Automotive QMS Update IATF 16949:2016 March 2017

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Automotive QMS UpdateIATF 16949:2016March 2017

Background on the Revision Project Revision work began in December 2014 and was completed inAugust 2016 The team completed a 5-Phase approach to develop IATF 16949– Pre-plan; Analyze; Build; Validate; and Deploy Revision Work Team consisted of 17 global partners from 14organizations (IATF OEMs, National Associations, Oversight Offices)AIAGIAOBANFIAIATF FranceBMWJaguar Land RoverFCA US LLC (formerly Chrysler)PSA GroupFCA Italy S.p.A. (formerly Fiat)SMMTFordVDA QMCGMVW2

ISO/TS 16949 to IATF 16949New automotive standard: IATF 16949:2016 IATF 16949:2016 follows the high level structure of ISO 9001:2015 IATF 16949:2016 must be used in conjunction with ISO 9001:2015 Two (2) separate documents must be used to have all requirements IATF 16949 cannot be used as a stand-alone requirements document 282 shalls / 16 shoulds in IATF 16949(292 shalls / 16 shoulds in ISO/TS 16949)3

Unprecedented stakeholder input IATF launched a survey (via the National Associations) early June2015 soliciting feedback from over 2,000 key stakeholders:––––––OEMsSuppliers (all Tiers)Certification BodiesWitness AuditorsSubject Matter ExpertsOversight Offices Over 1,700 comments were received for consideration of updatesto ISO/TS 16949. Additionally, the IATF conducted a face to face review of the draftIATF 16949 standard in Rome, Italy in April 2016with CBs and supplier representatives.4

Changes to Drive Value & Credibility IATF members focused on the linkage between ISO/TS 16949Certification and Supplier/Client quality performance– Increased focus on operational performance and customerfeedback (customer scorecards/metrics)– IATF 16949 contains many former OEM Customer SpecificRequirements (CSRs)– Most of the changes occurred in areas where IATF OEM’sobserved weakness trends and systematic issues5

Communication ProcessIt was important to keep the industry informedabout the project, so regular updates wereposted to the IATF Global Oversight website.6

Legend of changes The IATF 16949Revision project teamevaluated the changesand rated them as: New Modified Carryover For today’s event, wewill be reviewing theNew and Modifiedrequirements7

ChangesSection 4.3.1: Determining the scope of the quality managementsystem – supplemental These requirements were originally included in ISO/TS16949:2009 Sections 1.1 and 1.2. They have been moved toSection 4 within IATF 16949. The requirement relating to supporting functions was revised toensure that supporting functions not only address the need toinclude support functions in the audit, but also to ensure thatthey are included in the scope of the QMS. In addition, any exclusion sought for design and developmentactivities, now in Section 8.3, has to be preserved as documentedinformation.8

ChangesSection 4.3.2: Customer-specific requirements Although the need to fulfill and satisfy customer-specificrequirements was already mentioned throughout the wholeISO/TS 16949 document, in IATF 16949 this requirementspecifically addresses the need to evaluate the customer specificrequirements and include them where applicable in theorganization's quality management system. This means that the supplier would need some sort of process toevaluate each of their customer’s customer-specificrequirements and determine exactly how (and where) it appliesto their organization's QMS, as applicable.9

ChangesSection 4.4.1.1: Conformance of products and processes This requirement was adopted based on IATF survey feedbackreceived It ensures two things:– that the supplier (organization) is responsible for the conformity ofoutsourced processes, and– that all products and processes meet all applicable requirements andexpectations of all interested parties To ensure conformance of all products and processes, theorganization would need to take a proactive approach to assessand address risks, and not rely only on inspection10

ChangesSection 4.4.1.2: Product safety New section with enhanced requirements that address currentand emerging issues the automotive industry is facing related toproduct and process safety. Organizations (suppliers) are required to have documentedprocesses to manage product-safety related products andprocesses.11

ChangesSection 4.4.1.2: Product safety This section includes identification of statutory requirements;identifying and controlling product-safety-related characteristicsboth during design and at point of manufacture; definingresponsibilities, escalation processes, reaction plans, and thenecessary flow of information including top management andcustomers; receiving special approvals for FMEAs and ControlPlans; product traceability measures; and cascading ofrequirements throughout the supply chain.12

ChangesSection 5.1.1.1: Corporate responsibility ISO 9001:2015 expanded the ISO 9001:2009 concept of managementresponsibility into a set of leadership behaviors to ensure an effectiveQMS. IATF 16949 includes the requirement for an anti-bribery policy, anemployee code of conduct, and an ethics escalation policy to addressincreasing market and governmental expectations for improvedintegrity in social and environmental matters in the automotiveindustry. This implies responsibility and empowerment at all levels andfunctions of the supplier/organization to follow an ethical approachand report any observed unethical behavior without fear of reprisal.13

ChangesSection 5.1.1.2: Process effectiveness and efficiency The requirement for a supplier/organization to review theirprocesses to ensure effectiveness and efficiency was covered inISO/TS 16949, Section 5.1.1. Based on survey feedback, the IATF strengthened therequirement to ensure that the results of process reviewactivities will now be included in management review. Process review activities need to include evaluation methodsand, as a result, implement improvements. The results of these steps would be an input to the managementreview process. Top management is thus performing a review ofthe process-specific reviews performed by the process owners.14

ChangesSection 5.1.1.3: Process owners ISO/TS 16949:2009 addresses management responsibility andauthority, but it does not explicitly mention that managementensure process owners understand their role and arecompetent. The IATF adopted this new requirement to ensure thatmanagement understands this expectation, by specificallyidentifying these process owners and ensuring they canperform their assigned roles. This requirement recognizes that process owners have theauthority and responsibility for activities and results for theprocesses they manage.15

ChangesSection 5.3.1: Organizational roles, responsibilities, andauthorities – supplemental This requirement was already part of ISO/TS 16949:2009.However, based on IATF survey feedback, the IATF adopted somemodifications to the requirement to address the need todocument assigned personnel responsibilities and authorities. Additionally, this clause now clarifies that the goal is not just toaddress customer requirements but also to meet customerrequirements fully. Personnel involved in capacity analysis, logistics information,customer scorecards, and customer portals now also need to beassigned and documented, per the requirements in this section.16

ChangesSection 5.3.2: Responsibility and authority for productrequirements and corrective actions Based on survey feedback, the IATF adopted someenhancements to the requirement originally included inISO/TS 16949 to explicitly make Top Management responsible forensuring conformity to product requirements and that correctiveactions are taken. IATF 16949 clarifies that there must be a process to inform thosewith the authority and responsibility for corrective action inorder that they ensure non-conforming product is identified,contained, and not shipped to the customer. This implies that the assigned personnel must be always availableto take prompt action to prevent release.17

ChangesSection 6.1.2.1: Risk analysis The need to identify, analyze, and consider actual and potentialrisks was covered in various areas of ISO/TS 16949. The IATF adopted additional requirements for risk analysisrecognizing the continual need to analyze and respond to riskand to have suppliers/organizations consider specific risksassociated with the automotive industry. Organizations would need to periodically review lessons learnedfrom product recalls, product audits, field returns and repairs,complaints, scrap, and rework, and implement action plans inlight of these lessons. The effectiveness of these actions should be evaluated, andactions integrated in to the organization's QMS.18

ChangesSection 6.1.2.2: Preventive action The IATF enhanced the requirement found in ISO/TS 16949 byintegrating what is considered to be a best practice in theautomotive industry. Organizations would need to implement a process to lessen theimpact of negative effects of risk, appropriate to the severity ofthe potential issues. Such a process would include: identifying the risk ofnonconformity recurrence, documenting lessons learned,identifying and reviewing similar processes where thenonconformity could occur, and applying lessons learned toprevent such potential occurrence.19

ChangesSection 6.1.2.3: Contingency plans The expanded requirement ensures the organization defines andprepares contingency plans along with a notification process tothe customer or other interested parties. Organizations would first take a systematic approach toidentifying and evaluating risk for all manufacturing processes,giving particular attention to external risk. Contingency plans would be developed for any of the outlineddisruption conditions -- interruption of externally providedproducts, processes, and services, recurring natural disasters, fire,or infrastructure-related disruptions. Customer notification is a mandatory step in any contingencyplan, unless there is no risk to deliver nonconforming product oraffect on-time delivery.20

ChangesSection 6.2.2.1: Quality objectives and planning to achieve them –supplemental ISO/TS 16949 included the importance of addressing customerexpectations in the NOTE to Section 5.4.1.1. The IATF enhancedthe requirement by requiring that it be done at all levelsthroughout the organization. In ensuring quality objectives meet customer requirements,these objectives need to consider customer targets. Personnel should be aware of, and committed to, achievingresults that meet customer requirements. Quality objectives and related performance targets should beperiodically reviewed for adequacy (at least annually).21

ChangesSection 7.1.3.1: Plant, facility, and equipment planning This updated section includes an increased focus on riskidentification and risk mitigation, evaluating manufacturingfeasibility, re-evaluation of changes in processes, and inclusion ofon-site supplier activities. Many operational risks can be avoided by applying risk-basedthinking during planning activities, which also extends tooptimization of material flow and use of floor space to controlnon-conforming product. Capacity planning evaluation during manufacturing feasibilityassessments must consider customer-contracted productionrates and volumes, not only current order levels.22

ChangesSection 7.1.5.1.1: Measurement system analysis Records are now required for customer acceptance of alternativemethods. The previous requirement to analyze variation inmeasurement results is now extended specifically to inspectionequipment. IATF 16949 also clarifies that records of customer acceptanceneed to be retained along with results from alternativemeasurement system analysis.23

ChangesSection 7.1.5.2.1: Calibration/verification records This updated section helps ensure that customer requirementsare met through enhanced calibration/verification recordretention requirements, including software installed onemployee-owned or customer-owned equipment. IATF 16949 clarifies that a documented process is required tomanage calibration/verification records in order to provideevidence of conformity, and this includes any on-site supplierowned equipment. Inspection, measurement, and test equipmentcalibration/verification activities need to consider applicableinternal, customer, legislative, and regulatory requirements inorder to establish approval criteria.24

ChangesSection 7.1.5.3.2: External laboratory This updated section allows the organization to conduct secondparty assessments of laboratory facilities, but requires customerapproval of the assessment method. The clause also clarifies that internal laboratory requirementsapply even when calibration is performed by the equipmentmanufacturer, and that use of calibration services may be subjectto government regulatory confirmation.25

ChangesSection 7.2.1: Competence – supplemental This section adds a requirement of “awareness,” which includesknowledge of an organization’s (supplier’s) quality policy, qualityobjectives, personnel contribution to the QMS, benefits ofimproved performance, and implications of not conforming withQMS requirements. It also further emphasizes the customer requirements for OJT(on-the-job training), not just quality requirements. Note that the use of the term "process" rather than "procedure"implies that these activities need to be managed (via the plando-check-act cycle), and not merely performed.26

ChangesSection 7.2.2: Competence – on-the-job training IATF 16949 enhances the emphasis of on-the-job training and itsimportance in meeting customer requirements, including otherinterested parties. The process would consider any relevant interested partyrequirements as an input in determining the need for on-the-jobtraining, and then consider the level of education and complexityof the tasks in determining the method used. This training must also include contract or agency personnel, andconvey the consequences of nonconformity to customerrequirements to all persons whose work affects quality.27

ChangesSection 7.2.3: Internal auditor competency This section features greatly-enhanced requirements to theorganization's internal auditor competency to ensure a morerobust internal audit process. Organizations need to establish a documented process thatconsiders the competencies required by this clause, take actionsto address any deficiencies, assess the effectiveness of actionstaken, and record a list of the approved auditors. The clause differentiates between quality management systemauditors, manufacturing process auditors, and product auditors,and clarifies the competence requirements for each type ofaudit.28

ChangesSection 7.2.4: Second-party auditor competency This new section outlines requirements for second-party auditorsensuring they are properly qualified to conduct those types ofaudits, with customer specific requirements being a main focus. The same core competencies that apply to internal auditorsshould, at a minimum, also apply to second-party auditors.29

ChangesSection 7.3.1: Awareness – supplemental Includes additional requirements to ensure all employees areaware of their impact on the organization’s (supplier’s) productquality output, customer specific requirements, and risksinvolved for the customer with non-conforming product.30

ChangesSection 7.5.1.1: Quality management system documentation The IATF retained the quality manual requirement that wasremoved in ISO 9001:2015; however, the quality manual can beone main document or a series of multiple documents (hard copyor electronic). This section also requires that the organization’s processes andinteractions are documented as part of their QMS. The quality manual needs to document where in theorganization's QMS customer-specific requirements areaddressed.31

ChangesSection 7.5.3.2.1: Record retention This section now requires a record retention process that isdefined and documented, and that includes the organization’srecord retention requirements. Specifically calls out production part approvals, tooling records,product and process design records, purchase orders, andcontracts/amendments. If there is no customer or regulatory agency retention periodrequirements for these types of records, "the length of time thatthe product is active for production and service requirements,plus one calendar year" applies.32

ChangesSection 7.5.3.2.2: Engineering specifications Added an engineering specifications requirement that theprocess is documented and agreed with the customer. This section also clarifies product design changes and productrealization process changes, and the alignment to relatedsections. If there are no other overriding customer agreements, reviews ofengineering standards/specifications changes should becompleted within 10 working days of receipt of notification.33

ChangesSection 8.1.1: Operational planning and control — supplemental This section features enhanced detail to ensure key processes areincluded and considered when planning for product realization. The required topics include customer product requirements andtechnical specifications, logistics requirements, manufacturingfeasibility, project planning, and acceptance criteria. The section also clarifies the "resources needed to achieveconformity" encompasses all aspects of the developmentprocess, not just the manufacturing process requirements.34

ChangesSection 8.2.1.1: Customer communication — supplemental Added a requirement that the communication language (writtenor verbal) must be agreed with the customer. This should be considered when determining the necessarycompetence for roles that require customer communication.35

ChangesSection 8.2.2.1: Determining the requirements for products andservices – supplemental The IATF strengthened the standard by elevating Notes 2 and 3 ofthe former clause into requirements. This suggests current organizational knowledge regardingrecycling, environmental impact, and product and manufacturingprocess characteristics should be standardized. This knowledge would be systematically reviewed and usedwhen determining the requirements for the products andservices to be offered to customers.36

ChangesSection 8.2.3.1.1: Review of the requirements for products andservices — supplemental IATF 16949 strengthens this requirement by requiring theorganization to retain a documented customer authorization forwaivers of formal reviews for products and services.37

ChangesSection 8.2.3.1.3: Organization manufacturing feasibility Enhanced requirements for manufacturing feasibility analysisthrough the following changes: Requiring a multidisciplinary approach to analyze feasibility,considering all engineering and capacity requirements. Requiring this analysis for any new manufacturing or producttechnology, and for any changed manufacturing process orproduct design. The organization should validate their ability to make productspecifications at the required rate. These should considercustomer-specific requirements.38

ChangesSection 8.3.1.1: Design and development of products and services– supplemental Strengthened the standard by elevating the NOTE in the formersection to a requirement, and added a requirement fordocumentation of the design and development process. As the concept of the design and development process in theautomotive industry includes manufacturing design anddevelopment, the requirements from other parts in Section 8should be considered complimentary in the context ofmanufacturing and product design and development.39

ChangesSection 8.3.2.1: Design and development planning – supplemental Clarifies when the multidisciplinary approach is to be used andwho should be involved. Specifically, it must include all affectedstakeholders within the organization and, as appropriate, itssupply chain. Additional examples are provided of areas where such anapproach may be used during design and development planning(including project management), and the note further clarifiesthat purchasing, supplier, and maintenance functions might beincluded as stakeholders.40

ChangesSection 8.3.2.3: Development of products with embedded software This new clause adds requirements for organization-responsibleembedded software development and software developmentcapability self-assessments. Organizations must use a process for quality assurance ofproducts with internally developed embedded software, andhave an appropriate assessment methodology to assess theirsoftware development process. The software development process must also be included withinthe scope of the internal audit programme; the internal auditorshould be able to understand and assess the effectiveness of thesoftware development assessment methodology chosen by theorganization.41

ChangesSection 8.3.3.1: Product design input This section expanded the minimum set of product design inputrequirements, emphasizing regulatory and softwarerequirements. New and broadened requirements include: productspecifications; boundary and interface requirements;consideration of design alternatives; assessment of risks and theorganization's ability to mitigate/manage those risks; conformitytargets for preservation, serviceability, health, safety,environmental, and development timing; statutory andregulatory requirements for the country of destination; andembedded software requirements.42

ChangesSection 8.3.3.2: Manufacturing process design input Expanded the list of manufacturing process design inputsincluding: product design output data including specialcharacteristics, targets for timing; manufacturing technologyalternatives; new materials; product handling and ergonomicrequirements, and; design for manufacturing and design forassembly. This could include consideration of alternatives from innovationand benchmarking results, and new materials in the supply chainthat could be used to improve the manufacturing processcapacity. This section also further strengthened the requirements bytransforming the former NOTE regarding error-proofing methodsinto a requirement.43

ChangesSection 8.3.3.3: Special characteristics Identify the source of special characteristics and including riskanalysis to be performed by the customer or the organization. Expands the list of sources used to identify specialcharacteristics, along with the requirements related to thosespecial characteristics. Special characteristics need to be marked in all applicablecascaded quality planning documents; monitoring strategiesshould focus on reducing variation, which is typically done usingstatistical techniques. The organization must also consider customer-specificrequirements for approvals and use of certain definitions andsymbols, including submission of the symbol conversion table, ifapplicable and required.44

ChangesSection 8.3.4.1: Monitoring These changes align the IATF 16949 standard with IATF OEMadvanced quality activities and aim to reduce the number ofcustomer-specific requirements. The requirement clarifies that measurements apply at specifiedstages during the design and development of both products andservices, and that reporting must occur as required by thecustomer. This could include, for example, the periodic update of customerAPQP schedule milestones, gate reviews, and open issues listsrelated to development activities.45

ChangesSection 8.3.4.2: Design and development validation This section features a strengthening of the requirements fordesign and development validation, and also added embeddedsoftware. Customer specific requirements (CSRs), industry, andgovernmental agency-issued regulatory standards need to beconsidered when planning and performing design anddevelopment activities.46

ChangesSection 8.3.4.3: Prototype programme The changes in this section strengthen the standard byfocusing the organization on the quality management systemfor managing outsourced products and services. Regardless of whether the work is performed by theorganization or by an outsourced process, the prototypeprogramme and control plan are part of the scope of theQMS. This type of control should be considered a support processand be integrated into the design and development process.47

ChangesSection 8.3.4.4: Product approval process These changes clarify approval requirements, with anemphasis on outsourced products and/or services and recordretention required. The activities should be managed (with an effectiveness reviewand improvement actions applied) and not just performed. A part approval process for externally provided products andservices needs to be performed prior to final productsubmission to customers. Product approval must be obtained when the customerrequires it, and records retained.48

ChangesSection 8.3.5.1: Design and development outputs – supplemental Product design output additions include a recognition of the useof 3D models, and inclusion of service parts and packaging. IATF 16949 clarifies that it requires product design errorproofing methods, such as DFSS, DFMA, and FTA. Theapplication of GD&T tolerancing and positioning systems allowsorganizations to specify dimensions and related tolerancesbased on functionality relationships. Outputs include repair and serviceability instructions andservice parts requirements that will be used by approvedmaintenance organizations.49

ChangesSection 8.3.5.2: Manufacturing process design output Changes in this section strengthened verificationrequirements, process input variables, capacity analysis,maintenance plans and correction of processnonconformities. Clarifies that the process approach methodology of verifyingoutputs against inputs applies to the manufacturing designprocess. The list of manufacturing design outputs is also expanded50

ChangesSection 8.3.6.1: Design and development changes – supplemental This section strengthens the requirement for change validationand approval prior to implementation, and also addedembedded software. Design changes after initial product approval implies thatproducts, components, and materials need to be evaluated andvalidated prior to production implementation. This validation needs to be done by the organization and thecustomer, when there is a customer-specific requirement. For products with embedded software, the change record needsto document the revision level of the software and hardware tohelp assure that product configuration is managed appropriately.51

ChangesSection 8.4.1.1: General - supplemental (under Control ofexternally provided processes, products and services) The former NOTE about purchased products was broadenedand elevated into a requirement. It now clarifies that all the requirements of section 8.4 applyto sub-assembly, sequencing, sorting, rework, and calibrationservices.52

ChangesSection 8.4.1.2: Supplier selection process While ISO/TS 16949:2009 did address supplier selection in theISO 9001:2008 boxed text via the Purchasing Process (seeSection 7.4.1), the supplier selection process was not asdetailed. This section now specifically calls out supplier selection processcriteria, in addition to clarifying that it is a full process. The assessment used to select suppliers needs to be extendedbeyond typical QMS audits and include aspects such as: risk toproduct conformity and uninterrupted supply of theorganization's product to their customers, etc.53

ChangesSection 8.4.1.3: Customer-directed sources (also known as“Directed–Buy”) This section features a clarification of the organization’sresponsibilities for customer directed sources, even forcustomer directed-buy suppliers. Unless otherwise defined by contract, all requirements of IATF16949 Section 8.4 apply in this situation, except requirementsrelated to the selection of the supplier itself.54

ChangesSection 8.4.2.1: Type and extent of control – supplemental The changes in this section further strengthened the requirementfor control of outsourced processes, including the assessment ofrisk. Internal and customer requirements are inputs that need to beconsidered during the development of methods to controlexternally provided products, processes, and services. Type and control needs to be consistent with supplier performanceand an assessment of product, material, or service risk. This implies a constant monitoring of performance and assessmentof risk based on the established criteria, triggering the actions toescalate (increase) or reduce the types and extent of control.55

ChangesSection 8.4.2.2: Statutory and regulatory requirements The updates clarify the applicability of statutory andregulatory requirements and strengthen the requirements. Identification of applicable statutory and regulatoryrequirements needs to consider the country of receipt,shipment, and delivery. When special controls are required, the organization mustimplement these requirements and cascade thoserequirements down to their suppliers.56

ChangesSection 8.4.2.3: Supplier quality management systemdevelopment This section provides a method to strengthen ISO 9001certification, aligns with customer-specific requirements, andclarifies the acceptable third-party certification bodies (whichshall be recognized by the IATF). Instead of requiring organizations to simply "develop" thesupplier QMS, this section outlines a progressive approach thatgoes from compliance to ISO 9001 via second-party audits allthe way through certification to IATF 16949 through third-partycertification.57

ChangesSection 8.4.2.3.1: Automotive product-related software orautomotive products with embedded software This new section added requirements for softwaredevelopment assessment methodology. These requirements align to those presented within Section8.3, but ar

ISO/TS 16949 to explicitly make Top Management responsible for ensuring conformity to product requirements and that corrective actions are taken. IATF 16949 clarifies that there must be a process to inform those with the authority and responsibility for corrective action in ord

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