Changes in IATF 2016

Awareness Training Program on
IATF 16949:2016
Automotive Quality Management
System Standard
QMS requirements for automotive production and relevant service parts organisation
NICHE QUALITY SOLUTIONS PVT. LTD.
NICHE QUALITY SOLUTIONS PVT. LTD., INDORE www.nicheqs.com

Welcome!
• Safety – be aware of emergency exits

• Restroom and Telephones – nearest locations
• Contact Number – for urgent messages
• Personal Property – keep possessions secure
• Phones and Pagers – please avoid interruptions
• Recording Devices – not allowed in class
• Lunch and Breaks – please return on time
• Smoking – not permitted in the classroom
• Special Needs – please inform the instructor

Course Objective
• Upon completing this course, candidate

should
- Understand key definitions of IATF 16949
- Structure of IATF 16949
- Salient additional processes and related
records needed in various areas of MIEL
- Overview of Core Tools and how they are
significant
ISO 9001:2015 Concepts
ISO (International Organization for Standardization)

165 ISO
Member
Operational Set up in Bodies, e.g.
23rd Feb World-wide October
federation of India BIS
1947. ISO 1946 USA ANSI
First National (India one of UK BSI
Standard Standards 25 founder France AFNOR
Bodies Russia GOST R
Published members) Japan JISC
1950 China SAC
ISONICHE
9001:QUALITY ISO 9001:
1987 SOLUTIONS 1994 ISO 9001: 2000
PVT. LTD., INDORE
ISOwww.nicheqs.com
9001: 2008 ISO 9001: 2015
ISO 9001:2015 Concepts
 ISO 9001 “Specifies quality management

system requirements for organization to:
 demonstrate its ability to consistently provide
products and services that meet customer and
applicable statutory & regulatory requirements
 enhance customer satisfaction………”
An organization that demonstrates it is meeting

these requirements can then choose to be “ISO
9001 certified” by an independent certification
body
ISO 9001:2015 Concept extended to IATF
16949:2016
 IATF 16949 “Specifies quality management system
requirements particularly for automotive (part or
service) in supply chain for organization to:
 demonstrate its ability to consistently provide products
and services that meet customer (specially O.E.) and
applicable statutory & regulatory requirements
(Automotive regulatory)
 enhance customer satisfaction………”
An organization that demonstrates it is meeting these

requirements can then choose to be “ISO 9001 certified” by
an independent certification body accredited by IATF

Scope
• QMS Requirements for the design and development,
production and when relevant assembly, installation
and services of automotive related products, including
products with embedded software.
• Applicable to the sites of the organization where

manufacturing of customer-specified production parts,
service parts and/or accessory parts occur.
• This Technical Specification can be should be applied

throughout the automotive supply chain
Change in focus
Old (wrong!!)
“A” in the “PDCA” cycle:
 Correction
 Corrective action
 Preventive action
New (Correct!!):
“P” of the “PDCA” cycle:
 Risk identification and treatment / mitigation (“prevention”)
“A” of the “PDCA” cycle:
 Containment
 Correction
 Corrective action (to prevent recurrence!)
 Improvement (includes Kaizen, but also breakthrough improvements,

innovation etc)
ISO 9001:2015 is based on 7 Quality
Management Principles
7 (Yes, now only SEVEN!!) “Quality Management Principles”
– these apply to IATF in turn as it is.
 Customer Focus
 Leadership
 Engagement of people
 Process approach Details in ISO 9000:2015
 Improvement
 Evidence-based decision making
 Relationship management

High Level Structure
1. Scope 7. Support
2. Normative references • Resources
3. Terms and definitions • Competence
• Awareness
4. Context of the organization • Communication
• Understanding the organization and • Documented information
its context
• Needs and requirements of
8. Operation
interested parties • Operational planning and control
• Scope 9. Performance evaluation
• XXX-management system • Monitoring, measurement,
5. Leadership analysis and evaluation
• Leadership and commitment • Internal audit
• Policy • Management review
• Roles, responsibilities and 10. Improvement
authorities • Nonconformity and corrective
6. Planning action
• Actions to address risks and • Continual improvement
opportunities
• XXX-objectives and planning to
achieve them
QMS ISO 9001:2015 Framework (Interalia IATF
framework)
Quality Management System (4)
Organization Support
& its context & Customers
(4) operation Satisfaction
(7, 8)
Plan Do
Customers Performance Results

Planning Leadership Evaluation
requirements
(6) (5)
of the
(9)
QMS
Act Check
Needs &
expectations
of relevant Products and
Improvement
interested services
(10)
parties (4)
IATF History
ISO/ TS 16949:1999
(1st Edition)
ISO/TS 16949:2002
(2nd Edition)
ISO/ TS 16949:2009
(3rd Edition)
IATF 16949:2016
(1st Edition)

Goal of Automotive QMS Standard – IATF 16949
Development of QMS that provides for

• Continual improvement
• Emphasizing defect prevention, and
• Reduction of variation and waste in the supply
chain

IATF Introduction
0.1 General
0.2 Quality Management Principles
0.3.1 Process Approach - General Same as

ISO
0.3.2 Plan-Do-Check-Act Cycle
9001:2015
0.3.3 Risk-based Thinking
0.4 Relationship with other MS standards

3.1 Terms & Definitions
• Accessory Part • Design for Six Sigma (DFSS)
• Advanced Product Quality Planning (APQP)• Design – responsible organization
• Aftermarket Part • Error Proofing
• Authorization • Escalation Process
• Challenge (Master) Part • Fault Tree Analysis
• Control Plan • Laboratory
• Customer Requirements • Laboratory Scope
• Customer Specific Requirements • Manufacturing
• Design for Assembly (DFA) • Manufacturing Feasibility
• Design for Manufacturing (DFM) • Manufacturing Services
• Design for Manufacturing & Assembly
(DFMA)

3.1 Terms & Definitions
• Multi-disciplinary Approach • Reaction Plan

• No Trouble Found (NTF) • Remote Location
• Outsourced Process • Service Part
• Periodic Overhaul • Site
• Predictive Maintenance • Special Characteristic
• Premium Freight • Special Status
• Preventive Maintenance • Support Function
• Product • Total Productive
• Product Safety Maintenance
• Production Shutdown • Trade-off curves
• Trade-off Process

Definitions
Accessory Part
• Customer-specified additional component(s)
that are either mechanically or electronically
connected to the vehicle or powertrain before
(or after) delivery to the final customer (e.g.,
customer floor mats, truck bed liners, wheel
covers, sound system enhancements,
sunroofs, spoilers, super-chargers, etc.

Definitions
Advanced product quality planning (APQP)

• Product quality planning process that supports
development of a product or service that will satisfy
customer requirements; APQP serves as a guide in the
development process and also a standard way to share
results between organisations and their customers.
APQP covers design robustness, design testing and
specification compliance, production process design,
quality inspection standards, process capability,
production capacity, product packaging, product testing
and operator training plan, among other items
Definitions
Aftermarket Part
• Replacement part(s) not procured or released
by an OEM for service part applications, which
may or may not be produced to original
equipment specifications.

Definitions
Challenge (master) part

• Part(s) of known specification, calibrated and
traceable to standards, with expected results
(pass or fail) that are used to validate the
functionality of an error-proofing device or
check fixtures (e.g., go / no-go gauging).

Definitions
Control plan
• Documented description of the systems and
processes required for controlling the
manufacturing of product.

Definitions
Customer requirements
• All requirements specified by the customer
(e.g. technical, commercial, product and
manufacturing process-related requirements,
general terms and conditions, customer-
specific requirements, etc.)

Definitions
Customer-specific requirements (CSRs)

• Interpretations of or supplemental
requirements linked to a specific clause(s) of
this Automotive QMS Standard.

Definitions
Design for assembly (DFA)

• Process by which products are designed with
ease of assembly considerations (e.g. if a
product contains fewer parts it will take less
time to assemble, thereby reducing assembly
costs)

Definitions
Design for manufacturing (DFM)

• Integration of product design and process
planning to design a product that is easily and
economically manufactured.

Definitions
Design for manufacturing and assembly

(DFMA)
• Combination of two methodologies: Design for
Manufacture (DFM), which is the process of
optimising the design to be easier to produce, have
higher throughput, and improved quality; and Design
for Assembly (DFA), which is the optimization of the
design to reduce risk of error, lowering costs and
making it easier to assemble.

Definitions
Design for six sigma (DFSS)

• Systematic methodology, tools, and
techniques with the aim of being a robust
design of products or process that meets
customer expectations and can be produced
at a six sigma quality level

Definitions
Design-responsible organisation
• organisation with authority to establish a new,
or change an existing, product specification
Note: This responsibility includes testing and

verification of design performance within
thecustomer’s specified application.

Definitions
Error proofing
• Product and manufacturing process design
and development to prevent manufacture of
nonconfoming products.

Definitions
Escalation process
• Process used to highlight or flag certain issues
within an organisation so that the appropriate
personnel can respond to these situations and
monitor the resolutions.

Definitions
Fault tree analysis (FTA)

• Deductive failure analysis methodology in
which an undesired state of a system is
analysed; fault tree analysis maps the
relationship between faults, subsystems, and
redundant design elements by creating a logic
diagram of the overall system.

Definitions
Laboratory
• Facility for inspection, test, or calibration that
may include but is not limited to the
following: chemical, metallurgical,
dimensional, physical, electrical, or reliability
testing.

Definitions
Laboratory scope
Controlled document containing
• Specific tests, evaluations, and calibrations
that a laboratory is qualified to perform;
• A list of the equipment that the laboratory
uses to perform the above; and
• A list of methods and standards to which the
laboratory performs the above
Definitions
Manufacturing
Process of making or fabricating
• Production materials;
• Production parts or service parts;
• Assemblies; or
• Heat treating, welding, painting, plating, or
other finishing services

Definitions
Manufacturing feasibility
An analysis and evaluation of a proposed project to
determine if it is technically feasible to manufacture
the product to meet customer requirements. This
includes but is not limited to the following (as
applicable): within the estimated costs, and if the
necessary resources, facilities, tooling, capacity,
software, and personnel with required skills,
including support functions, are or are planned to be
available.
Definitions
Manufacturing services
Companies that test, manufacture, distribute,
and provide repair services for components
and assemblies

Definitions
Multi-disciplinary approach
Method to capture input from all interested parties
who may influence how a process is administered by
a team whose members include personnel from the
organsiation and may include customer and supplier
representative; team members may be internal or
external to the organisation; either existing teams or
ad hoc teams may be used as circumstances warrant;
input to the team may include both organization and
customer inputs.
Definitions
No trouble found (NTF)

Designation applied to a part replaced during a
service event that, when analysed by the
vehicle or parts manufacturer, meets all the
requirements of a good part” (also referred to
as “No Fault Found” or “ Trouble Not Found”)

Definitions
Outsourced process
Portion of an organization’s function (or
processes) that is performed by an external
organization

Definitions
Periodic overhaul
Maintenance methodology to prevent a major
unplanned breakdown where, based on fault
or interruption history, a piece of equipment,
or subsystem of the equipment, is proactively
taken out of service and disassembled,
repaired, parts replaced, reassembled, and
then returned to service.

Definitions
Predictive maintenance
An approach and set of techniques to evaluate
the condition of in-service equipment by
performing periodic or continuous monitoring
of equipment conditions, in order to predict
when maintenance should be performed.

Definitions
Premium freight
Extra costs or charges incurred in addition to
contracted delivery.
Note this can be caused by method, quantity,

unscheduled or late deliveries, etc.

Definitions
Preventive maintenance
Planned activities at regular intervals (time-
based, periodic inspection, and overhaul) to
eliminate causes of equipment failure and
unscheduled interruptions to production, as
an output of the manufacturing process
design.

Definitions
Product
Applies to any intended output resulting from
the product realization process

Definitions
Product safety
Standards relating to the design and
manufacturing of products to ensure they do
not represent harm or hazards to customers

Definitions
Production shutdown
Condition where manufacturing processes are
idle; time span may be a few hours to a few
months

Definitions
Reaction plan
Action or series of steps prescribed in a control
plan in the event abnormal or nonconforming
events are detected.

Definitions
Remote location
Location that supports manufacturing sites and
at which non-production processes occur.

Definitions
Service part
Replacement part(s) manufactured to OEM
specifications that are procured or released by
the OEM for service part applications,
including remanufactured parts

Definitions
Site
Location at which value-added manufacturing
processes occur

Definitions
Special characteristic
Classification of a product characteristic or
manufacturing process parameter that can
affect safety or compliance with regulations,
fit, function, performance, requirements, or
subsequent processing of product

Definitions
Special status
Notification of a customer-identified
classification assigned to an organisation
where one or more customer requirements
are not being satisfied due to a significant
quality or delivery issue

Definitions
Support function
Non-production activity (conducted on site or at
a remote location) that supports one (or
more) manufacturing sites of the same
organization

Definitions
Total productive maintenance

A system of maintaining and improving the
integrity of production and quality systems
through machines, equipment, processes, and
employees that add value to the organization

Definitions
Trade-off curves
Tools to understand and communicate the
relationship of various design characteristics
of a product to each other, a product’s
performance on one characteristic is mapped
on the Y-axis and another on the x-axis, then a
curve is plotted to illustrate product
performance relative to the two
characteristics
Definitions
Trade-off process
Methodology of developing and using trade-off
curves for products and their performance
characteristics that establish the customer,
technical, and economic relationship between
design alternatives

4. Context of the organization
Same as ISO 9001:2015
4.1 Understanding the organization & its context requirements
Same as ISO
4.2 Understanding the needs & expectations of interested parties 9001:2015
requirements
4.3 Determining the Scope of QMS
4.3.1 Determining the scope of QMS – supplemental (Earlier 1.1)

• No change (Permitted exclusion is 8.3 which do not include manufacturing process
design)
• The exclusion shall be justified and maintained as documented information.
4.3.2 Customer Specific Requirements (New)

CSRs shall be evaluated and included in the scope of the organization’s QMS.

4. Context of the organization
4.4 Quality Management Systems
4.4.1.1 Conformance of products and processes (Earlier 4.1)

• conformance of all products and processes, including service parts
and those that are outsourced, to all applicable customer, statutory
and regulatory requirements.
4.4.1.2 Product Safety (New)

• documented processes for the management of product –
safety related products and manufacturing processes
• Refer standard
4.4.2 (Earlier 4.2.3 & 4.2.4)

• Same as ISO 9001: 2015 requirements
• Maintain documented information
• Retain documented information
5. Leadership
5.1 Leadership and Commitment
5.1.1.1 Corporate Responsibility (New)
• define and implement corporate responsibility policies
• At minimum, an anti bribery policy, an employee code of conduct, and
an ethics escalation policy (“whistle blowing policy”) PART OF JSW
CORE POLICIES
5.1.1.2 Process effectiveness and efficiency (Earlier 5.1.1)

• No change
• results of the process review activities shall be included as an input to
the management review.
5.1.1.3 Process Owners (New)

• identify process owners who are responsible for managing the
organization’s processes and related outputs.
5.1.2 Customer Focus (Earlier 5.2)

• Same as ISO 9001:2015 requirements

5. Leadership
5.2 Policy
5.2.1 Establishing the Quality Policy (Earlier 5.3): Same as ISO 9001:2015
5.2.2 Communicating the Quality Policy (Earlier 5.3) requirements
5.3 Organizational roles, responsibilities and authorities
5.3.1 Organizational roles, responsibilities and authorities -

supplemental (Earlier 5.5.2.1)
• assign personnel with responsibility and authority to ensure that
customer requirements are met. These assignments shall be
documented.
• selection of special characteristics, setting quality objectives and
related training, corrective and preventive actions, product design
and development, capacity analysis, logistics information,
customer scorecards, and customer portals.
5. Leadership
5.3 Organizational roles, responsibilities and authorities
5.3.2 Responsibility and authority for product requirements and

corrective actions (Earlier 5.5.1.1)
Top management shall ensure that
a) Personnel responsible for conformity to product requirements have the
authority to stop shipment and stop production to correct quality problems.
NOTE: Due to the process design in some industries, it might not always be
possible to stop production immediately. In this case, the affected batch must be
contained and shipment to the customer prevented.
b) Managers Personnel with responsibility and authority for corrective action are
promptly informed of products or processes that do not conform to
requirements to ensure that non conforming product is not shipped to the
customer and that all potential non conforming product is identified and
contained.
c) Production operations across all shifts are staffed with personnel in charge of,
or delegated responsibility for, ensuring conformity to product requirements.
6. Planning
6.1 Actions to address risks and opportunities
6.1.1 & 6.1.2

Same as ISO 9001:2015 requirements
6.1.2.1 Risk Analysis (New)

• include in its risk analysis, at a minimum, lessons learned from
product recalls, product audits, field returns, and repairs,
complaints, scrap and rework.
6.1.2.2 Preventive Action (Earlier 8.5.3)

• No major change
• establish a process to lessen the impact of negative effects of
risk

6. Planning
6.1.2.3 Contingency Plan (Earlier 6.3.2)

Major changes
a) identify and evaluate internal and external risks to all manufacturing
processes and infrastructure equipment essential to maintain
production output and to ensure that customer requirements are met;
b) define contingency plans according to risk and impact to the
customer;
c) prepare contingency plans for continuity of supply in the event of any of
the following: key equipment failures; interruption from externally
provided products, processes, and services; recurring natural
disasters; fire; utility interruptions; labour shortages; or infrastructure
disruptions;
d) include, as a supplement to the contingency plans, a notification
process to the customer and other interested parties for the extent
and duration of any situation impacting customer operations;

6. Planning
6.1.2.3 Contingency Plan (Earlier 6.3.2) Contd….
e) periodically test the contingency plans for effectiveness (e.g.

simulations as appropriate)
f) conduct contingency plan reviews (at a minimum annually) using a
multi disciplinary team including top management, and update as
required.
g) Document the contingency plans and retain documented information
describing any revision(s) including the person who authorized the
change(s).
The contingency plans shall include the provisions to validate that the
manufactured product continues to meet customer specifications after
the restart of production following an emergency in which production was
stopped and if the regular shutdown processes were not followed.

6. Planning
6.2 Quality Objectives and planning to achieve them
6.2.1 & 6.2.1

6.2.2.1 Quality Objectives and planning to achieve them – supplemental

(Earlier 5.4.1)
• No major change
• results of the organization’s review regarding interested parties and
their relevant requirements shall be considered when the organization
establishes its annual (at a minimum) quality objectives and related
performance targets (internal and external).
6.3 Planning Same as ISO 9001:2015 requirements

7. Support
7.1 Resources
7.1.1 & 7.1.2 & 7.1.3

7.1.3.1 Plant, facility and equipment planning (Earlier 5.4.1)

The organization shall use a multidisciplinary approach including risk
identification and risk mitigation methods for developing and improving plant,
facility and equipment plans. In designing plant layouts, the organization shall
a) optimize material flow, material handling and value-added use of floor space
including control of non-conforming product
b) facilitate synchronous material flow, as applicable
Methods shall be developed and implemented to evaluate manufacturing

feasibility for new product or new operations. Manufacturing feasibility
assessments shall include capacity planning. These methods shall also be
applicable for evaluating proposed changes to existing operations.

7. Support
7.1 Resources
7.1.3.1 Plant, facility and equipment planning (Earlier 5.4.1) Contd…
The organization shall maintain process effectiveness, including periodic

re-evaluation relative to risk , to incorporate any changes made during
process approval, control plan maintenance and verification of job set-
ups.
Assessments of manufacturing feasibility and evaluation of capacity

planning shall be inputs to management reviews.
NOTE 1: These requirements should include lean manufacturing principles.
NOTE 2: These requirements should apply to on-site supplier activities,

as applicable.

7. Support
7.1 Resources
7.1.4 Environment for the operation of processes (New)
NOTE: Where third party certification to ISO 45001 (or equivalent)

is recognized, it may be used to demonstrate the organization’s
conformity to personnel safety aspects of this requirement.
7.1.4.1 Environment for the operation of processes –

supplemental (Earlier 6.4.2)
• No change

7. Support
7.1 Resources
7.1.5.1 General
7.1.5.1.1 Measurement systems analysis (Earlier 7.6.1)

• No change
Records of customer acceptance of alternative methods shall be

retained along with results from alternative measurement systems
analysis.
NOTE: Prioritization of MSA studies should focus on critical or

special product or process characteristics.

7. Support
7.1 Resources
7.1.5.2 Measurement traceability (Earlier 7.6 NOTE)

NOTE: A no. or another identifier traceable to the device calibration
record meets the intent of the requirements in ISO 9001:2015.
7.1.5.2.1 Calibration/ verification records (Earlier 7.6.2)

• documented process for managing calibration/ verification records.
• Records shall be retained and shall include at minimum:
a) revisions following engineering changes that impact measurement
systems;
b) any out-of-specification readings as received for calibration/
verification;

7. Support
7.1 Resources
7.1.5.2.1 Calibration/ verification records (Earlier 7.6.2) Contd..
c) an assessment of the risk of the intended use of the product caused by

the out-of-specification condition;
d) when a piece of inspection measurement and test equipment is found to

be out of calibration or defective during its planned verification or
calibration or during its use, documented information on the validity of
previous measurement results obtained with this piece of inspection
measurement and test equipment shall be retained, including the
associated standard's last calibration date and the next due date on the
calibration report;
e) notification to the customer if suspect product or material has been

shipped;

7. Support
7.1 Resources
7.1.5.2.1 Calibration/ verification records (Earlier 7.6.2) Contd..
f) statements of conformity to specification after calibration/verification;
g) verification that the software version used for product and process
control is as specified;
h) records of the calibration and maintenance activities for all gauging

(including employee-owned equipment, customer-owned equipment, or
on-site supplier-owned equipment);
i) production-related software verification used for product and process

control (including software installed on employee-owned equipment,
customer-owned equipment, or on-site supplier-owned equipment).

7. Support
7.1 Resources
7.1.5.3.1 Internal Laboratory (Earlier 7.6.3.1)

• No major change
7.1.5.3.2 External Laboratory (Earlier 7.6.3.1)

• No major change except:
• scope of accreditation (certificate) to include the relevant
inspection, test or calibration service;
• the certificate of calibration or test report shall include the
mark of accreditation body;
• calibration services may be performed by the equipment
manufacturer when a qualified laboratory is not available
7.1.6 Organizational Knowledge (New)

7. Support
7.2 Competence
7.2 Competence
7.2.1 Competence - supplemental (Earlier 6.2.2.2)

• documented process(es) for identifying training needs and including
awareness
• no major change
7.2.1 Competence – on-the- job training (Earlier 6.2.2.3)

• on-the-job training (which shall include customer requirements training)
for personnel in any new or modified responsibilities.
• The level of detail required for on-job-training shall be commensurate
with the level of education the personnel possess and the complexity
of task(s) they are required to perform for their daily work.

7. Support
7.2 Competence
7.2.3 Internal Auditor Competency (New)

• documented process(es) to verify that the internal auditors are
competent, taking into account any customer-specific requirements
• Refer ISO 19011 for additional guidance on auditor competencies
• maintain a list of qualified internal auditors
• QMS auditors, Manufacturing Process auditors, Product auditors shall
demonstrate minimum following competencies i.e. understanding of
a) automotive process approach for auditing, including risk-based
thinking;
b) applicable customer-specific requirements;
c) applicable ISO 9001 and IATF 16949 requirements related to the
scope of the audit;
d) applicable core tool requirements related to the scope of the
audit;
e) how to plan, conduct, report, and close out audit findings.
7. Support
7.2 Competence
7.2.3 Internal Auditor Competency (New) Contd..

• Manufacturing Process auditors shall have technical understanding
on manufacturing processes to be audited, process risk analysis
(such as PFMEA) and Control Plan
• Product auditors shall have competence in understanding product
requirements and use of relevant measuring and test equipment to
verify product conformity
• Maintenance of and improvement in internal auditor competence shall
be demonstrated through:
a) executing a minimum number of audits per year, as defined by
the organization; and
b) maintaining knowledge of relevant requirements based on
internal changes (e.g., process technology, product technology)
and external changes (e.g., ISO 9001, IATF 16949, core tools, and
CSRs).
7. Support
7.2 Competence
7.2.1 Second party auditor competency (New)

• Demonstrate competence of auditor
• Second-party auditors shall meet customer specific
requirements for auditor qualification
• Core competencies same as that of internal QMS auditor and
manufacturing process auditor

7. Support
7.3 Awareness
7.3.1 Awareness – supplemental (Earlier 6.2.2.4)

• documented information to demonstrate that employees are aware
of their impact on product quality and the importance of their
activities in achieving, maintaining, and improving quality, including
customer requirements and the risks involved for the customer with
non-conforming product
7.3.2 Employee motivation and empowerment (Earlier 6.2.2.4)

• documented process
• No change
7.4 Communication Same as ISO 9001:2015 requirements

7. Support
7.5 Documented information
7.5.1 General
7.5.1.1 QMS documentation (Earlier 4.2.2)
• QMS shall be documented and shall include Quality Manual (electronic or
hard copy) which can be a series of documents
• a list shall be retained of the documents that comprise the quality manual
for the organization
• Quality Manual shall include at minimum:
a) Scope of QMS including justification of exclusions
b) documented processes established for QMS, or reference to them;
c) organization’s processes and their sequence and interactions,
including type and extent of control of any outsourced processes;
d) a document indicating where within the organization’s QMS their
customer-specific requirements are addressed.
7. Support
7.5.2 Creating & Updating

7.5.3.1 & 7.5.3.2

7.5.3.2.1 Record retention (Earlier 4.2.4)

• Define, document and implement a record retention policy
• Production part approvals, tooling records, product and process
design records, purchase orders, contracts and amendments
retention period – Product Lifetime + 1 calendar year unless otherwise
specified
7.5.3.2.2 Engineering specifications (Earlier 4.2.3.1)

• Documented process
• Review period reduced to 10 working days.

7. Support
7.5.3.2.2 Engineering specifications (Earlier 4.2.3.1)

• Documented process describing the review, distribution, and
implementation of all customer engineering standards/specifications
and related revisions based on customer schedules, as required.
• When an engineering standard/specification change results in a
product design change, refer ISO 9001, Section 8.3.6
• When an engineering standard/specification change results in a
product realization process change, refer Section 8.5.6.1
• Review period reduced to 10 working days.

8. Operation
8.1 Operational planning and control
8.1.1 Operation planning and control – supplemental (Earlier 7.1.1)

• When planning for product realization, the following topics shall be
included:
a) customer product requirements and technical specifications;
b) logistics requirements;
c) manufacturing feasibility;
d) project planning;
e) acceptance criteria.
• Resources in reference to required verification, validation, monitoring,
measurement, inspection, and test activities specific to the product and the
criteria for product acceptance to be determined.
8.1.2 Confidentiality (Earlier 7.1.3)

• No change

8. Operation
8.2 Requirement for Product and Services
8.2.1.1 Customer Communication – supplemental (Earlier 7.2.3.1)

• Written or verbal communication shall be in the language agreed with the
customer.
• No change
8.2.2.1 Determining the requirements for products and services –

supplemental (Earlier Note of 7.2.1)
• No major change
8.2.3.1.1 Review of the requirements for products and services – supplemental

(Earlier 7.2.2.1)
• No major change
• documented evidence of a customer-authorized waiver

8. Operation
8.2 Requirement for Product and Services
8.2.3.1.2 Customer designated special characteristics (Earlier 7.2.1.1)

• No change
8.2.3.1.3 Organization manufacturing feasibility (Earlier 7.2.2.2)

• multidisciplinary approach to conduct an analysis to determine if it is
feasible that the organization’s manufacturing processes are capable
of consistently producing product that meets all of the engineering
and capacity requirements specified by the customer.
• feasibility analysis for any manufacturing or product technology new
to the organization and for any changed manufacturing process or
product design.
• validate their ability to make product to specifications at the required
rate through production runs, benchmarking studies, or other
appropriate methods

8. Operation
8.3 Design and Development of Product and Services
8.3.1.1 Design and development of products and services – supplemental

(Earlier Note to 7.3)
• shall document the design and development process
• No change
8.3.2.1 Design and development planning – supplemental (Earlier 7.3.1.1)

• design and development planning includes all affected stakeholders
within the organization and, as appropriate, its supply chain.
• areas for using such a multidisciplinary approach include but are not
limited to the following:
a) project management (for example, APQP or VDA-RGA);
b) product and manufacturing process design activities (for example,
DFM and DFA), such as consideration of the use of alternative
designs and manufacturing processes;

8. Operation
8.3.2.1 Design and development planning – supplemental (Earlier 7.3.1.1)

Contd…
d) development and review of product design risk analysis (FMEAs),

including actions to reduce potential risks;
e) development and review of manufacturing process risk analysis (for
example, FMEAs, process flows, control plans, and standard work
instructions).
8.3.2.2 Product design skills (Earlier 6.2.2.1)

• No change

8. Operation
8.3.2.3 Development of products with embedded software (New)

• shall use a process for quality assurance for their products with
internally developed embedded software
• software development assessment methodology shall be utilized to
assess the organization’s software development process.
• retain documented information of a software development capability
self-assessment
• include software development within the scope of the internal audit
programme

8. Operation
8.3.3.1 Product design input (Earlier 7.3.2.1)

• Product Design input includes but not limited to:
a) product specifications including but not limited to special characteristics
boundary and interface requirements;
b) identification, traceability, and packaging;
c) consideration of design alternatives;
d) assessment of risks with the input requirements and the organization’s
ability to mitigate/manage the risks, including from the feasibility
analysis;
e) targets for conformity to product requirements including preservation,
reliability, durability, serviceability, health, safety, environmental,
development timing, and cost;
f) applicable statutory and regulatory requirements of the customer-identified
country of destination, if provided;
g) embedded software requirements
• process to deploy information gained from…. (No change)

8. Operation
8.3.3.2 Manufacturing process design input (Earlier 7.3.2.2)

• Manufacturing process design input requirements including but not limited
to the following:
a) product design output data including special characteristics;
b) targets for productivity, process capability, timing, and cost;
c) manufacturing technology alternatives;
d) customer requirements, if any;
e) experience from previous developments;
f) new materials;
g) product handling and ergonomic requirements; and
h) design for manufacturing and design for assembly.
• use of error-proofing methods… (No change)

8. Operation
8.3.3.3 Special characteristics (Earlier 7.2.1.1)

• use a multidisciplinary approach to establish, document, and implement its
process(es) to identify special characteristics determined by the customer and the
risk analysis performed by the organization, and shall include the following:
a) documentation of all special characteristics in the drawings (as
required), risk analysis (such as FMEA), control plans, and standard
work/operator instructions; special characteristics are identified with
specific markings and are cascaded through each of these documents;
b) development of control and monitoring strategies for special
characteristics of products and production processes;
c) customer-specified approvals, when required;
d) compliance with customer-specified definitions and symbols or the
organization’s equivalent symbols or notations, as defined in a symbol
conversion table. The symbol conversion table shall be submitted to the
customer, if required.

8. Operation
8.3.4.1 Monitoring (Earlier 7.3.4.1)

• No major change
• When required by the customer, measurements of the product and
process development activity shall be reported to the customer at
stages specified, or agreed to, by the customer.
8.3.4.2 Design and development validation (Earlier 7.3.6.1)
• Design and development validation shall be performed in accordance
with customer requirements, applicable industry and governmental
agency-issued regulatory standards.
• timing of design and development validation shall be planned in alignment
with customer-specified timing, as applicable.
• Where contractually agreed with the customer, this shall include
evaluation of the interaction of the organization’s product, including
embedded software, within the system of the final customer’s
product.
8. Operation
8.3.4.3 Prototype programme (Earlier 7.3.6.2)

• No major change
8.3.4.4 Product approval process (Earlier 7.3.6.3)

• No major change
• documented product approval prior to shipment, if required by the
customer.
• Records of such approval shall be retained.

8. Operation
8.3.5.1 Design and development outputs – supplemental (Earlier 7.3.3.1)

• product design output shall include but is not limited to:
a) design risk analysis (FMEA);
b) reliability study results;
c) product special characteristics;
d) results of product design error-proofing, such as DFSS, DFMA, and FTA;
e) product definition including 3D models, technical data packages, product
manufacturing information, and geometric dimensioning & tolerancing
(GD&T);
f) 2D drawings, product manufacturing information, and geometric dimensioning
& tolerancing (GD&T);
g) product design review results;
h) service diagnostic guidelines and repair and serviceability instructions;
i) service part requirements;
j) packaging and labeling requirements for shipping.
• NOTE: Interim design outputs should include any engineering problems being
resolved through a trade-off process.
8. Operation
8.3.5.2 Manufacturing process design output (Earlier 7.3.3.2)

• manufacturing process design output shall includes but not limited to:
a) all requirements from the last edition of standard and
b) special characteristics for product and manufacturing process;
c) identification of process input variables that impact characteristics;
d) tooling and equipment for production and control, including capability
studies of equipment and process(es);
e) capacity analysis;
f) maintenance plans and instructions;
8.3.6 Design and development changes - supplemental (Earlier 7.1.4)

• No major change
• If required by the customer, documented approval, or a documented
waiver, from the customer prior to production implementation
• For products with embedded software, the organization shall document the
revision level of software and hardware as part of the change record.

8. Operation
8.4 Control of externally provided processes, Product and Services
8.4.1.1 General – supplemental (Earlier Note 1 to 7.4.1)

• No change
8.4.1.2 Supplier selection process (New)

• documented supplier selection process.
• The selection process shall include:
a) an assessment of the selected supplier’s risk to product
conformity and uninterrupted supply of the organization’s
product to their customers;
b) relevant quality and delivery performance;
c) an evaluation of the supplier’s quality management system;
d) multidisciplinary decision making; and
e) an assessment of software development capabilities, if
applicable.

8. Operation
8.4.1.2 Supplier selection process (New) Contd…
• Other supplier selection criteria that should be considered include the

following:
a) volume of automotive business (absolute and as a percentage of total business);
b) financial stability;
c) purchased product, material, or service complexity;
d) required technology (product or process);
e) adequacy of available resources (e.g., people, infrastructure);
f) design and development capabilities (including project management);
g) manufacturing capability;
h) change management process;
i) business continuity planning (e.g., disaster preparedness, contingency planning);
j) logistics process;
k) customer service.

8. Operation
8.4.1.3 Customer directed sources (also known as ‘Directed-buy”) (Earlier

7.4.1.3)
• No major change.
• All requirements of Section 8.4 except supplier selection are
applicable to the organization’s control of customer-directed sources
unless specific agreements are otherwise defined by the contract
between the organization and the customer.
8.4.2.1 Type and extent of control – supplemental (New)

• documented process to identify outsourced processes and to select
the types and extent of controls used
• include the criteria and actions to escalate or reduce the types and
extent of controls and development activities based on supplier
performance and assessment of product, material, or service risks.

8. Operation
8.4.2.2 Statutory and regulatory requirements (Earlier 7.4.1.1)

• document their process to ensure that purchased products, processes, and
services conform to the current applicable statutory and regulatory requirements
in the country of receipt, the country of shipment, and the customer-
identified country of destination, if provided.
• If the customer defines special controls for certain products with statutory
and regulatory requirements, the organization shall ensure they are
implemented and maintained as defined, including at suppliers.

8. Operation
8.4.2.3 Supplier QMS development (Earlier 7.4.1.2)

• No major change
• Unless otherwise specified by the customer, the following sequence should be
applied to achieve this requirement:
a) compliance to ISO 9001 through second-party audits;
b) certification to ISO 9001 through third-party audits; unless otherwise
specified by the customer by an ISO/IEC 17021 accredited third parties
c) certification to ISO 9001 with compliance to other customer-defined QMS
requirements (such as Minimum Automotive QMS Requirements for Sub-
Tier Suppliers [MAQMSR] or equivalent) through second-party audits;
d) certification to ISO 9001 with compliance to IATF 16949 through second-
party audits;
e) certification to 16949 through third-party audits (by an IATF-recognized
certification body).

8. Operation
8.4.2.3.1 Automotive product related software or automotive products

with embedded software (New)
• suppliers of automotive product-related software, or automotive
products with embedded software, to implement and maintain a
process for software quality assurance for their products.
• A software development assessment methodology shall be utilized to
assess the supplier’s software development process.
• Using prioritization based on risk and potential impact to the
customer, the organization shall require the supplier to retain
documented information of a software development capability self-
assessment.

8. Operation
8.4.2.4 Supplier monitoring (Earlier 7.4.3.2)

• documented process and criteria to evaluate supplier performance
• No change
8.4.2.4.1 Second party audits (New)

• include a second-party audit process in their supplier management
approach.
• Second-party audits may be used for the following:
a) supplier risk assessment;
b) supplier monitoring;
c) supplier QMS development;
d) product audits;
e) process audits.

8. Operation
8.4.2.4.1 Second party audits (New) Contd…
• document the criteria for determining the need, type, frequency,

and scope of second-party audits based on risk analysis,
performance of the supplier, and QMS certification level
• retain records of the second-party audit reports.
• If the scope of the second-party audit is to assess the supplier’s
quality management system, then the approach shall be
consistent with the automotive process approach.
• NOTE: Guidance may be found in the IATF Auditor Guide and ISO
19011.

8. Operation
8.4.2.5 Supplier development (New)

• determine the priority, type, extent, and timing of required supplier
development actions for its active suppliers.
• Determination inputs shall include but are not limited to the following:
a) performance issues identified through supplier monitoring;
b) second-party audit findings;
c) third-party quality management system certification status;
d) risk analysis.
• implement actions necessary to resolve open (unsatisfactory)
performance issues and pursue opportunities for continual
improvement.
8.4.3.1 Information for external providers – supplemental (New)

cascade all applicable statutory and regulatory requirements and special product
and process characteristics down the supply chain to the point of manufacture

8. Operation
8.5 Production and Service Provision
8.5.1 Control of production and service provision (Earlier 7.5.1)

• NOTE: Suitable infrastructure includes appropriate manufacturing
equipment required to ensure product compliance.
• Monitoring and measuring resources include appropriate monitoring
and measuring equipment required to ensure effective control of
manufacturing processes.
8.5.1.1 Control plan (Earlier 7.5.1.1)

• No major change
• The organization shall have a control plan for pre-launch and production that
shows linkage and incorporates information from the design risk analysis (if
provided by the customer), process flow diagram, and manufacturing
process risk analysis outputs (such as FMEA).

8. Operation
8.5.1.1 Control plan (Earlier 7.5.1.1) Contd…
• The organization shall, if required by the customer, provide

measurement and conformity data collected during execution of either
the pre-launch or production control plans.
• The organization shall include in the control plan:
a) controls used for the manufacturing process control, including
verification of job set-ups;
b) first-off/last-off part validation, as applicable;
c) methods for monitoring of control exercised over special characteristics
defined by both the customer and the organization;
d) the customer-required information, if any;
e) specified reaction plan; when nonconforming product is detected, the
process becomes statistically unstable or not statistically capable.

8. Operation
8.5.1.1 Control plan (Earlier 7.5.1.1) Contd…
• review control plans, and update as required, for any of the following:
a) the organization determines it has shipped nonconforming product
to the customer;
b) when any change occurs affecting product, manufacturing process,
measurement, logistics, supply sources, production volume changes, or
risk analysis (FMEA)
c) after a customer complaint and implementation of the associated
corrective action, when applicable;
d) at a set frequency based on a risk analysis.
• If required by the customer, the organization shall obtain customer approval
after review or revision of the control plan.

8. Operation
8.5.1.2 Standardized Work – operator instructions and visual standards

(Earlier 7.5.1.2)
ensure that standardised work documents are:
a) communicated to and understood by the employees who are
responsible for performing the work;
b) legible;
c) presented in the language(s) understood by the personnel
responsible to follow them;
d) accessible for use at the designated work area(s).
• also include rules for operator safety.

8. Operation
8.5.1.3 Verification of job set-ups (Earlier 7.5.1.3)

• verify job set-ups when performed, such as an initial run of a job, material
changeover, or job change that requires a new set-up;
• maintain documented information for set-up personnel;
• use statistical methods of verification, where applicable;
• perform first-off/last-off part validation,
• retain records of process and product approval following set-up and
first-off/last-off part validations.
8.5.1.4 Verification after shutdown (New)

• define and implement the necessary actions to ensure product compliance
with requirements after a planned or unplanned production shutdown
period.

8. Operation
8.5.1.5 Total Productive maintenance (Earlier 7.5.1.4)

• develop, implement, and maintain a documented total productive
maintenance system.
• At a minimum, the system shall include the following:
a) identification of process equipment necessary to produce conforming
product at the required volume;
b) availability of replacement parts for the equipment identified in item a);
c) provision of resource for machine, equipment, and facility
maintenance;
d) packaging and preservation of equipment, tooling, and gauging;
e) applicable customer-specific requirements;

8. Operation
8.5.1.5 Total Productive maintenance (Earlier 7.5.1.4) Contd…
• documented maintenance objectives, for example: OEE (Overall

Equipment Effectiveness), MTBF (Mean Time Between Failure), and
MTTR (Mean Time To Repair), and Preventive Maintenance compliance
metrics. Performance to the maintenance objectives shall form an
input into management review;
• regular review of maintenance plan and objectives and a documented action
plan to address corrective actions where objectives are not achieved;
• use of preventive maintenance methods;
• use of predictive maintenance methods, as applicable;
• periodic overhaul.

8. Operation
8.5.1.6 Management of production tooling, and manufacturing, test inspection

tooling and equipment (Earlier 7.5.1.5)
• No major change
• for production and service materials and for bulk materials, as applicable.
• verify that customer-owned tools, manufacturing equipment, and
test/inspection equipment are permanently marked in a visible location
• implement a system to monitor these activities if any work is outsourced
8.5.1.7 Production Scheduling (Earlier 7.5.1.6)
• No change
• include relevant planning information during production scheduling, e.g.,
customer orders, supplier on-time delivery performance, capacity, shared
loading (multi-part station), lead time, inventory level, preventive
maintenance, and calibration.

8. Operation
8.5.2 Identification and Traceability (Earlier 7.5.3)

• No change in Note
8.5.2.1 Identification and Traceability – supplemental (Earlier 7.5.3.1)

• purpose of traceability is to support identification of clear start and
stop points for product received by the customer or in the field that
may contain quality and/or safety-related nonconformities
• conduct an analysis of internal, customer, and regulatory traceability
requirements for all automotive products, including developing and
documenting traceability plans, based on the levels of risk or failure
severity for employees, customers, and consumers.
• These plans shall define the appropriate traceability systems,
processes, and methods by product, process, and manufacturing
location that:

8. Operation
8.5.2.1 Identification and Traceability – supplemental (Earlier 7.5.3.1)

Contd…
a) enable the organization to identify nonconforming and/or suspect

product;
b) enable the organization to segregate nonconforming and/or suspect
product;
c) ensure the ability to meet the customer and/or regulatory response time
requirements;
d) ensure documented information is retained in the format (electronic,
hardcopy, archive) that enables the organization to meet the response
time requirements;
e) ensure serialized identification of individual products, if specified by the
customer or regulatory standards;
f) ensure the identification and traceability requirements are extended to
externally provided products with safety/regulatory characteristics.

8. Operation
8.5.4.1 Preservation – supplemental (Earlier 7.5.5, and 7.5.5.1)

• include identification, handling, contamination control, packaging,
storage, transmission or transportation, and protection.
• shall apply to materials and components from external and/or internal
providers from receipt through processing, including shipment and
until delivery to/acceptance by the customer.
• In order to detect deterioration, the organization shall assess at appropriate
planned intervals the condition of product in stock, the place/type of
storage container, and the storage environment.
• FIFO – no change
• obsolete product control – no change
• comply with preservation, packaging, shipping, and labeling
requirements as provided by their customers.

8. Operation
8.5.4.1 Preservation – supplemental (Earlier 7.5.5, and 7.5.5.1)

• include identification, handling, contamination control, packaging,
storage, transmission or transportation, and protection.
• shall apply to materials and components from external and/or internal
providers from receipt through processing, including shipment and
until delivery to/acceptance by the customer.
• In order to detect deterioration, the organization shall assess at appropriate
planned intervals the condition of product in stock, the place/type of
storage container, and the storage environment.
• FIFO – no change
• obsolete product control – no change
• comply with preservation, packaging, shipping, and labeling
requirements as provided by their customers.

8. Operation
8.5.5.1 Feedback of information from service (Earlier 7.5.1.7)

• No major change
• NOTE 2 “Service concerns” should include the results of field failure
test analysis where applicable.
8.5.5.2 Service agreement with customer (Earlier 7.5.1.8)

• No change
8.5.6.1 Control of changes — supplemental (Earlier 7.5.5)

• Changes, including those made at suppliers, should require a
production trial run for verification of changes to validate the impact
of any changes on the manufacturing process.
• When required by the customer, the organization shall obtain
documented approval, prior to implementation of the change;
8. Operation
8.5.6.1.1 Temporary change of process controls (New)

• identify, document, and maintain a list of the process controls that
includes the primary process control and the approved back-up or
alternate methods.
• document the process that manages the use of alternate control
methods.
• include in this process, based on risk analysis (such as FMEA),
severity, and the internal approvals to be obtained prior to production
implementation of the alternate control method.
• Before shipping product that was inspected or tested using the
alternate method, if required, the organization shall obtain approval
from the customer(s).
• maintain and periodically review a list of approved alternate process
control methods that are referenced in the control plan.

8. Operation
8.5.6.1.1 Temporary change of process controls (New) Contd…
• standard work instructions shall be available for each alternate

process control method.
• review the operation of alternate process controls on a daily basis, at
a minimum, to verify implementation of standard work with the goal to
return to the standard process as defined by the control plan as soon
as possible.
• Example methods include but are not limited to the following:
a) daily quality focused audits (e.g., layered process audits, as
applicable);
b) daily leadership meetings.
• implement traceability of all product produced while any alternate
process control devices or processes are being used (e.g., verification
and retention of first piece and last piece from every shift).
8. Operation
8.6 Release of Product and Service
8.6.1 Release of products and services — supplemental (New)

• ensure that the planned arrangements to verify that the product and
service requirements have been met encompass the control plan and
are documented as specified in the control plan.
• ensure that the planned arrangements for initial release of products
and services encompass product or service approval.
• ensure that product or service approval is accomplished after
changes following initial release
8.6.2 Layout inspection and functional testing (Earlier 8.2.4.1)

• No change
• NOTE 2: The frequency of layout inspection is determined by the
customer.

8. Operation
8.6 Release of Product and Service
8.6.3 Appearance items (Earlier 8.2.4.2)

• No change
8.6.4 Verification and acceptance of conformity of externally provided

products and services (Earlier 7.4.3.1)
• No change
8.6.5 Statutory and regulatory conformity (New)

• Prior to release of externally provided products into its production flow, the
organization shall confirm and be able to provide evidence that externally
provided processes, products, and services conform to the latest applicable
statutory, regulatory, and other requirements in the countries where they are
manufactured and in the customer-identified countries of destination
8.6.6 Acceptance criteria (Earlier 7.1.2)
• No change
8. Operation
8.7 Control of Non-Conforming Outputs
8.7.1.1 Customer authorization for concession (Earlier 8.3.4)

• No change
• obtain customer authorization prior to further processing for “use as is” and rework
dispositions of nonconforming product. If sub-components are reused in the
manufacturing process, that sub-component reuse shall be clearly communicated
to the customer in the concession or deviation permit.
8.7.1.2 Control of nonconforming product — customer-specified process (New)
• comply with applicable customer-specified controls for nonconforming product(s).
8.7.1.3 Control of suspect product (Earlier 8.3.1)
• ensure that product with unidentified or suspect status is classified and controlled as
nonconforming product.
• ensure that all appropriate manufacturing personnel receive training for
containment of suspect and nonconforming product.

8. Operation
8.7.1.4 Control of reworked product (Earlier 8.3.2)

• utilize risk analysis (such as FMEA) methodology to assess risks in
the rework process prior to a decision to rework the product.
• If required by the customer, the organization shall obtain approval
from the customer prior to commencing rework of the product.
• documented process for rework confirmation in accordance with the
control plan or other relevant documented information to verify
compliance to original specifications.
• Instructions for disassembly or rework, including re-inspection and
traceability requirements, shall be accessible to and utilized by the
appropriate personnel.
• retain documented information on the disposition of reworked
product including quantity, disposition, disposition date, and
applicable traceability information.

8. Operation
8.7.1.5 Control of repaired product (New)

• utilize risk analysis (such as FMEA) methodology to assess risks in
the repair process prior to a decision to repair the product.
• obtain approval from the customer before commencing repair of the
product.
• documented process for repair confirmation in accordance with the
control plan or other relevant documented information.
• Instructions for disassembly or repair, including re-inspection and
traceability requirements, shall be accessible to and utilized by the
appropriate personnel.
• obtain a documented customer authorization for concession for the
product to be repaired.
• retain documented information on the disposition of repaired product
including quantity, disposition, disposition date, and applicable
traceability information.

8. Operation
8.7.1.6 Customer notification (Earlier 8.3.3)

• Initial communication shall be followed with detailed documentation
of the event.
8.7.1.7 Nonconforming product disposition (Earlier 8.3.1)

• documented process for disposition of nonconforming product not
subject to rework or repair.
• For product not meeting requirements, verify that the product to be
scrapped is rendered unusable prior to disposal.
• shall not divert nonconforming product to service or other use
without prior customer approval.

9. Performance Evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1.1.1 Monitoring and measurement of manufacturing processes (Earlier

8.2.3.1)
• No major change
• perform process studies on all new manufacturing (including assembly or
sequencing) processes to verify process capability and to provide additional
input for process control, including those for special characteristics.
• NOTE: Manufacturing processes for which it may not be possible to
demonstrate product compliance through process capability,
processes, alternate methods such as batch conformance to
specification may be used.
• maintain manufacturing process capability or performance results as
specified by the customer’s part approval process requirements.

9.1.1.1 Monitoring and measurement of manufacturing processes (Earlier

8.2.3.1) Contd...
• verify that the process flow diagram, PFMEA, and control plan are
implemented, including adherence to the following:
a) measurement techniques;
b) sampling plans;
c) acceptance criteria;
d) records of actual measurement values and/or test results for variable
data;
e) reaction plans and escalation process when acceptance criteria are not met.
• Significant process events, such as tool change or machine repair, shall be
recorded and retained as documented information.
• initiate a reaction plan indicated on the control plan and evaluated for
impact on compliance to specifications for characteristics that are either
not statistically capable or are unstable.
9.1.1.2 Identification of statistical tools (Earlier 8.1.1)

• determine the appropriate use of statistical tools.
• verify that appropriate statistical tools are included as part of APQP (or
equivalent) process and included in the design risk analysis (such as
DFMEA) (where applicable), the process risk analysis (such as
PFMEA), and the control plan.
9.1.1.3 Application of statistical concepts (Earlier 8.1.2)

• Statistical concepts, such as variation, control (stability), process capability,
and the consequences of over-adjustment, shall be understood
• used by employees involved in the collection, analysis, and
management of statistical data.

9.1.2.1 Customer satisfaction — supplemental (Earlier 8.2.1.1)

• No major change
• monitor the performance of manufacturing processes to demonstrate
compliance with customer requirements for product quality and
process efficiency.
• monitoring shall include the review of customer performance data
including online customer portals and customer scorecards, where
provided.
9.1.3.1 Prioritization (Earlier 8.4.1)

• Trends in quality and operational performance shall be compared with
progress toward objectives and lead to action to support prioritization of
actions for improving customer satisfaction.

9.2 Internal Audit
9.2.2.1 Internal audit programme (Earlier 8.2.2.4)

• documented internal audit process.
• process shall include the development and implementation of an
internal audit programme that covers the entire QMS including QMS
audits, manufacturing process audits, and product audits.
• audit programme shall be prioritized based upon risk, internal and
external performance trends, and criticality of the process(es).
• Where applicable, the organization shall include software
development capability assessments in their internal audit
programme.
• The frequency of audits shall be reviewed and, where appropriate, adjusted
based on occurrence of process changes, internal and external
nonconformities, and/or customer complaints.
• effectiveness of the audit programme shall be reviewed as a part of
management review.

9.2 Internal Audit
9.2.2.2 Quality management system audit (Earlier 8.5.2.4)

• audit all quality management system processes over each three-year
calendar period, according to an annual programme, using the
process approach to verify compliance with this Automotive QMS
Standard.
• Integrated with these audits, the organization shall sample customer-
specific quality management system requirements for effective
implementation.
9.2.2.3 Manufacturing process audit (Earlier 8.2.2.2)

• audit all manufacturing processes over each three-year calendar period
to determine their effectiveness and efficiency using customer-specific
required approaches for process audits.
• Where not defined by the customer, the organization shall determine
the approach to be used.

9.2 Internal Audit
9.2.2.3 Manufacturing process audit (Earlier 8.2.2.2) Contd…
• each manufacturing process shall be audited on all shifts where it

occurs, including the appropriate sampling of the shift handover.
• manufacturing process audit shall include an audit of the effective
implementation of the process risk analysis (such as PFMEA), control
plan, and associated documents.
9.2.2.4 Product audit (Earlier 8.2.2.3)

• audit products using customer-specific required approaches at
appropriate stages of production and delivery to verify conformity to
specified requirements.
• Where not defined by the customer, the organization shall define the
approach to be used.
9.3 Management Review
9.3.1.1 Management review — supplemental (Earlier 5.6.1)

• Management review shall be conducted at least annually
• frequency shall be increased based on risk to compliance with
customer requirements resulting from internal or external changes
impacting the quality management system and performance-related
issues.
9.3.2.1 Management review inputs — supplemental (Earlier 5.6.2.1)

• Input to management review shall include:
a) cost of poor quality (cost of internal and external
nonconformance);
b) measures of process effectiveness;
c) measures of process efficiency;
d) product conformance;
e) assessments of manufacturing feasibility made for changes to
existing operations and for new facilities or new product;
9.3 Management Review
9.3.2.1 Management review inputs — supplemental (Earlier 5.6.2.1)

Contd…
• customer satisfaction;
• review of performance against maintenance objectives;
• warranty performance (where applicable);
• review of customer scorecards (where applicable);
• identification of potential field failures identified through risk analysis
(such as FMEA);
• actual field failures and their impact on safety or the environment.
9.3.3.1 Management review outputs — supplemental (New)

• Top management shall document and implement an action plan when
customer performance targets are not met.

10. Improvement
10.2 Nonconformity and corrective action
10.2.3 Problem Solving (Earlier 8.5.2.1, 8.5.2.3)

documented process(es) for problem solving including:
• defined approaches for various types and scale of problems (e.g., new
product development, current manufacturing issues, field failures,
audit findings);
• containment, interim actions, and related activities necessary for
control of nonconforming outputs;
• root cause analysis, methodology used, analysis, and results;
• implementation of systemic corrective actions, including consideration of
the impact on similar processes and products;
• verification of the effectiveness of implemented corrective actions;
• reviewing and, where necessary, updating the appropriate
documented information (e.g., PFMEA, control plan).
• use customer specific prescribed processes processes, tools, or systems
for problem solving unless otherwise approved by the customer.
10. Improvement
10.2.4 Error-proofing (Earlier 8.5.2.2)

• documented process to determine the use of appropriate error-
proofing methodologies.
• Details of the method to be documented in the process risk analysis
(such as PFMEA) and test frequencies to be documented in the
control plan.
• The process shall include the testing of error-proofing devices for
failure or simulated failure.
• Records shall be maintained.
• Challenge parts, when used, shall be identified, controlled, verified,
and calibrated where feasible.
• Error-proofing device failures shall have a reaction plan.

10. Improvement
10.2.5 Warranty management systems (New)

• When organization is required to provide warranty for their product(s),
the organization shall implement a warranty management process.
• the process shall include a method for warranty part analysis,
including NTF (no trouble found).
10.2.6 Customer complaints and field failure test analysis (Earlier 8.5.2.4)
• analysis on customer complaints and field failures, including any
returned parts, and initiate problem solving and corrective action to
prevent recurrence.
• Where requested by the customer, this shall include analysis of the
interaction of embedded software of the organization’s product within
the system of the final customer’s product.
• communicate the results of testing/analysis to the customer and also
within the organization.

10. Improvement
10.3.1 Continual improvement — supplemental (Earlier 8.5.1.1, 8.5.1.2)

• documented process for continual improvement
• the process shall include the following:
a) identification of the methodology used, objectives,
measurement, effectiveness, and documented information;
b) a manufacturing process improvement action plan with
emphasis on the reduction of process variation and waste;
c) risk analysis (such as FMEA).
• NOTE: Continual improvement is implemented once manufacturing

processes are statistically capable and stable or when product
characteristics are predictable and meet customer requirements.

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Awareness Training Program on

NICHE QUALITY SOLUTIONS PVT. LTD.

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• Safety – be aware of emergency exits

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• Upon completing this course, candidate

ISO (International Organization for Standardization)

 ISO 9001 “Specifies quality management

An organization that demonstrates it is meeting

An organization that demonstrates it is meeting these

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• Applicable to the sites of the organization where

• This Technical Specification can be should be applied

“A” of the “PDCA” cycle:

 Corrective action (to prevent recurrence!)

 Improvement (includes Kaizen, but also breakthrough improvements,

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Quality Management System (4)

Customers Performance Results

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Development of QMS that provides for

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0.2 Quality Management Principles

0.3.1 Process Approach - General Same as

0.4 Relationship with other MS standards

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• Multi-disciplinary Approach • Reaction Plan

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Advanced product quality planning (APQP)

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Challenge (master) part

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Customer-specific requirements (CSRs)

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Design for assembly (DFA)

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Design for manufacturing (DFM)

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Design for manufacturing and assembly

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Design for six sigma (DFSS)

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Note: This responsibility includes testing and

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Fault tree analysis (FTA)

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No trouble found (NTF)

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