1. IAQG International Aerospace Quality Group QMS Standards: Change Overview Quality Management Systems (QMS) For Aviation, Space and Defense
April 16, 2010

2. Requirements Strategy Stream Team Leadership
Team Mentor Guy Dion (Zodiac Aerospace)
Team Leader Alan Daniels (Boeing)
AAQG Leader Buddy Cressionnie (Lockheed Martin)
APAQG Leader Masahiro Kawamoto (MHI)
EAQG Leader Guy Dion (Zodiac Aerospace) (Proposal)
Standards Leaders:
9100 Guy Dion (Zodiac)
9110 Jeff Wood (Boeing)
9120 Dale Gordon (MPC Products Corp)
9115 Michelle Pierce (Lockheed Martin)
9137 Francisco Losada (EADS CASA)
9101 Hans Luijt (OPMT) 2

3. Requirements Strategy Stream Mission
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 new requirements from aviation, space & defense and QMS standards
Represent IAQG at the ISO (TC 176) for future QMS activities
Stay abreast with emerging requirements
Sustain and improve the QMS audit process
Support the IAQG strategy : “90% of the supply chain certified”
Harmonization of Customer Requirements and assessment tools for suppliers
Work with Relationship Growth Teams
Civil Authorities, Space, Defense & National Trade Associations, MRO (Maintenance, Repair and Overhaul organizations) and Airlines 3

4. Requirements Strategy Stream Team Charter
Near-Term
Continue to develop guidance materials
Monitor/update FAQ’s
Provide standard communications
Support IAQG Integration activity by monitoring and taking actions on IAQG initiatives that overlap with REQ std
Provide IAQG Clarifications utilizing the SDR/IDR process according to procedure 103
Monitor and study ISO QMS activities
90% certification strategy support 4

5. Requirements Strategy Stream Team Charter
Mid-Term
IAQG Liaison with TC176 activity for the future revision to ISO 9001 (next ISO 9001 & 9004)
Ensure the compatibility and alignment of the Requirement Stream standards and their interfaces
Update standards based on stakeholder feedback and users satisfaction surveys
Measure success in achieving the IAQG Strategy Objectives
Long-Term
QMS concepts in the future: benchmarking other QMS standards, excellence models, maturity assessment (benchmarking on standard assessment method). 5

6. IAQG Standards Changes
The IAQG is committed to establishing commonality of aviation, space, and defense quality systems, as documented in published standards and as applied by Prime/Original Equipment Manufacturer’s internally and flowed to the supply chain. 6

7. Standards Revisions Revised in 2009
QMS – Requirements for Aviation, Space & Defense Organizations
QMS – Requirements for Aviation & Defense Maintenance Organizations
QMS – Requirements for Aviation, Space & Defense Distributors
9101 – QMS – Aviation, Space and Defense QMS Audits
9115 – QMS Requirements for Aviation, Space and Defense Organizations – Deliverable Software
Standards to be Cancelled (Combined in 9101)
9111 – QMS Assessment for Maintenance Organizations
9121 – QMS Assessment Applicable to Stockist Distributors

8. 9100:2009
Quality Management System for Aviation, Space and Defense Organizations
The IAQG is committed to establishing commonality of aviation, space, and defense quality systems, as documented in published standards and as applied by Prime/Original Equipment Manufacturer’s internally and flowed to the supply chain. 8

9. Focused on the needs of the AS&D industry
9100 QMS General
9100 Overview
Establishes quality management requirements for use by organizations that design, develop, or produce aviation, space and defense products
Utilizes ISO 9001 as a baseline and adds industry specific requirements based on product, customer and regulatory needs
Focused on the needs of the AS&D industry 9 9

10. Where ISO 9001 implies, 9100:2009 requires
9100:2009 Specifics
ISO 9001
Generic quality management system standard - applicable to a wide range of products
9100:2009
Includes all ISO 9001:2008 requirements
Adds the expectations of the aerospace industry for a robust quality management system for aviation, space and defense products
Continual Improvement
Continual improvement processes shall include provision for using the quality policy, quality objectives, project & risk management, audit results, measurement and analysis of data, variability reduction, corrective and preventive action, and management review (all but variability reduction are part of ISO 9001:2008 requirements)
Where ISO 9001 implies, 9100:2009 requires 10

11. AS&D products are often complex and high risk
Why 9100:2009?
To standardize Aviation, Space & Defense quality expectations on a global level
To achieve improvements in quality and reduce costs throughout the value stream
ISO 9000 model for quality does not capture regulatory requirements or importance of safety, reliability or maintainability
Captures aerospace supplements agreed to at an international level
Continued from slide 9
AS&D products are often complex and high risk 11

12. 9100 Revision Objectives Incorporated ISO 9001:2008 changes
Expanded scope to include land and sea based systems for defense applications
Ensured alignment with IAQG strategy (on-time, on-quality performance)
Adopted new requirements based on stakeholder needs
Improved existing requirements where stakeholders identified need for clarification, including when a documented procedure is required 12

13. ISO 9001 versus 9100
9100 version is formatted to match ISO 9001:2008 and added “requirements” that provide for:
Regulatory organizations interfaces
Project Management
Risk Management
Configuration Management
Control of Work Transfers
Design and Development V&V & V&V testing
Control of changes in Production Process
Control of production equipment, tools, NC machines
Control of service operations
Production process verification
These added requirements enables a standardized approach to supplier flow down requirements 13

14. 9100:2009 Key Changes Clause 3.1 – Risk Management
An undesirable situation or circumstance that has both a likelihood of occurring and a potentially negative consequence
Clause 3.2 – Special Requirements
Those requirements which have high risks to being achieved thus, requiring their inclusion in the risk management process
Clause 3.3 – Critical Items
Those items (e.g., functions, parts, software, characteristics, processes) having significant effect on the product realization and use of the product; including safety, performance, form, fit, function, producibility, service life, etc. that require specific actions to ensure they are adequately managed 14

15. 9100:2009 Key Changes 7.1 Planning of Product Realization
Interrelationship between Special Requirements, Critical Items, Key Characteristics, and Risk Management process
Customer Requirements including
Requirements identified as special by the customer
7.2 Determination and Review of Requirements Related to the Product
7.3 Design & Development
7.5 Production & service provision (Drawings, Instructions, Plans. etc.)
7.4
Purchasing -
Vendor/
Supplier
Provided
Products
Design Inputs
Design Outputs
Special Requirements as determined by customer or organization
7.3.3.e critical items, including Key Characteristics
appropriate processes to manage critical items
flow down req’t to suppliers
Statutory, Regulatory, and Other Requirements
7.1.2 Risk Management
8.2.3/ Monitoring & Measurement of Processes/Products
8.4 Analysis of Data
8.5 Improvement (CI, C/A, P/A) 15

16. 9100:2009 Key Changes Clause 4.1 – QMS General Requirements
The organization’s QMS shall address customer and applicable statutory and regulatory QMS requirements (previously located in the QMS documentation § 4.2.1) – Expands scope
Clauses 5.2/8.2.1 – Customer Focus/Satisfaction
Top management shall ensure that product conformity and on-time delivery performance are measured and that appropriate action is taken if planned results are not, or will not be, achieved (5.2)
Organizations shall develop and implement plans for customer satisfaction improvement that address deficiencies identified by these evaluations, and assess the effectiveness of the results (8.2.1) 16

17. 9100:2009 Key Changes 7.1.1 – Project Management
New requirement for planning and managing product realization in a structured and controlled way to meet requirements at acceptable risk, within resource and schedule constraints
7.1.2 – Risk Management
New requirement to implement a risk management process applicable to the product and organization covering: responsibility, criteria, mitigation and acceptance
The concept of risk is integrated within the revised 9100
7.1.3 – Configuration Management
Moved from Clause 4.3 to 7.1.3
Structured in line with ISO requirement 17

18. 9100:2009 Key Changes 7.1.4 – Work Transfer
Moved from clause (Production) to clause
The organization must have a process to plan and control the transfer activities
Expanded to cover permanent transfer (e.g., from one organization to another, from one organization to supplier, from one supplier to another)
Clause – Recognition of Supplier Quality Data
Added note to recognize that one factor that may be used during supplier selection and evaluation is objective and reliable data from external sources
Clause – Approval Status for Suppliers
Added and provided examples of “approval status” (e.g., approved, conditional, disapproved) and examples of “scope of approval” (e.g., product type, process family)
The organization must define the process for suppliers approval status decisions or changes 18

19. 9100:2009 Key Changes Clause 7.4.3 – Validation of Test Reports
Deletion: Where the organization utilizes test reports to verify purchased product, the data in those reports shall be acceptable per applicable specifications. The organization shall periodically validate test reports for raw material
Clause – Production Process Verification
Moved from (measurement) to (production)
Requirement to verify the production processes, documentation and tooling are capable of producing parts and assemblies that meet requirements. This process shall be repeated when changes occur that invalidate the original results (e.g., engineering or manufacturing processes changes, tooling changes) FAI
Clause –Sampling Inspection
When the organization uses sampling inspection as a means of product acceptance, the sampling plan shall be justified on the basis of recognized statistical principles and appropriate for use (i.e., matching the sampling plan to the criticality of the product and to the process capability) 19

20. 9110:2009
Quality Management Systems- Requirements for Aviation and Defense - Maintenance Organizations
The IAQG is committed to establishing commonality of aviation, space, and defense quality systems, as documented in published standards and as applied by Prime/Original Equipment Manufacturer’s internally and flowed to the supply chain. 20

21. 9110 QMS Maintenance 9110 Applicability
This standard is intended for use by maintenance organizations whose primary business is providing maintenance, repair and overhaul services for aviation commercial and military products; and for Original Equipment Manufacturer (OEM) organizations with maintenance, repair and overhaul operated autonomously or that are substantially different from their manufacturing/production operations.
It is tailored for organizations with National Airworthiness Authority (NAA) repair station certification and those that provide maintenance, repair and overhaul services for military aviation products 21

22. 9110 QMS Maintenance 9110 Overview Modeled after AS9100 Standard
Includes nearly every aerospace-unique requirement in AS9100, no clauses excluded
Includes all basic “ISO” requirements in ISO 9001:2008
Includes a few additional requirements unique to Aerospace Maintenance Organizations
Added Foreword which is similar to AS9100 but tailored for maintenance, repair and overhaul 22 22

23. 9110 QMS Maintenance Key Points
There are two significant themes in 9110 and they are:
Safety
Management Responsibility 23

24. 9110 QMS Maintenance Key Points 9110 Safety additions (examples):
4.2.1.e General – “documented statements of a safety policy and safety objectives”
5.1.f.g Management Commitment – “establishing the safety policy”, and “ensuring that safety objectives are established”
5.4.3 Safety Objectives – “Top management shall ensure that safety objectives”
5.6.1 Management Review – General – “assessing opportunities for improvement and the need for changes to the safety policy and safety objectives”
5.7 Safety Policy
3.5, Human Factors 24

25. 9110 QMS Maintenance Key Points 9110 Management additions (examples):
Accountable Executive Manager – “Top management shall appoint a manager with corporate authority”
Maintenance Manager(s) – “Top management shall appoint a manager(s) responsible for assuring that all maintenance required is carried out”
5.5.2.e Management Representative – “reporting to the Accountable Executive Manager and Maintenance Manager(s) on the performance of the quality management system and any need for improvement” 25

26. 9120:2009
Quality Management Systems- Requirements for Aviation, Space and Defense Distributor Organizations
The IAQG is committed to establishing commonality of aviation, space, and defense quality systems, as documented in published standards and as applied by Prime/Original Equipment Manufacturer’s internally and flowed to the supply chain. 26

27. 9120 QMS Distributors 9120 Overview
Used in organizations that are “pass through” distributors of aerospace Products
Means that the organizations are not performing work or altering the product in any way
Intended to meet requirements of FAA Advisory Circular (AC) “Voluntary Accreditation of Distributors of Aviation Parts”
Should replace SAE AS7003
Modeled after 9100:2009 Standard
Includes all basic “ISO” requirements in ISO 9001:2008
Includes a few additional requirements unique to Aerospace Distributor Organizations
Excludes four (4) main clauses of 9100:2009 27 27

28. 9120 QMS Distributors Key Points Excludes Clauses:
Project Management
Risk Management
Design and Development
Validation of Processes for Production and Service Provision
The Following Clauses Now Apply:
7.1 Planning of Product Realization
Configuration Management
Control of Work Transfers 28

29. Quality Management Systems
9115:2010
Quality Management Systems
-Requirements for Aviation, Space and Defense Organizations
– Deliverable Software
The IAQG is committed to establishing commonality of aviation, space, and defense quality systems, as documented in published standards and as applied by Prime/Original Equipment Manufacturer’s internally and flowed to the supply chain. 29

30. 9115 QMS Software
9115 Overview
Establishes software quality management requirements for the aviation, space and defense industry for deliverable embedded or loadable software products
Harmonizes the content of AS9006 with the content of ISO 12207:2007 and other applicable standards, using 9100 framework
Used as a 9100 software supplement when contractually flowed down 30

31. Quality Management Systems Assessment
9101:2009
Quality Management Systems Assessment
The IAQG is committed to establishing commonality of aviation, space, and defense quality systems, as documented in published standards and as applied by Prime/Original Equipment Manufacturer’s internally and flowed to the supply chain. 31

32. 9101 QMS Assessment Key Points
One document covering 9100/9110/9120 standards
Elimination of “scoring” and “key requirements” designation
Use of customer feedback concerning QMS organization performance as an input for process oriented audits (e.g., OASIS, customer satisfaction/performance scores)
In addition to conformity, also determination of effectiveness included
More emphasis on performance measuring
Introduction of the Objective Evidence Record

33. 9101 Audit Standard What hasn’t changed?
Determining conformity to the standard's
Nonconformity’s discovered during the audit are to be documented
Based on information collected during the audit, the auditor will have to draw conclusions on conformity and effectiveness of the organizations quality management system

34. Deployment Support
9101 and 9115
Coming soon 34

35. Transition Schedule 35

36. Questions?