group.
Copyright 2015 IAQG. All rights reserved.
IAQG Strategic
Focus
Relationship
Growth Strategy
Civil Authorities - Production

Space
Defense
Maintenance, Repair & Overhaul
Trade Associations
Improvement
Strategy
Requirements
People Capability
Product & Supply
Chain Improvement
Performance
IAQG Operating Management System

IAQG Other Party Management Team
3 Axes
Aligned to Address Challenges
12
9100 revision 2016

Reasons for revision

13
www.nt s . co m
Why AS9100
- Importance to NADCAP Accrediting a Process
Accreditation of Competence & Capability of Technical
Processes
Assurance that the Processes can Achieve Desired Results
Sustaining a Process
Ensuring the Organizations Quality Management System
(QMS) can Sustain & Improve Technical Processes.
NADCAP Requirement
QMS Requirement PD 1100 section 10.4
Minimum Compliance AC 7004
Or AS/EN/JIS 9100/9110
9100 revision 2016

The ISO 9001 needs to change, to:
Adapt to a changing world
Enhance an organization's ability to satisfy its customers
Reflect the increasingly complex environments in which organizations
operate
Ensure the new standard reflects the needs of all interested parties
ISO/TC 176/SC 2/WG23 N106
Integrate with other management systems
The 9100 needs to change, to:

Incorporate changes made by ISO TC176 to the embedded ISO
9001 requirements
Consider Aviation, Space and Defense stakeholders needs
identified since the last revision
Consider clarifications to 9100 series requests issued by IAQG
since the last revision

15
EMERGING CHALLENGES
POTENTIAL IMPACTS
Strong Focus on Prevention of Product
Defect Escapes to the Customer
Counterfeit
Risk
Parts;
Based
51.4Controls; 51.4
Broader International Activity Driving

New Risks
Expanded Capability and Capacity
Needs in the Supply Chain
Need For More Controls Deeper in the
Supply Chain
Development of New Quality/Process
Control Methods
Changes to QMS Standards (AS9100,
etc.)
CM Focus DPD/MBD;
51.4
Emerging
PPAP; 51.4
Areas of
Focus
Sub-Tier; 51.4
Asia Support; 51.4
Other; 51.4
Connect NADCAP Process

to sections of standard that
may impact these
processes
www.nt s . co m
Why AS9100
- Importance to NADCAP -
Standard Change impacts to

NADCAP Commodities
Raw
Mat
Test
Count
erfeit
Obsol
escen
ce
Escap
e
Preve
nt
Conventional Machining as a Special

Process
Elastomer Seals
X
Chemical Processing
X
Coatings
x
X
X
Composites
Electronics
X
X
Fluids Distribution
Heat Treating
Material Testing Labs

Measurement & Inspect
Nondestructive Testing
Have Deb
Confirm this
slide
9100 revision 2016

Key Changes (from ISO 9001:2015)
High level structure (HLS)

Terminology
Risk-based thinking
Process approach strengthened and more explicit with integration of the QMS
into organizations business processes
Concept of preventive action now addressed throughout the standard by risk
identification and mitigation
Emphasis on change management
Introduction of knowledge management
Clearer understanding of the organizations context
Aligning QMS policy and objectives with the strategy of the organization
Explicit performance evaluation requirements
Greater flexibility with documentation
More compatible with services

18
9100 revision 2016

9100 Series Changes - High Level Summary
No Requirements
Clause 1
Scope
Clause 2
Normative ref
New process model

Added a PDCA model
Added Risk-based thinking
Emphasis on defining the QMS and
context of the organization
Clause 7
Support
ISO 9000:2015 referenced
Clause 3
Terms and
definitions
ISO 9001 terms and definitions moved to

ISO 9000
Added 9100 product safety,
counterfeit product
Clause 4
Context of
the
organization
Quality manual not required, maintained

documentation (Quality Manual) is required
Justified exclusions not limited to
Realization/Operations processes
QMS processes have performance
indicators
Clause 5
Leadership
QMS compatible with strategic direction

QMS requirements integrated into
business processes
Processes deliver their intended outputs
Maintained Management Rep
Clause 6
Planning for
the QMS
When planning the QMS, determine the

actions needed to address opportunities
and risks (preventive)
Increases requirements for planning of
changes
Clause 8
Operation
Clause 9
Performance
evaluation
Clause 10
Improvement
Determine knowledge management

requirements
Awareness of contribution to compliance
and product safety
Focus on Human Factors in Work
Environment
Protection of Documented Information
Planning
For product obsolescence
To assure product safety
Adds APQP Terminology
Escape Prevention
Enhanced Configuration Management
Change Notification
Prevention of counterfeit products
Process to validate test reports for raw
material used in critical items
Assess performance of QMS processes

Added Note to evaluate performance
indicators on internal audits
Evaluate the need for action based on

human factors
All ISO MS standards will now have this common 10 clause structure 19

9100 revision 2016

HLS: High Level Structure (from ISO 9001)
Plan
4
Context of
organization
4.1
Understanding
context
4.2
Interested parties
4.3
Scope
4.4
Processes
Do
Check
Act
9
Performance
Evaluation
10
Improvement
5
Leadership
6
Planning
7
Support
8
Operation
5.1
Leadership and
commitment (MS)
6.1
Actions to
address risk and
opportunity
7.1
Resources
8.1
Operational
planning and
control
5.2
Policy
5.3
Organizational
roles,
responsibilities
and authorities
6.2
Objectives and
planning
6.3
Planning of
changes
7.2
Competence
7.3
Awareness
8.2
Determination of
requirements
requirements for
for
products & services
7.4
Communication
8.3
Design and
Development of
products & services
7.5
Documented
information
High Level Structure

ISO is going from 8 clauses to 10 clauses
Rationale
Common management system standards
Better alignment to business strategic direction
PDCA approach
8.4
Control of
externally provided
processes, products
&
& services
services
8.5
Production and
service provision
9.1
Monitoring,
measurement,
analysis and
evaluation
9.1.2
Customer
satisfaction
9.1.3
Analysis and
evaluation
10.1
General
10.2
Nonconformity
and corrective
action
10.3
Continual
improvement
9.2
Internal audit
9.3
Management
review
8.6
Release of
products & services
8.7
Control of
nonconforming
outputs
20
9100 revision 2016

Summary of changes - clause by clause
4. Context of the organization
4.1 Understanding the organization
and its context
4.2 Understanding the needs
and expectations of interested parties
4.3 Determining the scope of the quality

management system
4.4 Quality management system
and its processes
Determine relevant external issues (legal,

technological, competitive, market, cultural, social,
and economic environments)
and internal issues (values, culture, knowledge, and
performance of the organization)
Determine relevant interested parties and their

requirements (such as customers, partners,
authorities)
Document the scope of the QMS and justification for

any case where a requirement cannot be applied
(exclusion)
Define the documented information to be maintained
or to be retained to the extent necessary
Key changes are identified by:
ISO 9001 >>>>>>>
9100 additions >>>

Explicit requirement for documented

information (quality manual) with items to be
included identified (not required by ISO 9001)
21
9100 revision 2016

5. Leadership
5.1 Leadership and commitment
Leadership instead of only management of

responsibilities (management to demonstrate their
leadership)
5.2 Policy
Top management to ensure integration of QMS into

business processes (now explicit)
5.3 Organizational roles,

responsibilities and authorities
Policy aligned with organization strategic direction

A management representative required as focal
point for QM issues (removed from ISO 9001:2015)
6. Planning
6.1 Actions to address risks and
opportunities
6.2 Quality objectives and
planning to achieve them
6.3 Planning of changes

Determine risks and opportunities, considering the

issues raised and requirements identified.
Plan appropriate actions to reduce undesired effects
on the QMS and evaluate effectiveness
Planning the achievement of objectives more
prescriptive and includes the evaluation of results
Changes to the QMS to be carried out in a planned
manner
22
9100 revision 2016

7. Support
7.1 Resources
7.1.1 General
Environment includes human and physical

factors
7.1.2 People
7.1.3 Infrastructure
7.1.4 Environment for the operation of
Determine necessary knowledge gained from
experience, lessons learned, success, failures,
processes
7.1.5 Monitoring and measuring resources conferences,
7.1.6 Organizational knowledge
Added the requirement for persons to be aware of:
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information
7.5.1 General
their contribution to compliance and product safety

the importance of ethical behavior
7.5.2 Creating and updating

7.5.3 Control of documented Information

New terminology (replacing documents and

records)
No requirement for 6 mandated procedures, but
still a requirement to identify the documented
information & processes needed for the QMS
Added the requirements to handle
documented information managed
electronically (back-up, secured)
23
9100 revision 2016

8. Operation
8.1 Operational planning and control
8.1.1 Operation risk management
8.1.2 Configuration management

8.1.3 Product safety
8.1.4 Prevention of counterfeit products

Project Management (9100:2009 clause 7.1.1) and

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
transfer)
Reinforce the planning and control activities
with dispositions to ensure On-Quality and
On-Time delivery of products or services
Based on the requirements of 9100:2009 (7.1.1)
this clause is related to risks in operation (no
major change) while 6.1 is related to risks in QMS
of the organization
Based on the requirements of 9100:2009 (7.1.3),
revised to clarify stakeholders expectations
Added new requirements to address product
safety considerations throughout the product
lifecycle
Added new requirements to prevent the use
of counterfeit or suspect counterfeit products
24
9100 revision 2016

8. Operation
8.2 Requirements for products and services
8.2.1 Customer communication

8.2.2 Requirements related to products and
services
8.2.3 Review of requirements related to
products and services
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
8.3.3 Design and development Inputs
8.3.4 Design and development controls
8.3.5 Design and development outputs
8.3.6 Design and development changes

Added requirement that review shall be

coordinated with applicable functions of
the organization
Added requirement for actions in case of
not meeting some customer requirements
Clause re-structured to allow for a more

process orientated approach
Added requirement to take account of
handling obsolescence, where applicable
Added requirement for a process and
criteria for notifying customers, about
changes that affect customer requirements
25
9100 revision 2016

8. Operation
8.4 Control of externally provided
processes, products and services
8.4.1 General
New terminology,
Clause covering the previous purchases
and outsourcing
Explicit requirement for external providers to
apply appropriate control to their sub-tier
providers
8.4.2 Type and extent of control

8.4.3 Information for external providers

Added validation process of tests reports

accuracy for raw materials used in critical
items
Added evaluation of data on test reports
provided, to confirm the results comply with
requirements
26
Raw Material Testing
Risk Impact on Material Validation Approach
Program/Project Risk > Design > Purchasing

Design Criticality CI/KC Determining Purchasing
Decisions
Product/System
Supplier
CI/KC Driving Inspection & Validation Approach

Standard Focus
Evaluate Test Report to Material Requirements

Risk/CI/KC driving Test Report Validation Decisions

Inspection & Test Decisions

Material Supplier
27
9100 revision 2016

8. Operation
8.5 Production and service provision
8.5.1 Control of production and service
provision
8.5.2 Identification and traceability
8.5.3 Property belonging to customers or
external providers
This clause considers monitoring and

measurement activities will ensure the control of
processes and output, and that acceptance criteria
for products and services are met.
Review structure of sub-clauses:
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
New ISO clause (as per 9100:2009)
8.5.5 Post-delivery activities
Clarified that when problems are detected after

delivery the organization shall take appropriate
actions
8.5.6 Control of changes
New ISO clause to emphasize on this topic
8.6 Release of products and services
New ISO clause to verify that all activities have

been carried out before release and delivery by
authorized persons
8.7 Control of nonconforming outputs
Outputs including products and services
8.5.4 Preservation

Maintained the requirement for a procedure

to define the NC process and responsibilities
28
on this key topic for ASD
9100 revision 2016

9. Performance evaluation
9.1 Monitoring, measurement, analysis and
evaluation
9.1.1 General
9.1.2 Customer satisfaction
9.1.3 Analysis and evaluation
9.2 Internal audit
9.3 Management review
10. Improvement
10.1 General
10.2 Nonconformity and corrective action
10.3 Continual improvement
Annex (reference)
A. Clarification of new structure,
terminology and concepts
B. Deliverables developed by ISO/TC 176
Bibliography
Aviation Space and Defense Bibliography

Specific requirements for analysis and

evaluation when using results as inputs to
management review
Outputs from the analysis are clearer
Explicit topics to consider for the internal audit
programme(s)
Added review of on-time delivery
performance and actions resulting from
risks assessments
Added requirement to evaluate the need for
action based on human factors to ensure
nonconformities do not recur
For risk management, added the 9100

description
Full list of IAQG standards available at the
date of the 9100 publication
29
Requirement Threads
- Impacts To Audit Approach?? Standard Structure Approach
Broad Overarching Requirements in Section 4.0, 6.1 & 8.1

Supported by Specific Requirements at Key Points in Standard
Writing Team Approach
Used Some Overarching Approaches (8.1, 8.1.1 through 8.1.4)

Also Used A Fair Amount of Sprinkling of Requirements
Understanding Organizations Approach
Need to Understand The Sprinkling Attributes

Tie Threads Together in QMS Approach
Focus on QMS & Internal Audit Effectiveness, Taking Into
Consideration Appropriate Threads

30
Requirement Threads
- Impacts To Audit Approach?? 8.1
8.2
8.3
8.4.1/2
8.4.3
8.5.1
8.5
8.6
8.7
Plan & Cont
Reqts
D&D
Supl Cont
Puch
Info
Prod Plan
Prod Prov
Product Rel
NC Control
Escape
Prevention
Sub-tier Supplier
Management
Risk-Product
Risk-Supplier
Risk-Process
Counterfeit Parts
Other
4.4,
6.1
4.4,
6.1
X
X
Risk
4.4,
6.1
CPP
X
X
6.1
Escape Prev.
X
NOC
Notification of
Change
Obsolescence
Product
Obsolescence
Production
Capability
IT Security
6.3
X
6.3,
7.1.3
7.1,
7.5.3
Obs - Process
31
9100 Series Revision

- Integrated Schedule
2012
San Antonio Nagoya
05/2012 10/2012
2013
Moscow
05/2013
9100
SWG/Council
Project
Approval
2015
2014
Montreal
10/2013
2016
Brussels Long Beach Chengdu Madrid Singapore TBD

04/2014 10/2014
04/2015 10/2015 04/2016 10/2016
IAQG
9100 Team
Comments
IAQG
Working
/Structure Comments
Draft
Analysis /Design Spec Review
9100
Coordination 9100 9100 Publish
Draft for Ballot
/ Ballot
Comments Draft Comments
2017
TBD
04/2017
TBD
10/2017
Transition Period
Plan & Stakeholders feedback
Internal Dependencies
Standards & Training as needed for
publication
- Required for 9100 publication
- 9100 Transition Plan
- 9101 Update (as required)
- 9100 Training (as required)
9101 Audit Revision
9110, 9120, 9115
For more information,

see detailed schedule
Required for publication
Series Revisions
External dependencies
ISO 9001 publications
CD June 2013 Begin struct. draft
DIS : May 2014 Begin writing 9100
FDIS : Jul 2015 - Begin Coord. Draft
Publish : Sept. 2015 Prep. Ballot
Training - OPMT
Development
Recommended Schedule to satisfy
Preparing
Ballots, reviews and comments
Publications
Auditor training & Transition
32
Certification Transition
- Anticipated Outcomes & Organizational Impacts SR-003 - IAQG OPMT Requirements for Transition
Sets Requirements for All Stakeholders for Transition

Focus on Timelines and Risk to Impacting Integrity of Aerospace Supply Chain Certification
Transition Time
Standard Available in Late September/October 2016

Earliest January 2017 (pending Industry Competency and Oversight Readiness)
Deadline - September 14, 2018 (Tied to ISO 9001 Transition Period)
Transition Focus
Essentially a Full Systems Evaluation (Due to Depth of Changes)

Added Audit Time (Based on Risk Analysis, Transition Approach, etc. Also Dependent on
Potential Changes to SR-003))
Organizational Suggestions
Start Early
Internal Focus in Late 2016
Certification Activity in 2017
Internal Gap Analysis
Enhance Process & Any Needed Competencies
Internal Audit/Management Review After Enhancement Activities

33
Questions

34

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AS9100:2016

Space & Defense Forums

Aviation, Space & Defense Industry Certification Experience

Service Division Overview

Industries We Serve .. And A Variety other Global Markets

GLOBAL INTEGRITY AND EXPERTISE

NQA India, 2000

Top 5% of Global Certification Bodies

Leading Aerospace Industry Registrar

Providing certification for full spectrum of ISO

Local audit resources world-wide

Experienced auditors including salaried lead auditors

Head office in Bengaluru

ANAB ANSI ASQ Accreditation Board- US

UKAS United Kingdom Accreditation Service

IATF International Automotive Task Force

itSMF/APMG IT Service Management Forum

CB Leadership in Focused Industries

AEROSPACE INDUSTRY ENGAGEMENT

IAQG Space/Defense Forum,

Whose mission is to:

Civil Authorities - Production

IAQG Operating Management System

9100 revision 2016

IAQG is a trademark the International Aerospace Quality Group.

9100 revision 2016

Integrate with other management systems

The 9100 needs to change, to:

IAQG is a trademark the International Aerospace Quality Group.

Broader International Activity Driving

Asia Support; 51.4

Connect NADCAP Process

Standard Change impacts to

Conventional Machining as a Special

Material Testing Labs

9100 revision 2016

ISO/TC 176/SC 2/WG23 N106

High level structure (HLS)

IAQG is a trademark the International Aerospace Quality Group.

9100 revision 2016

New process model

ISO 9000:2015 referenced

ISO 9001 terms and definitions moved to

Quality manual not required, maintained

QMS compatible with strategic direction

When planning the QMS, determine the

Determine knowledge management

Assess performance of QMS processes

Evaluate the need for action based on

IAQG is a trademark the International Aerospace Quality Group.

9100 revision 2016

High Level Structure

9100 revision 2016

ISO/TC 176/SC 2/WG23 N106

4.3 Determining the scope of the quality

Determine relevant external issues (legal,

Determine relevant interested parties and their

Document the scope of the QMS and justification for

Key changes are identified by:

ISO 9001 >>>>>>>

9100 additions >>>

IAQG is a trademark the International Aerospace Quality Group.

Explicit requirement for documented