IATF GAP ANALYSIS TOOL GAP GAP /TS to

IATF 16949 GAP ANALYSIS TOOL GAP GAP /TS 16949 to
Rev-h Automotive Standard: IATF new (with IS base) • IATF 16949:2016 follows the high level structure of ISO 9001:2015 • IATF 16949:2016 must be used in conjunction with ISO 9001:2015  2 separate documents must be used to have all requirements  IATF cannot be used as a stand-alone requirements document Each section begins with reference back to the ISO-9001 Standard IAFT 16949 5 Leadership 5.1 Leadership and commitment 5.1.1 General See ISO 9001:2015 requirements Know Them Both! • 282 shalls / 16 shoulds in IATF shalls = 415 shalls (292 shalls / 16 shoulds in ISO/TS 16949) 21 Documented Processed in IAFT -&- 60 Documented Info / Rcds • • IATF created a transition plan and communicated April 2016 (further revised in November 2016), deadline of Sept 2018

Input from key automotive stakeholders
• IATF launched a survey (via the National Associations) early June 2015 soliciting feedback from over 2,000 key stakeholders: – OEMs – Witness Auditors – Suppliers (all Tiers) – Subject Matter Experts – Certification Bodies – Oversight Offices • Over 1,700 comments were received for consideration of updates to ISO/TS • Additionally, the IATF conducted a face:face review of the draft IATF standard in Rome, Italy in April 2016 with CBs and supplier representatives.

Value & Credibility • IATF OEMs look at the linkage
between ISO/TS Certification and Supplier/Client quality performance – Increased focus on operational performance and customer feedback (customer scorecards/metrics) – IATF contains many IATF OEM Customer Specific Requirements (CSRs) – OEMs are raising the bar regarding expectations for audits to reflect systemic weaknesses that affect supplier/client performance • Goal = Prevent problems before they occur

Communication Process
The IATF felt it was important to keep everyone informed about project updates, so they posted regular updates to the IATF Global Oversight website:

on each slide for QMS-team GAP assessment
ISO-9001:2015 & IATF 16949:2016 GAP Analysis INSTRUCTIONS: Review with Leadership Team for best results. Each slide is used to identify gaps and where to revise your documented Quality System for new requirements. Include document title, responsible process owner, target date to revise and review document(s), and implementation plans . Also think error proofing to automate QMS functions (software) to reduce risk of human error in designing your Quality System . EXAMPLE : Revise QA manual , section 1.0, Sam Hill QA , Jan 2017 Use GAP Action /note section on each requirement/slide Exa: Revise Quality manual , procedure , process map, work instruction , form , FMEA / CP, software system error proofing. Include due date + process owner. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) on each slide for QMS-team GAP assessment QMS

Mandatory Docs

Mandatory Docs GAP Actions / Date / Resp. (id-Names of assessment for self-declared training record) CEO VP. SALES , Supply chain MGR, MFG Mgr , HR mgr , ENG Mgr , QA Mgr +++ Add names / date of overview training

Changes to LEGEND of the
ISO-9 & IATF-16 ISO-9 - Base Standard ISO-9001:2015 requirements to be met ISO-9001:2015 & IATF :2016 Elements Scope Normative References Terms & Definitions Context of The Organization Leadership Planning Support Operations Performance Evaluation Improvement

Changes Section 4.1 Understanding ISO-9 Fundamentals Training Approach
ISO 9001:2015 Structure Changes Key Concept: Process Approach Key Concept: Risk-Based Thinking 2015 Terminology GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) CEO VP. SALES , Supply chain MGR, MFG Mgr , HR mgr , ENG Mgr , QA Mgr +++ Add names / date of overview training

Changes Section 4.1 Understanding ISO-9 Fundamentals
2008 version 2015 version Clause 1 Scope Clause 2 Normative References Clause 3 Terms and Definitions Clause 4 Quality Management System REQUIREMENTS Context of the Organization Clause 5 Management Responsibility Leadership Clause 6 Resource Management Planning for the QMS Clause 7 Product/Service Realization Support Clause 8 Measurement, Analysis & Imprvmt Operation Clause 9 Performance Evaluation Clause 10 Improvement Annex A Clarification of New Structure, Terminology and Concepts Annex B Quality Management Principles Annex C ISO Portfolio of Quality Management Standards Clauses 1, 2 & 3 remain the same. 2008 requirements were clauses 4 thru 8 vs requirements are clauses 4 thru 10. Additional assistance is provided in Annexes A, B and C.

Changes Key Concept – Process Approach & Risk-Based Thinking
ISO-9 Changes Key Concept – Process Approach & Risk-Based Thinking These concepts are particularly important for: Top management as they are required to demonstrate leadership and commitment by promoting the use of these concepts. Employees tasked with the implementation and maintenance of the QMS. Internal auditors are required to use a process approach when auditing. Requirements Specified Requirements Satisfied (including resource ) (results of a process) Inputs and intended outputs may be tangible (such as equipment, materials or components) or intangible (such as energy or information). Outputs can also be unintended, such as waste or pollution. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) CEO VP. SALES , Supply chain MGR, MFG Mgr , HR mgr , ENG Mgr , QA Mgr +++ Add names / date of overview training REVIEW ALL process MAPS RISK & METRICS Red Yellow Green

ISO-9 Changes Key Concept – Process Approach & Risk-Based Thinking This is a schematic representation of the elements of a single process Types of Processes: Production/Service stamping, welding, assembly, design, repair, etc. Management - risk mgmt, Mgmt Rvw, training, QMS- planning/objectives, management reviews , audits and corrective actions Support - purchasing, document control, calibration and maintenance Customer - sales, customer communication, order processing, supplier mgmt GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) CEO VP. SALES , Supply chain MGR, MFG Mgr , HR mgr , ENG Mgr , QA Mgr +++ Add names / date of overview training

ISO-9 Changes Key Concept – Process Approach & Risk-Based Thinking Representation of the structure of ISO 9001:2015 standard in the PDCA cycle (numbers in brackets refer to the clauses of the standard)

RISK Changes Key Concept – Process Approach & Risk-Based Thinking
ISO-9 Changes Key Concept – Process Approach & Risk-Based Thinking Representation of the structure of ISO 9001:2015 standard in the PDCA cycle (numbers in brackets refer to the clauses of the standard) 2008 version: “prevention” as a separate component of a QMS. Required that you react to prevent or reduce undesired effects. 2015 version: application of risk-based thinking throughout QMS. Requires a proactive approach to prevent or reduce undesired effects, as well as reacting if they occur. Makes preventive action a part of planning, operation, analysis and evaluation of the QMS. Effect of uncertainty on an expected result Effects can be positive or negative consequences Risk is characterized by potential events and consequences RISK

ISO-9 Changes Key Concept – Process Approach & Risk-Based Thinking Risk-based thinking is required in the following clauses 4 – Context Determine the contributers to risk 5 – Leadership Promote risk-based thinking & ensure clause 4 is followed 6 – Planning Identify risks and take appropriate action to address them 7 – Resources Determine and provide necessary resources 8 – Operation Implement and manage operations 9 – Performance Monitor/measure/analyze/evaluate effectivess of actions taken to address risks 10 – Improvement Improve by responding to changes in risk All Clauses Risk is implied whenever “suitable” or “appropriate” is mentioned even though is it not plainly expressed. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) training

ISO-9 Changes Terminology shall indicates a requirement should indicates a recommendation (does not appear in the 2015 version) May indicates a permission (only used once in the 2015 version) can indicates a possibility or a capability (mainly used in notes) NOTE Provide guidance in understanding or clarifying the associated requirement. (the yare NOT requirements) Product & Services includes all output categories (hardware, services, software and processed materials) Train GAP Actions / Date / Resp (id-Names of assessment for self-declared training record)

Changes Terminology 2008: Exclusions / 2015: Not used
ISO-9 Changes Terminology 2008: Exclusions / 2015: Not used Instead clause 4.3 defines conditions under which an organization can decide that a requirement cannot be applied to any of its QMS processes. The org can only decide that a requirement is not applicable if the decision will not result in failure to achieve conformity of products / services & enhancement of customer satisfaction. The impact of this change will be reviewed in detail when we discuss clause 4.3 in an upcoming training session. 2008: Documentation & Records / 2015: Documented Information GAP Actions / Date / Resp (id-Names of assessment for self-declared training record)

Changes Section 4.1 Understanding The Organization & Its Context
ISO-9 Changes Section 4.1 Understanding The Organization & Its Context The organization shall determine external & internal issues relevant to its purpose & its strategic direction that affect its ability to achieve the intended result(s) of its QMS. shall monitor & review information about these external & internal issues. Note 1: Issues can include positive/negative factors or conditions for consideration. Note 2: Understanding external context considers issues arising legal, technological, competitive, market, cultural, social and economic environments, whether international, national, regional or local. Note 3: Understanding the internal context considers values, culture, knowledge and performance of the organization. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write VP / QA / CEO NEW process maps Date XXX

ISO-9 Changes Section 4.1 Understanding The Organization & Its Context - Associated Clauses: When determining the scope, the organization shall consider the external and internal issues referred to in 4.1 Top management shall ensure that the quality policy / quality objectives are established for the QMS and compatible with the organization’s strategic direction and its context. 5.2.1a Top management shall establish, review and maintain its quality policy appropriate to the purpose and context of the organization. When planning the QMS, the org shall consider issues referred to in 4.1 and determine risks and opportunities that need to be addressed. The management review shall be planned and carried out taking into consideration changes in external and internal issues relevant to its QMS that includes its strategic direction. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX Process map leadership / Risk VP date XXX

ISO-9 Changes Section 4.2 Understanding Needs & Expectations of Interested Parties Due to their effect (potential or real) on the organization’s ability to consistently provide products & services to customer, regulatory, statutory requirements, the organization shall determine: interested parties that are relevant to the QMS requirements of these parties The organization shall monitor and review information about these interested parties and their relevant requirements. ISO-9001:2015; Interested Party: person or group having an interest in the performance or success of an organization (3.3.1) Example: Customers (3.3.5), owners, people in an organization, suppliers (3.3.6), bankers, unions, partners or society. Note: A group can comprise an org / part thereof, or more than one org.

Changes Section 4.2 Interested Parties - Associated Clauses:
ISO-9 Changes Section 4.2 Interested Parties - Associated Clauses: When determining the scope, the org shall consider requirements of relevant interested parties referred to in 4.2 5.2.2 Quality policy is available to relevant interested parties, as appropriate. 6.1.1 When planning QMS, the organization shall consider the requirements referred to in 4.2 & determine risks / opportunities need to be addressed 8.3.2 In determining the stages and controls for design and development, the organization shall consider the level of control expected for the design and development process by customers and other relevant interested parties. 9.3.2 Management review is planned / carried out considering information on QMS performance and effectiveness, including trends in customer satisfaction and feedback from relevant interested parties. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX Revised Mgt review form Risk / Opp VP Date XXX

Changes Section 4.3 Determining The Scope of The QMS
ISO-9 Changes Section 4.3 Determining The Scope of The QMS The org determines boundaries & applicability of its QMS to establish its scope. When determining this scope, the organization shall consider: the external and internal issues referred to in 4.1; the requirements of relevant interested parties referred to in 4.2; the products and services of the organization. The organization shall apply all the requirements of this International Standard if they are applicable within the determined scope of its QMS. ISO-9 does not require the org to maintain a Quality Manual – but IATF-16 does

Changes 4th to 5th Ed Rules
IATF requirements for TS Scope Statements: TS scope statements must be formulated as follows and only include products and services supplied to the automotive industry and thus built into the vehicle: Design & Manufacturing of XXX or Production of XXX When identifying functions performed by remote sites, only terms used are: Aftersales Human resources Policy making Sequencing Calibration Information technologies Process design Servicing Continuous improvement Internal audit management Product design Strategic planning Contract review Laboratory Production equipment development Supplier mgmt Customer service Logistics Purchasing Testing Distribution Maintenance Quality system management Training Engineering Management review Research & Development Warehousing Facilities management Marketing Repair Warranty mgmt Finance Packaging Sales GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) CEO VP. QA Mgr +++ Check current certificate & process maps to match reality Note these are IATF termimnology iology not ours ,

Changes 4th to 5th Ed Rules
IATF requirements for TS Scope Statements: Mfg-Site vs RSL (Remote Support Location) QMS Structure Matrix know your Mfg-Sites & all RSL-RSL interactions

Changes Section 4.3.1: Determining the scope of the quality mgmt system – supplemental These requirements were originally included in ISO/TS 16949:2009; Sections 1.1 and They have been moved to Section 4 within IATF The requirement relating to supporting functions was revised to ensure that supporting functions not only address the need to include support functions* in the audit, but also to ensure that they are included in the scope of the QMS. ( Sales/Design / Warehouses …. Other support locations/ functions *) In addition, any exclusion sought for design and development activities, now in Section 8.3, has to be preserved as documented information. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX

Changes Section 4.3.2: Customer-specific requirements
Although the need to fulfill and satisfy customer-specific requirements was already mentioned throughout the whole ISO/TS document, in IATF this requirement specifically addresses the need to evaluate the customer specific requirements and include them where applicable in the organization's quality management system. This means that the supplier would need some sort of process to evaluate each of their customer’s customer-specific requirements (CSR) and determine exactly how (and where) it applies to their organization's QMS, as applicable. 3.1 Terms and Definitions: CSR – interpretation of or supplemental requirements linked to a specific clause(s) of this Automotive QMS Standard. Exa: is your customers Supplier QA manual , and /or see IATF.org for OEM CSR’s GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX CSR process / processs MAP QA / VP date xxx

Changes Section 4.4.1.1: Conformance of products and processes
This requirement was adopted based on IATF survey feedback that was received It ensures two things: that the supplier (organization) is responsible for the conformity of outsourced processes, and that all products and processes meet all applicable requirements and expectations of all interested parties To ensure conformance of all products and processes, the organization would need to take a proactive approach to assess and address risks, and not rely only on inspection. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX Check SC’s regulations / risks / error proofing / CpK - ENG / MFG

Changes Section 4.4.1.2: Product safety (Documented Process)
New section with enhanced requirements that address current and emerging issues the automotive industry is facing related to product and process safety. Organizations (suppliers) are required to have documented processes to manage product-safety related products and processes. Examples: Safety items may include FMVSS/ ECE regulations such as brakes, lighting, steering, seating, airbags. Process safety may include stampings that could produce sharp edges / burs and machine guarding for safety. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX Process MAP for Product safety / Regulations / SCs Eng Mgr Date XXX LINK to APQP . SHOP Floor awareness safety related product – print / FMEA / CP / WI / Label

Changes Section 4.4.1.2: Product safety
This section includes identification of statutory requirements; identifying and controlling product-safety-related characteristics both during design and at point of manufacture; defining responsibilities, escalation processes, reaction plans, and the necessary flow of information including top management and customers; receiving special approvals for FMEAs and Control Plans; product traceability measures; and cascading of requirements throughout the supply chain. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX

QMS-Team GAP Participant Names
 Section 4; Context of The Org Changes to ISO-9 / IATF-16 GAP Summary ISO-9 & IATF-16 QMS-Team GAP Participant Names Title QMS Rep Confirmation – Na: Da: Additional Notes: Check manual re write

Changes Section 5.1.1: Leadership & Commitment
ISO-9 Changes Section 5.1.1: Leadership & Commitment Top mgmt shall demonstrate leadership and commitment with respect to the QMS by Taking accountability for the effectiveness of the QMS. Ensuring quality policy and quality objectives are established for the QMS and are compatible with context and strategic direction of the organization. Ensuring integration of QMS rqmts into organization’s business processes. Promoting the use of the process approach and risk-based thinking. Ensuring that the resources needed for the QMS are available. Communicating the importance of effective quality mgmt & of conforming to the QMS requirements. Ensuring that the QMS achieves its intended results. Engaging, directing & supporting persons to contribute to the effectiveness of QMS. Promoting improvement. Supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX Verify metrics are in line with customer requirements & strategy VP Date XXX

Changes Section 5.1.1.1: Corporate Responsibility
The organization is to define and implement corporate responsibility policies… at a minimum an anti-bribery policy, an employee code of conduct, and an ethics escalation policy (“whistle-blowing policy”). GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX Develop training for all on ethics policy , conduct , anti bribe , and whistle blowers Delivery of training & records / add to training matrix HR date XXX Audit new employees & those absent for this

Changes Section 5.1.1.2: Process effectiveness and efficiency
The requirement for an organization to review their processes to ensure effectiveness and efficiency was covered in ISO/TS 16949, Section Based on survey feedback, the IATF strengthened the requirement to ensure that the results of process review activities will now be included in management review. Process review activities need to include evaluation methods and, as a result, implement improvements. The results of these steps would be an input to the management review process. Top management is thus performing a review of the process-specific reviews performed by the process owners. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX VP to review all metrics to assure E/E are intact & if not establish new ,metrics Date XXX

Changes Section 5.1.1.3: Process Owners
ISO/TS 16949:2009 addresses management responsibility and authority, but it does not explicitly mention that management ensure process owners understand their role and are competent. The IATF adopted this new requirement to ensure that management understands this expectation, by specifically identifying these process owners and ensuring they can perform their assigned roles. This requirement recognizes that process owners have the authority and responsibility for activities and results for the processes they manage. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX Each process owner to update their process maps Date xxx

Changes Section 5.2.1: Quality Policy - Establish
ISO-9 Changes Section 5.2.1: Quality Policy - Establish Top mgmt shall establish, implement and maintain a quality policy that: is appropriate to the purpose & context of the org & supports its strategic direction provides the framework for setting its quality objectives; includes commitment to satisfy applicable requirements; includes commitment to continual improvement of the QMS. Section 5.2.2: Quality Policy - Communication The Quality Policy available as documented information communicated, understood and applied within the organization available to relevant interested parties, as appropriate. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX

Changes Section 5.3: Org Roles, Responsibility & Authority
ISO-9 Changes Section 5.3: Org Roles, Responsibility & Authority Top mgmt shall ensure responsibilities & authorities for relevant roles are assigned, communicated & understood within the organization. Top management shall assign the responsibility and authority for: ensuring QMS conforms to requirements of this International Standard ensuring that the processes are delivering their intended outputs reporting on the performance of the QMS & opportunities for imprvmt (10.1), for top mgmt ensuring the promotion of customer focus throughout the organization (VOC) ensuring the integrity of QMS is maintained when changes to QMS are planned / implemented Refer to ISO-9001:2015; Section 9.3 – Mgmt Review for additional Mgmt Roles/Resp GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX

Changes Section 5.3.1: Organ’tnl roles, responsibilities, and authorities – supplemental This requirement was already part of ISO/TS 16949:2009. However, based on IATF survey feedback, the IATF adopted some modifications to the requirement to address the need to document assigned personnel responsibilities and authorities. Additionally, this clause now clarifies that the goal is not just to address customer requirements but also to meet customer requirements fully. Personnel involved in capacity analysis, logistics information, customer scorecards, and customer portals now also need to be assigned and documented, per the requirements in this section. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XX Assign process owner customer portal / scorecard / cap/ logistsics Sales Date XXX

Changes Section 5.3.2: Responsibility & authority for product rqmts & corrective Actions Differs from ISO/TS16949:2009; Section (Modification) Note: Due to the process design in some industries, it might not always be possible to stop production immediately. In this case, the affected back must be contained and shipment to the customer prevented. Production operations across all operational shifts staffed with personnel in charge of / or delegated responsibility to ensure conformity to product requirements GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX STOP call wait signs order & post Date XXX Mfg VP

 Section 5; Leadership Changes to ISO-9 / IATF-16 GAP Summary ISO-9 & IATF-16 QMS-Team GAP Participant Names Title QMS Rep Confirmation – Na: Da: Additional Notes:

ISO-9 Changes Section 6 – Planning; 6.1: Actions to Address Risk & Opportunities When planning QMS, the org shall consider issues referred to in 4.1 & the requirements referred to in 4.2 & determine the risks & opportunities that need to be addressed to: give assurance that the QMS can achieve its intended results; enhance desirable effects; prevent, or reduce, undesired effects; achieve improvement. Section 6 – Planning; 6.2: The org shall plan: Actions to address the risk & opportunities How to: 1) integrate and implement the actions into its QMS processes (see 4.4) 2) evaluate the effectiveness of these actions. Refer to ISO “Notes” for more detail GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX

Changes Section 6.1.2.1: Risk analysis
The need to identify, analyze, and consider actual and potential risks was covered in various areas of ISO/TS The IATF adopted additional requirements for risk analysis recognizing the continual need to analyze and respond to risk and to have suppliers/organizations consider specific risks associated with the automotive industry. Organizations would need to periodically review lessons learned from product recalls, product audits, field returns and repairs, complaints, scrap, and rework, and implement action plans in light of these lessons. The effectiveness of these actions should be evaluated, and actions integrated in to the organization's QMS. Objective Evidence – Retained documented information as results of risk analysis GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX Quick response board in MFG / OPL / Q alerts Mfg VP Date XXX

Changes Section 6.1.2.2: Preventive action
The IATF enhanced the requirement found in ISO/TS by integrating what is considered to be a best practice in the automotive industry. Organizations would need to implement a process to lessen the impact of negative effects of risk, appropriate to the severity of the potential issues Such a process would include: identifying the risk of nonconformity recurrence, documenting lessons learned, identifying and reviewing similar processes where the nonconformity could occur, and applying lessons learned to prevent such potential occurrence. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX

Changes Section 6.1.2.3: Contingency plans
The expanded requirement ensures the organization defines and prepares contingency plans along with a notification process. Organizations first take a systematic approach to identifying and evaluating risk for all manufacturing processes, giving particular attention to external risk. Contingency plans( CP) would be developed for any of the outlined disruption conditions -- interruption of externally provided products, processes, and services, recurring natural disasters, fire, or infrastructure-related disruptions. Shall periodically test CP. Customer notification is a mandatory step in any contingency plan, unless there is no risk to deliver nonconforming product or affect on-time delivery GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX Update Contingency plan see bold above Date XXX VP Reminder for annual table top test / perform table top review Date VP

Changes 6.2: Quality Objectives & Planning;
ISO-9 Changes 6.2: Quality Objectives & Planning; The organization shall establish quality objectives at relevant functions, levels and processes needed for the QMS. The quality objectives shall: be consistent with the quality policy be measurable take into account applicable requirements be relevant to conformity of products & services & enhance cust-satisfaction be monitored be communicated be updated as appropriate. The organization shall maintain documented information on the quality objectives. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX

Changes POLICY 6.2: Quality Objectives & Planning;
ISO-9 Changes 6.2: Quality Objectives & Planning; 6.2.2 When planning how to achieve its quality objectives, the org shall determine: what will be done what resources will be required who will be responsible when it will be completed how the results will be evaluated. The organization shall maintain documented information on the quality objectives. Strategic Q-Plan StrategicAction1 POLICY GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX

Changes Section : Quality objectives & planning to achieve them – supplemental ISO/TS included the importance of addressing customer expectations in the NOTE to Section The IATF enhanced the requirement by requiring that it be done at all levels throughout the organization. In ensuring quality objectives meet customer requirements, these objectives need to consider customer targets. Personnel should be aware of, and committed to, achieving results that meet customer requirements. Quality objectives and related performance targets should be periodically reviewed for adequacy (at least annually). GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX Mgt review process review perf targets Date XXX VP

Changes 6.3: Planning of Changes
ISO-9 Changes 6.3: Planning of Changes When the organization determines the need for changes to the QMS, the changes shall be carried out in a planned manner (see 4.4). The org shall consider: the purpose of the changes and their potential consequences the integrity of the QMS the availability of resources the allocation or reallocation of responsibilities and authorities. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX

 Section 6; Planning Changes to ISO-9 / IATF-16 GAP Summary ISO-9 & IATF-16 QMS-Team GAP Participant Names Title QMS Rep Confirmation – Na: Da: Additional Notes:

ISO-9 Changes 7.1: Resources The organization shall determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the QMS. The org shall consider: the capabilities of, and constraints on, existing internal resources what needs to be obtained from external providers. People - The organization shall determine and provide the persons necessary for the effective implementation of its QMS and for the operation and control of its processes. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX

ISO-9 Changes 7.1: Resources Infrastructure – The organization shall determine, provide and maintain the infrastructure necessary for the operation of its processes and to achieve conformity of products and services. Note: Infrastructure can include: the capabilities of, and constraints on, existing internal resources what needs to be obtained from external providers. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX

Changes Section 7.1.3.1: Plant, facility, and equipment planning
This updated section includes an increased focus on risk identification and risk mitigation, evaluating manufacturing feasibility, re-evaluation of changes in processes, and inclusion of on-site supplier activities. Many operational risks can be avoided by applying risk-based thinking during planning activities, which also extends to optimization of material flow and use of floor space to control non-conforming product. Capacity planning evaluation during manufacturing feasibility assessments must consider customer-contracted production rates and volumes, not only current order levels. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX

Changes 7.1: Resources 7.1.4 Environment for the Operation of Process
ISO-9 Changes 7.1: Resources Environment for the Operation of Process The organization shall determine, provide and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services. Note: A suitable environment can be a combination of human and physical factors, such as: social (e.g. non-discriminatory, calm, non-confrontational psychological stress-reducing, burnout prev’tn, emotionally protective physical (e.g. temperature, heat, humidity, light, airflow, hygiene, noise) Factors can differ depending on the products & services provided. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX

Changes Section : Environment for the operation of processes – supplemental This requirement for an organization to "maintain its premises in a state of order, cleanliness, and repair" was preserved from ISO/TS and transferred to IATF GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX

Changes 7.1.5: Monitoring & Measuring Resources
ISO-9 Changes 7.1.5: Monitoring & Measuring Resources Monitoring & Measuring Resources The org shall determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements. The organization shall ensure that the resources provided are: suitable for specific type of monitoring & measurement undertaken maintained to ensure their continuing fitness for their purpose. The organization shall retain appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX

Changes Section >>> 7.1.5.1.1: Measurement system analysis
Records are now required for customer acceptance of alternative methods. The previous requirement to analyze variation in measurement results is now extended specifically to inspection equipment. IATF also clarifies that records of customer acceptance need to be retained along with results from alternative measurement system analysis. Note: Prioritization of MSA studies to focus on critical or special product or process characteristics. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX QA to check MSA records for alt methods get customer agreement DATE xxx

Changes 7.1.5.2: Measurement Traceability
ISO-9 Changes : Measurement Traceability When measurement traceability is a requirement, or is considered by the organization to be an essential part of providing confidence in the validity of measurement results, measuring equipment shall be: calibrated or verified, or both, at specified intervals, or prior to use, against measurement stds traceable to international or national measurement stds when no such std exist, the basis used for calibration or verification shall be retained as documented information identified in order to determine their status safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results. The organization shall determine if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose, and shall take appropriate action as necessary. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX

Changes Section : Calibration/verification records (Documented Process) This updated section helps ensure that customer requirements are met through enhanced calibration/verification record retention requirements, including software installed on employee-owned or customer-owned equipment. IATF clarifies that a documented process is required to manage calibration/verification records in order to provide evidence of conformity, and this includes any on-site supplier-owned equipment. Inspection, measurement, and test equipment calibration/verification activities need to consider applicable internal, customer, legislative, and regulatory requirements in order to establish approval criteria. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX QA to create cal procedure / process including software test Date xxx

Changes Section 7.1.5.3.2: External laboratory
This updated section allows the organization to conduct second-party assessments of laboratory facilities, but requires customer-approval of the assessment method. The clause also clarifies that internal laboratory requirements apply even when calibration is performed by the equipment manufacturer, and that use of calibration services may be subject to government regulatory confirmation. Example: scales – USA / State weights & measures GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX

Changes 7.1.6: Organizational Knowledge
ISO-9 Changes 7.1.6: Organizational Knowledge The organization shall determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services. This knowledge shall be maintained and made available to the extent necessary. When addressing changing needs and trends, the organization shall consider its current knowledge and determine how to acquire or access any necessary additional knowledge and required updates. See ISO-9001:2015 for [2] Notes GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX

Changes 7.2: Competence – the org shall:
ISO-9 Changes 7.2: Competence – the org shall: determine the necessary competence of person(s) doing work under its control that affects the performance and effectiveness of the QMS ensure that these persons are competent on the basis of appropriate education, training, or experience where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness of the actions taken; retain appropriate documented information as evidence of competence NOTE: Applicable actions can include, for example, the provision of training to, the mentoring of, or the reassignment of currently employed persons; or the hiring or contracting of competent persons. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX

Changes Section 7.2.1: Competence – supplemental (Documented Process)
This section adds a requirement of “awareness,” which includes knowledge of an organization’s (supplier’s) quality policy, quality objectives, personnel contribution to the QMS, benefits of improved performance, and implications of not conforming with QMS 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 plan-do-check-act cycle), and not merely performed. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX HR procedure competence / training matrix update Date XXX

Changes Section 7.2.2: Competence – on-the-job training
IATF enhances the emphasis of on-the-job training and its importance in meeting customer requirements, including other interested parties. The process would consider any relevant interested party requirements as an input in determining the need for on-the-job training, and then consider the level of education and complexity of the tasks in determining the method used. This training must also include contract or agency personnel, and convey the consequences of nonconformity to customer requirements to all persons whose work affects quality. Examples of competence: conformity to quality requirements, internal requirements, regulatory or legislative requirements GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX

Changes Section 7.2.3: Internal auditor competency (Documented Process) This section features greatly-enhanced requirements to the organization's internal auditor competency to ensure a more robust internal audit process. Organizations need to establish a documented process that considers the competencies required by this clause, take actions to address any deficiencies, assess the effectiveness of action taken, and record a list of the approved auditors. The clause differentiates between quality management system auditors, manufacturing process auditors, and product auditors, and clarifies the competence requirements for each type of audit. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX HR competence procedure / trainimg matrix update Date XXX List of system , product , mfg process auditors Date XXX

Changes Section 7.2.4: Second-party auditor competency
This new section outlines requirements for second-party auditors ensuring they are properly qualified to conduct those types of audits, with customer specific requirements being a main focus. The same core competencies that apply to internal auditors should, at a minimum, also apply to second-party auditors. Understanding of: Automotive Risk-base thinking, Customer/Org specific requirements, ISO-9001 & IATF16949 requirements as related to audit scope, manufacturing process(es) / P-FMEA and Control Plans, applicable AIAG Core Tools & Audit Guidelines in accordance with ISO GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX Training matrix HR date XXX

ISO-9 Changes 7.3: Awareness The org shall ensure that persons doing work under the org’s control are aware of: the quality policy relevant quality objectives their contribution to the effectiveness of the QMS, including the benefits of improved performance the implications of not conforming with the QMS requirements GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX

Changes Changes Section 7.3.1: Awareness – supplemental
Includes additional requirements to ensure all employees are aware of their impact on the organization’s (supplier’s) product quality output, customer specific rqmts, and risks involved for the customer with non-conforming product. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX (Documented Process) Changes Section 7.3.2: Employee motivation & empowerment This section did not substantially change, but now requires "maintain[ing] a documented process(es)" for employee motivation and empowerment, instead of simply "having a process." GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX HR procedure for Motiv/ empower Date XXX

Changes 7.4: Communication
ISO-9 Changes 7.4: Communication The organization shall determine the internal and external communications relevant to the QMS, including: on what it will communicate when to communicate with whom to communicate how to communicate who communicates GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX

Changes 7.5: Documented Information Terminology
ISO-9 Changes 7.5: Documented Information Terminology 2008: Document, documented procedure, quality manual, quality plan, etc. 2015: Maintain documented information 2008: Records 2015: Retain documented information. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX

Changes 7.5: Documented Information
ISO-9 Changes 7.5: Documented Information 7.5.1 The organization’s QMS shall include documented information: required by this International Standard determined by the org necessary for the effectiveness of the QMS. NOTE: The extent of documented information for a QMS can differ from one organization to another due to the: - size of org & its type of activities, processes, products, and services - complexity of processes and their interactions - competence of persons When creating & updating documented information, the org ensure appropriate: identification and description (e.g. a title, date, author, or reference no) format (language, software version, graphics) & media (paper, electronic) review and approval for suitability and adequacy GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX

Changes Section : Quality mgmt system documentation (Documented Process) The IATF retained the quality manual requirement that was removed in ISO 9001:2015; however, the quality manual can be one main document or a series of multiple documents (hard copy or electronic). This section also requires that the organization’s processes and interactions are documented as part of their QMS. The quality manual needs to document where in the organization's QMS customer-specific requirements are addressed. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX QA procedure / process maps / CSR requirement need be identified Date XXX

Changes 7.5.3: Control of Documented Information
ISO-9 Changes 7.5.3: Control of Documented Information Documented information required by the QMS and by this International Standard shall be controlled to ensure it is: available and suitable for use, where and when it is needed; adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity). GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX

Changes 7.5.3: Control of Documented Information
ISO-9 Changes 7.5.3: Control of Documented Information For the control of documented information, the organization shall address the following activities, as applicable: distribution, access, retrieval and use storage and preservation, including preservation of legibility control of changes (e.g. version control) retention and disposition. Documented information of external origin determined by the organization to be necessary for the planning and operation of the QMS shall be identified as appropriate, and be controlled. Documented information retained as evidence of conformity shall be protected from unintended alterations. NOTE: Access can imply a decision regarding the permission to view the documented information only, or permission & authority to view & change the documented information. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX

Changes Section 7.5.3.2.1: Record retention
This section now requires a record retention process that is defined and documented, and that includes the organization’s record retention requirements. Specifically calls out production part approvals, tooling records, product and process design records, purchase orders, and contracts/amendments. If there is no customer or regulatory agency retention period requirements for these types of records, "the length of time that the product is active for production and service requirements, plus one calendar year" applies. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX VP / QA revise record retention list Date XXX

Changes Section : Engineering specifications (Documented Process) Added an engineering specifications requirement that the process is documented and agreed with the customer. This section also clarifies product design changes and product realization process changes, and the alignment to related sections. If there are no other overriding customer agreements, reviews of engineering standards/specifications changes should be completed within 10 working days of receipt of notification. Engineering standards/changes resulting in produce change must refer back to ISO-9001, Section 8.3.6 Key: keep in mind the interaction of ISO-9001 & IATF-16949 GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX ENG procdure for change control including Eng specs / 10 days Date XXX

 Section 7; Support Changes to ISO-9 / IATF-16 GAP Summary ISO-9 & IATF-16 QMS-Team GAP Participant Names Title QMS Rep Confirmation – Na: Da: Additional Notes:

Changes 8.1: Operational Planning & Control
ISO-9 Changes 8.1: Operational Planning & Control The org shall plan, implement &control the processes (see 4.4) needed to meet rqmts for provision/products & services, & to implement actions determined in Clause 6, by: determining the requirements for the products and services establishing criteria for the: processes & acceptance of product and services determining resources to achieve conformity to product & service rqmts implement control of the processes in accordance with the criteria; determining, maintaining &retaining documented information necessary to: have confidence that the processes have been carried out as planned demonstrate products & services conformity to their requirements. The output of this planning shall be suitable for the organization’s operations. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX

Changes 8.1: Operational Planning & Control
ISO-9 Changes 8.1: Operational Planning & Control The organization shall control planned changes and review the consequences of unintended changes; taking action to mitigate any adverse effects, as necessary. The organization shall ensure that outsourced processes are controlled (see 8.4). Outsourced: an arrangement made where an external organization performs part of an organization’s function or process. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX

Changes Section 8.1.1: Operational planning and control — supplemental
This section features enhanced detail to ensure key processes are included and considered when planning for product realization. The required topics include customer product requirements and technical specifications, logistics requirements, manufacturing feasibility, project planning, and acceptance criteria. The section also clarifies the "resources needed to achieve conformity" encompasses all aspects of the development process, not just the manufacturing process requirements. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX

Changes 8.2.1: Customer Communications
ISO-9 Changes 8.2.1: Customer Communications Communication with customers shall include: providing information relating to products and services; handling enquiries, contracts or orders, including changes; obtaining cust feedback relating to products and services, incldg cust complaints; handling or controlling customer property; establishing specific requirements for contingency actions, when relevant. 8.2.2: Determining Product & Services Requirements When determining the requirements for the products and services to be offered to customers, the organization shall ensure that: the requirements for the products and services are defined, including: - any applicable statutory and regulatory requirements; - those considered necessary by the organization; the organization can meet the claims for the products and services it offers. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX

Changes Section 8.1.2: Confidentiality
Only a minor edit to clarify confidentiality "includes" related product information, instead of using the word "and." There is no change in intent. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX Section : Customer communication — supplemental Added a requirement that the communication language (written or verbal) must be agreed with the customer. This should be considered when determining the necessary competence for roles that require customer communication GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX

Changes Section : Determining requirements for products & services – supplemental The IATF strengthened the standard by elevating Notes 2 and 3 of the former clause into requirements. This suggests current organizational knowledge regarding recycling, environmental impact, and product and manufacturing process characteristics should be standardized. This knowledge would be systematically reviewed and used when determining the requirements for the products and services to be offered to customers. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX

Changes 8.2.3: Review of Product & Services Requirements
ISO-9 Changes 8.2.3: Review of Product & Services Requirements The org shall ensure the ability to meet the requirements for products and services to be offered to customers & shall conduct a review before committing to supply products and services to customer, to include: requirements specified by the customer, including the requirements for delivery and post-delivery activities requirements not stated by the customer, but necessary for the specified or intended use, when known requirements specified by the organization statutory and regulatory requirements applicable to the products and services contract or order requirements differing from those previously expressed. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX

Changes 8.2.3: Review of Product & Services Requirements
ISO-9 Changes 8.2.3: Review of Product & Services Requirements (continued) The organization shall ensure that contract or order requirements differing from those previously defined are resolved. The customer’s requirements shall be confirmed by the organization before acceptance, when the customer does not provide a documented statement of their requirements. NOTE: In some instances, such as internet sales, a formal review is impractical for each order. Instead, the review can cover relevant product information, such as catalogues. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX

Changes Section : Review requirements for products & services — supplemental IATF strengthens this requirement by requiring the organization to retain a documented customer authorization for waivers of formal reviews for products and services. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX Section : Customer-designated special characteristics This section changes the action from "demonstrate conformity“ to "conform," and clarifies that it refers to "approval documentation," rather than just "documentation.“ There is no change in intent. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record)

Changes Section 8.2.3 (continued)
ISO-9 Changes Section (continued) The organization shall retain documented information, as applicable: on the results of the review; on any new requirements for the products and services. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX

Changes Section 8.2.3.1.3: Organization manufacturing feasibility
Enhanced requirements for manufacturing feasibility analysis through the following changes: Requiring a multidisciplinary approach to analyze feasibility, considering all engineering and capacity requirements Requiring this analysis for any new manufacturing or product technology, and for any changed manufacturing process or product design. The organization should validate their ability to make product specifications at the required rate. These should consider customer-specific requirements. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX

Changes 8.2.4 Changes to Requirements for Products & Services
ISO-9 Changes 8.2.4 Changes to Requirements for Products & Services The organization shall ensure that relevant documented information is amended, and that relevant persons are made aware of the changed requirements, when the requirements for products and services are changed. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX

Changes Section : Design & development of products and services – supplemental Strengthened the standard by elevating the NOTE in the former section to a requirement, and added a requirement for documentation of the design and development process. As the concept of the design and development process in the automotive industry includes manufacturing design and development, the requirements from other parts in Section 8 should be considered complimentary in the context of manufacturing and product design and development. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX

Changes Section : Design and development planning – supplemental Clarifies when the multidisciplinary approach is to be used and who should be involved. Specifically, it must include all affected stakeholders within the organization and, as appropriate, its supply chain. Additional examples are provided of areas where such an approach may be used during design and development planning (including project management), and the note further clarifies that purchasing, supplier, and maintenance functions might be included as stakeholders. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX Changes Section : Product design skills This section adds a NOTE as an example of a product design skillset. There is no change in intent.

Changes Section : Development of products with embedded software This new clause adds requirements for organization-responsible embedded software development and software development capability self-assessments. Organizations must use a process for quality assurance of products with internally developed embedded software, and have an appropriate assessment methodology to assess their software development process. The software development process must also be included within the scope of the internal audit program; the internal auditor should be able to understand and assess the effectiveness of the software development assessment methodology chosen by the organization GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX If future products have embedded software we will carry out reqts at that time

Changes Section 8.3.3.1: Product design input
This section expanded the minimum set of product design input requirements, emphasizing regulatory and software requirements. New and broadened requirements include: product specifications; boundary and interface requirements; consideration of design alternatives; assessment of risks and the organization's ability to mitigate/manage those risks; conformity targets for preservation, serviceability, health, safety, environmental, and development timing; statutory and regulatory requirements for the country of destination; and embedded software requirements. GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX

Changes Section 8.3.3.2: Manufacturing process design input
Expanded the list of manufacturing process design inputs including: product design output data including special characteristics, targets for timing; manufacturing technology alternatives; new materials; product handling and ergonomic requirements, and; design for manufacturing and design for assembly. This could include consideration of alternatives from innovation and benchmarking results, and new materials in the supply chain that could be used to improve the manufacturing process capacity. This section also further strengthened the requirements by transforming the former NOTE regarding error-proofing methods into a requirement GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX

Changes Section 8.3.3.3: Special characteristics (Documented Process)
Identify the source of special characteristics and including risk analysis to be performed by the customer or the organization. Expands the list of sources used to identify special characteristics, along with the requirements related to those special characteristics. Special characteristics need to be marked in all applicable cascaded quality planning documents; monitoring strategies should focus on reducing variation, which is typically done using statistical techniques. The organization must also consider customer-specific requirements for approvals and use of certain definitions and symbols, including submission of the symbol conversion table, if applicable and required GAP Actions / Date / Resp (id-Names of assessment for self-declared training record) QA manual re-write QA Mgr/ VP Date XXX Procedure for SC’s eng date XXX

IATF GAP ANALYSIS TOOL GAP GAP /TS to

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IATF GAP ANALYSIS TOOL GAP GAP /TS to

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