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9100 revision 2016Changes presentationclause-by-clauseIAQG 9100 TeamFebruary 2017The IAQG is a legally incorporated international not for profit association(INPA) with membership from the Americas, Europe and the Asia Pacific Region

9100 revision 2016INTRODUCTIONIn September 2016, a revision of the 9100 standard has been publishedby the IAQG (International Aerospace Quality Group)The 9100 standard is based on the ISO 9001 standard, with specificrequirements for the Aviation, Space and Defense Industry. Its revisionincludes the ISO 9001 content published in September 2015.A “key changes presentation” from the 9100:2009 to the 9100:2016is available on the IAQG web site. It provides general information about themain changes introduced in the ISO 9001 content and in the 9100additions.This presentation complements the previous one. It is organized clause byclause and is more intended for experts.The IAQG is a legally incorporated international not for profit association(INPA) with membership from the Americas, Europe and the Asia Pacific RegionOctober 20162

What is 9100?ISO 9001:2015 Baseline Text9100 SeriesInterna.onal Avia.on,Space and DefenseQuality RequirementsADDITIONAL REQUIREMENTS- Opera1ons Risk Management- Product Safety- Special Requirements- Cri1cal Items- Configura1on Management- On Time Delivery- Counterfeit Parts- Expanded requirements for produc1onand external providersThe IAQG is a legally incorporated international not for profit association(INPA) with membership from the Americas, Europe and the Asia Pacific RegionOctober 2016ISO 9001Quality Management System3

9100 revision 2016The “ISO 9001” needed to change, to:– Adapt to a changing world– Enhance an organization's ability to satisfy its customers– Provide a consistent foundation for the future– Reflect the increasingly complex environments in whichorganizations operate– Ensure the new standard reflects the needs of all interestedparties– Integrate with other management systemsThe IAQG is a legally incorporated international not for profit association(INPA) with membership from the Americas, Europe and the Asia Pacific RegionOctober 20164

9100 revision 2016The “9100” needs to change, to:– Incorporate changes made by ISO TC176 tothe ISO 9001:2015 requirements(ISO liaison organized to collaborate with the IAQG 9100 team and toobtain consideration for IAQG requirements)– Consider Aviation, Space and Defense stakeholders’ needsidentified since the last revision(web survey performed in 2013)– Consider clarifications to 9100 series requests issued by IAQGsince the last revision(requirements clarified or notes added)The IAQG is a legally incorporated international not for profit association(INPA) with membership from the Americas, Europe and the Asia Pacific RegionOctober 20165

9100 revision 2016In the following slides, the changes are identified by:§ ISO 9001 § 9100 additions (specific to AS&D: Aviation, Space & Defense)Additional slides provide more information on topics identified withüüüüüüInterested partiesScope of a QMSQuality manualOrganizational knowledgeAwarenessDocumented informationThe IAQG is a legally incorporated international not for profit association(INPA) with membership from the Americas, Europe and the Asia Pacific RegionüüüüüRisk managementProduct safetyPrevention of counterfeit partsEvaluation of test reportsHuman factorsOctober 20166

9100 revision 2016Summary of changes - clause by clauseForeword, Revision summary/Rationale, Intended applicationIntroduction0.1 GeneralIncludes verbal significations of“shall, should, may, can”0.2 Quality management principles0.3 Process approachPlan-Do-Check-Act cycleRisk-based thinking0.4 Relationship with othermanagement system standards7 principles to considerSchematic representations of:- a process- the standard (with a PDCA approach)Requirements1. Scope2. Normative references3. Terms and definitions§§§§§Special requirementsCritical itemsKey characteristicCounterfeit partProduct safetyDefinition addedDefinition addedThe IAQG is a legally incorporated international not for profit association(INPA) with membership from the Americas, Europe and the Asia Pacific RegionOctober 20167

9100 revision 2016Summary of changes - clause by clause4. Context of the organization4.1 Understanding the organizationand its context4.2 Understanding the needsand expectations of interested parties4.3 Determining the scope of the qualitymanagement system4.4 Quality management systemand its processesDetermine relevant external issues (legal,technological, competitive, market, cultural, social,and economic environments)and internal issues (values, culture, knowledge, andperformance of the organization)Determine relevant interested parties and theirrequirements (such as customers, partners,authorities)Document the scope of the QMS and justification forany case where a requirement cannot be applied(exclusion)Define the documented information to be maintainedor to be retained “to the extent necessary”Explicit requirement for a documentedinformation maintained with content defined(can be called quality manual) (not required by ISO)The IAQG is a legally incorporated international not for profit association(INPA) with membership from the Americas, Europe and the Asia Pacific RegionOctober 20168

9100 revision 2016More information about Interested partiesDefinition (ISO 9000)§ stakeholder§ person or organization that can affect, be affected by, or perceive itself to beaffected by a decision or activityExamples of interested parties:§§§§employees, management, organization owners, unionssuppliers, customers, partnersregulatory authorities (Aviation, Space, Defense)certification organizations, Criteria to determine interested parties relevancy, requirements and clauseapplicability:§ Tier level in the supply chain: Original Equipment Manufacturers, ProductionApproval Holders / Design Organization Approval / Production OrganizationApproval, Systems integrators§ Product families: raw materials, components, assemblies§ Activity: distribution, design, maintenance, manufacturing, serviceThe IAQG is a legally incorporated international not for profit association(INPA) with membership from the Americas, Europe and the Asia Pacific RegionOctober 20169

9100 revision 2016More information about Scope of the QMS9100:2016 no longer refers to “exclusions” in relation to the applicability of itsrequirements to the organization’s quality management system.The applicability of each requirement of the standard depends on:§§§§the size or complexity of the organizationthe management model of the organizationthe range of the organization’s activitiesthe nature of the risks and opportunities for the organizationThe organization can decide that a requirement is not applicable,only if this decision will not result in failure to achieve:§ conformity of products and services§ enhancement of customer satisfactionJustifications must be provided for non applicabilityFor AS&D, non applicability outside clause 8 (Operation) would be unusualThe nega1ve word « exclusion » is not usedThe posi1ve word « applicability » is preferredThe IAQG is a legally incorporated international not for profit association(INPA) with membership from the Americas, Europe and the Asia Pacific RegionOctober 201610

9100 revision 2016More information about Quality Manual§ The 9100 requires to establish and maintain documented informationdescribing: Interested Parties; QMS Scope; Process Description, Sequence &Interactions; and Responsibilities and Authorities.§ The requirement can be met in different ways: document, webpages, CD Rom,electronic document management system, etc.§ The intent of the AS&D note “The above description of the quality management system canbe compiled into a single source of documented information and referred to as a quality manual.” isØ to convey the practicality to maintain the required information in a centralized locationfor ease of audit and availability for customers and other interested partiesØ to highlight that this documented information may or not, be called a quality manual.(terms “management handbook” or “company management manual” are often used).NOTE: A document called “quality manual” may be required for the organization by relevantinterested partiesThe IAQG is a legally incorporated international not for profit association(INPA) with membership from the Americas, Europe and the Asia Pacific RegionOctober 201611

9100 revision 2016Summary of changes - clause by clause5. Leadership5.1 Leadership and commitmentLeadership instead of only management ofresponsibilities (management to demonstrate theirleadership)5.2 PolicyTop management to ensure integration of QMS intobusiness processes (now explicit)5.3 Organizational roles,responsibilities and authoritiesPolicy aligned with organization strategic directionA “management representative” required as focalpoint for QM issues (removed from ISO 9001:2015)6. Planning6.1 Actions to address risks andopportunities6.2 Quality objectives andplanning to achieve them6.3 Planning of changesDetermine risks and opportunities, considering theissues raised and requirements identified.Plan appropriate actions to reduce undesired effectson the QMS and evaluate effectivenessPlanning the achievement of objectives moreprescriptive and includes the evaluation of resultsChanges to the QMS to be carried out in a plannedmannerThe IAQG is a legally incorporated international not for profit association(INPA) with membership from the Americas, Europe and the Asia Pacific RegionOctober 201612

9100 revision 2016Summary of changes - clause by clause7. SupportEnvironment includes human and physicalfactors7.1 Resources7.1.1 General7.1.2 People7.1.3 Infrastructure7.1.4 Environment for the operation ofprocesses7.1.5 Monitoring and measuring resources7.1.6 Organizational knowledge7.2 CompetenceAdded the requirement for persons to beaware of: their contribution to product or service conformity their contribution to product safety the importance of ethical behaviorDetermine the external communications relevantto the QMS7.3 Awareness7.4 Communication7.5 Documented information7.5.1 General7.5.2 Creating and updating7.5.3 Control of documented informationThe IAQG is a legally incorporated international not for profit association(INPA) with membership from the Americas, Europe and the Asia Pacific RegionDetermine necessary knowledge gained fromexperience, lessons learned, success,failures, conferences, October 2016New terminology (replacing “documents” and“records”)No requirement for 6 mandated procedures, butstill a requirement to identify the documentedinformation & processes needed for the QMSAdded the requirement to define “dataprotection processes” for documentedinformation managed electronically13

9100 revision 2016More information about Organizational knowledgeKnowledge specific to the organization is gained by experience.Rationale:§ To safeguard the organization from loss of knowledge, e.g., through staff turnover failure to capture and share informa1on§ To encourage the organization to acquire (e.g., learning from experience,benchmarking .) and share knowledge (e.g. mentoring of newcomers);Implementation consideration§ Activities to benefit from lessons learned, e.g., database, communications,incorporation of lessons learned in processes and procedures§ Identification of experts able to transfer knowledge, on job training, tutorialsessions§ Implement succession planning activitiesThe IAQG is a legally incorporated international not for profit association(INPA) with membership from the Americas, Europe and the Asia Pacific RegionOctober 201614

9100 revision 2016More information about Awareness§ The 9100:2016 requires the employees aware of:ü their contribution to product or service conformityü their contribution to product safetyü the importance of ethical behavior§ Awareness activities can be performed in different ways: direct communication of expectations between managers and employees communication campaigns on dedicated topics, e.g., posters, pamphlets,fliers, newsletters, videos identification of focal points with responsibility for communication andpromotion formal training§ What is expected: individuals should be able to explain their own role, how they contribute to qualityquality basics (follow instructions, report events, maintain records )individuals know the use of the products and potential impact of failuresThe IAQG is a legally incorporated international not for profit association(INPA) with membership from the Americas, Europe and the Asia Pacific RegionOctober 201615

9100 revision 2016More information about “importance of ethical behavior”§ Organizations should make their own determination of what isimportant to communicate to their employees in regard to ethics§ Below some examples:ü Establishing a culture where employees understand their responsibilitiesü Managers listening to employees and effectively recognizing their work (inaddition it can help boost productivity)ü Reporting and not passing on defects or non conformances (e.g., linestoppage as appropriate, recalling delivered non conforming product, .)ü A culture allowing unethical behavior can breed all manner of damagingand even criminal activityü Respect the laws, regulations, internal rules, regarding e.g. : conflict ofinterests, export compliance regulations, intellectual property agreements,acceptance or proposals of gifts, invitations or favors with customers andsuppliersThe IAQG is a legally incorporated international not for profit association(INPA) with membership from the Americas, Europe and the Asia Pacific RegionOctober 201616

9100 revision 2016More information about Documented informationThere is no longer a requirement for six mandatory documented procedures inthe ISO 9001:2015, however the extent of the documentation that is needed willdepend on the business context.§ It is the responsibility of the organization to maintain documented informationto support the operation of its processes:Ø Topics to be documented: Interested parties; QMS scope; Process description, sequence & interactions;Responsibilities and authorities Quality Policy and ObjectivesØ AS&D requires maintained documented information regardingnonconformity and corrective action management processesas it is a key process for aerospace.Ø Various methods can be used to meet the requirement(e.g., procedures, process flow diagrams, videos, graphic instructions, screen shots,etc.)§ It is the responsibility of the organization to retain the documented informationnecessary to have confidence that the processes are being carried out asplanned.17The IAQG is a legally incorporated international not for profit association(INPA) with membership from the Americas, Europe and the Asia Pacific RegionOctober 2016

9100 revision 2016Summary of changes - clause by clause8.1 Operational planning and controlProject Management (9100:2009 clause 7.1.1) andControl of Work Transfers (9100:2009 clause 7.1.4)no more separated clauses but incorporated inclause 8.1 (with risk concept introduced for worktransfer) and clarified8.1.1 Operation risk managementReinforce the planning and control activitieswith dispositions8. Operation8.1.2 Configuration management8.1.3 Product safety to ensure On-Quality and On-Time deliveryof products or services to prevent delivery of nonconformingproducts and services to ensure involvement of representativesfrom all functions8.1.4 Prevention of counterfeit partsPromoting in a note the implementation of“integrated phased processes” as a method toachieve operational planning and controlThe IAQG is a legally incorporated international not for profit association(INPA) with membership from the Americas, Europe and the Asia Pacific RegionOctober 201618

9100 revision 2016Summary of changes - clause by clause8. Operation8.1 Operational planning and controlBased on the requirements of 9100:2009 (7.1.1)this clause is related to risks in operationalprocesses defined in clause 8 (no major change)while 6.1 is related to risks in QMS of theorganization8.1.1 Operation risk management8.1.2 Configuration managementBased on the requirements of 9100:2009 (7.1.3),revised to clarify stakeholders expectations8.1.3 Product safety8.1.4 Prevention of counterfeit partsAdded new requirements to address “productsafety” considerations throughout the productlifecycleAdded new requirements to prevent the use ofcounterfeit or suspect counterfeit partsThe IAQG is a legally incorporated international not for profit association(INPA) with membership from the Americas, Europe and the Asia Pacific RegionOctober 201619

9100 revision 2016More information about Risk managementClause 6.1 is related to risks in “QMS of the organization”:§ Manage risks at organization / processes level(such as: new customers, new market, company partnerships, businesslocalizations, )Clause 8.1.1 is related to the risks in “Operational Processes”defined in clause 8:§ Implement a formal process to manage risks§ Adapt the process to the organization and the product(e.g. quantitative requirements and probabilistic risk analysis may be required insome cases ; determine people involved in this activity)§ Deploy the risks analysis within the operation activities(such as : contract review and signature, new technologiesintroduction, external providers selection, )The IAQG is a legally incorporated international not for profit association(INPA) with membership from the Americas, Europe and the Asia Pacific RegionOctober 201620

9100 revision 2016More information about Risk managementAnnex A.4 – ISO 9001– Risk--based thinking è the organization to understand its context anddetermine risks as a basis for planning– Key purpose of QMS is to act as a preventive tool, hence no separateclause on preventive action– Risk--based thinking has enabled some reduction in prescriptiverequirements and greater flexibility– There is no requirement for formal methods for risk managementAnnex A.4 – 9100 additions– Within Aviation, Space, and Defense (AS&D) , risk is expressed as acombination of severity and likelihood of having a potential negativeimpact to processes, products, services, customer, or end users.– Due to the complexity of AS&D processes, products, and services, andthe severity of the potential consequences of failures, a formal processto manage operational risks is requiredThe IAQG is a legally incorporated international not for profit association(INPA) with membership from the Americas, Europe and the Asia Pacific RegionOctober 201621

9100 revision 2016More information about Product safetyAddition§ New clause (8.1.3) on Product Safety, including requirements to addressproduct safety considerations throughout the product lifecycle (use the NOTE asguidance) revision for consistency of other clauses related to safety – 7.3, 8.1, 8.4.3 & 8.5.4§ A full Safety Management System (SMS) as defined by ICAO (InternationalCivil Aviation Organization) is not required by 9100, but the introduction of thisnew clause contributes to the SMS approachRationale§ Industry acknowledgement of the importance of increasing safety§ Recognition of the 9100 certifications by authorities is part of IAQG strategyDefinition§ “The state in which a product is able to perform to its designed or intendedpurpose without causing unacceptable risk of harm to persons or damage toproperty”The IAQG is a legally incorporated international not for profit association(INPA) with membership from the Americas, Europe and the Asia Pacific RegionOctober 201622

9100 revision 2016More information about Product safetyExamples of activities to consider:§ Assessment of hazards and mitigation of associated risks:ü Implement FMEA relating to product (DFMEA) and process (PFMEA)ü Perform safety analysisü Identify and mitigate risks relating to the organization and its personnel(human factors, management of responsibilities)§ Management of safety critical items:ü Define and implement a monitoring control plan for critical items identifiedthrough FMEA and safety analysisThe IAQG is a legally incorporated international not for profit association(INPA) with membership from the Americas, Europe and the Asia Pacific RegionOctober 201623

9100 revision 2016More information about Examples of activities to consider (cont.)Product safety§ Analysis and reporting of occurred events affecting safety:ü Organize the collection of potential and occurred events, and analyzetheir impacts with specialistsü Organize the internal escalation process and external reporting tointerested partiesü Analyze the adverse trends of products in service reliability and defineappropriate actions§ Communication of these events and training of personnel:ü Promote safety culture and lessons learned from occurred events(impacts of the parts delivered by the organization on the final product safety)ü Prevent occurrence of safety issues by taking into account industryexperience (including occurrences on other products with similar functions or based onsame technologies or components)The IAQG is a legally incorporated international not for profit association(INPA) with membership from the Americas, Europe and the Asia Pacific RegionOctober 201624

9100 revision 2016More information about AdditionCounterfeit parts prevention§ New clause (8.1.4) including requirements for prevention of counterfeit partsand a note giving examples of the associated processes revision of affected clauses: 8.4.2 ; 8.4.3 (external provisions) & 8.7 (nonconformities)Rationale§ Mitigate effects of growing threat of counterfeit / fraudulent product§ Recognize the emerging counterfeit/fraudulent statutory/regulatoryrequirements on QMS processesDefinition§ “An unauthorized copy, imitation, substitute, or modified part (e.g., material,part, component), which is knowingly misrepresented as a specified genuinepart of an original or authorized manufacturer.NOTE: Examples of a counterfeit part can include, but are not limited to, the falseidentification of marking or labeling, grade, serial number, date code, documentation, orperformance characteristics.”The IAQG is a legally incorporated international not for profit association(INPA) with membership from the Americas, Europe and the Asia Pacific RegionOctober 201625

9100 revision 2016More information about Processes to consider:Counterfeit parts prevention§ Training in the awareness and prevention of counterfeit partsü Procurement personnel in trusted source selec1on and requirementsü Inspec1on personnel for preven1on of counterfeit items (visual/test)ü Design personnel in obsolescence management§ Obsolescence monitoring è design decisions and parts selections to beappropriate for service life of product§ Controls for acquiring parts from original manufacturers, authorizeddistributors, or other approved sources§ Assuring traceability of parts and components to their original manufacturers :ü Original Equipment Manufacturer (OEM) orü Authorized manufacturer (e.g., in case of PMA, direct delivery authoriza1ons)The IAQG is a legally incorporated international not for profit association(INPA) with membership from the Americas, Europe and the Asia Pacific RegionOctober 201626

9100 revision 2016More information about Processes to consider:Counterfeit parts prevention§ Verification and test methodologies to detect counterfeit parts:ü Parts identification or markingü Tests or chemical analysis§ Counterfeit parts reportingü Monitoring reporting from external sources (access to databases,information letters from OEMs)ü Quarantine and reporting of internal incidences in appropriategovernment and industry reporting systems(determine the responsibilities in the escalation process, the process to follow toreport to authorities / customers)Requirement regarding non conformance control:ü Segregate and control suspected or known counterfeit productsü Ensure these products are not re-introduced into the supply chainThe IAQG is a legally incorporated international not for profit association(INPA) with membership from the Americas, Europe and the Asia Pacific RegionOctober 201627

9100 revision 2016Summary of changes - clause by clause8. Operation8.2 Requirements for products and services8.2.1 Customer communicationExtended to requirements regardingcontingency actions8.2.2 Determining the requirements relatedto products and servicesAdded consideration for the organization tomeet the claims for products and services8.2.3 Review of the requirements relatedto products and servicesAdded requirement that review shall becoordinated with applicable functions ofthe organization8.2.4 Changes to requirements for productsand servicesThe IAQG is a legally incorporated international not for profit association(INPA) with membership from the Americas, Europe and the Asia Pacific RegionOctober 2016Added requirement for actions in case ofnot meeting some customer requirements28

9100 revision 2016Summary of changes - clause by clause8. OperationClause re-structured to allow for a moreprocess orientated approachRequirement to maintain a “process”8.3 Design and developmentof products and servicesClear flexibility (nature, duration and complexity ) indetermining stages and controls8.3.1 General8.3.2 Design and development planning8.3.3 Design and development inputs8.3.4 Design and development controls8.3.5 Design and development outputs8.3.6 Design and development changesConsider documented information needed fordemonstration of compliance to requirementsAdded requirement to take account ofhandling obsolescence, where applicableEnsure monitoring and measuring devicesused for testing are properly controlledOutputs shall be approved by authorizedperson(s) prior to releaseAdded requirement for a process andcriteria for notifying customers, aboutchanges that affect customer requirementsThe IAQG is a legally incorporated international not for profit association(INPA) with membership from the Americas, Europe and the Asia Pacific RegionOctober 201629

9100 revision 2016Summary of changes - clause by clause8. Operation8.4 Control of externally providedprocesses, products and servicesNew terminology. Clause covering the previous“purchases” and “outsourcing”Externally provided processes include “outsourcedprocesses” (processes needed for the QMS, forwhich 4.4 applies in addition to 8.4).Explicit requirement for external providers toapply appropriate controls to their direct andsub-tier external providers, to ensure theconsistency in the whole supply chainNB: a sub-tier external provider means theexternal providers of a direct external provider ofan organization.8.4.1 General8.4.2 Type and extent of control8.4.3 Information for external providersAdded evaluation of data on test reportsprovided, to confirm the results comply withrequirementsAdded validation process of tests reportsaccuracy for raw materials identified as asignificant operational riskMore explicit topics to be considered tocommunicate requirements to externalprovidersThe IAQG is a legally incorporated international not for profit association(INPA) with membership from the Americas, Europe and the Asia Pacific RegionOctober 201630

9100 revision 2016More information about Requirements added back-in from previous 9100 versionEvaluation of data on test reportsRationale§ Avoid non compliance of test reports results with the requirementsImplementation§ Determine the products for which test reports will be required§ At receiving, check the test results are compliant before accepting the partsValidation process of tests reports accuracy for raw materialsRationale§ Inaccurate, incomplete or unduly altered test reports for raw materials haveintroduced undue risks on critical applicationsImplementation§ Determine the critical raw material for which this clause will apply (according tocustomers requirements or as design outputs, safety analysis outputs)§ Define the process to be applied (e.g. periodic scheduled retests performed onsamples)§ Apply the process and take necessary actionsThe IAQG is a legally incorporated international not for profit association(INPA) with membership from the Americas, Europe and the Asia Pacific RegionOctober 201631

9100 revision 2016Summary of changes - clause by clause8. Operation8.5 Production and service provision8.5.1 Control of production and serviceprovision8.5.2 Identification and traceability8.5.3 Property belonging to customers orexternal providers8.5.4 PreservationThis clause considers monitoring andmeasurement activities will ensure the control ofprocesses and outputs, and that acceptancecriteria for products and services are met.Review structure of sub-clauses:・ 8.5.1.1 “Control of equipment, tools and softwareprograms”・ 8.5.1.2 “Validation and control of special processes”・ 8.5.1.3 “Production process verification”New ISO clause (as per 9100:2009)8.5.5 Post-delivery activitiesClarified that when problems are detected afterdelivery the organization shall take appropriateactions8.5.6 Control of changesNew ISO clause to emphasize on this topic8.6 Release of products and servicesNew ISO clause to verify that all activities havebeen carried out before release and delivery byauthorized persons8.7 Control of nonconforming outputsOutputs including products and servicesThe IAQG is a legally incorporated international not for profit association(INPA) with membership from the Americas, Europe and the Asia Pacific RegionMaintained the requirement for a “procedure”to define the NC process and responsibilities32October 2016on this key topic for AS&D

9100 revision 2016Summary of changes - clause by clause9. Performance evaluation9.1 Monitoring, measurement, analysis andevaluation9.1.1 General9.1.2 Customer satisfaction9.1.3 Analysis and evaluation9.2 Internal auditExplicit topics to consider for the internal audi

requirements for the Aviation, Space and Defense Industry. Its revision includes the ISO 9001 content published in September 2015. A “key changes presentation” from the 9100:2009 to the 9100:2016 is available on the IAQG web site. It provides general information about the main changes introduced in the ISO 9001 content and in the 9100 .

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