IATF 16949 2016 LAtest version training.pptx

IATF16949: Automotive Quality Management System
Modified and New Added Clauses - Learning Material

Sr. No. Content Slide No.
1 What is QMS? 4
2 QMS Requirements 5
3 Introduction to IATF 16949 10
4 What is IATF 16949? 11
5 History of IATF 16949 12
6 Why implement IATF 16949? 13
7 Six Steps to successful implementation 14
8 Clauses of IATF 16949 15
9 IATF 16949 Target dates for Transition & Focus Areas 16
10 Risk Based Approach / Management 17
11 Changes from ISO/TS 16949 to IATF 16949 18
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CONTENT OF MATERIAL

Sr. No. Content Slide No.
12 Goals of IATF 16949:2016 20
13 Section wise details for Modification / new requirements 22
13.1 Clause 4 : Context of the Organization 23
13.2 Clause 5 : Leadership 29
13.3 Clause 6 : Planning for the QMS 34
13.4 Clause 7 : Support 42
13.5 Clause 8 : Operation 53
13.6 Clause 9 : Performance Evaluation 78
13.7 Clause 10 : Improvement 85
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CONTENT OF MATERIAL

1. WHAT IS QMS (QUALITY MANAGEMENT SYSTEM)?
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A quality management system (QMS) is a set of policies, processes and
procedures
required for planning and execution ( production / service /development )
in the
core business area of an organization. (i.e. areas that can impact the
organization's
ability to meet customer requirements).
A QMS should be able to provide a frame work for continual improvement
and
to increase the profitability of enhancing customer satisfaction.

2. QMS REQUIREMENTS
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Establishing A QMS
To establish QMS, an organization must:
• Understand internal factor such as organizational culture
•Understand external factors such as the socio-economic conditions under which
it operates;
• Determine the needs and expectations of customers and other interested parties.
• Establish a quality policy and quality objectives for the organization
• Determine the processes and responsibilities necessary to achieve objectives
• Establish and apply methods to measure the effectiveness of each process.
• Determine the means of preventing nonconformities and eliminating their causes.
• Providing an adequate monitoring and review system.
• Establish and apply a process of continual improvement of the quality management system.

Benefits of a QMS:
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The benefits of such a system include:
 Improved business planning .
 Greater quality awareness throughout the organization
 Improved communication
 Higher customer satisfaction
 Reduced costs of non-quality
An effective QMS provides confidence to the organization and its customers,
confidence of capability to supply products that consistently meet requirements.
2. QMS REQUIREMENTS – Cont..

Seven Principles for QMS
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Explanation of Principles:
 Customer Focus – The need to understand current and future customer needs, to meet customer requirement
and exceed expectations is central to the standard as a consistent theme throughout.
 Leadership – The purpose of leadership is to ensure unity of purpose, direction and engagement of people to
enable the alignment of strategies, polices, processes and resources to achieve the objectives, goals and targets of
the organization.
 Engagement of People – Since the success of the organization depends so much on the people employed, they
need to be competent, empowered and engaged in delivering value to the organization’s capability to create
value. The standard argues that people must be respected as individuals. Recognition, empowerment and
enhancement of skills and knowledge facilitate the engagement of people in achieving the objectives of the
organization.
 Process Approach – Consistent and predictable results are achieved most efficiently when resources and
activities are understood and managed as interrelated processes that function as a coherent system. The QMS is
composed of interrelated processes. Understanding how results are produced by this system, including all its
processes, resources, controls and interactions, allow the organization to optimize its performance.
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 Improvement – Successful organizations have an ongoing focus on improvement. Improvement is essential for an
organization to maintain current levels of performance, to react to changes in its internal and external conditions
and to create new opportunities.
 Evidence – based decision making – Decisions based on the analysis and evaluation of data and information are
more likely to produce desired results. Decision-making can be a complex process, and it always involves some
uncertainty. It often involves multiple types and sources of inputs, as well as their interpretation, which can be
subjective. It is important to understand cause and effect relationships and potential unintended consequences.
Facts, evidence and data analysis lead to greater objectivity and confidence in decision made.
 Relationship Management – For sustained success, organizations manage their relationship with interested parties,
such as suppliers. Sustained success is more likely to be achieved when an organization manages relationships with
its interested parties to optimize their impact on its performance.
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Explanation of Principles – cont..:

 This standard is applicable for all automotive industry irrespective of the scale of the industry.
 The 1st edition of ISO/TS 16949 was published in 1999 by the International Automotive Task Force
(IATF)
 ISO 9001:2015 is a fundamental requirement of the Quality management system.
 IATF 16949 includes all requirement of ISO 9001 and additional automotive industry-specific
requirements.
 IATF 16949:2016 was developed and operated by the International Automotive Task Force (IATF)
 This standard gave a common platform for assessment and certification for the supply chain for the
automotive industry in the world.
 The latest Automotive QMS standard 16949:2016 is updated based on the feedback of certification
bodies, auditors, suppliers, and OEMs
 This standard is easily integrated with other ISO standards such as 14001, 45001, etc.
 The major focus of this standard is to develop the quality management system that emphasizes continual
improvement, defect prevention, reduce variation &waste in the supply chain.
 This standard also includes the Customer's Specific Requirements (CSR's) along with the standard's
requirement.
 IATF 16949:2016 is fully in line with the requirements of ISO 9001:2015.
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3. INTRODUCTION TO IATF 16949

4. WHAT IS IATF 16949?
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 The members of IATF are Daimler AG, Ford Motor Company, BMW Group,
Daimler AG, General Motors Company, PSA Group, Renault, Volkswagen
AG, etc.
 Revised Quality Management System (QMS) standard for the automotive
Industry, developed by International Automotive Task Force (IATF)
 This revised standard cancels &replaces ISO/TS 16949– 2009
 Aligned with ISO 9001 – 2015
 Not a standalone QMS – must be used in conjunction with ISO 9001 – 2015

5. HISTORY OF IATF 16949
 IATF 16949 previously known as an ISO/TS 16949.
 The 1st edition of ISO/TS 16949 was published in 1999.
 This standard gave a common platform for assessment and certification for the
supply chain for the automotive industry in the world.
 Then after 2nd edition was published in 2002 and 3rd edition in 2009.
 The 3rd edition of ISO/TS 16949:2009 is replaced by IATF 16949:2016 (1st
edition).
 The latest Automotive QMS standard 16949:2016 is updated based on the
feedback of certification bodies, auditors, suppliers, and OEMs.
 This standard is easily integrated with other ISO standards such as 9001, 14001,
45001, etc.
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6. WHY IMPLEMENT IATF 16949 ?
 Effectively Implemented IATF 16949 make sure that our customers receive constant, good quality
products and services.
 It will help us to acquire new businesses.
 IATF 16949 defines the requirements for a Quality Management System when an organization
wants to:
Clearly show the evidence of its ability to consistently provide products & services that meet
customer's requirements.
Also, meet the applicable statutory, regulatory & product safety requirements.
Intensify customer satisfaction through the effective implementation of the Quality Management
System
Implement processes for improvement of the system
Clearly, state objectives which are specific, measurable, achievable, time-bound &realistic and
identify new business opportunities
Always customers first and make sure that consistently meet their requirement and intensify
customer's satisfaction.
Identify the risks related to your business process and also take appropriate action to eliminate
or minimize the effect of the risk.
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 Familiarize yourself with ISO 9001 – 2015 and IATF 16949 – 2016
 Perform an organizational gap analysis against both standards
 Develop and implementation plan
 Provide training for all relevant individuals
 Update your existing system
 Provide evidence that your organization has met the new requirements
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7. SIX STEPS TO SUCCESSFUL IMPLEMENTATION

8. CLAUSES OF IATF 16949:2016
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9. TARGET DATES FOR TRANSITION AND THE FOCUS AREAS
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Target Dates:
 Certificates to ISO/TS 16949:2009 will no longer be valid after 14th September 2018
 After 1 October 2017 no audits (initial, surveillance, recertification or transfer) shall be conducted to
ISO/TS 16949:2009
Focus Areas:
 Risk – based thinking
 Integration of customer specific requirements
 First and second – party auditor competency
 Product Safety
 Manufacturing Feasibility
 Warranty Management
 Development of products with embedded software

10. RISk BASED APPROACH /MANAGEMENT
 To improve customer confidence and satisfaction
 To assure consistency of quality of products and services
 To establish a proactive culture or prevention and improvement
 Successful companies intuitively take a risk based approach
Emphasis on Process Approach:
 Understanding and meeting customer requirements
 How do processes value add
 Measure process performance and effectiveness
 Continual improvement of processes based on measurement
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11. CHANGES FROM ISO/TS 16949 TO IATF 16949
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New automotive standard: IATF 16949:2016
 Key Revisions – IATF 16949
 Addition of original equipment manufacturers (OEM) customer-specific requirements (CSRs) –
meant to help the process by unifying and reducing CSR implementation requirements by the certified organization
and those that would require third-party auditing from a certification body.
Note: CSRs will still be issued by OEMs and throughout the supply chain.
 Requirements for safety-related parts and processes
 Improved product traceability requirements, addressing the latest regulatory changes
 New requirements for products featuring embedded software
 Requirement for a warranty management process addressing no trouble found (NTF)
 Increased focus on corporate responsibility requirements
 Clarification of sub-tier supplier management and development requirements
 Implementation of Annex SL high-level structure that adds process consistency with ISO 9001:2015

Change Contents from ISO/TS to IATF
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11. CHANGES FROM ISO/TS 16949 TO IATF 16949 – Cont..

12. GOALS OF IATF 16949
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IATF 16949 is based on the PDCA Cycle
PLAN – DO – CHECK -ACT

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PDCA Tool
PDCA is a tool that can be used to manage processes and systems:-
 Plan : set the objectives of the system and processes to deliver results (“What to do” and
“How to do it”)
 Do : implement and control what was planned
 Check : monitor and measure processes and results against policies, objectives and
requirement, and report results
 Act : take action to improve the performance of processes
PDCA operates as a cycle of continual improvement, with risk – based thinking
at each stage.
12. GOALS OF IATF 16949 – Cont..

Clause (4-10) wise Structure for PDCA Cycle in IATF 16949
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13. SECTION WISE DETAILS FOR MODIFICATION / NEW ADDED

1. :CLAUSE 4 – CONTEXT OF THE ORGANIZATION
 This is a new clause and
organization
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provides a key insight into the
 What constitutes the organization’s quality management system
 Determine the internal and external issues relevant to the QMS
 Must monitor these issues
 Determines interested parties relevant to the QMS
 Determine their needs and expectations
 Must monitor information about interested parties requirements
 establish scope by determining boundaries and applicability of the QMS
 scope must be documented and available
 any N/A clauses must not effect conformity of products / services and customer satisfaction
 must establish, implement, maintain and continually improve the QMS
 interaction of processes required
 assign responsibilities and authorities for processes
 retain documented information to ensure in the processes

4.1 Understanding the Organization and its Context
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• An organizations context is influenced by its business environment that characterizes each sector or industry; the customers and
their needs, the required knowledge and technologies, the materials, services and systems that are required for producing the
product or service.
• To determine context means to identify the internal and external factors that can impact the organizations strategic objectives and
the planning of the QMS.
• Focus on factors that can affect customer satisfaction and delivery of quality products and / or service.
• ISO 9001:2015 provides no suggested methods to analyse the context of an organization, but there are many models
that can help an organization to understand the strategic nature of their industry and how they fit into that
environment
• Such as PESTLE analysis (political, economic, social technological, legal and environmental) this analysis determines
which factors can influence how the organization operates.
• The SWOT analysis (Strengths, Weaknesses, Opportunities and threats), by SWOT analysis organization can
identify their overall strengths and weaknesses along with opportunities and threats.
13.1 : CLAUSE 4 – CONTEXT OF THE ORGANIZATION – Cont..

Internal Context:
o Performance factors – Financial results, regulatory requirements
o Resources factors – Infrastructure, Organization knowledge, Capabilities
o Human factors – competence of personnel, Org culture, Unions, Suppliers
o Operational factors – production / process capabilities, QMS performance
o Factors in the governance of the organization - Rules and procedures for decision making or
organization’s structure.
External Context:
o Economic factors – Money exchange rate, credit availability
o Social factors – Public holidays, working days, education level
o Political factors – Political stability, International trade agreements
o Technology factors – material and equipment
o Market Factors – Competition, market share, market stability
o Statutory and Regulatory factors – legal and statutory requirements
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Types of Context

4.2 Understanding the needs and expectations of interested parties
 The definition of “interested parties” states that it is a “person or organization that can affect, be affected by, or perceive
itself to be affected by, a decision or activity.
 The intent of this requirement is to ensure that you consider the requirements of relevant interested parties, beyond just
those of the customer and end user.
 There will be those external interested parties that impose specific legal, regulatory or contractual requirements.
 There may be also requirements specified by internal interested parties, such as : management, staff, shareholders, trade
unions, etc.
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4.3 Determining the Scope of the QMS
o The scope is a vital part of the QMS as it defines how far the QMS extends within the company’s operations (boundaries)
o The scope shall state the type of products and services covered, and provide justification for any requirement of ISO
9001:2015 that the organization determines is not applicable to the scope of its QMS.
o The organization’s scope shall be maintained as documented information, e.g.:- quality manual; marketing materials;
website; etc. must be clear on the scope of its QMS certification to avoid confusing or misleading customers.
Modification in Scope of QMS : Section 4.3.1
o These requirements were originally included in ISO/TS 16949:2009 Sections 1.1 and 1.2.
o They have been moved to Section 4 within IATF 16949.
o 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.
o In addition, any exclusion sought for design and development activities, now in Section 8.3, has to be preserved as
documented information.
New Added Scope of QMS : Section 4.3.2 : CUSTOMER SPECIFIC REQUIREMENT
o Although the need to fulfill and satisfy customer-specific requirements was already mentioned throughout the whole
ISO/TS 16949 document, in IATF 16949 this requirement specifically addresses the need to evaluate the customer specific
requirements and include them where applicable in the organization's quality management system.
o This means that the supplier would need some sort of process to evaluate each of their customer’s customer-specific
requirements and determine exactly how (and where) it applies to their organization's QMS, as applicable.
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New Added in QMS &Its Process : Section 4.4.1.1 : CONFFORMANCE OF PRODUCT &PROCESSES
o This requirement was adopted based on IATF survey feedback received.
o 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
o 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
New Added in QMS &Its Process : Section 4.4.1.2 : PRODUCT SAFETY
o New section with enhanced requirements that address current and emerging issues the automotive industry is facing
related to product and process safety.
o Organizations (suppliers) are required to have documented processes to manage product-safety related products and
processes.
 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.
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4.4 QMS and it Process

13.2 : CLAUSE 5 – LEADERSHIP
 This is a new clause and must take accountability for the QMS
effectiveness
 Customer and regulatory requirements are met
 Risk and opportunities are determined and addressed
 Focus on enhancing customer requirements
 Now split into two sub clauses to save the confusion in the previous version of what must be in the
policy and what must be done with the policy
 Must be documented
 Must be available internally and interested parties
 Ensure responsibilities and authorities for relevant roles are assigned, communicated and understood
 No formal requirement for specific management representative
 Specific mention of changes to QMS
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5.1 Leadership and Commitment
This is a new added clause and must include:
o must take accountability for the QMS’ effectiveness
o ensure Quality Policy and quality objectives are established
o ensure QMS is integrated into business processes
o ensure resources are available;
o communicate importance of effective QMS
o promote improvement &ensure QMS achieves intended results
 The intent of this requirement is to ensure that top management, demonstrate leadership and commitment by taking an
active role in engaging, promoting, and ensuring, communicating and monitoring the performance and effectiveness of the
QMS.
 The role of top management is to inspire by leading by example.
 Top Management is expected to ensure that the quality policy &quality objectives are consistent with the overall strategy &
context.
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13.2 : CLAUSE 5 – LEADERSHIP – Cont..

5.1 Leadership and Commitment – cont..
New Added in Leadership &Commitment: Section 5.1.1.1 : CORPORATE RESPONSIBILITY
 ISO 9001:2015 expanded the ISO 9001:2009 concept of management responsibility into a set of leadership behaviors to
ensure an effective QMS.
 IATF 16949 includes the requirement for an anti-bribery policy, an employee code of conduct, and an ethics escalation
policy to address increasing market and governmental expectations for improved integrity in social and environmental
matters in the automotive industry.
 This implies responsibility and empowerment at all levels and functions of the supplier/organization to follow an ethical
approach and report any observed unethical behaviour without fear of reprisal.
Modification in Leadership &Commitment : Section 5.1.1.2 : PROCESS EFFECTIVENESS &EFFICIENCY
 The requirement for a supplier/organization to review their processes to ensure effectiveness and efficiency was covered in
ISO/TS 16949, Section 5.1.1.
 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.
 Preview 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.
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5.1 Leadership and Commitment – cont..
New Added in Leadership &Commitment: 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.
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5.3 Organizational Roles, Responsibilities &Authorities
Modification: Section 5.3.1 : 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.
Modification: Section 5.3.2 : RESPONSIBILITY &AUTHORITY FOR PRODUCT
REQUIREMENT &CORRECTIVE ACTIONS
 Based on survey feedback, the IATF adopted some enhancements to the requirement originally included in 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 order that they ensure non-conforming product is identified, contained, and not shipped to the customer.
 This implies that the assigned personnel must be always available to take prompt action to prevent release.
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 Introducing Risk based approach to planning
 Addresses risks, opportunities and quality objectives
 Determine risks to ensure QMS achieves results, enhance desirable effect and achieve improvement
 Must evaluate the effectiveness of actions
 Must be risk based
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 Quality objectives should be:
-- consistent with the quality policy measureable and take into account applicable requirement
-- relevant to conformity of product & services, and the enhancement of customer satisfaction
--monitored, communicated and updated
 Must be documented
 Where changes is needed, it need to be carried out in a planned and systematic manner
 Must ensure integrity of QMS
13.3 : PLANNING FOR THE QMS

6.1 Actions to Addresses Risk &Opportunities
 Actions to address risk include developing appropriate process controls, for example
 The inspection, monitoring and measuring of processes, products and services;
 Calibration;
 Product and process design;
 Corrective actions;
 Specified methods and work instructions;
 The training and use of competent persons
Risk – Based Thinking
oIs not new
oIs something you do probably
o Ensures greater knowledge of risks and improves preparedness
o Increase the probability of reaches objectives
oReduces the probability of negative results
oMake prevention a habit
o Is a systematic approach to risk management
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13.3 : PLANNING FOR THE QMS – Cont..

6.1 Actions to Addresses Risk &Opportunities – cont..
Modification: Section 6.1.2.1 : RISK ANALYSIS
 The IATF adopted additional requirements for risk analysis recognizing the continual need to analyse and respond to risk
and to have suppliers/organizations consider specific risks associated with the automotive industry, and shall retain
documented information of the results of the risk analysis.
 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.
Modification: Section 6.1.2.2 : PREVENTIVE ACTIONS
 The IATF enhanced the requirement found in ISO/TS 16949 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 non-conformity could occur, and applying lessons learned to prevent such potential
occurrence.
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6.1 Actions to Addresses Risk &Opportunities – cont..
Modification: Section 6.1.2.3 : CONTIGENCY PLANS
 The expanded requirement ensures the organization defines and prepares contingency plans and retain documented
information along with a notification process to the customer or other interested parties.
 Organizations would first take a systematic approach to identifying and evaluating risk for all manufacturing processes, giving
particular attention to external risk.
 Contingency plans 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.
 Customer notification is a mandatory step in any contingency plan, unless there is no risk to deliver nonconforming product
or affect on-time delivery.
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6.2 Quality Objectives &Planning
 Establishing objectives and planning how to achieve them can help your organization to accomplish its business goals.
 The quality objectives take the goals stated in the quality policy and turn these into statements for improvement against which
plans can be made
 Quality objectives may be established to measure the performance of products, processes, customer satisfaction, suppliers,
use of resources, and the overall effectiveness of the QMS
 If you state in your policy that you will“meet customer requirements”, then you might set customer focused objectives for:
product defects, customer complaints and return, on-time delivery, etc.
Quality Objectives Shall:
oConsistent with Quality Policy
oRelevant to Product and Service
oMeasureable
oMonitored
oUpdated
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6.2 Quality Objectives &Planning – cont..
Modification: Section 6.2.2.1 : SUPPLEMENTAL
 ISO/TS 16949 included the importance of addressing customer expectations in the NOTE to Section 5.4.1.1.
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).
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6.3 Planning of Changes
How Change is addressed
 One of the goals of the ISO 9001:2015 is to enhance the requirements for addressing changes at system and operational
levels. Once an organization has identified its context and interested parties and then identified the process that support this
linkage, addressing changes becomes an increasing important component of continued success.
 Changes are intended to be beneficial to the organization and need to be carried out as determined by the organization
(change control) to prevent undesirable effects during and after a change.
Steps to Implement Changes
 Define the specifics of what is to be changed
 Have a plan (tasks, timeline, responsibilities, authorities, budget, resources, needed information, others)
 Engage other people and develop a communication plan (appropriate people within the organization, customers, suppliers,
interested parties, etc. May need to be formed)
 Use a cross functional team review the plan to provide feedback related to the plan and associated risks.
 Train people
 Measure the effectiveness and identify any additional problems.
 The organization shall retain documented information describing the results of the review of the changes.
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6.3 Planning of Changes – cont..
Types of Changes
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 Process Changes (Input Activities, Outputs and Controls)
 Communication with customers
 Communication with supply chain
 Inspection, Equipment
 Employee Training / Competence
 Introducing a new process
 Provide / change documented information
 Outsource a process
 Many Others

 New Constructed Clause
 Much of what was in Ver. 2008 clauses 4,5,6
 Must provided resources for the implementation & maintenance of the QMS
 Must consider constraints of existing resources and what may be provided from external providers
 Similar to clause 6.2.2
 determine the necessary competence of persons who can affect the performance and effectiveness of
the QMS ensure that these persons are competent
 Documented information must be obtained of competence
 Specific clause for awareness.2
 Persons working the organization must be aware of quality policy, objectives, their contribution to
effectiveness of QMS and implication of not confirming to QMS
 Much expanded clause for communication
 Must now determine what will be communicated internally and externally about the QMS, when, to
whom, how and by whom.
 QMS documented information required by the standard and as determined by the organization
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13.4 : SUPPORT

7. Support
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13.4 : SUPPORT – Cont..

7.1 Resources
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7.1.1 General
 Must provide resources for the implementation and maintenance of the QMS
 Must consider constraints of existing resources and what may be provided from external providers.
7.1.2 People
 New clause
 Must determine and provide people necessary for effective information of QMS and operations/control of processes
7.1.3 Infrastructure
 Same as for previous clause 6.3
Modification: Section 7.1.3.1 : PLANT FACILITY AND EQUIPMENT PLANNING
o 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.
o Capacity planning evaluation during manufacturing feasibility assessments must consider customer-contracted production
rates and volumes, not only current order levels.

7.1 Resources – cont..
7.1.4 Environment for the Operation of Processes
 Same as for previous clause 6.4
7.1.5 Monitoring &Measuring Resources
 Determine resources needed to ensure valid and reliable monitoring and measuring results
 Resources must be suitable for the activity and maintained as fit for purpose
 Evidence of fit for purpose must be retained
 Other requirements for measuring equipment unchanged.
Modification: Section 7.1.5.1.1 : MEASUREMENT SYSTEM ANALYSIS
 Records are now required for customer acceptance of alternative methods. The previous requirement to analyse variation in
measurement results is now extended specifically to inspection equipment.
 IATF 16949 also clarifies that records of customer acceptance need to be retained along with results from alternative
measurement system analysis.
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7.1 Resources – cont..
7.1.5 Monitoring &Measuring Resources – cont..
Modification: Section 7.1.5.2.1 : CALIBRATION / VERIFICATION RECORDS
 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 16949 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.
Modification: 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.
7.1.6 Organizational Knowledge
 New clause required to determine, maintain and make available the knowledge necessary for the operation of its processes
and to achieve conformity of products and services
 Particular care required for changing need and trends.
 May consider:
• internal sources (e.g. learning from failures and successful projects, capturing undocumented knowledge and expert
experience)
• external sources (e.g. standards, training, conferences, knowledge from customers or providers).

7.2 Competence
47
 Very similar to previous Clause 6.2.2
 Removal of providing ‘training’to ‘competence’
 Determine the necessary competence of persons who can affect the performance and effectiveness of the QMS and ensure
that these persons are competent
 Documented information (record) must be obtained of competence.
Modification: Section 7.2.1 : SUPLEMENTAL
 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
Modification: Section 7.2.2 : COMPETENCE - OJT
 IATF 16949 enhances the emphasis of on-the-job training and its importance in meeting customer requirements, including
other interested parties.
 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.

7.2 Competence – cont..
48
Modification: Section 7.2.3 : COMPETENCE – INTERNAL AUDITOR
 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 actions 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
New Added in Competence : Section 7.2.4 : COMPETENCE – SECONT PARTY AUDITOR
 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.

7.3 Awareness
49
 Specific clause for awareness
 Persons working in the organization must be aware of Quality Policy, quality objectives, their contribution to effectiveness
of QMS and implication of not conforming with QMS.
 Includes additional requirements to ensure all employees are aware of their impact on the organization’s (supplier’s)
product quality output, customer specific requirements, and risks involved for the customer with non-conforming product.
The documented information shall maintain for this requirement.
Modification: Section 7.3.2 : EMPLOYEE MOTIVATION &EMPOWERMENT
 This section did not substantially change, but now requires "maintaining a documented process" for employee motivation
and empowerment, instead of simply "having a process.“

7.5.1 General
 QMS needs documented information required by the Standard and as determined by the organisation
 Note: the extent of documented information can differ from one organisation to another due to its size, activities, processes,
products and services, complexity of processes and their interactions, and the competence of people. Must provide resources
for the implementation and maintenance of the QMS
Modification: Section 7.5.1.1 : QMS DOCUMENTATION
 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). The Quality Management System shall be
documented.
 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.
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7.5 Documented Information

7.5.2 Creating and Updating
 Documented information requires:
o identification and description
o format and media
o review and approval
7.5.3 Control of Documented Information
 Combines previous clauses 4.2.3 (Documentation) and 4.2.4 (Records)
Modification: Section 7.5.3.2.1 : RECORD RETENTION
 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.
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7.5 Documented Information – cont..

7.5 Documented Information – cont..
52
Modification: Section 7.5.3.2.2 : ENGINEERING SPECIFICATIONS
 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.

o Covers many of the Product
Realisation
o Requirements contained in Clause
7 of the 2008 version.
o The heart of the management
system (the business).
13.5 : OPERATION
53

8.1 Operational Planning &Control
 Similar to previous Clause 7.1
 Must plan, implement and control processes needed to meet requirements for the provision of products and services
 Must control planned changes and review unintended changes
 Any outsourced processes must be controlled.
 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.
54
13.5 : OPERATION – Cont..

55
8.2 Requirements for Product and Services
8.2.1 Customer Communication
 Same as previous Clause 7.2.3
 Includes communicating with customers about handling and controlling their property,
requirements, when relevant.
Modification: Section 8.2.1.1 : SUPLEMENTAL
establishing contingency
 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.
8.2.2 Determining the Requirements for Product &Services
 Same as previous Clause 7.2.1
 Plus the organisation must meet the claims of products or services it offers.
 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.

8.2 Requirements for Product and Services – cont..
8.2.3 Reviewof Requirements for Product &Services
56
 Combines previous Clauses 7.2.1 and 7.2.2
 Documented information required on results of the review and any new requirements.
Modification: Section 8.2.3.1.1 : SUPLEMENTAL
 IATF 16949 strengthens this requirement by requiring the organization to retain a documented customer authorization
for waivers of formal reviews for products and services.
Modification: 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

8.3 Design &Development of Product and Services
57
 where the detailed requirements of the organisation’s products and services are not already established or not defined by
the customer or by other interested parties, such that they are adequate for subsequent production or service provision, the
organisation shall establish, implement and maintain a design and development process;
 changes are mainly terminology and simplified wording
 there is, however, a significantly increased focus on the role the customer has in all stages of the design process
 the need for documented information to confirm appropriateness of all stages is also clearly stated
 any changes made to design inputs and design outputs during the design and development must be clearly identified.
 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.

58
8.3 Design &Development of Product and Services – cont..
Modification: Section 8.3.2.1 : D &D PLANNING - SUPLEMENTAL
 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.
New Added : Section 8.3.2.3 : DEVELOPMENT OF PRODUCTS WITH EMBEDED SOFTWARE
 This new clause adds requirements for organization-responsible embedded software development and software
development capability self-assessments, &shall retain documented information.
 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.
Modification: 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

Modification: 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 etc. shall identify and document.
Modification: Section 8.3.3.3 : 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.
Modification: Section 8.3.4.1 : MONITORING
 This could include, for example, the periodic update of customer APQP schedule milestones, gate reviews, and open
issues lists related to development activities.
Modification: Section 8.3.4.2 : VALIDATION
 This section features a strengthening of the requirements for design and development validation, and also added
embedded software.
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60
Modification: Section 8.3.4.3 : PROTOTYPE PROGRAME
 The changes in this section strengthen the standard by focusing the organization on the quality management system for
managing outsourced products and services.
 Regardless of whether the work is performed by the organization or by an outsourced process, the prototype programme
and control plan are part of the scope of the QMS.
Modification: Section 8.3.4.4 : PRODUCT APPROVAL PROCESS
 These changes clarify approval requirements, with an emphasis on outsourced products and/or services and record
retention required.
 Apart approval process for externally provided products and services needs to be performed prior to final product
submission to customers.
 Product approval must be obtained when the customer requires it, and records retained.
 This section features a strengthening of the requirements for design and development validation, and also added
embedded software.

Modification: Section 8.3.5.1 : D &D OUTPUTS - SUPPLEMENT
 Product design output additions include a recognition of the use of 3D models, and inclusion of service parts and
packaging.
 IATF 16949 clarifies that it requires product design error-proofing methods, such as DFSS, DFMA, and FTA. The
application of GD&T tolerancing and positioning systems allows organizations to specify dimensions and related
tolerances based on functionality relationships.
 Outputs include repair and serviceability instructions and service parts requirements that will be used by approved
maintenance organizations.
Modification: Section 8.3.5.2 : MANUFATURING PROCESS DESIGN OUTPUT
 Changes in this section strengthened verification requirements, process input variables, capacity analysis, maintenance
plans and correction of process nonconformities.
 Clarifies that the process approach methodology of verifying outputs against inputs applies to the manufacturing design
process.
 The list of manufacturing design outputs is also expanded.
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Modification: Section 8.3.6.1 : D &D CHANGES - SUPPLEMENT
 This section strengthens the requirement for change validation and approval prior to implementation, and also added
embedded software.
 Design changes after initial product approval implies that products, components, and materials need to be evaluated and
validated prior to production implementation.
 This validation needs to be done by the organization and the customer, when there is a customer-specific requirement.
 For products with embedded software, the change record needs to document the revision level of the software and
hardware to help assure that product configuration is managed appropriately.
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8.4 Control of Externally Provided Processes, Products &Services
 changes are mainly terminology and revised wording (i.e. suppliers become ‘external providers!’)
 much as before, each stage of the purchasing process, including evaluation, selection, performance monitoring and re-
evaluation remains a key requirement
 there is a significant increase in the steps needed to control external provision.
Modification: Section 8.4.1.1 : GENERAL - SUPPLEMENTAL
 Under Control of externally provided processes, products and services
 The former NOTE about purchased products was broadened and elevated into a requirement.
 It now clarifies that all the requirements of section 8.4 apply to sub-assembly, sequencing, sorting, rework, and calibration
services.
Modification: Section 8.4.1.2 : SUPPLIER SELECTION PROCESS
 This section now specifically calls out supplier selection process criteria, in addition to clarifying that it is a full process.
 The assessment used to select suppliers needs to be extended beyond typical QMS audits and include aspects such as:
risk to product conformity and uninterrupted supply of the organization's product to their customers, etc.
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8.4 Control of Externally Provided Processes, Products &Services – cont..
64
Modification: Section 8.4.1.2 : SUPPLIER SELECTION PROCESS
 This section now specifically calls out supplier selection process criteria, in addition to clarifying that it is a full process.
 The assessment used to select suppliers needs to be extended beyond typical QMS audits and include aspects such as:
risk to product conformity and uninterrupted supply of the organization's product to their customers, etc.
Modification: Section 8.4.1.3 : CUSTOMER DIRECTED SOURCES (DIRECTED-BUY)
 This section features a clarification of the organization’s responsibilities for customer directed sources, even for customer
directed-buy suppliers.
 Unless otherwise defined by contract, all requirements of IATF 16949 Section 8.4 apply in this situation, except
requirements related to the selection of the supplier itself.
Modification: Section 8.4.2.1: TYPE & EXTENT OF CONTROL -SUPPLEMENTAL
 Type &control needs to be consistent with supplier performance and an assessment of product, material, or service risk.
 This implies a constant monitoring of performance &assessment of risk based on the established criteria, triggering the
actions to escalate (increase) or reduce the types and extent of control.

65
Modification: Section 8.4.2.2 : STATUTORY &REGULATORY REQUIREMENTS
 Updates clarify the applicability of statutory and regulatory requirements and strengthen the requirements.
 Identification of applicable statutory and regulatory Requirements needs to consider the country of receipt, shipment, and
delivery.
Modification: Section 8.4.2.3 : SQM SYSTEM DEVELOPMENT
 This section provides a method to strengthen ISO 9001 certification, aligns with customer-specific requirements, and
clarifies the acceptable third-party certification bodies (which shall be recognized by the IATF).
 Instead of requiring organizations to simply "develop" the supplier QMS, this section outlines a progressive approach that
goes from compliance to ISO 9001 via second-party audits all the way through certification to IATF 16949 through third-
party certification.
New Added : Section 8.4.2.3.1 : AUTOMOTIVE-PRODUCT RELATED SOFTWARE
 This new section added requirements for software development assessment methodology.
 These requirements align to those presented within Section 8.3, but are now cascaded down to suppliers.

66
Modification: Section 8.4.2.4 : SUPPLIER MONITORING
 Organizations should continuously review inputs and introduce improvement actions regarding supplier monitoring data,
as needed.
 Documented and non-documented yard holds and stop ships should be considered customer disruptions, and the
number of premium freight occurrences need to be monitored.
 Performance indicators provided by the customer and from service need to be included within the organization's supplier
monitoring
New Added : Section 8.4.2.4.1 : SECOND PARTY AUDIT
 This new section aligns customer-specific requirements into the IATF 16949 standard.
 Second-party audits should consider issues relevant to the organization beyond simply the maturity of their QMS
development.
 Examples of situations that could trigger a second-party audit include: input from supplier performance indicators; risk
assessment results and follow-up of open issues from process and product audits; and new development launch readiness.
 The organization's criteria for determining the need, type, frequency, and scope of second-party audits must be based on
a risk analysis.

67
Modification: Section 8.4.2.5 : SUPPLIER DEVELOPMENT
 This section adds an emphasis on performance-based supplier development activities.
 Supplier monitoring process should be considered an input to the supplier development activities. These development
activities should consider both short term and long term goals.
o Short term efforts would generally focus on supplier products, and would require defining suitable methods to
assure the quality of purchased product from each supplier.
o Long term efforts would generally focus on supplier QMS and manufacturing processes on the whole, and
consider audits, training, and enhancement efforts that implement and enhance quality assurance agreements
between suppliers and the organization, and further reduce risk.
Modification: Section 8.4.3.1 : INFORMATION FOR EXTERNAL PROVIDERS - SUPPLMENTAL
 The organization is required to provide key information to their supply chain through this new requirement.
 This information includes all applicable statutory and regulatory requirements and special product and process
characteristics.

8.5 Production &Service Provision
68
 Changes are mainly terminology and revised wording
 The most significant change is the move of monitoring and measuring equipment to Section 7
 Reference to ‘changes and post delivery activities’have been strengthened.
Modification: Section 8.5.1.1 : CONTROL PLAN
 This section strengthened the control plan requirements and aligned IATF OEM customer-specific requirements into
the IATF 16949 standard. It also elevated a NOTE regarding customer approval to a requirement, and strengthened the
control plan review and update criteria and linked to the PFMEA updates.
 Control plans are needed for the relevant manufacturing site and all product supplied, and not just for the final product
or final assembly line, as an example.
 Although family control plans are acceptable for bulk material and similar parts using a common manufacturing process,
care should be given to identify the degree of difference that is acceptable to apply this common control.
Modification: Section 8.5.1.2 : STANDARDIZE WORK – OPERATOR INSTRUCTIONS
&VISUAL STANDARD
 Through this section, IATF 16949 strengthens the requirements for standardized work, including the requirement to
address specific language needs.
 Standardized work documents need to be clearly understood by the organization's operators and should include all
applicable quality, safety, and other aspects necessary to consistently perform each manufacturing operation.

8.5 Production &Service Provision – cont..
69
Modification: Section 8.5.1.3 : VERIFICATION OF JOB SETUPS
 The changes in this section elevate a NOTE to a requirement, and clarify record retention.
 Clarify that the organization shall verify job changes that require a new set-up; maintain documented information for set-
up personnel; perform first-off/last-off part validation, as applicable, including retention and comparison; and retain
records of process and product approval following these validation actions.
New Added: Section 8.5.1.4 : VERIFICATION AFTER SHUTDOWN
 Defines a new requirement for verification after shutdown, integrating industry lessons learned and/or best practices.
 The necessary actions after the shutdown period should be anticipated in the PFMEA, control plans, and maintenance
instructions, as appropriate.
 A multidisciplinary approach should be used to identify any additional actions needed to address unexpected shutdown
events.
Modification: Section 8.5.1.5 : TOTAL PRODUCTIVE MAINTENANCE
 TPM is a system for maintaining and improving the integrity of production and quality systems through machines,
equipment, processes, and employees that add value to the manufacturing process. TPM should be fully integrated
within the manufacturing processes and any necessary support processes.

Modification: Section 8.5.1.6 : MANAGEMENT OF PRODUCTION TOOLING AND
MANUFACTURING, TEST, INSPECTION TOOLING AND EQUIPMENT
 IATF 16949 features strengthened tooling and equipment marking and tracking requirements.
 This requirement extends the scope to production and service materials and for bulk materials, as applicable, and
clarifies that requirements apply whether tooling is owned by the organization or by the customer.
 The updates clarify that the system for production tooling management must include tool design modification
documentation and tool identification information.
 Customer-owned tools and equipment need to be permanently marked in a visible location
Modification: Section 8.5.1.7: PRODUCTION SCHEDULING
 This section emphasized the importance of planning information and integrated IATF OEM customer lessons learned.
 Ensure that customer orders/demands will be achieved.
 This suggests the organization needs a robust feasibility review process regarding production scheduling. The production
scheduling activities also need to include all relevant planning information as inputs to their feasibility review and make
any necessary adjustments.
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71
Modification: Section 8.5.2.1 : IDENTIFICATION AND TRACEABILITY —SUPPLEMENTAL
 Strengthened the requirements for traceability to support industry lessons learned related to field issues.
 Requirement of clear start and stop points for product received by the customer is aligned with the definition of
traceability in ISO 9000:2015.
Modification: Section 8.5.4.1: PRESERVATION – SUPPLEMENTAL
 Adds specificity to preservation controls and includes application to internal and/or external providers.
 Preservation activities are expanded in two ways: first, activities that are considered preservation controls, and second,
locations where preservation controls apply.
 Preservation controls include the preservation of identification during the product shelf life; a contamination control
program appropriate to identified risks; design and development of robust packaging and storage areas; adequate
transmission and transportation considerations; and measures to protect product integrity.
Modification: Section 8.5.5.1: FEEDBACK OF INFORMATION FROM SERVICE
 Requirements for this section feature an expanded scope to include material handling and logistics.
 The new second NOTE also clarifies that "service concerns“ should include the results of field failure test analysis where
applicable
o the intent of this addition is to ensure that the organization is aware of nonconformities that occur outside of its
organization

Modification: Section 8.5.6.1 : CONTROL OF CHANGES – SUPPLEMENTAL
 The process to control and react to changes needs to include risk analysis and to retain records of verification and
validation.
 FMEAs should be reviewed for any manufacturing or product changes, prior to implementation. Production trial run
activities should be planned based on the risk and complexity of the changes
New Added: Section 8.5.6.1.1 : TEMPORARY CHANGE OF PROCESS CONTROLS
 This new requirement for temporary control of process changes addresses issues experienced by the IATF OEM
customers.
 The organization must identify, document, and maintain a list of process controls that includes both the primary process
control (example: automated nut driver) and the approved back-up or alternate methods (example: manual torque
wrench). The list must be updated regularly to reflect the current and approved process controls.
72

8.6 Release of Product &Services
73
 Must verify that product and service requirements have been meet and evidence of conformity retained
 Release to customer does not proceed until the planned verification of conformity has been satisfactorily completed,
unless otherwise approved by a relevant authority and by the customer
 Documented information to provide traceability to the person(s) authorising release for delivery to the customer.
Modification: Section 8.6.1 : RELEASE OF PRODUCTS AND SERVICES –SUPPLEMENTAL
 These updates strengthen the standard to ensure process controls align with the control plan.
 To achieve coherence between the control plan and the planned arrangements to verify product and service conformity,
the organization should conduct a regular control plan audit that compares the current approval status of the product and
process with the actual controls applied in the manufacturing process.
Modification: Section 8.6.2 : LAYOUT INSPECTION AND FUNCTIONAL TESTING
 An added note clarifies that frequency of layout inspections is determined by the customer.
Modification: Section 8.6.3: APPEARANCE ITEMS
 This section requires organizations to provide masters for haptic technology, as appropriate. Haptic technology
recreates the sense of touch by applying forces, vibrations, or motions to the user.

8.6 Release of Product &Services – cont..
Modification: Section 8.6.4 : VERIFICATION AND ACCEPTANCE OF CONFORMITY
OF EXTERNALLY PROVIDED PRODUCTS AND SERVICES
 Changes in this section align with ISO 9001:2015 terminology and clarify the source of statistical data as that provided by
the supplier to the organization.
Modification: Section 8.6.5 : STATUTORY AND REGULATORY CONFORMITY
 Strengthens the standard for statutory and regulatory conformity to require evidence of compliance.
 These requirements must consider both the countries where products are manufactured and the destination countries.
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8.7 Control of Nonconforming Outputs
Modification: Section 8.7.1.1 : CONTROL OF NONCONFORMING OUTPUTS
 The changes clarify that the organization must obtain customer authorization prior to further processing for "use as is" and
rework disposition of nonconforming products, and subcomponent reuse must be clearly communicated to the
customer.
 Appropriate internal verification and validation activities of any rework or reuse of sub-components should be approved
prior to customer submission.
Modification: Section 8.7.1.2 : CONTROL OF NONCONFORMING OUTPUTS
CUSTOMER SPECIFIED PROCESS
 This section ensures customer controlled shipping requirements are followed, and that these customer-specific
requirements are integrated into the organization's internal activities for the control of nonconforming product.
Modification: Section 8.7.1.3 : CONTROL OF SUSPECT PRODUCT
 The updates in this section augment the requirements for control of suspect product by ensuring containment training is
implemented.
 Appropriate training should consider, for example, awareness about special characteristics, customer-specific
requirements related to nonconforming product control, product safety, escalation processes, storage areas, and related
roles.

8.7 Control of Nonconforming Outputs – cont..
Modification: Section 8.7.1.4 : CONTROL OF REWORKED PRODUCT
 This update increases the scope of control of reworked product requirements to include: customer approval, risk
assessment, rework confirmation, traceability, and retention of documented information.
 The risk analysis and customer approval requirements are interrelated; FMEAs should identify and address risks related
to each possible rework of the characteristics stated in the control plan.
Modification: Section 8.7.1.5 : CONTROL OF REPAIRED PRODUCT
 The changes in this section clarify the requirement and the need for follow-up with detailed information for reworked
product.
 The organization shall obtain a documented customer approval for concession of the product to be repaired.
New Added: Section 8.7.1.6 : CUSTOMER NOTIFICATION
 This new section features a new automotive requirement to address modifications in ISO 9001 requirements and address
customer issues for IATF OEM concerns.
 While customer notification is mentioned twice in ISO/TS 16949:2009 (see Section 7.4.3.2 and Section 8.2.1.1), it did
not address customer notification in a standalone section.
 The organization is required to immediately notify the customer if they ship nonconforming product, and follow up with
detailed documentation.
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8.7 Control of Nonconforming Outputs – cont..
Modification: Section 8.7.1.7 : NON-CONFORMING PRODUCT DISPOSITION
 Strengthen the requirement of disposition of nonconforming product by clarifying that organizations must also have a
documented process for disposition of nonconforming product not subject to rework or repair.
 Planned activities need to be managed and the results considered to improve this process.
 Contamination control practices should be applied to avoid any risk of unintended use of this type of nonconforming
products.
 Customer approval is required before nonconforming products in this category can be diverted for service or any other
use.
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 Determining what is to be monitored, measured, analysed and
evaluated will enable the organisation to determine ‘if the
management system suitable, adequate and effective ?’
 must determine what needs to be monitored and measured, the methods for monitoring,
measurement, analysis and evaluation, as applicable, to ensure valid results
 additionally, when the monitoring and measuring is to be performed and when the results from
monitoring and measurement is to be analysed and evaluated
 retain appropriate documented information as evidence of the results.
 same as previous Clause 8.2.2
 split into two sub-clauses
 still at planned intervals
 evidence of internal audits and results must be documented.
 monitoring and measurement results;
 issues concerning external providers &relevant interested parties;
 adequacy of resources
 effectiveness of actions taken to address risks and opportunities
 evidence of management review results must be documented.
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13.6 : PERFORMANCE EVALUATION

9. Performance Evaluation
Modification: Section 9.1.1.1 : MONITORING AND MEASUREMENT OF
MANUFACTURING PROCESSES
 Clarifies the requirement for targeting process effectiveness and efficiency (not just “having” a process, but monitoring it)
 Further ensures that organizations support the manufacturing process through defined roles, responsibilities, and effective
escalation processes to drive process capability and stability.
 The NOTE clarifies that it may not be possible or feasible to measure product or manufacturing process characteristics
through process capability assessments. In such cases, a rate or index of lot conformity may be acceptable.
Modification: Section 9.1.1.2 : IDENTIFICATION OF STATISTICAL TOOL
 Requirements for the identification of statistical tools feature clarifications regarding the documented deployment of the
use of statistical tools from DFMEA, PFMEA, and the APQP (or equivalent) process.
 The tool chosen in the APQP (or equivalent) process must be included in design/process risk analysis and the control
plan.
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13.6 : PERFORMANCE EVALUATION – Cont..

9. Performance Evaluation – cont..
Modification: Section 9.1.1.3 : APPLICATION OF STATISTICAL CONCEPTS
 This section features a clarification regarding requirements for those involved in capturing and analysing data; previously,
this was driven across all employees regardless of relevance.
 These concepts should be included in the competencies required for "employees involved in the collection, analysis, and
management of statistical data.“
Modification: Section 9.1.2.1 : CUSTOMER SATISFACTION – SUPPLEMENTAL
 Clarify customer satisfaction monitoring criteria and introduction of additional focus on warranty management.
 Additional focus to ensure all customer performance measures are regularly reviewed to reduce the risk of failure to
achieving customer satisfaction.
 The organization has a responsibility to access, review, and take appropriate action about information published in
customer portals.
 When identifying the need for correction or improvement actions, customer scorecard deficiencies should be given
priority.
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81
Modification: Section 9.1.3.1 : PRIORITIZATION
 The emphasis of the requirement changed from the ISO/TS 16949 standard's “Analysis of data" to the prioritization of
actions based on performance and risk management.
 Actions to improve customer satisfaction need to take precedence as the organization considers trends and drives towards
improvement.
Modification: Section 9.2.2.1 : INTERNAL AUDIT PROGRAMME
 Strengthened the need to drive a risk-based approach to the development and deployment of an organization-wide
internal audit programme.
 Internal audit activities are considered a process, which require a clear definition of expected inputs, planned activities,
intended outputs, and monitored performance.
 The process needs to identify and evaluate the level of risk related to each QMS process, internal and external
performance trends, and process criticality.
 Then, the process would need to continuously monitor this information to trigger special internal audits and/or to plan
periodic internal audits.

Modification: Section 9.2.2.2 : QMS AUDIT
 Strengthen the quality management system audit and the use of process approach, which further drives process
improvements organization-wide.
 The audit programme is continuously monitoring information that could trigger the need for an unplanned internal audit.
 The use of the automotive process approach, including risk based thinking, needs to be applied during the audit.
 The internal audit must also sample customer-specific QMS requirements for effective implementation.
Modification: Section 9.2.2.3 : MANUFACTURING PROCESS AUDIT
 Strengthens the formal approaches to ensure organizations achieve the benefits of effective manufacturing process audits.
 Shift handover should be considered a significant process event; internal auditors should look for objective evidence of
an effective process to communicate and address relevant information.
 The audit must also evaluate the effective implementation of the process risk analysis, control plan, and associated
documents
Modification: Section 9.2.2.4 : PRODUCT AUDIT
 The strengthened product audit requirements now require the use of customer-specified approaches, when applicable.
 If not applicable, the organization shall define their process.
82

Modification: Section 9.3.1.1 : MANAGEMENT REVIEW – SUPPLEMENTAL
 The one-year frequency is a minimum, as the process is driven by the continuous assessment of the risks related to
internal and external changes and performance-related issues.
 As changes and issues increase, the frequency of management review activities should increase in turn, preserving the
minimum of at least an annual review.
Modification: Section 9.3.2.1 : MANAGEMENT REVIEW INPUTS –SUPPLEMENTAL
 Enhanced details for management review input requirements, including those related to cost of poor quality,
effectiveness, efficiency, conformance, feasibility assessments, customer satisfaction, performance against maintenance
objectives, warranty performance, review of customer scorecards, and the identification of potential field failures through
risk analysis.
 The above should be considered the minimum information that should be covered during management review; a
monitoring system should be in place, with criteria that trigger special unplanned management review activities.
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84
Modification: Section 9.3.3.1 : MANAGEMENT REVIEW OUTOUT – SUPPLEMENTAL
 Enhanced section ensures action is taken where customer requirements are not achieved, and supports the continual
analysis of process performance and risk.
 Even though process owners should address customer performance issues related to the processes they manage, this
requirement gives top management the clear and ultimate responsibility to address customer performance issues and
ensure the effectiveness of corrective actions.

13.7 : IMPROVEMENT
85
10. Improvement
 QMS must continually improve
 nonconformities must be identified and reacted to,
 corrective action must be considered
 nonconformities (including complaints) must be
reacted to and applicable action taken
 root cause analysis must be considered based on its
significance
 evidence of action taken from nonconformities must
be documented
 evidence of results of corrective action must be
documented.
 organisations must continually improve the suitability,
adequacy and effectiveness of the QMS
 must consider results of analysis and evaluation, and
outputs from management review.

86
13.7 : IMPROVEMENT – Cont..
10. Improvement
Modification: Section 10.2.3 : PROBLEM SOLVING
 Updates to this section are to facilitate the consolidation of IATF OEM customer specific minimum requirements.
 The organization's defined process for problem solving must consider: various types and scales of problems; control of
nonconforming output; systemic corrective action and verification of effectiveness; and review/updates to documented
information.
 In addition, CSRs related to nonconformity and corrective action need to be used and integrated within the internal
corrective action process.
Modification: Section 10.2.4 : ERROR PROOFING
 This section, which previously only mentioned the use of error proofing methods in corrective action, includes new
requirements to strengthen the approach to error proofing and consolidate
 customer-specific requirements.
 The organization needs a process that both identifies the need or opportunity for an error-proofing device/method, and
designs and implements the device/method.
 The FMEA would document whether the method impacts occurrence (a prevention control) or impacts detection (a
detection control).
 The control plan needs to include the test frequency of the error-proofing devices, and records must be maintained for
the performance of these tests.

10. Improvement – cont..
New Added : Section 10.2.5 : WARRANTY MANAGEMENT SYSTEM
 This is a new requirement based on the increasing importance of warranty management and consolidates IATF OEM
customer specific requirements.
 The warranty management process should address and integrate all applicable customer-specific requirements, and
warranty party analysis procedures to validate No Trouble Found (NTF) decisions should be agreed by the customer,
when applicable.
Modification: Section 10.2.6 : CUSTOMER COMPLAINTS AND FIELD FAILURE
TEST ANALYSIS
 Includes a new requirement regarding embedded software and identification of preferred approaches.
 The organization's analysis is extended beyond parts to the customer complaints and field failures themselves, and the
results must be communicated to the customer and also within the organization.
Modification: Section 10.3.1 : CONTINUAL IMPROVEMENT – SUPPLEMENTAL
 Changes in this section clarify the minimum process requirements for continual improvement: identification of methods,
information and data; an improvement action plan that reduces variation and waste; and risk analysis (such as FMEA).
 Use of TPM, Lean, Six Sigma, and other manufacturing excellence programs or methodologies should follow a structured
approach that continuously identifies and addresses opportunities for improvement.
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13.7 : IMPROVEMENT – Cont..

IATF 16949 2016 LAtest version training.pptx

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IATF 16949 2016 LAtest version training.pptx