Dion[1] 9100
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Transcript of Dion[1] 9100
Orlando Page 1Guy DION – Requirements Strategy Stream Leader
Requirements Strategy Stream
Orlando, Florida, USA
7-12 October, 2007
Orlando Page 2Guy DION – Requirements Strategy Stream Leader
AgendaAgenda
Team MembershipTeam MembershipMission & Future StateMission & Future StateInitiative StatusInitiative Status–– REQREQ--001001 9100 general QMS standard9100 general QMS standard–– REQREQ--006006 9110 maintenance QMS standard9110 maintenance QMS standard–– REQREQ--007007 9120 distributor QMS standard9120 distributor QMS standard–– REQREQ--008008 9115 software QMS standard9115 software QMS standard–– REQREQ--009009 9101 (9111/9121) Audit process 9101 (9111/9121) Audit process standardstandard
5 active initiatives
Orlando Page 3Guy DION – Requirements Strategy Stream Leader
Team MembershipTeam Membership
Team leadership:Team leadership:Team Leader Team Leader –– Guy Dion *Guy Dion *AAQG Leader AAQG Leader –– Alan DanielsAlan DanielsAPAQG Leader APAQG Leader –– Minoru Minoru KasanoKasanoEAQG Leader EAQG Leader –– Guy DionGuy DionFacilitator Facilitator –– Wayne JohnsonWayne Johnson
* * Also SWG mentor forAlso SWG mentor forRequirements Strategy StreamRequirements Strategy Stream
Operating Management SystemOperating Management SystemRepresentative:Representative:
John AddeyJohn Addey
Initiative Leaders:Initiative Leaders:REQREQ--001001 9100 9100 Guy DionGuy DionREQREQ--006006 91109110 Vince BartramVince BartramREQREQ--007007 91209120 Dale GordonDale GordonREQREQ--008008 91159115 Giovanni Giovanni CalcagniCalcagniREQREQ--009009 91019101 Hans LuijtHans Luijt
Orlando Page 4Guy DION – Requirements Strategy Stream Leader
Mission & Future StateMission & Future State
Maintain Maintain Focus Focus on on Quality Management SystemQuality Management System (QMS) Standards(QMS) Standards–– Improve the Improve the supplier performancesupplier performance and and customer satisfactioncustomer satisfaction,,
especially especially Product QualityProduct Quality & & OnOn--time Deliveriestime Deliveries–– Take into account the Take into account the new new requirements from aviation, space & requirements from aviation, space &
defensedefense–– Stay abreast with Stay abreast with emergingemerging requirementsrequirements–– Sustain and improve theSustain and improve the audit processaudit process–– Support Support QMS revisionQMS revision year year 20082008
Harmonization of Harmonization of Customer RequirementsCustomer Requirements for suppliersfor suppliers
Work with Work with Relationship GrowthRelationship Growth Teams Teams –– Civil Authorities, Space, Defense & National Trade AssociationsCivil Authorities, Space, Defense & National Trade Associations
Establish, Develop, and Maintain Industry Quality Requirements to improve product and process integrity
Orlando Page 5Guy DION – Requirements Strategy Stream Leader
A suite of existing IAQG QMS standards, based on ISO 9001
Various adoption of standards
Many other requirements- Authorities- Associations- Customers
Different Areas- Civil- Space- Defense
Current StateQMS 9100 series
• based on ISO 9001 new revision
• the foundation of the requirements applicable to the whole industry
• improve the suppliers performances and customer satisfaction (OTOQD)
International unique Certification Scheme
• taking into account quality performances and customer satisfaction
• with an improved audit process
• worldwide implemented and recognized by the stakeholders
Future State
Dedicated Working Groups
Relationship with TC 176
Data mining of current 9100 standard, 9101 and others
Web surveys
Benchmarking with other industries
Relationship with civil authorities, defense & space
Monitor emergent new requirements
Actions
OTOQD: On-Time and On Quality Delivery
Mission & Future StateMission & Future State
Orlando Page 6Guy DION – Requirements Strategy Stream Leader
Initiative StatusInitiative Status
Orlando Page 7Guy DION – Requirements Strategy Stream Leader
““ 9100 9100 ““
–– General QMS Standard General QMS Standard ––
Leader: Guy DionLeader: Guy Dion
Orlando Page 8
9100 Standard 9100 Standard -- 2008 Revision2008 Revision
Initiative Summary:Initiative Summary:Revise 9100 to incorporate ISO 9001Revise 9100 to incorporate ISO 9001--2008 changes2008 changesExpand scope to include the Defense sectorExpand scope to include the Defense sectorAnalyze needs of stakeholders and add/revise requirementsAnalyze needs of stakeholders and add/revise requirementsComply with IAQG strategyComply with IAQG strategy
Status
GreenPhase 0 Phase 1 Phase 2 Phase 3
Progress
IAQG & 9100 Team Meetings Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul
Stakeholder Input
Analysis/Draft/Ballot/Release
Stakeholder Input
Supplier Input
IAQG 9100:2008 RevisionMilestones
IAQG 9100 Team IAQG Requirements Strategy Stream2006 2007 2008
8/15
6/10
San Diego Seville
8/15 10/1
Input Consolidation
Melbourne Orlando Naples
1/15
4/15Prepare 9100 First Draft
10/1
1st SMLBallot
4/15 7/15
9100 Release for Publication
4/15
10/152nd SML
Ballot
1/15
7/15 10/15Resolve
Comments
ISO 9001:2009 Estimated Timeline
ResolveComments
ISO 9001 PublicationOct 2008
IAQG Gate 1
IAQG Gate 3
IAQG Gate 2a
IAQG Gate 2b
Committee DraftFeb 2007
9001 CDAnalysis
9001 DISAnalysis
9001 FDISAnalysis
Note: Exact dates for release of 9001 drafts not known – forecast by TC176 is by month.
Yokohama
2009
Draft International StandardSep 2007
Final Draft InternationalStandard – July 2008
Prepare 9100 Coord. draft& Informal Review
4/110/15
Review 9001 ISfor changes
5
1
2
3
4
9100 Team Meetings – Projected ActivitiesParis: Writing sub-team prepares first smooth draft; draft sent to entire team for review prior to Orlando.Orlando: Review first draft, modify/refine as necessary. After meeting, Scribe to prepare coordination draft (preferably based on ISO 9001 DIS) to be used for sector review.Naples: Review/resolve coordination draft comments. After meeting, Scribe to prepare draft (still based on ISO 9001 DIS) for formal SML ballot.Yokohama: Review/resolve comments from formal SML ballot, agree to changes. After meeting, Scribe to prepare draft (based on ISO 9001 FDIS) for 2nd formal SML ballot (if necessary based on volume of comments to 1st SML ballot) or final draft. If 2nd SML ballot not necessary, stage final draft for release upon ISO 9001 publication.(Americas): Review/resolve comments from 2nd SML ballot (if performed). After meeting, Scribe to prepare final draft.Virtual: After ISO 9001 publication, Scribe to review 9001 for final changes and revise ISO 9001 text in 9100 if necessary.
4
12
3
5
6
(Americas)Paris
6
Review Data Mining Inputs
6
ISO 9001 publication now forecast for Oct ’08
9100 to be ready for publication
November 2008
Orlando Page 10
9100 9100 RevisionRevision ProcessProcess
Stakeholders inputsWeb survey
Data mining
Consolidation
Started in April 2005 (Amsterdam)
339 itemsMCRT(Master Review Comments Template)
Page 1
IAQG Stakeholder IAQG Stakeholder FocalsFocals& 9100 Team Liaisons& 9100 Team Liaisons
StakeholderStakeholder IAQG FocalIAQG Focal 9100 Team Liaison9100 Team LiaisonCertification/RegistrationCertification/Registration Rick DOWNSRick DOWNS Hans LUIJTHans LUIJTBodiesBodiesCivil Aviation AuthoritiesCivil Aviation Authorities Edward BAYNEEdward BAYNE Alan DANIELSAlan DANIELSDefense / NATODefense / NATO Jack FLETCHERJack FLETCHER Francisco LOSADAFrancisco LOSADASpaceSpace Roberto CIASCHIRoberto CIASCHI Roberto CIASCHIRoberto CIASCHIOASIS SuppliersOASIS Suppliers Hans LUIJTHans LUIJT Hans LUIJTHans LUIJTIAQG & Sector CompaniesIAQG & Sector Companies ** **IAQG Strategy Streams:IAQG Strategy Streams:–– People CapabilityPeople Capability Herbert MAIROSEHerbert MAIROSE Henry JOHANNSONHenry JOHANNSON–– Product and Supply Chain Product and Supply Chain Susan ARMSTRONG/Susan ARMSTRONG/ Buddy CRESSIONNIE/Buddy CRESSIONNIE/
Larry WENG Larry WENG (co(co--chairs)chairs) JeanJean--Louis DOULIERYLouis DOULIERY
* * 9100 Team Sector Leaders9100 Team Sector Leaders
Page 1
1. Improve the suppliers performances and customer satisfaction, especially : Quality of the products & On-time deliveries
2. Be the foundation of the requirements applicable to the whole aerospace and defense industry
3. Be recognized by the authorities
4. Be applicable to 10 000 suppliers in 35 countries, applied and adapted to : primes, systems manufacturers, equipment manufacturers, sub-contractors, components manufacturers (mecanics, electronics, …) …
5. Allow a common interpretation of the 9100 standard by auditors, audited companies, at all levels
6. Take into account the new requirements from the aerospace and defense industry
The 9100 standard shall :
Objectives for theObjectives for the9100 QMS Standard 9100 QMS Standard (IAQG Strategy)(IAQG Strategy)
Design Specification &IAQG Strategy > 9100 objectives
Review process MCRTAccept / Reject /
Proposals / Comments40 %
accepted
Nov. 2005 (Paris)
Oct. 2006 (Sevilla)
Apr. 2007 (Melbourne)
Orlando Page 1
Stakeholder requests for changes to ISO 9001 are Stakeholder requests for changes to ISO 9001 are out of scopeout of scopeChanges/additions to be considered are those that:Changes/additions to be considered are those that:–– constitute quality management system requirements that are not constitute quality management system requirements that are not
contractual in nature or contain product specific requirements, contractual in nature or contain product specific requirements, and and thatthat
–– enhance clarity of requirements or enhance clarity of requirements or address stakeholder needsaddress stakeholder needs, and , and thatthat
–– are auditable and define are auditable and define ““whatwhat”” not not ““how,how,”” and thatand that
–– are compatible for use by all stakeholder segments and by are compatible for use by all stakeholder segments and by organizations of all types and sizes, and whenorganizations of all types and sizes, and when
–– the benefit of the proposed change/addition outweighs the impactthe benefit of the proposed change/addition outweighs the impact of of implementationimplementation
9100 Design SpecificationKey considerations
Orlando Page 11
9100 draft
18 June 2007
18-20 July 2007 (Paris)
7-8, 12 Oct 2007(Orlando)
9100 draft
7 August 2007
Writing the first draft prepared by the scribe(Sub-team : scribe + 2 people per sector)
AAQG : Sept. 18 & 19(Los Angeles)
EAQG : Oct 2 & 3(Paris)
Review of the first draftissued by the sub-team- in each 9100 WG sector- by the whole team (in Orlando)
9100 coordination
draftEnd of 2007
Planned to be issued (end of 2007) :for stakeholders commentsto be reviewed in each sector(under the coordination of each 9100 sector leader) prior to formal sector ballot
++New ISO 9001 scheduleNew ISO 9001 schedule
(TC176 changed their (TC176 changed their estimated release date from estimated release date from June 2009 to October 2008)June 2009 to October 2008)
9100: Progress Since Last Report9100: Progress Since Last Report
Orlando Page 12
9100: Progress Since Last Report9100: Progress Since Last Report
Writing SubWriting Sub--Team meeting Team meeting –– 1818--20 July20 July–– First 9100 draftFirst 9100 draft preparedprepared
Orlando 9100 meeting:Orlando 9100 meeting:–– Full TeamFull Team review of first 9100 draftreview of first 9100 draft–– Planned for a Planned for a ““coordination draftcoordination draft””
((to be prepared and routed to stakeholders for comment)to be prepared and routed to stakeholders for comment)comments from this coordination to be reviewed comments from this coordination to be reviewed in Naplesin Naples
–– Reviewed new ISO 9001 Reviewed new ISO 9001 scheduleschedule(TC176 changed their estimated release date from June (TC176 changed their estimated release date from June 2009 to October 2008)2009 to October 2008)
Orlando Page 13
Product quality and onProduct quality and on--time delivery performancetime delivery performanceAdded requirement for Added requirement for ““product conformityproduct conformity”” and and ““onon--time time deliverydelivery”” to be measured and appropriate actions taken if to be measured and appropriate actions taken if planned results are not achieved planned results are not achieved
benefitsbenefits: : Linkage between the QMS and organization performance,Linkage between the QMS and organization performance,In line with the IAQG strategy In line with the IAQG strategy
Formal monitoring of customer satisfaction dataFormal monitoring of customer satisfaction dataAdded the requirement to monitor data and to develop Added the requirement to monitor data and to develop improvement plans that address deficienciesimprovement plans that address deficiencies
benefitsbenefits: : To promote continuous improvement of the product and To promote continuous improvement of the product and customer satisfaction,customer satisfaction,Address the ICOP requests Address the ICOP requests
9100 9100 –– Main proposed changesMain proposed changes
Additions
Orlando Page 14
9100 9100 –– Main proposed changesMain proposed changes
Added to 7.1 Added to 7.1 –– Planning of Product RealizationPlanning of Product Realization7.1.1 Project Management7.1.1 Project Management
New requirement for planning and managing product realization in a structured and controlled way
7.1.2 Risk Management7.1.2 Risk ManagementNew requirement of implementation of a risk management New requirement of implementation of a risk management process applicable to the projects & products : responsibility, process applicable to the projects & products : responsibility, criteria, mitigation & acceptancecriteria, mitigation & acceptance
7.1.3 Configuration Management7.1.3 Configuration ManagementMoved to clause 7 + more details on the different activities to Moved to clause 7 + more details on the different activities to be coveredbe covered
benefitsbenefits: Pro: Pro--active approach for management of projects, risk, active approach for management of projects, risk, and configurationand configuration
Additions
Orlando Page 15
Expanded Expanded ““key characteristicskey characteristics”” to to ““essential essential items/featuresitems/features””
9100 will introduce 9100 will introduce ““essential items/featuresessential items/features”” (that (that includes key characteristics)includes key characteristics) that require particular attention that require particular attention throughout product realization and use to assure they throughout product realization and use to assure they are adequately managed are adequately managed
benefitsbenefits: To provide focus on important items/features: To provide focus on important items/features
Recognition of external certificationsRecognition of external certificationsSupplier evaluation may include data from external Supplier evaluation may include data from external sourcessources
benefitsbenefits: To avoid duplications of audits: To avoid duplications of audits
9100 9100 –– Main proposed changesMain proposed changes
Additions
Orlando Page 16
Update the requirement for controlling suppliersUpdate the requirement for controlling suppliersApproval status and scope Approval status and scope (i.e., approved, conditional, disapproved)(i.e., approved, conditional, disapproved),,Authority for decision, change and controlled use of suppliersAuthority for decision, change and controlled use of suppliersRequirements to be flowed down the supply chainRequirements to be flowed down the supply chain
First article inspection requirementsFirst article inspection requirementsFormal requirement to validate the production processes, Formal requirement to validate the production processes, documentation and tooling + repeat the process when necessary documentation and tooling + repeat the process when necessary (engineering or manufacturing processes changes). (engineering or manufacturing processes changes).
Control of work transfersControl of work transfersMust have a process to plan and control the transfer activitiesMust have a process to plan and control the transfer activities
9100 9100 –– Main proposed changesMain proposed changes
Clarifications
Orlando Page 17
Requirements already covered by Requirements already covered by ““contractcontract”” or or ““regulatory requirementsregulatory requirements”” (redundancy)(redundancy)
Availability of QMS documentation or records for customers or Availability of QMS documentation or records for customers or regulatory authoritiesregulatory authoritiesRecords available to customers or regulatory authoritiesRecords available to customers or regulatory authorities
Not justified requirement for all the organizationsNot justified requirement for all the organizationsAcceptability of selected internal audit tools Acceptability of selected internal audit tools Periodic validation of test reports for raw materialPeriodic validation of test reports for raw material
9100 9100 –– Main proposed changesMain proposed changes
Removed
Orlando Page 18Guy DION – Requirements Strategy Stream Leader
““ 9110 9110 ””
–– Maintenance QMS Standard Maintenance QMS Standard ––
Leader: Vince BartramLeader: Vince Bartram
Orlando Page 19
9110 Standard 9110 Standard –– 2009 Revision2009 Revision
Initiative Summary:Initiative Summary:Revise and align with the next revision of IAQG 9100Revise and align with the next revision of IAQG 9100Review scope and identify stakeholder needsReview scope and identify stakeholder needs
Status
GreenPhase 0 Phase 1 Phase 2 Phase 3
Progress
Orlando Page 20
9110: Progress Since Last Report9110: Progress Since Last Report
Survey sent to 9110 certificated Survey sent to 9110 certificated organizations listed in OASIS organizations listed in OASIS -- 88--2727
Orlando 9110 Meeting Orlando 9110 Meeting –– Preliminary Review of Preliminary Review of ISO/9100 changesISO/9100 changes–– Reviewed Reviewed 9110 unique requirements9110 unique requirements–– APAQGAPAQG now has Team representative now has Team representative –– Agreed to Agreed to meet meet during AAQG conferenceduring AAQG conference
((March 11March 11--13)13)
Orlando Page 21Guy DION – Requirements Strategy Stream Leader
““ 9120 9120 ““
–– Distributor QMS Standard Distributor QMS Standard ––
Leader: Dale GordonLeader: Dale Gordon
Orlando Page 22
IAQG 9120 Standard IAQG 9120 Standard -- 2009 Revision2009 Revision
Initiative Summary:Initiative Summary:Revise 9120 to incorporate ISO 9001:2008 changesRevise 9120 to incorporate ISO 9001:2008 changesRevise 9120 to incorporate 9100:2008 changesRevise 9120 to incorporate 9100:2008 changesAnalyze needs of 9120 Stakeholders and add/revise Analyze needs of 9120 Stakeholders and add/revise requirementsrequirements
Status
GreenPhase 0 Phase 1 Phase 2 Phase 3
Progress
Orlando Page 23
9120: Progress Since Last Report9120: Progress Since Last Report
Writing SubWriting Sub--Team meeting Team meeting –– 21 Aug.21 Aug.–– First 9120 draftFirst 9120 draft preparedprepared
Orlando 9120 meeting:Orlando 9120 meeting:–– Full TeamFull Team review of first 9120 draftreview of first 9120 draft–– Plan for a Plan for a ““coordination draftcoordination draft”” to be prepared and to be prepared and
routed to stakeholders for commentrouted to stakeholders for comment–– Reviewed new ISO 9001 Reviewed new ISO 9001 scheduleschedule
(TC176 changed their estimated release date from(TC176 changed their estimated release date from2Q 2009 to 4Q 2008)2Q 2009 to 4Q 2008)
–– Kept 9120 schedule Kept 9120 schedule to release in 1Q 2009to release in 1Q 2009
Orlando Page 24Guy DION – Requirements Strategy Stream Leader
“ 9115 “
–– Software QMS Standard Software QMS Standard ––
Leader: Michelle PierceLeader: Michelle PierceFormer Leader: Giovanni Former Leader: Giovanni CalcagniCalcagni
Orlando Page 25Guy DION – Requirements Strategy Stream Leader
IAQG 9115 StandardIAQG 9115 StandardInitiative Summary:Initiative Summary:
To establish software quality management requirements To establish software quality management requirements for the Aerospace and Defense industry for deliverable for the Aerospace and Defense industry for deliverable embedded or loadable software products embedded or loadable software products
To harmonize the content of AS9006 with the content of To harmonize the content of AS9006 with the content of ISO 12207:2007 and other applicable standards, ISO 12207:2007 and other applicable standards, retaining the 9100 frameworkretaining the 9100 framework
Phase 0 Phase 1 Phase 2 Phase 3Status
Orlando Page 26Guy DION – Requirements Strategy Stream Leader
9115: Progress Since Last Report9115: Progress Since Last Report
Rough Draft generated from analysis ofRough Draft generated from analysis ofISO 12207 ISO 12207 (Birmingham)(Birmingham)
Additional comments received and reconciled Additional comments received and reconciled (Orlando)(Orlando)
Draft Reviewed for flow, terminology and Draft Reviewed for flow, terminology and inconsistencies inconsistencies (Orlando)(Orlando)
Next Meeting: Review comments from Internal Next Meeting: Review comments from Internal Review on DraftReview on Draft
Orlando Page 27Guy DION – Requirements Strategy Stream Leader
IAQG & REQ-008 Team Meetings Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Jan Feb Mar Apr
Stakeholder Input
Analysis/Draft/Ballot/Release
Collect Input(Stakeholder&
Supplier)
2006 2007 2008 2009
10/2 3/15
IAQG Melbourne
Req.008 Team - Seville
IAQG OrlandoIAQG Seville
Req.008 Team - Yokohama
InputAnalysis(8/30)
IAQG Naples IAQG Yokohama
Prepare a DraftStandard
(9/15)
2nd Draft Standard preparation
and collectionof comments
(4/31)
Release for Publication
10/0309/29
10/0309/29
Req.008 Team - Orlando10/1210/8
Req.008 Team - Naples4/184/15
4/184/1510/1210/84/194/16
10/410/3
10/610/3
IAQG Gate 0 Approval
4/6
Req.008 Team - Vancouver3/73/6
IAQG Gate 1Approval
(04/18) IAQG Gate 3(06/- -)
Analysis of existingstandards
2/28
Draft StandardAnalysis(10/10) Disposition
Comments(01/31)
Req.008 Team - Birmingham06/2706/26
9115 Initiative Program - new
Req.008 Team - Arizona04/--
04/-- 04/--
04/--
Req.008 Team - Arizona
Req.008 Team - TBD
02/--01/--
Req.008 Team - TBD
07/--07/--
Req.008 Team - TBD
02/--01/--
Final Standardpreparation
(1/31)
DispositionComments
(7/31)
IAQG Gate 2(10/- -)
Orlando Page 28Guy DION – Requirements Strategy Stream Leader
1.1. The 9115 Standard used as a The 9115 Standard used as a supplement to 9100supplement to 9100..If contractually flowed down, then customer will monitor If contractually flowed down, then customer will monitor compliance to the standardcompliance to the standard
2.2. When audited against 9100, if software is being developed, When audited against 9100, if software is being developed, then 9115 should be utilized to then 9115 should be utilized to aid in theaid in the interpretation of interpretation of 9100 for software9100 for software
3.3. In the future, consider investigating the potential of aIn the future, consider investigating the potential of a9115 certification scheme9115 certification scheme under the OPMT responsibilityunder the OPMT responsibility(like(like 9100 certification scheme) 9100 certification scheme) with recognition in OASISwith recognition in OASIS
Proposal for utilization of 9115
Orlando Page 29Guy DION – Requirements Strategy Stream Leader
““ 9101 9101 ““
–– Audit Process Standard Audit Process Standard ––
(9111, 9121)(9111, 9121)
Leader: Hans LuijtLeader: Hans Luijt
Orlando Page 30Guy DION – Requirements Strategy Stream Leader
Initiative Summary:Initiative Summary:Amend 9101 Assessment standard in order Amend 9101 Assessment standard in order to enhance to enhance its clarity and compatibility with process based its clarity and compatibility with process based management QMS (ISO 9001) and IAQG 9100 Standard management QMS (ISO 9001) and IAQG 9100 Standard update to be published end 2008update to be published end 2008””. .
Phase 0 Phase 1 Phase 2 Phase 3Status
9101: Audit Process Standard
Orlando Page 31Guy DION – Requirements Strategy Stream Leader
Status:–– IAQG Council Gate 0 approval received in SevilleIAQG Council Gate 0 approval received in Seville–– Meetings organised in 2007 :Meetings organised in 2007 :
•• January 16January 16--18, in Paris18, in Paris•• May 20May 20--24, in Montreal 24, in Montreal
–– Work to continue in Toulouse Work to continue in Toulouse (planned Nov 2007)(planned Nov 2007)
Stakeholder Survey– available on OASIS and IAQG web sites (March_April 2007)– approx. 130 answers received – first conclusions discussed
Design Specification– established and validated by the team
9101: Audit Process Standard
Orlando Page 32Guy DION – Requirements Strategy Stream Leader
Process Audit Methodologies– Definition agreed of the QMS audit steps
(basis : new ISO 17021)– Detail of activities for each audit step have been identified
Audit Practice material review– From ISO TC176 Audit Practices Group– Relevancy of material determined
Consideration for scoring– Present scoring is not really used:
• Proposal is to delete the present scoring,(negative cost/benefit ratio)
• Too early to use the CMMI/SCMH model scoring as replacement
9101: Audit Process Standard
Orlando Page 33Guy DION – Requirements Strategy Stream Leader
2007 2008 2009
WG Kick offSuresnes FranceJan. 16-18
StakeholderSurvey March 15-April 15
WG MeetingMontreal CanadaMay 22-24
1st Draft 9101Oct., 2007
Feedback /Coordinationof 1st Draft March, 2008
Pilot ProjectsJan.-Feb., 2008
Gate 1 BallotingApril, 2008
WG MeetingNov., 2007
WG MeetingTBD-Reserve
Training DevelopmentApril., 2008-November 2008
IAQG Gate 0ApprovalSeville, SpainOct 5, 2006
ReleaseNovember, 2008
Target is to release 9101 and training materialin conjunction with 9100 -
October 2007 meeting postponed to November, Target is still to have first working draft ready end of this year
9101: Audit Process Standard
Orlando Page 34Guy DION – Requirements Strategy Stream Leader
IAQG Certification SchemeImprovement
Orlando Page 35Guy DION – Requirements Strategy Stream Leader
Documents Relationships
9120 (Distributors)9110 (Maintenance)
9100 (General) 9101Audit Process
9100 Guidance Material
ICO
P : Certification Schem
eB
est practices
QMS Requirements
9103Key Charact.
Oversight of Certification Scheme9104-1 (organization) 9104-2 (surveillance) 9104-3 (auditors)
9102FAI
9107DDA
9114Direct ship.
9131Non conf.
91XX……..
REQ
UIR
EMEN
TSSt
rate
gy S
trea
mSU
PPY
CH
AIN
Stra
tegy
Str
eam
Oth
er P
arty
M
anag
tSys
tem
Maintenance of standards issued by IA
QG
(IAQ
G103)
People Capability documents : dictionary…
Peop
le
Cap
abily
Stra
tegy
St
ream
Guides
Supply Chain Management HandbookSales,MasterScheduling
& Sequencing
ContractRequirt. & Flow down
Design and
Developt.
Capacity planning & scheduling
Manufact.and
inspection
Operational managt and
product validation
Non conf, corrective preventive
actions
Order Managt & logistic
Customer Support
Supplier sourcing selection
& approval
.
Orlando Page 36Guy DION – Requirements Strategy Stream Leader
Orlando Page 37Guy DION – Requirements Strategy Stream Leader
Certification Scheme ImprovementCertification Scheme Improvement
In progress :In progress :9100 Updated9100 Updated > REQ Strategy Stream
9101 Audit process9101 Audit process > REQ Strategy Stream
Proposals :Proposals :Enhancement of auditors qualification Enhancement of auditors qualification
•• interview of the candidatesinterview of the candidates•• exam for the candidatesexam for the candidates
Extension of audit durationExtension of audit duration> IAQG Other Party Management Team
Improvement of ICOP robustnessImprovement of ICOP robustness•• permanent staff (1 full time person per sector)permanent staff (1 full time person per sector)
> IAQG Strategy WG and> IAQG Other Party Management Team
Orlando Page 38Guy DION – Requirements Strategy Stream Leader
Questions?Questions?
Questions for Requirements Strategy Stream ?