9104-1

1
9104-1Requirements for Aviation, Space, and
Defense Quality Management System Certification
Programs

• Prepared and Presented by
• Michael C. Roberts, Boeing Technical Fellow
• Auditor Training and Workshop Session
• Minneapolis, MN
• July 30-31, 2009

2
Michael C. Roberts (mini-bio)

• Boeing Technical Fellow Quality Technology
• 35 Years in Failure Analysis, Reliability,
  Quality at McDonnell Douglas and Boeing IDS
• Focus Areas in Microelectronics, Metrology, and
  Quality Technology
• Past Chair and Charter Member of the RMC
• Past Co-Chair and Charter Member of the OPMT
• RMC Member at Large and OPMT Alternate Member
• Education BSEE, MSEE, MSEngMgt
• Boards SAE Institute, UL-DQS
• ASQ Certs CQE, CQM

3
Caveat Emptor

• Note The 9104/1 Standard Has Neither Been
  Balloted Nor Published. Therefore, All
  Information Contained Herein Is Considered
  Proposed and Subject to Change

4
In the beginning
There was AIR 5359
and everything was right and proper in the
aerospace world.
But man was not satisfied

• so he asked for OASIS

and surveillance
and ICOP.
And the ABs, CBs and Auditors multiplied.
5
So, 9104 was born !
It was Internationally harmonized
and became the standard from which the
Aerospace Industry managed ICOP.
But man was still not satisfied

• so he asked for a separate Surveillance doc,

and a separate Training and Qualification doc,
and wanted a number of topics redefined.
And thus, the 9104 Trilogy was created.
6
The 9104 TRILOGY
General Requirements
-1
9104
-2
-3
Training and Qualification
Oversight Activity
7
History of 9104-series Releases

• AS9104A Jan 2005
• Quality Management System Certification/Registrati
  on Programs
• AS9014 July 2006
• AAQG Requirements for AQMS Certification/Registrat
  ion Programs
• AS9104-2 Mar 2007
• Oversight of Aerospace QMS Registration/Certificat
  ion Programs
• AS9104-3 Mar 2007
• Aerospace Auditor Competency and Training Programs

• AS9104-1 Est. 1Q2010
• Aviation, Space and Defense QMS Certification
  Programs

8
Todays Game Plan

• International Team Approach
• Review of Changes to 9104-1
• High Level Changes Per Chapter
• Discuss Audit Day Table
• Discuss Multiple Site Certifications
• Whats Next
• Schedule / Predictions
• Questions ?

9
9104-1 International Re-write Team
10
Chapters, Book Bosses, Etc.
11
Chapters, Book Bosses, Etc. (continued)
12
Significant Changes to 9104-1

• Note 9104-1 is a total rewrite of the original
  9104 document. This presentation will only focus
  on the major changes that deviate significantly
  from the past standard and implementation
  practices.

13
Changes to 9104-1 (C 1)

• 1. Scope significant changes
• Introduces ICOP
• Sets Applicability to SMS, OPMT, ABs, CBs, and
  CBMCs
• Expands Applicability to IAQG Member Companies,
  AABs, TPABs, etc.
• Defines AQMS as 9100, 9110, 9120
• Sets Confidentiality Expectations

14
Changes to 9104-1 (C 2)

• 2. References significant changes
• Upgrades to the New ISO/IEC Documents
• 17011, 17021, etc.
• Upgrades to the New IAF Documents
• MD 1, MD 2, MD 3, MD 4, MD 5, ML 4, GD 3, etc.
• References IAQG Procedures
• Establishes Equivalencies for AS, EN, JISQ, SJAC,
  NBR, etc. (sector publications)

15
Changes to 9104-1 (C 3)

• 3. Definitions significant changes
• Increased of Definitions from 11 to 27
• 17 new, 1 deleted, most others slight changes
• Added Definitions for
• AQMS, AAB, CBMC, ICOP, OPMT, TPAB
• Assessment, Audit, Containment, Pre-Audit, Office
  Assessment, Witness Audit, Witness Assessment
• Multiple Site Organization, Single Site
  Organization, Head Office
• Cross Frontier

16
Changes to 9104-1 (C 4)

• 4. General replaced with
• 4. Requirements for Sector Mgt Structure
• Defines authority for the SMS, CBMC for
• Review and Recognition of ABs, Accreditation of
  CBs
• Review and Recognition of AABs and TPABs
• Data Reporting to OPMT and OASIS
• Approval, Suspension and Withdraw of Entities
• Defining a Process for Resolutions
• Define and Enforce impartiality / Conflict of
  Interest

17
Changes to 9104-1 (C 5a)

• 5. Accreditation Bodies significant changes
• Defines requirements for
• Conformance to ISO 17011 and IAF ML 4
• AB Personnel Aviation Experience
• CB Application and Review Process
• Scope of Accreditation
• Right of Access
• Surveillance Requirements (new table)
• of CB Client Files to be Reviewed Annually
• of Witness Assessments

18
Changes to 9104-1 (C 5b)

• 5. Accreditation Bodies (cont.) significant
  changes
• Defines requirements for (continued)
• Auditor Competency
• Marks and Logo Use
• Suspension and Withdrawal Process
• Closure of Nonconformities
• Records Retention
• Complaint/Issue Resolution Process
• Personnel / Assessor Team Requirements

19
Changes to 9104-1 (C 6a)

• 6. Certification Bodies significant changes
• Defines requirements for
• Conformance to ISO 17021 and IAF MD ML Docs
• CB Maintaining ISO 9001 Accreditation
• CBs Audit Program Must Conform to 9101
• CBs Certification Function Must Have a Person
  with Aviation, Space, or Defense competence
• CB Auditors Must Be Competent and Authenticated
  to ISO/IEC 17021, 9104/3, and this standard
• Periodic Surveillance and Oversight
• CB is Responsible for Ensuring Data is Accurately
  Entered Into OASIS

20
Changes to 9104-1 (C 6b)

• 6. Certification Bodies (cont.) significant
  changes
• Defines requirements for (continued)
• CBs Must Have an OASIS Administrator
• CBs Must Have a Complaint/Resolution Process
• CBs Audit Program Must Conform to 9101
• NO CB Consultancy
• Responsibility for Integrity and Validity of
  Certificates
• CB Suspension and Withdrawal
• CB Rules for ASRP and CAAT
• Audits Involving Areas and Materials Which Are
  Classified and/or Export Controlled

21
Changes to 9104-1 (C 7)

• 7. Auditors reference to 9104/3
• Re-states (simplified) requirements for
• Auditor Competency Detailed in 9104/3
• Responsibility for Evaluation, Authentication,
  and Re-Authentication of AQMS Auditors
• Auditors Authenticated in One IAQG Sector Shall
  Be Recognized by the Other Sectors
• Withdrawn Auditors May NOT Re-Apply for 12 Months
  in Any IAQG Sector

22
Changes to 9104-1 (C 8a)

• 8. Audits and Reporting significant changes
• Defines requirements
• Audit Team Leader Must Be an AEA and Be On-Site
  and Participating in All Audits, Including
  Multi-site
• Audit Team Leader Shall Be Limited to a Maximum
  of Two Consecutive Certification Cycles at Same
  Client
• Audit Team Leader Must Provide Nonconformity
  Reports (re. 9101) at the Closing Meeting
• Cannot Issue Certification or Re-Certification
  Until
• All Major and Minor Nonconformities Have Been
  Contained, Satisfactorily Corrected with Root
  Cause Analysis, Corrective Action Has Been
  Implemented, Reviewed, Accepted, and Verified by
  the CB.

23
Changes to 9104-1 (C 8b)

• 8. Audits and Reporting (cont.) significant
  changes
• Defines requirements (continued)
• Duration of Audit
• New Audit Day Table
• NO Reductions From Audit Day Table Is Allowed
• Increases To Audit Day Table Is Allowed and
  Expected
• Table is Compliant to IAF MD 5
• New Table Specifies Initial, Surveillance,
  Recertification Days for 9100/9110, 9100/9110
  Less Design, and 9120.
• Audit Day Table DOES NOT Include Non-Audit Time
  (travel, meals, breaks, etc.)
• Audit Day Table DOES NOT Include Auditor Time for
  Audit Planning, Writing of Reports, Filling Out
  9101 Forms, etc.

24
New Audit Day Table (partial)
25
Changes to 9104-1 (C 8c)

• 8. Audits and Reporting (cont.) significant
  changes
• Defines requirements (continued)
• Audit Days
• Audit Day is 8 Hours
• Working Longer Still Counted As 8 Hours
• (cannot do 4 days of 10 hrs to equal 40
  hours)
• Must Audit All Working Shifts
• Table is Compliant to IAF MD 5
• Shift Auditing Still Meets 8 Hour Daily
  Limitation
• Audit Day Rules for Multiple AQMS Standards
• Audit Day Rules for Adding AQMS Standards

26
Changes to 9104-1 (C 8d)

• 8. Audits and Reporting (cont.) significant
  changes
• Defines requirements for (continued)
• Multiple Site Certifications
• Must Comply with IAF MD 1, PLUS Requirements in
  9104/1
• IAF MD 1 Section 0.4 is not applicable for
  aviation, space and defense organization
  certifications
• Temporary sites is also not applicable
• All Sites Audited to the Complete and Applicable
  AQMS Standard Prior to Certificate Issuance
• Sampling of Sites for Surveillance and
  Recertification is ONLY Allowed for 9120, and
  Limited to Same Country

27
Changes to 9104-1 (C 8d)

• 8. Audits and Reporting (cont.) significant
  changes
• Defines requirements for (continued)
• Multiple Site Certifications
• For 9100 and 9110 Certifications, Two (2)
  Categories of Certification of Multiple Sites Are
  Defined
• Cat 1 Sites meet eligibility criteria for IAF MD
  1
• Cat 2 Sites meet eligibility criteria for IAF MD
  1 3

Note It is anticipated that 90 will
seek/attain Category 1, and less than 10 will
seek or achieve Category 2.
28
New Multiple Site Certification Categories
28
29
Changes to 9104-1 (C 8e)

• 8. Audits and Reporting (cont.) significant
  changes
• Defines requirements for (continued)
• Multiple Site Certifications (Categories 1 2)
• Central Function MUST Be Identified and Meet
  Criteria
• Audit Days Calculated For Employee Count For Each
  Individual Site (NOT the cumulative sum of
  employees at all sites covered by the
  certification)
• Central Function Audited Yearly
• All Sites Visited At Least Once During
  Certification Cycle
• Once Total Audit Day Requirement is Calculated,
  Some Allowance Is Given to Reduce Time At One
  Site and Add Time At Another Site For Proper
  Justification. (Time at one site cannot be
  reduced by more than 33 for Cat 1 or 50 for Cat
  2.)

30
Changes to 9104-1 (C 8f)

• 8. Audits and Reporting (cont.) significant
  changes
• Defines requirements for (continued)
• Issuance of Certificates
• Required Info (e.g.. AQMS Std, Rev Level, Audit
  in Accordance with AS9104/1, CB Identity, Issue
  Expiration Dates, Scope, Multi-site info,
  Marks/Logos) in English
• Information Posted to OASIS
• Transfer of Certificates
• Loss of Certification
• ASRP
• CAAT

31
Changes to 9104-1 (C 9)

• 9. Oversight Process reference to 9104/2
• Defines requirements
• Refers to 9104/2 for Detailed Requirements
• Requires ICOP Declaration Form Completed and
  Filed
• Sharing of Results

32
Changes to 9104-1 (C 10)

• 10. Auditor Auth. Bodies new section
• Defines requirements
• AAB Must Be In Accordance With ISO 17024
• AAB Must Comply with 9104/3
• Agree to Oversight / Surveillance
• Auditor Complaint / Appeal Process
• Activities Outside of Region / Sector
• Process to Determine Auditor Competency
• Marks / Logos
• Suspension / Withdrawal
• Record Retention

33
Changes to 9104-1 (C 11)

• 11. Train Prov. Approval Bodies new section
• Defines requirements
• TPAB Must Comply with 9104/3
• Agree to Oversight / Surveillance
• Conflict of Interest
• Auditor Complaint / Appeal Process
• Activities Outside of Region / Sector
• Suspension / Withdrawal
• Re-application After 12 Months
• Record Retention

34
Changes to 9104-1 (C 12)

• 12. OASIS new section
• Defines requirements
• OPMT Has the Responsibility for OASIS
• OASIS Administrators Required
• Only CB Administrator Can Enter Audit Data Into
  OASIS
• Client Administrator to Input/Validate
  Demographic Data
• Withdrawn CBs Visible for 6 Months
• Created a Responsibility Matrix for Data
  Correctness

35
Changes to 9104-1 (C 13)

• 13. Other Party Mgt. Team new section
• Defines requirements
• The OPMT Has The Authority to Publish the
  9104-Series Standards Per IAQG Procedure 103
• Sector Reviews (Audits) Required Every 2 Years
• OPMT Has the Responsibility for OASIS
• Periodic Reviews of OASIS Management, Operations
• Reports to IAQG (Intl OPMT and Sectors)
• Improvements to ICOP Scheme
• Monitor Feedback Process

36
Changes to 9104-1 (C 14)

• 14. OASIS Feedback Process new section
• Defines requirements for

37
Changes to 9104-1 (C 15)

• 15. Sector Mgt. Structure further definition
• Defines requirements
• ICOP Scheme Globally Supported by SMS
• Authority / Recognition
• AB and CB Suspensions
• Resolutions
• SMS Represented on OPMT

38
Sector Management Structure
39
Changes to 9104-1 (C 16)

• 16. Cross Frontier new section
• Defines requirements
• Compliance to IAF GD 3
• ABs, SMSs, and CBMCs Conducting Oversight In
  Countries Other Than Their Country of
  Accreditation
• ABs Can Sub-Contract Work to Other ABs/Sectors
• Accrediting AB Retains Responsibility
• Fees Can Be Levied On CBs For Oversight Outside
  SMS/CBMC Region.

40
Changes to 9104-1 (C 18)

• 18. Certified Organizations new section
• Defines requirements
• Certified Organizations Must Allow CB to Post
  Tier 1 and Tier 2 Audit Data to OASIS Database.
• Agree Tier 1 Is Public Information
• Agree to Provide Access to Tier 2 Upon Request of
  Aviation, Space, and Defense Customers (unless
  justification of competition confidentiality,
  conflict of interest, etc.)
• Agree to Notify Their Aviation, Space, and
  Defense Customers in Case of Loss of
  Certification
• Shall Provide Right of Access to Their
  Facilities, People, and Processes For Review by
  Customers and Authorities.

41
Changes to 9104-1 (C 19)

• 19. Fees and Financials minor changes
• Defines requirements ...
• OPMT Can Recommend Fees For Registration of Audit
  Data in the OASIS Database
• OPMT Must Prepare an Annual Budget
• Submit to IAQG Treasurer
• Estimate Contract Labor, Meeting/Workshop Costs,
  Sector ICOP Projects, and OASIS Sustainment and
  Improvements

42
Whats Next

• Schedule / Predictions

43
Revised Schedule
44
9100/9101 Transition Plan (Proposed)
Release of 9104/1
45
9104/1 Transition Plan (Proposed)
Est. 9-12 Months
9104/1 Release
9104/1 Ballot
1 Month
2 Months
6-9 Months
5 Months
Existing Contracts Must Be Changed to Meet
9104/1 At Next Audit (I,S,R)
Maximum Allowed Time to Upgrade
All New Contracts Must Be Written to New
Auditor Time Tables and 9104/1 Requirements
All ABs CBs Must Be Compliant to New 9104/1,
Except Audit Day Times and M/S
46
QUESTIONS?
Interrogação?
Poser une question?