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

9104-1 ’Requirements for Aviation, Space, and Defense Quality Management System Certification Programs’. Prepared and Presented by Michael C. Roberts, Boeing Technical Fellow AAQG Council, RMC, and AAQSC Meetings Charlotte, North Carolina September 14 - 17, 2009. Caveat Emptor.

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

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  1. 9104-1’Requirements for Aviation, Space, and Defense Quality Management System Certification Programs’ Prepared and Presented by Michael C. Roberts, Boeing Technical Fellow AAQG Council, RMC, and AAQSC Meetings Charlotte, North Carolina September 14 - 17, 2009

  2. 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” 2

  3. The 9104 TRILOGY General Requirements -1 9104 -2 -3 Oversight Activity Training and Qualification 3

  4. 9104-1 International Re-write Team 4

  5. New Audit Day Table (partial) 5

  6. Section 8.2 Duration of the Audit a. The minimum duration for initial, surveillance, and recertification audits are shown in Table 2. No reductions from Table 2 audit duration days are allowed for the ICOP scheme. Increases to the audit duration days are allowed and expected for areas with identified risk, complexity, or increased scope.

  7. Section 8.2 (continued) • 8.2.2 Audit Day Activity Requirements • a. Audit time in Table 2 includes Stage 1 and Stage 2 activities. Table 2 represents minimum on-site audit time from the opening meeting to the closing meeting. • b. Table 2 audit time does not include non-audit time (e.g., travel, meals, extended break times). • c. Table 2 is for on-site audit time only. Table 2 does not include auditor time used for planning, report writing, and/or completion of the 9101 forms. • d. An audit day is a normal working day of eight hours. The number of audit days cannot be reduced by programming longer hours per workday (e.g., five audit days of eight hours cannot be executed as four audit days of ten hours). • e. Auditing of the entire AQMS standard on all shifts is required for initial and recertification. For surveillance audits, the planning shall include coverage of multiple shifts. • f. Shift auditing whereby a longer day is planned; cannot reduce required audit days.

  8. Section 8.4 8.4 Audit Team Conclusions and Reporting • The audit team leader shall provide the organization with all nonconformity reports at the closing meeting. The audit team leader shall present the audit report to the organization within two weeks of the closing meeting using the audit report and associated forms defined in 9101. As a minimum, the audit report shall state its conclusions on conformity, effectiveness of the quality management system to the AQMS standard’s requirements, and the objectives established for the audit in accordance with 9101.

  9. New Multiple Site Certification Categories 9

  10. New Oversight Requirements 5.3.3 Certification Body Accreditation Surveillance and Recertification For surveillance and recertification of the CB accreditation to provide AQMS certification, the AB’s management system shall ensure, at a minimum, the required assessment activities defined in Table 1 are conducted, including:

  11. Revised Schedule 11

  12. Expanded ‘Likely’ Schedule 12

  13. Expanded ‘Aggressive’ Schedule 13

  14. 9100/9101/9104-1 Transition Plan (Proposed) OPMT Training Go-Ahead Release of 9104/1 9101 Release Estimated 6 Months Estimated 8 Months Proposed 12 Months Training of Certification Bodies and Auditors Develop Auditor Training All Companies Must Upgrade to New Standard At Next Surveillance Audit Or Re-Certification Earliest Opportunityfor Certification to New Standard (i.e. the early adopters) Maximum Allowed Time to Upgrade

  15. 9104/1 Section Implementation Section 60 days Extended Implementation 3 YY As applicable (ie. Single Site) 4 YY 5 Y 5.3.3 5.3 f (OASIS change) 6 Y 6.5 L As applicable 7 YY 8 Y 8.2 Applicable in 2010 – Mandatory upon transition to 9100:2009 9 YY 10 Evidence of approval in 2010, Evidence of oversight in 2011 11 Evidence of approval in 2010, Evidence of oversight in 2011 12 YY 13 YY 14 YY YY = Complete Section 15 YY Y = Partial Section 16 YY 17 YY 18 YY 19 YY Appx A Y Mandatory in full upon transition to 9100:2009

  16. 9104/1 Transition Plan (Proposed) All New Contracts Should Be Written to the New Auditor Time Tables and 9104/1 Requirements Est. 1/1/12 9104/1 Ballot 9104/1 Release ~ 5 Months 2 Months 6 Months Proposed 12 Months Existing Contracts Must Be Changed to Meet 9104/1 At Next Audit (I,S,R) Maximum Allowed Time to Upgrade All ABs & CBs Must Be Compliant to New 9104/1, Except Audit Day Times and M/S

  17. QUESTIONS? Interrogação? Poser une question? 17

  18. Back-upDetailed Presentation from Auditor Workshop

  19. 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”

  20. 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” 20

  21. There was AIR 5359 … In the beginning … … 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.

  22. It was Internationally harmonized … So, 9104 was born ! … 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.

  23. The 9104 TRILOGY General Requirements -1 9104 -2 -3 Oversight Activity Training and Qualification

  24. History of 9104-series Releases: • AS9104A Jan 2005 • Quality Management System Certification/Registration Programs • AS9014 July 2006 • AAQG Requirements for AQMS Certification/Registration Programs • AS9104-2 Mar 2007 • Oversight of Aerospace QMS Registration/Certification Programs • AS9104-3 Mar 2007 • Aerospace Auditor Competency and Training Programs • AS9104-1 Est. 1Q2010 • Aviation, Space and Defense QMS Certification Programs

  25. Today’s Game Plan • International Team Approach • Review of Changes to 9104-1 • High Level Changes Per Chapter • Discuss Audit Day Table • Discuss Multiple Site Certifications • What’s Next • Schedule / Predictions • Questions ?

  26. 9104-1 International Re-write Team

  27. Chapters, Book Bosses, Etc.

  28. Chapters, Book Bosses, Etc. (continued)

  29. 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.

  30. Changes to 9104-1(C 1) • 1. Scopesignificant 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

  31. Changes to 9104-1(C 2) • 2. Referencessignificant 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)

  32. Changes to 9104-1(C 3) • 3. Definitionssignificant 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

  33. 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

  34. 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

  35. 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

  36. 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

  37. 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

  38. 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

  39. 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.

  40. 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.

  41. New Audit Day Table (partial)

  42. 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

  43. 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

  44. 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.

  45. New Multiple Site Certification Categories 45

  46. 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.)

  47. 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

  48. 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

  49. 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

  50. 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

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