9104-001 Evolution Main Changes

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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
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