iaqg 9110:2009 revision overview prepared by iaqg 9110 team please contact jeff wood at...

IAQG 9110:2009IAQG 9110:2009 Revision Overview Revision Overview

Prepared by IAQG 9110 TeamPrepared by IAQG 9110 TeamPlease contact Jeff Wood at Please contact Jeff Wood at [email protected] or

Jean-Francis Suquet at Jean-Francis Suquet at [email protected]@eurocopter.comfor questions or comments.for questions or comments.

Overview ObjectivesOverview Objectives

Provide an overview of:Provide an overview of:

• 9110 Team Membership9110 Team Membership

• 9110 Revision Process9110 Revision Process

• 9100:2009 Overview9100:2009 Overview

• 9110:2009 Key Changes (revised/relocated, 9110:2009 Key Changes (revised/relocated, additions, and deletions of requirements)additions, and deletions of requirements)

• 9110 Implementation Schedule9110 Implementation Schedule

• IAQG Document RelationshipsIAQG Document Relationships

9110 Team Membership9110 Team Membership

12 Members on 9110 Team12 Members on 9110 Team

Representing:Representing:

• Americas and Europe IAQG sectorsAmericas and Europe IAQG sectors

• 5 different countries5 different countries

• 8 different IAQG 8 different IAQG member companiesmember companies

• 3 different CBs3 different CBs

IAQG IAQG –– Global TeamGlobal TeamInternational Aerospace Quality GroupInternational Aerospace Quality GroupInternational Aerospace Quality Group

IAQGCouncil

General Assembly Forums

AAQG

(Americas)

EAQG

(Europe)

APAQG

(Asia & Pacific)

18 AAQG

members

33 EAQG

members

12 APAQG

membersEvery Major Aerospace company in the World

9110 Stakeholders9110 Stakeholders

Civil Aviation AuthoritiesCivil Aviation Authorities Defense Industry and AuthoritiesDefense Industry and Authorities AirlinesAirlines Certification BodiesCertification Bodies Trade AssociationsTrade Associations SuppliersSuppliers Maintenance Repair & Overhaul ProvidersMaintenance Repair & Overhaul Providers IAQG Member CompaniesIAQG Member Companies IAQG Strategy Streams and TeamsIAQG Strategy Streams and Teams

9110 Revision Objectives9110 Revision Objectives

Incorporate ISO 9001:2008 changesIncorporate ISO 9001:2008 changes

Incorporate 9100:2009 changes that are applicable to Incorporate 9100:2009 changes that are applicable to maintenance activities maintenance activities

Ensure clarity of requirements to resolve interpretation Ensure clarity of requirements to resolve interpretation issuesissues

Consider / address stakeholder needsConsider / address stakeholder needs

Promote industry standard and ensure that the standard Promote industry standard and ensure that the standard is compatible for use by all stakeholdersis compatible for use by all stakeholders

Prepare for the forthcoming Safety Management System Prepare for the forthcoming Safety Management System implementation requirements in accordance with implementation requirements in accordance with International Civil Aviation Organization (ICAO) directiveInternational Civil Aviation Organization (ICAO) directive

9110 Revision Process9110 Revision Process

Data Mining and ConsolidationData Mining and Consolidation- 136 items 136 items - 45 items accepted / 91 items rejected45 items accepted / 91 items rejected

Project Mgmt Design Specification & Objectives (initially drafted July 2006)

MCRTMCRT(Master Comments Review Template)


Stakeholder Stakeholder InputInput

Web SurveyWeb Survey Solicited stakeholder / industry input

9110 Coordination9110 CoordinationDraftDraft ReleasedReleased on 30 June 2008on 30 June 2008

9110 Revision Process9110 Revision Process

9110 9110 BallotBallotDraftDraft

9110 9110 BallotBallotDraftDraft

Expected release - June 2009



- Formal Ballot - November 2008- Development of deployment support materials

Data Mining and ConsolidationData Mining and Consolidation- 92 items 92 items - 22 items accepted / 70 items rejected22 items accepted / 70 items rejected

9110 9110 ReleaseRelease

9110 9110 ReleaseRelease

The 9110 revision was directly influenced by the The 9110 revision was directly influenced by the revision to ISO 9001 and IAQG 9100 standards; revision to ISO 9001 and IAQG 9100 standards; the applicable “9100 Revision Overview” slides have the applicable “9100 Revision Overview” slides have been integrated into this presentation to identify the key been integrated into this presentation to identify the key changes to this standardchanges to this standard

Revision Key ChangesRevision Key Changes• 9100 – (6) additions; (7) revisions / relocations; (3) deletions9100 – (6) additions; (7) revisions / relocations; (3) deletions• 9110 – (9) additions; (1) revision9110 – (9) additions; (1) revision

Structure of Key Changes SlidesStructure of Key Changes Slides• Revision / Relocation, Addition, or DeletionRevision / Relocation, Addition, or Deletion• RationaleRationale• Implementation / Audit ConsiderationsImplementation / Audit Considerations

9110 Change Overview9110 Change Overview

The ‘Key Changes’ are not inclusive of all the changes in the 9110 standard

Key Changes - Key Changes - Derived from 9100:2009Derived from 9100:2009

Clause 3.4 -Clause 3.4 - Critical ItemsCritical Items (9100 - clause 3.3)(9100 - clause 3.3)

• Addition:Addition: Defined new term - “critical item” Defined new term - “critical item” Those items (e.g., functions, parts, software, Those items (e.g., functions, parts, software,

characteristics, processes) having significant effect characteristics, processes) having significant effect on the product realization and use of the product; on the product realization and use of the product; including safety, performance, form, fit, function, including safety, performance, form, fit, function, producibility, service life, etc.producibility, service life, etc. that require specific that require specific actions to ensure they are adequately managed actions to ensure they are adequately managed

Examples of critical items include:Examples of critical items include:• safety critical itemssafety critical items• fracture critical itemsfracture critical items• mission critical itemsmission critical items• key characteristicskey characteristics


Clause 3.4 - Clause 3.4 - Critical ItemsCritical Items (cont.)(cont.)

• Rationale:Rationale: Improve understanding of “critical items” coming from Improve understanding of “critical items” coming from

“special requirements” “special requirements” Ensure these items are systemically addressed and Ensure these items are systemically addressed and

linked to risk management activities and processes linked to risk management activities and processes utilized by the organizationutilized by the organization

• Implementation / Audit Considerations: Implementation / Audit Considerations: Understanding this term is important to implement Understanding this term is important to implement “critical items” into applicable product realization “critical items” into applicable product realization processesprocesses


Clause 3.9 - Clause 3.9 - RiskRisk (9100 - clause 3.1)(9100 - clause 3.1)

• Addition:Addition: Defined new term - “risk” Defined new term - “risk” An undesirable situation or circumstance that has both An undesirable situation or circumstance that has both

a likelihood of occurring and a potentially negative a likelihood of occurring and a potentially negative consequenceconsequence

• Rationale:Rationale: The understanding of risk is importantThe understanding of risk is important for an for an

organization to develop a proactive quality organization to develop a proactive quality management systemmanagement system

• Implementation / Audit Considerations:Implementation / Audit Considerations: Understanding this term is important to support the Understanding this term is important to support the

implementation of a risk management processimplementation of a risk management process


Clause 3.11 -Clause 3.11 - Special RequirementsSpecial Requirements (9100 - clause 3.2)(9100 - clause 3.2)

• Addition:Addition: Defined new term - “special requirements” Defined new term - “special requirements” Those requirements which have high risks to being Those requirements which have high risks to being

achieved thus, requiring their inclusion in the risk achieved thus, requiring their inclusion in the risk management process management process

Factors used to determine “special requirements” Factors used to determine “special requirements” include:include:• product or process complexityproduct or process complexity• past experiencepast experience• product or process maturity product or process maturity

Examples include:Examples include:• performance requirements imposed by the customer performance requirements imposed by the customer

that are at the limit of the state-of-the-artthat are at the limit of the state-of-the-art• requirements determined by the organization to be at requirements determined by the organization to be at

the limit of their technical or process capabilitiesthe limit of their technical or process capabilities


Clause 3.11 -Clause 3.11 - Special RequirementsSpecial Requirements (cont.)(cont.)

• Rationale: Rationale: Improve understanding of “special requirements” and Improve understanding of “special requirements” and

the potential chain of flow to “critical items” and to the potential chain of flow to “critical items” and to “key characteristics” “key characteristics”

Ensure these important requirements are Ensure these important requirements are systemically addressed and linked to risk systemically addressed and linked to risk management activities by the organization management activities by the organization

• Implementation / Audit Considerations:Implementation / Audit Considerations: Understanding this term is important to identify and Understanding this term is important to identify and

integrate “special requirements” into a risk integrate “special requirements” into a risk management processmanagement process

7.1 Planning of Product Realization


7.4Purchasing -

Vendor / SupplierProvidedProducts

Statutory, regulatory and

other requirements

Customer requirements

includingrequirements identified as

special by the customer

7.2 Determination and Review of Requirements Related to the

Product

“Special Requirements” as determined by customer or organization

7.3 Design & Development

7.3.3.e critical items, including “Key

Characteristics”

7.5 Production &

Service Provision (drawings,

instructions, plans, etc.)

8.2.3 / 8.2.4 Monitoring & Measurement of Processes / Products8.4 Analysis of Data

8.5 Improvement (Continual Improvement, Corrective / Preventive Action)

Design Inputs

Design Outputs

7.1.2 Risk Management

Interrelationship between Special Requirements, Critical Items,Key Characteristics and Risk Management Process

7.5.1 appropriate

processes to manage

critical items

7.4.2 flow down

requirements to

suppliers


Clause 4.1 -Clause 4.1 - QMS General RequirementsQMS General Requirements• Revision / Relocation:Revision / Relocation:

The organization’s QMS shall address customer and applicable The organization’s QMS shall address customer and applicable statutory and regulatory QMS requirements (previously located statutory and regulatory QMS requirements (previously located in the QMS documentation § 4.2.1)in the QMS documentation § 4.2.1)

• Rationale: Rationale: Clarify that the requirement is placed at the QMS level and not Clarify that the requirement is placed at the QMS level and not

only at the documentation levelonly at the documentation level

• Implementation / Audit Considerations:Implementation / Audit Considerations: The concept of a “Basic QMS” (common processes and The concept of a “Basic QMS” (common processes and

associated documentation applicable to all customers / associated documentation applicable to all customers / activities) may be used, but the documentation (e.g., Quality activities) may be used, but the documentation (e.g., Quality Management Plans) which address specific customers Management Plans) which address specific customers requirements shall not be overlooked as it is a critical part of the requirements shall not be overlooked as it is a critical part of the QMSQMS


Clause 4.2.2 - Clause 4.2.2 - Quality Manual RelationshipsQuality Manual Relationships• Deletion:Deletion:

Requirement to create a document showing the Requirement to create a document showing the relationship between 9100 / 9110 requirements and relationship between 9100 / 9110 requirements and the organizations documented proceduresthe organizations documented procedures

• Rationale: Rationale: Requirement added no value to assuring product Requirement added no value to assuring product

qualityquality• Implementation / Audit Considerations:Implementation / Audit Considerations:

Auditors need to identify appropriate documented Auditors need to identify appropriate documented procedures as an inherent part of carrying out an procedures as an inherent part of carrying out an auditaudit


Clauses 5.2 / 8.2.1 -Clauses 5.2 / 8.2.1 - Customer Focus / SatisfactionCustomer Focus / Satisfaction• Addition:Addition:

Management responsibility for measuring “product conformity” Management responsibility for measuring “product conformity” and “on-time delivery” and for taking appropriate remedial and “on-time delivery” and for taking appropriate remedial actions (5.2)actions (5.2)

Requirement to evaluate customer satisfaction using Requirement to evaluate customer satisfaction using - product conformity and on-time delivery performance, - product conformity and on-time delivery performance, - customer complaints and corrective actions requests, - customer complaints and corrective actions requests, then develop plans that address deficiencies (8.2.1) then develop plans that address deficiencies (8.2.1)

• Rationale:Rationale: Establish clear relationship between the QMS and organizational Establish clear relationship between the QMS and organizational

performance, in line with IAQG strategy performance, in line with IAQG strategy To promote continual improvement of customer satisfactionTo promote continual improvement of customer satisfaction

• Implementation / Audit Considerations:Implementation / Audit Considerations: Evaluate management “customer focus” and associated Evaluate management “customer focus” and associated

organizational processes to evaluate / measure customer organizational processes to evaluate / measure customer satisfaction and planned improvementssatisfaction and planned improvements


7.1.1 - 7.1.1 - Project ManagementProject Management• Addition:Addition:

New requirement for planning and managing product realization New requirement for planning and managing product realization in a structured and controlled way to meet requirements at in a structured and controlled way to meet requirements at acceptable risk, within resource and schedule constraintsacceptable risk, within resource and schedule constraints

• Rationale:Rationale: Most aviation, space and defense products are complex and Most aviation, space and defense products are complex and

involve multi-tier partners and suppliers involve multi-tier partners and suppliers This clause provides additional focus on upfront planning and This clause provides additional focus on upfront planning and

the management of project plans throughout product realizationthe management of project plans throughout product realization

• Implementation / Audit Considerations:Implementation / Audit Considerations: Evaluate how the organization manages product realization Evaluate how the organization manages product realization

planning to ensure quality and schedule are not compromisedplanning to ensure quality and schedule are not compromised

7.1.2 - 7.1.2 - Risk ManagementRisk Management• Addition:Addition:

New requirement to implement a “risk management” process New requirement to implement a “risk management” process applicable to the product and organization covering: applicable to the product and organization covering: responsibility, criteria, mitigation and acceptance responsibility, criteria, mitigation and acceptance

The concept of “risk” is integrated within the revised standardThe concept of “risk” is integrated within the revised standard

• Rationale:Rationale: Risk management was placed in clause 7.1.2 to provide Risk management was placed in clause 7.1.2 to provide

additional focus on product “risk” during product realizationadditional focus on product “risk” during product realization

• Implementation / Audit Considerations:Implementation / Audit Considerations: Ensure the organization have a risk management process that Ensure the organization have a risk management process that

addresses all of the applicable requirementsaddresses all of the applicable requirements Ensure the definition of “risk” is understood and appropriately Ensure the definition of “risk” is understood and appropriately

applied in associated processesapplied in associated processes Evaluate that risks are identified and successfully managed Evaluate that risks are identified and successfully managed

within the organizationwithin the organization


7.1.3 - 7.1.3 - Configuration ManagementConfiguration Management• Revision / Relocation:Revision / Relocation:

Relocated content from clause 4.3 to 7.1.3.Relocated content from clause 4.3 to 7.1.3. Structured requirements consistent with ISO 10007Structured requirements consistent with ISO 10007

• Rationale:Rationale: Focuses “configuration management” on the product and Focuses “configuration management” on the product and

how it is sustained throughout product realization how it is sustained throughout product realization (maintenance process / activities)(maintenance process / activities)

Provided further process definition / requirementsProvided further process definition / requirements• Implementation / Audit Considerations:Implementation / Audit Considerations:

Configuration management processes should be adequate Configuration management processes should be adequate to ensure adequate configuration control of productto ensure adequate configuration control of product

Some level of “configuration management” is expected to Some level of “configuration management” is expected to exist within all organizations / levels of the supply chain; exist within all organizations / levels of the supply chain; see exclusion criteria (clause 1.2) see exclusion criteria (clause 1.2)



7.1.4 - 7.1.4 - Work TransferWork Transfer• Revision / Relocation:Revision / Relocation:

Relocated content from clause 7.5.1.4 to clause 7.1.4Relocated content from clause 7.5.1.4 to clause 7.1.4 The organization must have a process to plan and control work The organization must have a process to plan and control work

transfer activitiestransfer activities Expanded to cover permanent work transfer (e.g., from one Expanded to cover permanent work transfer (e.g., from one

organization facility to another, from one supplier to another, organization facility to another, from one supplier to another, from one supplier to another supplier)from one supplier to another supplier)

• Rationale:Rationale: Recognition the “work transfer” can occur at anytime during Recognition the “work transfer” can occur at anytime during

product realization (maintenance process / activities)product realization (maintenance process / activities) Work transfer processes should address common situations and Work transfer processes should address common situations and

associated problems that often occur during work transfer to associated problems that often occur during work transfer to minimize “risk” associated to product conformity and on-time minimize “risk” associated to product conformity and on-time delivery performancedelivery performance

• Implementation / Audit Considerations:Implementation / Audit Considerations: A process must exist to control the transfer of work, including A process must exist to control the transfer of work, including

planning and subsequent control of the transferplanning and subsequent control of the transfer


Clause 7.4.1 - Clause 7.4.1 - Recognition of Supplier Quality DataRecognition of Supplier Quality Data• Revision:Revision:

Added ‘Note’ to recognize that one factor that may be Added ‘Note’ to recognize that one factor that may be used during supplier selection and evaluation is used during supplier selection and evaluation is objective and reliable data from external sourcesobjective and reliable data from external sources

• Rationale:Rationale: Recognition that the industry trend is to use Recognition that the industry trend is to use

externally provided supplier performance data externally provided supplier performance data [e.g., Online Aerospace Supplier Information System [e.g., Online Aerospace Supplier Information System (OASIS)](OASIS)]

• Implementation / Audit Considerations:Implementation / Audit Considerations: ‘‘Guidance Note’ providedGuidance Note’ provided

Clause 7.4.1 -Clause 7.4.1 - Approval Status for SuppliersApproval Status for Suppliers• Revision:Revision:

Added and provided examples of “approval status” Added and provided examples of “approval status” (e.g., approved, conditional, disapproved)(e.g., approved, conditional, disapproved) and examples of and examples of “scope of approval” “scope of approval” (e.g., product type, process family, type (e.g., product type, process family, type of service)of service)

The organization must define the process for suppliers The organization must define the process for suppliers approval status decisions or changesapproval status decisions or changes

• Rationale:Rationale: Clarify that the conditions for using a supplier Clarify that the conditions for using a supplier

depends on its approval status depends on its approval status

• Implementation / Audit Considerations:Implementation / Audit Considerations: The process, responsibilities and authority must be The process, responsibilities and authority must be

defined for this process defined for this process



Clause 7.4.3 -Clause 7.4.3 - Validation of Test ReportsValidation of Test Reports• Deletion:Deletion:

Where the organization utilizes test reports to verify purchased Where the organization utilizes test reports to verify purchased product, the data in those reports shall be acceptable per applicable product, the data in those reports shall be acceptable per applicable specifications. The organization shall periodically validate test specifications. The organization shall periodically validate test reports for raw material.reports for raw material.

• Rationale:Rationale: Misunderstood concept that was frequently misappliedMisunderstood concept that was frequently misapplied Requirement not applicable to all stakeholders (especially small Requirement not applicable to all stakeholders (especially small

organizations) and for all types of productsorganizations) and for all types of products

• Implementation / Audit Considerations:Implementation / Audit Considerations: If an organization is making critical items where the material If an organization is making critical items where the material

chemical/physical requirements are important, are they verifying chemical/physical requirements are important, are they verifying test reports as part of their risk management process?test reports as part of their risk management process?


Clause 7.5.1.1 - Clause 7.5.1.1 - Maintenance Process VerificationMaintenance Process Verification• Revision / Relocation:Revision / Relocation:

Relocated content from clause 8.2.4.2 to 7.5.1.1 Relocated content from clause 8.2.4.2 to 7.5.1.1 Requirement to verify that new maintenance processes, documentation Requirement to verify that new maintenance processes, documentation

and tooling are capable of supporting maintenance activities; qualified and tooling are capable of supporting maintenance activities; qualified and approved by the customer and/or Authorityand approved by the customer and/or Authority

This process shall be repeated when changes occur that invalidate the This process shall be repeated when changes occur that invalidate the original resultsoriginal results (e.g., engineering or manufacturing processes changes) (e.g., engineering or manufacturing processes changes)

• Rationale:Rationale: Movement to clause 7 acknowledges that this requirement is not Movement to clause 7 acknowledges that this requirement is not

primarily a monitoring and measurement process, but a process used to primarily a monitoring and measurement process, but a process used to assure product realization capability under controlled conditionsassure product realization capability under controlled conditions

Allows justifiable exclusion (see clause 1.2)Allows justifiable exclusion (see clause 1.2)

• Implementation / Audit Considerations:Implementation / Audit Considerations: Evaluate process definition and effectivenessEvaluate process definition and effectiveness Validation of all requests for exclusion; ensure exclusions do not affect Validation of all requests for exclusion; ensure exclusions do not affect

the organization’s ability to provide conforming product and meet the organization’s ability to provide conforming product and meet applicable customer, statutory and regulatory requirementsapplicable customer, statutory and regulatory requirements


Clause 8.2.2Clause 8.2.2 -- Detailed Tools and TechniquesDetailed Tools and Techniques• Deletion: Deletion:

““Detailed tools and techniques shall be developed such as Detailed tools and techniques shall be developed such as check sheets, process flowcharts, or any similar method to check sheets, process flowcharts, or any similar method to support audit of the quality management system requirements. support audit of the quality management system requirements. The acceptability of the selected tools will be measured against The acceptability of the selected tools will be measured against the effectiveness of the internal audit process and overall the effectiveness of the internal audit process and overall organization performance.”organization performance.”

• Rationale:Rationale: Requirement was previously too prescriptiveRequirement was previously too prescriptive Reference to specific tools in a “such as” statement is more Reference to specific tools in a “such as” statement is more

appropriate as guidance materialappropriate as guidance material

• Implementation / Audit Considerations:Implementation / Audit Considerations: Methods / effectiveness measures remain intact in the ISO text Methods / effectiveness measures remain intact in the ISO text Tools and techniques may still be needed to support the audit Tools and techniques may still be needed to support the audit

processprocess


Clause 8.2.4 -Clause 8.2.4 - Sampling InspectionSampling Inspection• Revision:Revision:

““When the organization uses sampling inspection as a When the organization uses sampling inspection as a means of product acceptance, the sampling plan shall be means of product acceptance, the sampling plan shall be justified on the basis of recognized statistical principles justified on the basis of recognized statistical principles and appropriate for use (i.e., matching the sampling plan and appropriate for use (i.e., matching the sampling plan to the criticality of the product and to the process to the criticality of the product and to the process capability)”capability)”

• Rationale:Rationale: Further definition provided; numerous requests were Further definition provided; numerous requests were

received to enhance clause 8.2.4received to enhance clause 8.2.4

• Implementation / Audit Considerations:Implementation / Audit Considerations: Validate that recognized statistical principles were utilized Validate that recognized statistical principles were utilized

for sampling plan development / applicationfor sampling plan development / application Evaluate process used to determine ‘criticality’ of productEvaluate process used to determine ‘criticality’ of product

Key Changes - Key Changes - Specific to 9110:2009Specific to 9110:2009

Clause 1.2 - Clause 1.2 - ApplicationApplication• Addition: Addition: Bold / italic text clarifying standard industry applicationBold / italic text clarifying standard industry application

““This standard is intended for use by maintenance organizations whose This standard is intended for use by maintenance organizations whose primary business is providing maintenance, repair and overhaul services primary business is providing maintenance, repair and overhaul services for aviation commercial and military products; and for Original Equipment for aviation commercial and military products; and for Original Equipment Manufacturer (OEM) organizations with maintenance, repair and overhaul Manufacturer (OEM) organizations with maintenance, repair and overhaul operated autonomously or that are substantially different from their operated autonomously or that are substantially different from their manufacturing/production operations.manufacturing/production operations.

It is tailored for organizations with National Airworthiness Authority (NAA) It is tailored for organizations with National Airworthiness Authority (NAA) repair station certification and those that provide maintenance, repair and repair station certification and those that provide maintenance, repair and overhaul services for military aviation products; but the standard could overhaul services for military aviation products; but the standard could significantly benefit non-certificated maintenance organizations that significantly benefit non-certificated maintenance organizations that choose to adopt it.”choose to adopt it.”

• Rationale: Rationale: Text added to clarify industry application and promote Text added to clarify industry application and promote use by non-certificated maintenance organizationsuse by non-certificated maintenance organizations

• Implementation / Audit Considerations: Implementation / Audit Considerations: Purchasing process Purchasing process should consider flow down of 9110 QMS standard to suppliers should consider flow down of 9110 QMS standard to suppliers (certificated and/or non-certificated suppliers) (certificated and/or non-certificated suppliers)


Clause – Clause – 3.3 Counterfeit Part3.3 Counterfeit Part

3.12 Suspect Unapproved Part3.12 Suspect Unapproved Part• Addition:Addition: Defined new terms - “counterfeit part” and “suspect Defined new terms - “counterfeit part” and “suspect

unapproved part”unapproved part”

• Rationale: Rationale: Improve understanding of what constitutes a “counterfeit” or Improve understanding of what constitutes a “counterfeit” or

“suspect unapproved part”“suspect unapproved part” Further clarity provided to critical requirement defined in clause Further clarity provided to critical requirement defined in clause

7.4.1.g – “take appropriate measures to prevent the purchase of 7.4.1.g – “take appropriate measures to prevent the purchase of counterfeit and suspect unapproved parts”counterfeit and suspect unapproved parts”

• Implementation / Audit Considerations:Implementation / Audit Considerations: Understanding these terms is important to ensure that adequate Understanding these terms is important to ensure that adequate

measures are taken to ensure genuine parts are procured for measures are taken to ensure genuine parts are procured for maintenance activities; evaluate process and measures taken to maintenance activities; evaluate process and measures taken to identify and contain counterfeit or suspected unapproved partsidentify and contain counterfeit or suspected unapproved parts


Clause – 3.5 Clause – 3.5 Human FactorsHuman Factors• Revision:Revision:

Improve understanding of “human factors” Improve understanding of “human factors” ““The study of how humans behave physically and The study of how humans behave physically and

psychologically in relation to particular environments, products psychologically in relation to particular environments, products or services and the potential effect on safety. Recognition that or services and the potential effect on safety. Recognition that personnel performing tasks are affected by physical fitness, personnel performing tasks are affected by physical fitness, physiological characteristics, personality, stress, fatigue, physiological characteristics, personality, stress, fatigue, distraction, communication and attitude in order to ensure a safe distraction, communication and attitude in order to ensure a safe interface between the personnel and all other environmental interface between the personnel and all other environmental elements such as other personnel, equipment, facilities, elements such as other personnel, equipment, facilities, procedures and data.”procedures and data.”

• Rationale: Rationale: Further clarity / definition providedFurther clarity / definition provided • Implementation / Audit Considerations: Implementation / Audit Considerations: Understanding this Understanding this

term is important as “human factors” are evaluated / addressed for term is important as “human factors” are evaluated / addressed for maintenance processes / activitiesmaintenance processes / activities


Clauses: 8.4 – Clauses: 8.4 – Analysis of DataAnalysis of Data; ;

8.5.2 / 8.5.3 – 8.5.2 / 8.5.3 – Corrective / Preventive Action Corrective / Preventive Action • Addition: Addition: Analysis of “human factors” has been integrated into Analysis of “human factors” has been integrated into

these clauses / processesthese clauses / processes 8.4.e – the analysis of data shall provide information relating to 8.4.e – the analysis of data shall provide information relating to

human factor eventshuman factor events 8.5.2.j – define requirements for evaluating the need for action 8.5.2.j – define requirements for evaluating the need for action

based on human factors to ensure that nonconformities do not based on human factors to ensure that nonconformities do not recurrecur

8.5.3.f – define requirements for evaluating the need for action 8.5.3.f – define requirements for evaluating the need for action based on human factors to prevent occurrence of based on human factors to prevent occurrence of nonconformitiesnonconformities

• Rationale: Rationale: Human factors analysis should be used in the Human factors analysis should be used in the development and continual improvement of maintenance processesdevelopment and continual improvement of maintenance processes

• Implementation / Audit Considerations: Implementation / Audit Considerations: Ensure evidence that Ensure evidence that analysis of “human factors” are appropriately evaluated / appliedanalysis of “human factors” are appropriately evaluated / applied


Clause 3.10 – Clause 3.10 – Safety PolicySafety Policy • Addition: Addition: Defined new term - “safety policy”Defined new term - “safety policy”

““Management formally expressed commitment to Management formally expressed commitment to product product safetysafety. . This policy should reflect the organization’s philosophy This policy should reflect the organization’s philosophy of safety management and outlines the methods and processes of safety management and outlines the methods and processes that the organization will use to achieve desired safety that the organization will use to achieve desired safety outcomes”outcomes”

• Rationale:Rationale: Ensure understanding of this term; numerous new Ensure understanding of this term; numerous new

requirements associated to the “safety policy” have been requirements associated to the “safety policy” have been added to the standardadded to the standard

• Implementation / Audit Considerations:Implementation / Audit Considerations: Understanding of this term is important to the development and Understanding of this term is important to the development and

implementation of the organization’s “safety policy”implementation of the organization’s “safety policy” Ensure the organization’s “safety policy” is adequately definedEnsure the organization’s “safety policy” is adequately defined


Clauses (4.2.1, 5.1, 5.4.3, 5.6.1, 5.7, 7.1) – Clauses (4.2.1, 5.1, 5.4.3, 5.6.1, 5.7, 7.1) – Safety Policy and Safety ObjectivesSafety Policy and Safety Objectives

• Addition:Addition: Numerous new requirements associated to the “safety policy” and Numerous new requirements associated to the “safety policy” and “safety objectives” have been added to the standard“safety objectives” have been added to the standard

4.2.1.e – documented statements of a safety policy / objectives4.2.1.e – documented statements of a safety policy / objectives 5.1.f / .g – management commitment to safety policy / objectives5.1.f / .g – management commitment to safety policy / objectives 5.4.3 – management to ensure safety objectives are established at 5.4.3 – management to ensure safety objectives are established at

relevant functions / levels within the organizationrelevant functions / levels within the organization 5.6.1 – safety policy / objectives linked to “Management Review”5.6.1 – safety policy / objectives linked to “Management Review” 5.7 – safety policy requirements further defined5.7 – safety policy requirements further defined 7.1.g – safety objectives and requirements for the product integrated into 7.1.g – safety objectives and requirements for the product integrated into

planning of product realizationplanning of product realization

• Rationale:Rationale: Integrating requirements associated to “safety policy / objectives” Integrating requirements associated to “safety policy / objectives” is consistent with ICAO directive for implementation of a Safety Management is consistent with ICAO directive for implementation of a Safety Management System in maintenance organizationsSystem in maintenance organizations

• Implementation / Audit Considerations:Implementation / Audit Considerations: Ensure that safety policy / Ensure that safety policy / objectives have been developed, implemented, and are periodically reviewedobjectives have been developed, implemented, and are periodically reviewed


Clause 4.2.2 – Clause 4.2.2 – Quality Manual Quality Manual • Addition:Addition: The maintenance organization shall establish and The maintenance organization shall establish and

maintain a quality manual that includes a description of key maintain a quality manual that includes a description of key maintenance processes and procedures; these processes and maintenance processes and procedures; these processes and procedures are consistent with most sector Authority requirementsprocedures are consistent with most sector Authority requirements

• Rationale:Rationale: These processes and procedures are critical to the operation of These processes and procedures are critical to the operation of

an effective maintenance organizationan effective maintenance organization Although required by most sector Authorities, these Although required by most sector Authorities, these

requirements were added for emphasis to require application for requirements were added for emphasis to require application for non-certificated maintenance organizations that choose or are non-certificated maintenance organizations that choose or are required to implement the 9110 standardrequired to implement the 9110 standard

• Implementation / Audit Considerations:Implementation / Audit Considerations: Ensure that these processes and procedures are integrated into Ensure that these processes and procedures are integrated into

the maintenance organization’s quality manualthe maintenance organization’s quality manual Evaluate process performance and effectivenessEvaluate process performance and effectiveness


Clause 5.6 – Clause 5.6 – Management ReviewManagement Review• Addition:Addition: Expanded management review inputsExpanded management review inputs

“…“…assessing opportunities for improvement and need for assessing opportunities for improvement and need for changes to the safety policy and safety objectives”changes to the safety policy and safety objectives”

customer audit results and requests for corrective actioncustomer audit results and requests for corrective action ““the achievement, adequacy and effectiveness of the personnel the achievement, adequacy and effectiveness of the personnel

training program”training program” ““changes to Authority requirements that could impact the changes to Authority requirements that could impact the

organization”organization”

• Rationale:Rationale: Expanded management review inputs to ensure Expanded management review inputs to ensure top management visibility and that appropriate decisions and top management visibility and that appropriate decisions and actions are taken to address QMS / process performanceactions are taken to address QMS / process performance

• Implementation / Audit Considerations:Implementation / Audit Considerations: Ensure evidence these topics were management review inputsEnsure evidence these topics were management review inputs Evaluate process performance, and decisions and actions takenEvaluate process performance, and decisions and actions taken


Clause 6 – Clause 6 – Resource ManagementResource Management• Addition: Addition: Added requirements to strengthen text resource Added requirements to strengthen text resource

management to ensure safe completion of maintenance activitiesmanagement to ensure safe completion of maintenance activities 6.1 – system required to continually assess the availability of tools, 6.1 – system required to continually assess the availability of tools,

technical data and necessary qualified personneltechnical data and necessary qualified personnel 6.2.1 – personnel management expanded to ensure certificated personnel 6.2.1 – personnel management expanded to ensure certificated personnel

continue to maintain eligibility and process required for qualification and continue to maintain eligibility and process required for qualification and surveillance of non-certificated personnelsurveillance of non-certificated personnel

6.2.2 –6.2.2 – training program (initial and recurrent) , including personnel training training program (initial and recurrent) , including personnel training associated to human factors and relevant Authority requirements associated to human factors and relevant Authority requirements

6.3 – facility requirements away from an organization’s fixed location6.3 – facility requirements away from an organization’s fixed location

• Rationale:Rationale: Resource management is critical for effective completion Resource management is critical for effective completion of maintenance activitiesof maintenance activities

• Implementation / Audit Considerations:Implementation / Audit Considerations: Evaluate maintenance organization’s resource management Evaluate maintenance organization’s resource management

processes; ensure adequate process definition and evaluate processes; ensure adequate process definition and evaluate process effectivenessprocess effectiveness


Clause 7.5.1 – Clause 7.5.1 – Control of Production and Service ProvisionControl of Production and Service Provision• Addition: Addition: Added requirements associated to technical data and Added requirements associated to technical data and

equipment, tools and material equivalencyequipment, tools and material equivalency 7.5.1.h – provided further definition regarding use of technical data; “… 7.5.1.h – provided further definition regarding use of technical data; “…

technical data that has been approved, as applicable…, or that is technical data that has been approved, as applicable…, or that is acceptable to the Authority,”acceptable to the Authority,”

7.5.1 k - criteria for workmanship, specified in the clearest practical way…7.5.1 k - criteria for workmanship, specified in the clearest practical way…in accordance with applicable technical data,in accordance with applicable technical data,

7.5.1.o – “the equipment, tools and materials shall be those recommended 7.5.1.o – “the equipment, tools and materials shall be those recommended by the manufacturer of the article…and acceptable to the customer and/or by the manufacturer of the article…and acceptable to the customer and/or Authority.”Authority.”

• Rationale:Rationale: Added emphasis items to ensure these requirements are Added emphasis items to ensure these requirements are integrated with proper controls into maintenance activitiesintegrated with proper controls into maintenance activities

• Implementation / Audit Considerations: Implementation / Audit Considerations: Evaluate maintenance Evaluate maintenance organization’s processes associated to use of technical data and organization’s processes associated to use of technical data and equivalent equipment, tools and materials; ensure adequate process equivalent equipment, tools and materials; ensure adequate process definition and evaluate process effectivenessdefinition and evaluate process effectiveness

Proposed 9110 Proposed 9110 Implementation ScheduleImplementation Schedule

Actual IAQGPublicationDate?

+ 6Months

+ 18Months

+ 30Months

6 Months 12 Months 12 Months

DevelopAuditorTraining

Train Certification Bodiesand Auditors

All Companies toUpgrade to New Standardat Next Surveillance Audit

or Recertification

Maximum 30 month implementation from publication Maximum 30 month implementation from publication of both the 9110:2009 and 9101:2009 standardsof both the 9110:2009 and 9101:2009 standards

Earliest Opportunityfor Certification to

New Standard(i.e., the early adopters)

MaximumAllowedTime toUpgrade

In ClosingIn Closing

The 9110 Team Goals and Objectives were toThe 9110 Team Goals and Objectives were to:: Ensure extensive stakeholder involvement in revision effort by Ensure extensive stakeholder involvement in revision effort by

use of a project management approach to solicit input and use of a project management approach to solicit input and manage the revision; consider / address stakeholder needsmanage the revision; consider / address stakeholder needs

Promote industry standard and ensure that the standard is Promote industry standard and ensure that the standard is compatible for use by all stakeholders segments and by compatible for use by all stakeholders segments and by organizations of all types and sizesorganizations of all types and sizes

Provide emphasis on product and process improvement Provide emphasis on product and process improvement (e.g., risk management, critical items, project management)(e.g., risk management, critical items, project management)

Provide additional focus on IAQG strategies / objectives Provide additional focus on IAQG strategies / objectives (e.g., product conformity, on-time delivery performance)(e.g., product conformity, on-time delivery performance)

Prepare for the forthcoming Safety Management System Prepare for the forthcoming Safety Management System implementation requirements in accordance with International implementation requirements in accordance with International Civil Aviation Organization (ICAO) directiveCivil Aviation Organization (ICAO) directive

Ensure clarity of requirements to resolve interpretation issuesEnsure clarity of requirements to resolve interpretation issues

The key changes are not inclusive of all the changes in the 9110 standard

iaqg 9110:2009 revision overview prepared by iaqg 9110 team please contact jeff wood at...

Documents

revision overviewprepared

standardkey changes

revision overview slides

items rejected9110 releasethe

stakeholder industry

overview objectivesprovide

clarity of requirements

product realization