Dion[1] 9100

Requirements Strategy Stream

Orlando, Florida, USA
7-12 October, 2007

Orlando Guy DION – Requirements Strategy Stream Leader Page 1

Agenda

Team Membership
Mission & Future State
Initiative Status
– REQ-001 9100 general QMS standard
– REQ-006 9110 maintenance QMS standard
– REQ-007 9120 distributor QMS standard
– REQ-008 9115 software QMS standard
– REQ-009 9101 (9111/9121) Audit process standard

5 active initiatives

Team Membership

Team leadership: Initiative Leaders:
Team Leader – Guy Dion * REQ-001 9100 Guy Dion
AAQG Leader – Alan Daniels REQ-006 9110 Vince Bartram
APAQG Leader – Minoru Kasano REQ-007 9120 Dale Gordon
REQ-008 9115 Giovanni Calcagni
EAQG Leader – Guy Dion
REQ-009 9101 Hans Luijt
Facilitator – Wayne Johnson

* Also SWG mentor for
Requirements Strategy Stream

Operating Management System
Representative:

John Addey


Establish, Develop, and Maintain Industry Quality
Requirements to improve product and process integrity

Maintain Focus on Quality Management System (QMS) Standards
– Improve the supplier performance and customer satisfaction,
especially Product Quality & On-time Deliveries
– Take into account the new requirements from aviation, space &
defense
– Stay abreast with emerging requirements
– Sustain and improve the audit process
– Support QMS revision year 2008

Harmonization of Customer Requirements for suppliers

Work with Relationship Growth Teams
– Civil Authorities, Space, Defense & National Trade Associations



Actions
Current State Future State
QMS 9100 series
A suite of existing IAQG Dedicated Working Groups • based on ISO 9001 new revision
QMS standards, based on
ISO 9001 Relationship with TC 176 • the foundation of the
requirements applicable to the
Various adoption of Data mining of current 9100 whole industry
standards standard, 9101 and others
• improve the suppliers
Many other requirements Web surveys performances and customer
- Authorities satisfaction (OTOQD)
- Associations Benchmarking with other
- Customers industries
International unique
Different Areas Relationship with civil Certification Scheme
- Civil authorities, defense & space
- Space • taking into account quality
Monitor emergent new performances and customer
- Defense requirements satisfaction
• with an improved audit process
• worldwide implemented and
OTOQD: On-Time and recognized by the stakeholders
On Quality Delivery

Initiative Status


“ 9100 “

– General QMS Standard –

Leader: Guy Dion


9100 Standard - 2008 Revision
Initiative Summary:
Revise 9100 to incorporate ISO 9001-2008 changes
Expand scope to include the Defense sector
Analyze needs of stakeholders and add/revise requirements
Comply with IAQG strategy

Status Progress
Phase 0 Phase 1 Phase 2 Phase 3
Green

Orlando Page 8

IAQG 9100:2008 Revision
Milestones
IAQG 9100 Team IAQG Requirements Strategy Stream
2006 2007 2008 2009
Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul

IAQG & 9100 Team Meetings
San Diego Seville Melbourne Paris Orlando Naples Yokohama (Americas)

Stakeholder Input
8/15
Stakeholder Input

Supplier Input
6/10 8/15 10/1

Input Consolidation
ISO 9001 publication
Analysis/Draft/Ballot/Release now forecast for Oct ’08
Review Data Mining Inputs

9001 CD
Analysis
4/15
1
10/1
9100 to be ready for
Prepare 9100 First Draft
2 publication
9001 DIS
Analysis November 2008
10/15 4/1
Prepare 9100 Coord. draft
& Informal Review 3
4/15 7/15
1st SML
9100 Team Meetings – Projected Activities IAQG Gate 1 Ballot
7/15 10/15
1 Paris: Writing sub-team prepares first smooth draft; draft sent to entire team for review prior to Orlando. Resolve
2 Orlando: Review first draft, modify/refine as necessary. After meeting, Scribe to prepare coordination IAQG Gate 2a Comments 4
draft (preferably based on ISO 9001 DIS) to be used for sector review.
9001 FDIS
3 Naples: Review/resolve coordination draft comments. After meeting, Scribe to prepare draft (still based Analysis
on ISO 9001 DIS) for formal SML ballot. 10/15 1/15
2nd SML
4 Yokohama: Review/resolve comments from formal SML ballot, agree to changes. After meeting, Scribe Ballot
to prepare draft (based on ISO 9001 FDIS) for 2nd formal SML ballot (if necessary based on volume of 1/15 4/15
Resolve
comments to 1st SML ballot) or final draft. If 2nd SML ballot not necessary, stage final draft for release IAQG Gate 2b Comments
upon ISO 9001 publication. 5
5 (Americas): Review/resolve comments from 2nd SML ballot (if performed). After meeting, Scribe to 6 Review 9001 IS
6
prepare final draft. for changes
6 Virtual: After ISO 9001 publication, Scribe to review 9001 for final changes and revise ISO 9001 text in
9100 if necessary. 9100 Release
for Publication IAQG Gate 3

ISO 9001:2009 Estimated Timeline
Note: Exact dates for release of
9001 drafts not known – forecast Committee Draft Draft International Standard Final Draft International ISO 9001 Publication
by TC176 is by month. Feb 2007 Sep 2007 Standard – July 2008 Oct 2008

9100 Revision Process IAQG Stakeholder Focals
& 9100 Team Liaisons
Stakeholder IAQG Focal 9100 Team Liaison
Certification/Registration Rick DOWNS Hans LUIJT
Bodies
Civil Aviation Authorities Edward BAYNE Alan DANIELS
Defense / NATO Jack FLETCHER Francisco LOSADA
Space Roberto CIASCHI Roberto CIASCHI
OASIS Suppliers Hans LUIJT Hans LUIJT
IAQG & Sector Companies * *
IAQG Strategy Streams:
– People Capability Herbert MAIROSE Henry JOHANNSON
– Product and Supply Chain Susan ARMSTRONG/ Buddy CRESSIONNIE/
Larry WENG (co-chairs)
(co- Jean-Louis DOULIERY
Jean-

* 9100 Team Sector Leaders

Page 1

Data mining Stakeholders inputs Started in April 2005
(Amsterdam)
Web survey

MCRT
Consolidation
339 items
(Master Review Comments Template)

Review process MCRT Nov. 2005 (Paris)
Design Specification & Accept / Reject / 40 %
Oct. 2006 (Sevilla)
Proposals / Comments accepted
IAQG Strategy > 9100 objectives Apr. 2007 (Melbourne)
9100 Design Specification
Key considerations
Stakeholder requests for changes to ISO 9001 are
Objectives for the
out of scope
9100 QMS Standard (IAQG Strategy)
Changes/additions to be considered are those that:
– constitute quality management system requirements that are not The 9100 standard shall :
contractual in nature or contain product specific requirements, and 1. Improve the suppliers performances and customer satisfaction,
that especially : Quality of the products & On-time deliveries
– enhance clarity of requirements or address stakeholder needs, and
needs,
that 2. Be the foundation of the requirements applicable to the whole
aerospace and defense industry
– are auditable and define “what” not “how,” and that
what” how,”
– are compatible for use by all stakeholder segments and by 3. Be recognized by the authorities
organizations of all types and sizes, and when 4. Be applicable to 10 000 suppliers in 35 countries, applied and adapted
– the benefit of the proposed change/addition outweighs the impact of to : primes, systems manufacturers, equipment manufacturers, sub-contractors,
components manufacturers (mecanics, electronics, …) …
implementation
5. Allow a common interpretation of the 9100 standard by auditors,
Orlando Page 1 audited companies, at all levels

6. Take into account the new requirements from the aerospace and
defense industry
Page 1

Orlando Page 10

9100: Progress Since Last Report

9100
Writing the first draft 18-20 July 2007
prepared by the scribe draft (Paris)
18 June 2007
(Sub-team : scribe + 2 people per sector)

AAQG : Sept. 18 & 19
Review of the first draft 9100 (Los Angeles)
issued by the sub-team EAQG : Oct 2 & 3
draft (Paris)
- in each 9100 WG sector 7 August 2007

- by the whole team (in Orlando) 7-8, 12 Oct 2007
(Orlando)

Planned to be issued (end of 2007) : +
for stakeholders comments New ISO 9001 schedule
to be reviewed in each sector 9100 (TC176 changed their
(under the coordination of coordination estimated release date from
each 9100 sector leader) draft June 2009 to October 2008)
prior to formal sector ballot End of 2007

Orlando Page 11

Writing Sub-Team meeting – 18-20 July
– First 9100 draft prepared

Orlando 9100 meeting:
– Full Team review of first 9100 draft
– Planned for a “coordination draft”
(to be prepared and routed to stakeholders for comment)
comments from this coordination to be reviewed
in Naples
– Reviewed new ISO 9001 schedule
(TC176 changed their estimated release date from June
2009 to October 2008)

Orlando Page 12

9100 – Main proposed changes
Product quality and on-time delivery performance
Added requirement for “product conformity” and “on-time
delivery” to be measured and appropriate actions taken if
planned results are not achieved
benefits:
Linkage between the QMS and organization performance,
In line with the IAQG strategy

Formal monitoring of customer satisfaction data
Added the requirement to monitor data and to develop
improvement plans that address deficiencies
benefits:
To promote continuous improvement of the product and
customer satisfaction,

itions
Address the ICOP requests
Add
Orlando Page 13

Added to 7.1 – Planning of Product Realization
7.1.1 Project Management
New requirement for planning and managing product
realization in a structured and controlled way
7.1.2 Risk Management
New requirement of implementation of a risk management
process applicable to the projects & products : responsibility,
criteria, mitigation & acceptance
7.1.3 Configuration Management
Moved to clause 7 + more details on the different activities to
be covered

benefits: Pro-active approach for management of projects, risk,
and configuration

Add itions
Orlando Page 14

Expanded “key characteristics” to “essential
items/features”
9100 will introduce “essential items/features” (that
includes key characteristics) that require particular attention
throughout product realization and use to assure they
are adequately managed
benefits: To provide focus on important items/features

Recognition of external certifications
Supplier evaluation may include data from external
sources
benefits: To avoid duplications of audits

Add itions
Orlando Page 15

Update the requirement for controlling suppliers
Approval status and scope (i.e., approved, conditional, disapproved),
Authority for decision, change and controlled use of suppliers
Requirements to be flowed down the supply chain

First article inspection requirements
Formal requirement to validate the production processes,
documentation and tooling + repeat the process when necessary
(engineering or manufacturing processes changes).

Control of work transfers
Must have a process to plan and control the transfer activities

tions
Cla rifica
Orlando Page 16


Requirements already covered by “contract” or
“regulatory requirements” (redundancy)
Availability of QMS documentation or records for customers or
regulatory authorities
Records available to customers or regulatory authorities

Not justified requirement for all the organizations
Acceptability of selected internal audit tools
Periodic validation of test reports for raw material

Removed

Orlando Page 17

“ 9110 ”

– Maintenance QMS Standard –

Leader: Vince Bartram


9110 Standard – 2009 Revision
Initiative Summary:
Revise and align with the next revision of IAQG 9100
Review scope and identify stakeholder needs

Status Progress
Green

Orlando Page 19


Survey sent to 9110 certificated
organizations listed in OASIS - 8-27

Orlando 9110 Meeting
– Preliminary Review of ISO/9100 changes
– Reviewed 9110 unique requirements
– APAQG now has Team representative
– Agreed to meet during AAQG conference
(March 11-13)

Orlando Page 20

“ 9120 “

– Distributor QMS Standard –

Leader: Dale Gordon


IAQG 9120 Standard - 2009 Revision
Initiative Summary:
Revise 9120 to incorporate ISO 9001:2008 changes
Revise 9120 to incorporate 9100:2008 changes
Analyze needs of 9120 Stakeholders and add/revise
requirements

Status Progress
Green

Orlando Page 22

Writing Sub-Team meeting – 21 Aug.
– First 9120 draft prepared

Orlando 9120 meeting:
– Full Team review of first 9120 draft
– Plan for a “coordination draft” to be prepared and
routed to stakeholders for comment
– Reviewed new ISO 9001 schedule
(TC176 changed their estimated release date from
2Q 2009 to 4Q 2008)
– Kept 9120 schedule to release in 1Q 2009

Orlando Page 23

“ 9115 “

– Software QMS Standard –

Leader: Michelle Pierce
Former Leader: Giovanni Calcagni


IAQG 9115 Standard
Initiative Summary:
To establish software quality management requirements
for the Aerospace and Defense industry for deliverable
embedded or loadable software products
To harmonize the content of AS9006 with the content of
ISO 12207:2007 and other applicable standards,
retaining the 9100 framework

Status Phase 0 Phase 1 Phase 2 Phase 3



Rough Draft generated from analysis of
ISO 12207 (Birmingham)

Additional comments received and reconciled
(Orlando)

Draft Reviewed for flow, terminology and
inconsistencies (Orlando)

Next Meeting: Review comments from Internal
Review on Draft


9115 Initiative Program - new
2006 2007 2008 2009
Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Jan Feb Mar Apr

IAQG & REQ-008 Team Meetings
10/3 10/6 4/16 4/19 10/8 10/12 4/15 4/18 09/29 10/03 04/-- 04/--
IAQG Seville IAQG Melbourne IAQG Orlando IAQG Naples IAQG Yokohama Req.008 Team - Arizona
10/3 10/4 3/6 3/7 10/8 10/12 4/15 4/18 09/29 10/03 04/-- 04/--
Req.008 Team - Seville Req.008 Team - Vancouver Req.008 Team - Orlando Req.008 Team - Naples Req.008 Team - Yokohama Req.008 Team - Arizona

Stakeholder Input 06/26 06/27 01/-- 02/-- 07/-- 07/-- 01/-- 02/--
Req.008 Team - Birmingham
10/2 3/15 Req.008 Team - TBD Req.008 Team - TBD Req.008 Team - TBD
Collect Input
(Stakeholder&
Supplier)

Analysis/Draft/Ballot/Release
4/6
IAQG Gate 0 Analysis of existing
Approval standards
2/28 Input
Analysis
(8/30)
Prepare a Draft
Standard
(9/15) Draft Standard
Analysis
(10/10)
Disposition
Comments
(01/31)
2nd Draft
Standard preparation
and collection
of comments
(4/31) Disposition
Comments
(7/31)
Final Standard
preparation
(1/31)
IAQG Gate 1 IAQG Gate 2
Approval (10/- -)
(04/18) IAQG Gate 3
(06/- -)

Release for
Publication


Proposal for utilization of 9115

1. The 9115 Standard used as a supplement to 9100.
If contractually flowed down, then customer will monitor
compliance to the standard

2. When audited against 9100, if software is being developed,
then 9115 should be utilized to aid in the interpretation of
9100 for software

3. In the future, consider investigating the potential of a
9115 certification scheme under the OPMT responsibility
(like 9100 certification scheme) with recognition in OASIS


“ 9101 “

– Audit Process Standard –

(9111, 9121)

Leader: Hans Luijt


9101: Audit Process Standard
Initiative Summary:
Amend 9101 Assessment standard in order to enhance
its clarity and compatibility with process based
management QMS (ISO 9001) and IAQG 9100 Standard
update to be published end 2008”.

Status Phase 0 Phase 1 Phase 2 Phase 3


Status:
– IAQG Council Gate 0 approval received in Seville
– Meetings organised in 2007 :
• January 16-18, in Paris
• May 20-24, in Montreal
– Work to continue in Toulouse (planned Nov 2007)

Stakeholder Survey
– available on OASIS and IAQG web sites (March_April 2007)
– approx. 130 answers received
– first conclusions discussed

Design Specification
– established and validated by the team


Process Audit Methodologies
– Definition agreed of the QMS audit steps
(basis : new ISO 17021)
– Detail of activities for each audit step have been identified

Audit Practice material review
– From ISO TC176 Audit Practices Group
– Relevancy of material determined

Consideration for scoring
– Present scoring is not really used:
• Proposal is to delete the present scoring,
(negative cost/benefit ratio)
• Too early to use the CMMI/SCMH model scoring as
replacement

WG Kick off WG Meeting WG Meeting WG Meeting
Suresnes France Montreal Canada Nov., 2007 TBD-Reserve
Jan. 16-18 May 22-24

Release
2007 2008 2009 November, 2008

IAQG Gate 0 Stakeholder 1st Draft 9101 Feedback /Coordination Training Development
Approval Survey Oct., 2007 of 1st Draft March, 2008 April., 2008-November 2008
Seville, Spain March 15-
Oct 5, 2006 April 15

Pilot Projects Gate 1 Balloting
Jan.-Feb., April, 2008
2008

Target is to release 9101 and training material
in conjunction with 9100 -

October 2007 meeting postponed to November,
Target is still to have first working draft ready end of this year


IAQG Certification Scheme
Improvement


Documents Relationships
Managt System
Other Party

Oversight of Certification Scheme

ICOP : Certification Scheme
9104-1 (organization) 9104-2 (surveillance) 9104-3 (auditors)

Maintenance of standards issued by IAQG
9120 (Distributors)
9110 (Maintenance)
REQUIREMENTS
Strategy Stream

9100 (General) 9101
QMS Requirements Audit Process

(IAQG 103)
9100 Guidance Material
Strategy Stream
SUPPY CHAIN

Best practices
Supply Chain Management Handbook
Sales,Master Supplier Operational Non conf,
Order
Scheduling Contract Design sourcing
Capacity Manufact. managt and corrective
Customer
& Requirt. & and planning & Managt & and product
selection preventive Support
Sequencing Flow down Developt. scheduling logistic inspection validation
& approval actions
.
Guides 9102 9103 9107 9114 9131 91XX
FAI Key Charact. DDA Direct ship. Non conf. ……..
Capabily
Strategy
Stream
People

People Capability documents : dictionary…


Certification Scheme Improvement
In progress :
9100 Updated > REQ Strategy Stream
9101 Audit process > REQ Strategy Stream

Proposals :
Enhancement of auditors qualification
• interview of the candidates
• exam for the candidates
Extension of audit duration
> IAQG Other Party Management Team

Improvement of ICOP robustness
• permanent staff (1 full time person per sector)
> IAQG Strategy WG and
> IAQG Other Party Management Team


Questions?

Questions for Requirements
Strategy Stream ?


Dion[1] 9100

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