AS9104/1: The Main Changes Tim Lee 12 March 2012 Company Confidential 1 Why AS9104/1? • Feedback from the IAQG leadership resulted in ICOP improvement projects • Audit Process Improvements – Improved through changes in 9101:2009 – Now published as AS9101 Rev D • Consistency of Auditor Training – Addressed through common global Aerospace Auditor Transition Training (AATT) sanctioned by the IAQG • All other areas are addressed through changes in the scheme requirements i.e. with the introduction of AS9104/1 published in January 2012 2 Original Requirements for AS9104/1 • Complete the Trilogy of 9104-series documents, by revising AS9104 • Remove sections made redundant by the release of AS9104/2 (Oversight) and AS9104/3 (Auditor Training and Qualification) • Address the areas of ICOP concern, by enhancing/revising topics identified in the OPMT FMEA (e.g. audit days, multi-site, etc.) • Upgrade to the new ISO and IAF audit docs. 3 Significant Changes to AS9104/1 • AS9104/1 is a total rewrite of the original 9104 document • From AS9104 to AS9104/1 the document increased from 30 to 49 pages • This training focuses on major changes that deviate significantly from the AS9104 standard. 4 AS9104/1 Significant Changes 1. Scope Significant Changes • Introduces ICOP scheme concept • Sets applicability to SMS, OPMT, ABs, CBs, and CBMCs • Expands applicability to IAQG Member Companies, AABs, TPABs, TPs and organizations seeking or obtaining AQMS standard certification. • Defines AQMS standards as 9100, 9110 and 9120 • Introduces IAQG Member recognition of supplier certification to AQMS standards 5 AS9104/1 Significant Changes 2. References Significant Changes • Updates revised ISO/IEC documents (e.g. 17011, 17021, 19011 etc.) • Includes AS9104/2 and AS9104/3 • Updates to revised IAF (International Accreditation Forum)documents - MD 1, MD 2, MD 3, MD 4, MD 5, ML 4, GD 3, etc. • Establishes equivalencies for AS, EN, JISQ, SJAC, NBR, etc. (sector publications in USA, Europe, Japan, Japan and Brazil, etc.) 6 AS9104/1 Significant Changes 3. Definitions Significant Changes • Increased number of definitions from 11 to 29 • 22 new, 1 deleted, most others small changes • Added definitions include: - AQMS, AQMS Auditor, AAB, CBMC, ICOP, OPMT, TPAB - Assessment, Audit, Containment, Pre-Audit, Office Assessment, Witness Audit, Witness Assessment - Site, Certification Structures, Lead Office, Central Office, Combined Audit, Integrated management System, Organization - Cross Frontier Accreditation 7 AS9104/1 Significant Changes 4. General replaced with 4. Requirements of the Sector Management Structure • Defines authority for the SMS, CBMC for: • Approving ABs for ICOP participation • Review and recognition of accreditation of CBs • Approval of AABs and TPABs • Data reporting to OPMT and OASIS • Approval, Suspension & Withdrawal of entities • Defining Operating Procedures including a Resolutions process • Recognition of entities approved or recognized in other sectors 8 AS9104/1 Significant Changes 5. Accreditation Bodies Significant Changes • Conformance to ISO 17011 and IAF ML 4 • SMS recognition of AB accreditation decisions for accredited CBs in ICOP scheme • Enhanced detail for the CB Application and Review Process • 9104-1 Accreditation for CBs scoped by AQMS • Detail on OASIS entry requirements • Surveillance requirements (new table) ‒ Includes number of CB Client Files and number of Witness Assessments to be assessed annually 9 AS9104/1 Significant Changes 5. Accreditation Bodies Significant Changes • Closure time frames for AB Nonconformity Reports raised on CBs • CB suspension and withdrawal process including specific conditions causing suspension • Complaint and issue resolution process • AAB notification for AQMS auditor competence issues • AB personnel competence including decision-making personnel Aviation, Space & Defense (A, S & D) competence 10 AS9104/1 Significant Changes 6. Certification Bodies Significant Changes • Conformance to ISO 17021 and IAF Mandatory Documents (MD) • No AQMS certificates before accreditation • CB to maintain accreditation for ISO 9001 to keep accreditation for AQMS certification • CB certification decisions must utilise a person with A, S or D competence • CB Auditors must be competent per ISO/IEC 17021 and authenticated to AS9104/1 and AS9104/3 requirements • Allow periodic Surveillance and Oversight 11 AS9104/1 Significant Changes 6. Certification Bodies Significant Changes • CB is responsible for ensuring data is accurately entered into OASIS • CBs must ensure clients have an OASIS Administrator • CBs must have a complaint / issue resolution process • CBs Audit Program to conform to 9101, 9104 series, 17021 and applicable IAF MDs • No CB Consultancy • Responsibility for certificate integrity and validity 12 AS9104/1 Significant Changes 6. Certification Bodies Significant Changes • Rules and consequences for Suspension and Withdrawal of a CB • CB rules for application of Advanced Surveillance and Recertification Procedures (ASRP) and Computer Aided Auditing Techniques (CAAT) • Ensure access for audits involving areas and materials which are classified and/or export controlled • Restrictions on clients demanding audit team changes without good reason 13 AS9104/1 Significant Changes 7. AQMS Auditors Reference to AS9104/3 • Auditor competency detailed in AS9104/3 and is required to be demonstrated • AAB responsibility for evaluation, authentication, and re-authentication of AQMS Auditors (both AA and AEA) • Auditor Applicants to inform AAB of a previous rejection, suspension, or withdrawal in another SMS • Withdrawn Auditors may NOT re-apply for 12 months in any IAQG Sector • Consequences for not re-authenticating on time (i.e. apply more than 3 months before expiry, no application before expiry = withdrawal) 14 AS9104/1 Significant Changes 8. Audits and Reporting Significant Changes • Certification structures defined in Appendix B – New: campus, several sites and complex organizations – As before: single site and multiple site • Eligibility criteria for each structure documented (Appendix B) • CB and client to agree structure type • CB to retain records of structure determination • For Complex organization structures the CB is to refer rationale and justification to the IAQG OPMT Certification Structure Oversight Committee (CSOC) for approval 15 AS9104/1 Significant Changes 8. Audits and Reporting Significant Changes • Minimum audit days – New Audit Day Table – NO reductions from Audit Day Table are allowed except as specified for ASRP, CAAT and Several Sites – Increases to Audit Day Table are both allowed and expected – Audit Day Table is Compliant to IAF MD 5 – New table specifies Initial, Surveillance, & Recertification Days for 9100/9110, 9100/9110 less Design, and 9120. 16 AS9104/1 Significant Changes 8. Audits and Reporting Significant Changes • Minimum audit days (continued …) – Audit Day Table DOES NOT include Non-Audit Time (travel, meals, extended breaks, etc.) – Audit Day Table DOES NOT include Auditor Time for Audit Planning, Writing of Reports, Filling Out 9101 Forms, etc. – Justification for audit days required to be documented – Extra time for correction and corrective action verification, use of translators, etc. – Method for calculation of audit days set for each certification structure type 17 AS9104/1 Significant Changes 8. Audits and Reporting Significant Changes • Minimum audit days (continued …) – Audit Days - Audit Day is 8 Hours – Working longer is still counted as 8 hours – (cannot do 4 days of 10 hrs to equal 40 hours) – Must audit ALL working shifts – Shift auditing still meets 8 hour daily limitation – If work less than 8 hours per day add extra days to compensate to maintain on-site duration – If stage 1 required at recertification, audit time is to be added 18 AS9104/1 Significant Changes 8. Audits and Reporting Significant Changes • Minimum audit days (continued …) – Requirements for auditing management systems with multiple AQMS applicability – Multiple AQMS additional minimum audit days based on level of integration of activities and processes » >80% integrated = Fully Integrated = +15% » >50% to 80% integrated = Partially Integrated = +30% » <50% integrated = Not Integrated Audit duration is independent from each other i.e. add 100% table 2 for headcount for additional AQMS standard. • Audit Team Leader to be on one site and an AEA to be on site at each site throughout the whole of the audit 19 AS9104/1 Significant Changes 8. Audits and Reporting Significant Changes • Nonconformities – Client suspension if conformance not established within 60 days from issue of NCR – Customer notification included where applicable • NCRs as a minimum to be provided at closing meeting • Complete audit report within two weeks of closing meeting • Certified organisations to provide a copy of audit report to customers upon request 20 AS9104/1 Significant Changes 8. Audits and Reporting Significant Changes • Transfer of AQMS certificates – IAF MD 2 applies in full – If transfer < 12 months before expiry full stage 1 and stage 2 audits required – On site audit always required • Advanced Surveillance and Recertification Procedures (ASRP) – In accordance with IAF MD 3 requirements i.e. CB must be accredited to apply ASRP – Reduction in on-site audit duration not exceed 30% – CB client internal auditors must be AA equivalent and one must be AEA equivalent to lead internal audit 21 AS9104/1 Significant Changes 8. Audits and Reporting Significant Changes • Computer Aided Auditing Techniques (CAAT) – IAF MD 4 applies in full – Audit time transferred to off-site activity and is not reduced overall – Combined CAAT and ASRP shall not reduce on-site audit time by more than 30% 22 AS9104/1 Significant Changes 9. Oversight Reference to AS9104/2 • Combines previous chapters 9, 10 and 11 • Refers to AS9104/2 for detailed requirements • For those conducting oversight requires ICOP Declaration Form completed and filed • Other ICOP committee members to sign a confidentiality agreement • Allows sharing of results with applicable AAB for determined AQMS auditor competency issues 23 AS9104/1 Significant Changes 10. Auditor Authentication Bodies New Section • AAB must comply with AS9104/3 • Introduces concept of auditor suspension • AAB agrees to periodic oversight • Must have a person with A, S or D knowledge to support AEA authentication • Requires a management system for authentication • Clarifies authentication only for AA and AEA • Sets out requirements for independence of authentication decisions (i.e. no conflicts of interest) • Auditor Complaint / Appeal Process required • Disclosure of any previous applications, authentications or rejections 24 AS9104/1 Significant Changes 10. Auditor Authentication Bodies New Section • Process required for dealing with alleged auditor competency issues within 60 days • Establishes consequences post withdrawal of auditor authentication • Use of marks and logos • Record retention for two authentication cycles 25 AS9104/1 Significant Changes 11. Training Provider Approval Bodies New Section • TPAB must comply with AS9104/3 • TPAB agrees to periodic oversight surveillance and rights of access including to TP classes • Industry specific courses require SMS concurrence • Oversight or approval of class = no credit for attending • Requires TPAB to have a management system • Sets out requirements for conflict of interest avoidance during approval decisions • Complaint / Appeal Process required • Consequences for withdrawal of approval • A, S or D competence required for evaluation of industry specific training courses 26 AS9104/1 Significant Changes 12. OASIS New Section • OPMT has Responsibility for OASIS • OPMT may make changes to OASIS functionality • CB OASIS Administrators Required • When CB accreditation withdrawn, CBs client data only visible for 6 Months • Created a Responsibility Matrix for data correctness • Certification structures and associations with OINs established • The central site shall be identified for all certificated organisations in OASIS • All entities to establish an OASIS administrator for data control / entry 27 AS9104/1 Significant Changes 13. Requirements of the OPMT New Section • Previously section 14 but re-titled with minor changes • May publish resolutions to clarify 9104 requirements • Establishes Certification Structure Oversight SubCommittee requirements and process 28 AS9104/1 Significant Changes 14. OASIS Feedback Process New Section • Establishes feedback process and mechanism FEEDBACK - B Certification Body Product / Process Quality Audit Audit Findings Supplier Customer FEEDBACK - A FEEDBACK - C • Also describes feedback to Accreditation Bodes 29 AS9104/1 Significant Changes 15. Sector Management Structure Minor Changes • Responsibility for conformance of sector • Establishes voting rights of sector at IAQG OPMT • Only IAQG or IAQG sector member company representatives have voting rights • Further details suspension of a national scheme • Adds IAQG OPMT and sector diagram 30 AS9104/1 Significant Changes 16. Cross Frontier Policy New Section • Enables AB operations and Oversight in countries or sectors away from home country or sector • ABs to follow IAF GD 3 • ABs can sub-contract work to other approved ABs in other countries or Sectors • Accrediting AB retains responsibility for the work • OP Assessors can also sub-contract work to OP Assessors in other countries or sectors • Subcontracting sector or CBMC retains responsibility • Fees can be levied on CBs for Oversight outside SMS/CBMC home region 31 AS9104/1 Significant Changes 17. Records Minor Changes • All entities to keep records for a minimum of six years • IAQG OPMT, EAQG OPMT and CBMCs are required to define and list records to be retained • Rights of access to records including OASIS for oversight re-affirmed 32 AS9104/1 Significant Changes 18. Certified Organizations New Section • Requires certified organizations to comply with AS9104 • Requires CBs to flow down requirement to certified clients • 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 A, S and D customers (unless justification of competition confidentiality, conflict of interest, etc.) Agree to Notify their A, S and D customers in case of Loss of Certification • Shall provide ‘Right of Access’ to their facilities, people, and processes for oversight or CB review • Failure to abide by requirements is cause for withdrawal of AQMS certification 33 AS9104/1 Significant Changes 19. Confidentiality and Conflict of Interest New Section • Expanded from section 4.3 of 9104:2006 • Data collected is confidential • Not to be shared unless agreed in writing by affected parties • Participants to review and declare any potential or actual conflicts of interest 34 AS9104/1 Significant Changes 20. Fees and Financials • New Section OPMT can recommend Fees for Registration of Audit Data in the OASIS Database – ‒ to be approved by IAQG Council • OPMT must prepare an Annual Budget ‒ Estimate Contract Labour, Meeting/Workshop Costs, Sector ICOP Projects, and OASIS Sustainment and Improvements ‒ Submit to IAQG Treasurer for approval • SMS or CBMC fees can also be recommended but must be approved by the sector 35 Questions 36