IATF 16949:2016 Training on Quality Management Systems and Audit Concepts

Training on IATF 16949 : 2016 Quality Management Systems
(QMS), and Audit Concepts
IATF : 16949
Brief History
ISO 9000:
ISO 9001:2000 ISO 9001:2008 ISO 9001:2015
1994
ISO / TS ISO / TS IISO/ TS IATF 16949 :

16949:1999 16949:2002 16949 : 2009 2016
2
Transition Timing
Expiration of all TS
Release of IATF
16949:2009
16949: 2016
certificates
01-Oct-2016
14-Sep-2018
Suspension of Audit In
Release of ISO 9001:
accordance to TS
2015
16949:2009
23-Sep-2015
1-Oct-2017
2015 2016 2017 2018
Transition Period of ISO 9001:2015
Transition Period of IATF 16949:2016
Quality Management Principles
Customer Focus Leadership Engagement of Process Approach

People
Improvement Evidence Based Relationship

Decision Making Management
ISO 9001:2008 Principles
1 Customer Focus. 2 Leadership 3 Involvement of people 4 Process approach
5 System approach to management 6 Continual Improvement 7 Factual Approach to decision making
8 Mutually beneficial supplier relationship 4
Structure of IATF 16949:2016
• Section 1 – Scope
• Section 2 – Normative references
• Section 3 – Terms & definitions
• Section 4 – Context of the organization
• Section 5 – Leadership
• Section 6 – Planning
• Section 7 – Support
• Section 8 – Operation
• Section 9 – Performance evaluation
• Section 10 – Improvement
ISO 9001:2008 Clauses
Section4 – Quality Management System
Section 5 – Management responsibility
Section 6 – Resource Management
Section 7 – Product realisation
Section 8 - Measurement, Analysis and Improvement
5
IATF cooperates with ISO 9001
ISO
9001
IATF IATF
16949 Implementation
CSR
6
Key changes in approach
o Risk based thinking

o Consideration of interested parties
o Greater focus on customer
o Aligning QMS objective with organizational strategy
o Greater responsibility for top management under clause
leadership
High level structure
A new common format has been developed for use in all management system
standards: “high-level structure”.
Organizations implementing multiple management systems

(e.g. quality, environmental, information security) can
achieve better integration and easier implementation
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Process Approach
PDCA Representation
Quality Management System (4)

Organization
and its Support
context (7),
(4) Operation Customer
Plan (8) Do satisfaction
Performanc
Customer Planning Leadership e Results of the
requirements (6) (5) evaluation QMS
(9)
Check
Act Products and
Improveme services
Needs and nt
expectation (10)
of relevant
interested
parties (4)
10
Key Changes in IATF
• Consideration of support functions on-site or remote (now included in standard)
• Periodicity / frequency (re)defined.
Contingency plan review – at a minimum annually
Establishing quality objectives – annual, at a minimum
audit all quality management system processes and all manufacturing processes over
each three-year calendar period
Management review shall be conducted at least annually
Record retention of …. for the length of time that the product is active for production
and service requirements, plus one calendar year
Review of Engineering Specifications should be completed within 10 working days
• prioritization of MSA studies should focus on critical or special product or process
characteristics
• Corporate Responsibility
• Step-by-step development of supplier quality management system
• Auditors competency
• OEE , MTBR, MTBF
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Section 1- Scope
• Needs to demonstrate its ability to consistently provide product or service that meets
customer and applicable statutory and regulatory requirements, and
• Aims to enhance customer satisfaction through the effective application of the system,
including processes for improvement of the system and the assurance of conformity to
customer and applicable statutory and regulatory requirements.
Changes:
– Exclusion now get addressed at clause 4.3
– Used Improvement in place of continual improvement
– Used products and services in place of product
Training on ISO 9001 QMS Concepts, Audit Concepts @

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TPIPL
1.1- Scope – Automotive supplemental
IATF
This defines the quality management system requirement for
• Design and development, assembly, installation and services for automotive related
products, including products with embedded software
• Applicable to the site of organisation where manufacturing of customer specified production
part, service part accessories parts occur
• To be applied throughout the automotive supply chain
Changes:
– Inclusion of embedded software
– Supporting function (design center, corporate, distribution center ) moved to clause 4.3.1
(determining the scope of quality management system supplemental)
– Section 1.2 - Application removed, exclusion included in clause 4.3.1
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Section 2- Normative reference
ISO 9000:2015, Quality Management System – Fundamentals and vocabulary refered
2.1 - Normative and informative references IATF
Inclusion of Annex A – Control Plan, Annex B - Bibliography

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Section 3- Terms & Definitions
Interested party - person or organization that can affect, be affected by, or perceive themselves to be
affected by a decision or activity
Management system -set of interrelated or interacting elements of an organization to establish policies
and objectives and processes to achieve those objectives
Effectiveness- extent to which planned activities are realized and planned results achieved
Policy- intentions and direction of an organization, as formally expressed by its top management
Risk - effect of uncertainty on an expected result
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)
Audit -systematic and independent process for obtaining objective evidence and evaluating it objectively
to determine the extent to which the audit criteria are fulfilled
Context of the organization -business environment combination of internal and external factors and
conditions that can have an effect on an organization's approach to its products, services and
investments and interested parties
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3.1 - Terms & Definitions for the automotive industry

o After market parts IATF
o Challenge part
o Design for assembly and manufacturing
o Design for six sigma
o Escalation process
o Fault Tree Analysis (deductive failure analysis methodology)
o Remote location (support manufacturing has non production processes)
o Service Parts (replacement part based on OEM spec and released by OEM)
o Trade-off curve (Curve indicates the product performance relative to two characteristics)
o Trade-off process (methodology to develop trade off curve)
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Section 4 – Context of organization
4.1Understanding the organisation and

its context
4.2 Understanding the needs and

expectations of interested parties
4.3 Determining the scope of the quality

management system
4.4 Quality management system

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4.1 : Context
 Entire clause 4 requires the organisation to consider itself and its context, determination of scope,
issues and requirement,
 This is taken as an input to the development f QMS
 SWOT Analysis – Strength Weakness Opportunity and Threat

 PEST Analysis – Political, Economical, Social and Technical
 SOAR Analysis – Strength, Opportunity ,Aspiration , Result
 Value chain analysis
 Context analysis also helps in identifying opportunity. Opportunities thus identified to be included in
business plan

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TPIPL
4.1 : Context
 Determine external and internal context that are relevant to its purpose and its strategic
direction and that affect its ability to achieve the intended result(s) of its quality management
system
 Monitor and review the information about these issues and consider these as an input to
development of QMS
 External context – market, competitive, legal & Regulatory, technological, Social, local etc..
 Internal context – Knowledge level, culture, values, organisation performance etc.

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4.2 : Needs & Expectations of Interested Parties
 Goes beyond customer

 Consider all interested parties
 Identify interested parties which can pose significant risk on organisation sustainability if their
needs are met
 Both internal and external interested parties to be considered
Internal Interested parties: External Interested parties:

o Employee o Financial Institution
o Board of directors o Supplier
o Management Team o Customer, distributor, end user
o Unions o Legislator
o Media
o Stake holder
o Society etc..
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4.3 : Determining the scope of the quality management
system
 Determine and boundaries and applicability of QMS

 Input form context and interested party consideration should flow in scope definition
 Should cover all types of products and services
 Should also mention exclusion if any
 Exclusion should not effect the organisation ability to ensure conformity of product and services
and enhancement of customer satisfaction
 Issues identified at this stage to be addressed in clause 6, planning
 Scope definition should include 1) Product and services 2) Processes to deliver them , and 3) Sites
included
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4.3.1 : Determining the scope of the quality management

system - supplemental
NEW
IATF
 Supporting functions , on-site or remote (design function, corporate head quarters and distribution
centers) are now in scope
 Only exclusion design and development (clause 8.3)
 No exclusion in manufacturing process design
4.3.2 : Customer Specification Requirement (CSR)
 To be evaluated and included in QMS
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4.4 : Quality management system
 Organisation shall establish, implement, maintain and continually improve a quality management
system, including the processes needed and their interactions, in accordance with the
requirements of this International Standard.

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4.4.1 : Quality management system

The organization shall determine the processes needed for the quality management system and shall
determine:
a) the inputs required and the outputs expected from these processes;
b) the sequence and interaction of these processes;
c) the criteria, methods, including measurements and related performance indicators needed
to ensure the effective operation, and control of these processes;
d) the resources needed and ensure their availability;
e) the assignment of the responsibilities and authorities for these processes;
f) the risks and opportunities in accordance with the requirements of 6.1, and plan and
implement the appropriate actions to address them;
g) the methods for monitoring, measuring, as appropriate, and evaluation of processes and, if
needed, the changes to processes to ensure that they achieve intended results;
h) opportunities for improvement of the processes and the quality management system.
Organisation shall retain documented information to have confidence that the processes are being
carried out as planned
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4.4.1.1 : Conformance of Products & Processes
Organisation shall ensure conformance of all product and processes including service IATF
parts & outsourced part for customer, statutory and regulatory requirements
4.4.1.2 : Product safety
 Identify statutory and regulatory product safety requirement

 Notify customer
 Approval of DFMEA and PFMEA, CP including reaction plan
 Identify safety related characteristics and control at manufacturing point
 Define responsibility and escalation process
 Training of personnel involved
 Transfer the safety requirement through out supply chail

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TPIPL
4.4.2 : Quality Management System and its process
a. Maintain documented information to support the operation of processes.

b. Retain documented information to have confidence that the processes are being carried
out as planned.
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Section 5 – Leadership
5.1 Leadership and

commitment
5.2 Quality policy
5.3 organisation role,

responsibility and authority

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TPIPL
5.1 : Leadership & commitment

Top management shall demonstrate leadership and commitment to QMS by:
taking accountability of QMS;
o ensuring that the quality policy and quality objectives are established for the QMS and are
compatible with the strategic direction and the context of the organization
o ensuring that the quality policy is communicated, understood and applied
o ensuring the integration of the QMS requirements into the organization’s business processes;
o promoting awareness of the process approach;
o ensuring that the resources needed for the quality management system are available;
o communicating the importance of effective quality management and of conforming to the quality
management system requirements;
o ensuring that the quality management system achieves its intended results;
o engaging, directing and supporting persons to contribute to the effectiveness of the QMS;
o promoting continual improvement;
o supporting other relevant management roles to demonstrate their leadership as it applies to their
areas of responsibility
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5.1 : Leadership & commitment
o Replaces 5.1 of older version of management commitment

o Requires top management greater involvement
o Stronger focus on integration of QMS with business
o No management representative
o This has got no mention in system and hence organisation can opt for a different structure to
assign the responsibility
o Top management and its leadership to effective implement requires greater involvement

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TPIPL
5.1.1 : Leadership & commitment
This clause identifies specific aspects of the QMS where top management
are expected to play an important role to demonstrate both leadership and
commitment where they :
 take accountability for effectiveness of QMS

 ensure that their organization’s quality policy and objectives are compatible with strategic direction
and the context of organization..
 promote the adoption of the “process approach” and risk based thinking,

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TPIPL
5.1.1 : Leadership & commitment
• New requirements of IATF

5.1.1.1 Corporate responsibility
Define and implement corporate responsibility policies, including anti-bribery policy,
employee code of conduct, ethics escalation policy (“whistle-blowing policy”).
5.1.1.2 Process effectiveness and efficiency
Review product realization process and support process, evaluate and improve
effectiveness and efficiency
Include results of review as input to the management review
5.1.1.3 Process owners
Identify process owners who are responsible for managing the organization’s processes and
related outputs. Process owners shall understand their roles and be competent to perform
those roles

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TPIPL
5.1.2 : Customer focus
Top management shall demonstrate leadership and commitment with respect to customer focus
by ensuring that:
o customer requirements and applicable statutory and regulatory requirements are
determined and met;
o the risks and opportunities that can affect conformity of products and services and the
ability to enhance customer satisfaction are determined and addressed;
o the focus on enhancing customer satisfaction is maintained.

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TPIPL
5.2 : Quality Policy
5.2.1 Establishing the Quality Policy

Top management shall establish, review and maintain a quality policy that:
o is appropriate to the purpose and context of the organization;
o provides a framework for setting and reviewing quality objectives;
o includes a commitment to satisfy applicable requirements
o includes a commitment to continual improvement of the quality management system.
5.2.2 Communicating the Quality Policy

The quality policy shall:
o be available as documented information;
o be communicated, understood and applied within the organization;
o be available to relevant interested parties, as appropriate.

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TPIPL
5.3 : Organization role, responsibilities and

authorities
Top management shall ensure that the responsibilities and authorities for relevant roles are
assigned, communicated and understood within the organization
Top management shall assign the responsibility and authority for:

o ensuring that the quality management system conforms to the requirements of this
International Standard;
o ensuring that the processes are delivering their intended outputs;
o reporting on the performance of the quality management system , on opportunities for
improvement and on the need for change or innovation, and especially for reporting to top
management;
o ensuring the promotion of customer focus throughout the organization;
o ensuring that the integrity of the QMS is maintained when changes are done

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TPIPL
5.3.1 : Organization role, responsibilities and
authorities - supplemental
IATF
Define personnel responsible for identification of special characteristics, setting quality

objective and related training, corrective and preventive actions , design and development,
capacity analysis, logistic information, customer score card , customer portal etc..
5.3.2 : Responsibilities and authorities for product requirement and

corrective actions
o Personnel responsible for conformity of product to have authority to stop shipment / production
to correct quality problem.
o Effected product must be contained
o Immediately inform to person with responsibility of corrective action
o Person responsible for product conformance to be available in all shifts

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TPIPL
Section 6 – Planning
6.1 Action to address risk and

opportunity
6.2 Quality objective and planning to

achieve them
6.3 Planning of changes

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TPIPL
6.1 : Action to address risk and opportunity
6.1.1
When planning for the quality management system, the organization shall consider the issues
referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and
opportunities that need to be addressed to:
o give assurance that the QMS can achieve its intended result(s)
o prevent, or reduce, undesired effects;
o achieve continual improvement.

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TPIPL
6.1.2
The organization shall plan:
actions to address these risks and opportunities;
how to:
1) integrate and implement the actions into its QMS processes (see 4.4);
2) evaluate the effectiveness of these actions.
Actions taken to address risks and opportunities shall be proportionate to the potential impact on
the conformity of products and services.

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TPIPL
o This now requires identification, analysis and action on risk and opportunity
o An organisation can address risk by avoiding, mitigating, sharing, taking as opportunity etc.
o This sets platform for a risk based thinking and a proactive approach
o Implements a PDCA approach

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TPIPL
6.1.2.1 Risk Analysis

IATF
Include lesion learned from product recall, product audits, field returns and repairs, complaints
scrap and rework etc..
6.1.2.2 Preventive Action
Determine and take action to prevent potential non conformities , preventive act ion to be
appropriate to the severity. Action to include :
Determine potential non conformities and their causes
Evaluate the need for action to prevent occurrence
Determine and implement action
Review the effectiveness
Lesion learned record
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TPIPL
6.1.2.3 Contingency Plan
IATF
o Identify internal and external risk to all manufacturing processes and infrastructure including
externally provided product and services, labour interruption, utility services, natural
disasters etc..
o Define contingency plan and impact on customer
o Notification process to customer
o Periodically test the contingency plan and its effectiveness (simulate as appropriate)
o Review with multidisciplinary team and update revision number for any change

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TPIPL
Risk Management
Can be done in accordance with ISO 31000

Where
Risk management = Risk assessment + Risk Control + Residual Risk
Risk assessment = Risk Identification + Risk analysis + Risk evaluation
Risk control and risk treatment by:

Terminate (Alternatives) MATH :
Treat (Action) Mitigate
Avoid
Tolerate (Hold)
Transfer
Transfer (Pass on) Hold
(4T concept)
Preliminary hazard analysis, Fault tree analysis or FMEA can be used for risk management

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TPIPL
6.2 – Quality Objective and planning to achieve
them
Smart Objective
Specific
Measurable
Achievable
Results orientated
Time bound

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TPIPL
6.2 – Quality Objective and planning to achieve

them
6.2.1 : The organization shall establish quality objectives at relevant functions, levels and
processes.
The quality objectives shall:
o be consistent with the quality policy,
o be measurable;
o take into account applicable requirements;
o be relevant to conformity of products and services and the enhancement of customer
satisfaction;
o be monitored;
o be communicated;
o be updated as appropriate.
o The organization shall retain documented information on the quality objectives

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TPIPL
6.2 – Quality Objective and planning to achieve them
6.2.2: When planning how to achieve its quality objectives, the organization shall determine:
o what will be done;
o what resources will be required;
o who will be responsible;
Strictly defining the
o when it will be completed; structure to drive
quality objective
o how the results will be evaluated.
6.2.2.1 – Quality Objective and planning to achieve them -

IATF
supplemental
To be done for all function through out the organisation, consideration of requirement of interested
parties to have performance targets
Reviewed at least once in a year
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Quality Objectives - Example

• Reducing defects/errors/wastages/wasteful activities
• Reducing customer complaints
• Error free communication with the customers
• Timely availability of chemicals/consumables
• Improved service delivery time
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6.3 – Planning of changes
The organisation shall determine the need to change the QMS and while changing the
organization shall consider:
o the purpose of the change and any of its potential consequences;
o the integrity of the quality management system;
o the availability of resources;
o the allocation or reallocation of responsibilities and authorities.

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TPIPL
Section 7 - Support
7.1 Resource
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information

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TPIPL
7.1 - Resources
7.1.1 General
The organization shall determine and provide the resources needed for the establishment,
implementation, maintenance and continual improvement of the quality management system.
The organization shall consider:
a) the capabilities of, and constraints on, existing internal resources;
b) what needs to be obtained from external providers.
External Providers have been explicitly considered

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TPIPL
7.1 - Resources
7.1.2 People
To ensure that the organization can consistently meet customer and applicable statutory and
regulatory requirements, the organization shall provide the persons necessary for the effective
operation of the quality management system, including the processes needed.
Expectation from people defined

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7.1 - Resources
7.1.3 Infrastructure
The organization shall determine, provide and maintain the infrastructure for the operation of its
processes to achieve conformity of products and services.
Infrastructure can include:
a) buildings and associated utilities;
b) equipment including hardware and software;
c) transportation;
d) information and communication technology.
No major changes

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TPIPL
7.1 - Resources
7.1.3.1 Plant Facility and Resource Planning
IATF
o Use multidisciplinary approach for risk identification and risk mitigation methods for
developing and improving plant, facility and equipment plan.
o While designing layout optimise material flow, material handling ad value added use of
floor space including control of non conforming product
o Facilitate synchronous material flow as applicable
o Develop method for evaluate manufacturing feasibility for new product or new operations
including capacity planning
o Monitor process effectiveness, including periodic re-evaluation and changes and approval
of changes
o Apply lean manufacturing principles
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7.1 - Resources
7.1.4 Environment for operation of its processes
The organization shall determine, provide and maintain the environment necessary for the
operation of its processes and to achieve conformity of products and services.
NOTE: Environment for the operation of processes can include physical, social, psychological,
environmental and other factors (such as temperature, humidity, ergonomics and cleanliness).
Physical, social, psychological environment included
7.1.4 Environment for operation of its processes - supplemental

Third party certification to ISO 45001 (or equivalent) is recognised and can be used as an
evidence to meet safety related requirements
IATF
7.1.4.1 Environment for the operation of processes – supplemental
Maintain premises cleanliness and maintenance consistence with product and manufacturing
process need.
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7.1 - Resources
7.1.5 Monitoring and measuring resources

Shall determine the resources needed to ensure valid and reliable monitoring and measuring
results.
The organization shall ensure that the resources provided:
a) are suitable for the specific type of monitoring and measurement activities being undertaken;
b) are maintained to ensure their continued fitness for their purpose.
The organization shall retain appropriate documented information as evidence of fitness for
purpose of monitoring and measurement resources.
7.1.5.1.1
Prioritisation of MSA can be done

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7.1 - Resources
7.1.5.2 Measurement Traceability
Where measurement traceability is required , measuring instrument shall be:
o verified or calibrated at specified intervals or prior to use against measurement standards
traceable to international or national measurement standards. Where no such standards
exist, the basis used for calibration or verification shall be retained as documented
information; identified in order to determine their calibration status
o safeguarded from adjustments, damage or deterioration
7.1.5.2.1 Calibration/verification records

Organisation to maintain a documented process and consider –
o On-site supplier-owned equipment
o Internal, legal and customer-defined requirements
o Records of calibration for all equipment at all places
o Notification to customer if suspected product have been shipped
IATF
o Production related software verification used for product and process control
7.1.5.3 Laboratory requirement

7.1.5.3.1 Internal Laboratory – define scope , ensure adequacy of technical procedure,
competency, customer requirement etc. (alternatively – ISO/ IEC 17025 certification)
7.1.5.3.2 External Laboratory - ISO/ IEC 17025 certified
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7.1 - Resources
7.1.6 Organizational knowledge

The organization shall determine the knowledge necessary for the operation of its processes
and to achieve conformity of products and services.
This knowledge shall be maintained, and made available to the extent necessary.
When addressing changing needs and trends, the organization shall consider its current
knowledge and determine how to acquire or access the necessary additional knowledge.
A whole new requirement

Introduction to knowledge management for internal and external knowledge

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TPIPL
7.1 - Resources
7.1.6 Organizational knowledge

Organizational knowledge can include information such as intellectual property and lessons
learned.
To obtain the knowledge required, the organization can consider:
a) internal sources (e.g. learning from failures and successful projects, capturing undocumented
knowledge and experience of topical experts within the organization);
b) external sources (e.g. standards, academia, conferences, gathering knowledge with
customers or providers).
A whole new requirement

Introduction to knowledge management for internal and external knowledge

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TPIPL
7.2 - Competence
a) determine the necessary competence of person(s) doing work under its control
that affects its quality performance;
b) persons are competent on the basis of appropriate education, training, or
experience;
c) where applicable, take actions to acquire the necessary competence, and evaluate
the effectiveness of the actions taken;
d) retain appropriate documented information as evidence of competence.
NOTE Applicable actions can include, for example, the provision of training to, the
mentoring of, or the re- assignment of currently employed persons; or the hiring or
contracting of competent persons.

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7.2 - Competence
a) Replaces 6.2.2 of older version competence, training and awareness

b) Work being performed under its control and not work being done by the person put
larger accountability on the managers
c) Competence is more clearly referred to education, training or experience
d) Training not the only source of addressing competency gap

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7.2 - Competence
a) Replaces 6.2.2 of older version competence, training and awareness

b) Work being performed under its control and not work being done by the person put
larger accountability on the managers
c) Competence is more clearly referred to education, training or experience
d) Training not the only source of addressing competency gap
7.2.1 Competence – supplemental

Requires documented process(es) for identifying training needs including
awareness and achieving competence
7.2.2 Competence – on-job training

On-the-job training (includes customer requirements training) for personnel in any
new or modified responsibilities
The level of detail required for on-the-job training shall be commensurate with the
level of education the personnel possesses and the complexity of the task(s).
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7.2 - Competence
7.2.3 Internal auditor Competency

• Applicable for QMS, Manufacturing process and product audit
• Have documented process to verify competency
• Maintain a list of qualified internal auditor
• understanding of the automotive process approach and risk-based thinking; customer-
specific requirements; ‘Standard’s’ requirements; core tool requirements
• Demonstrate the trainer’s competency with the above requirements.
• Maintain and improve internal auditor competence
7.2.4 Second-party auditor competency

Must ne competent with applicable manufacturing process(es) to be audited, including
PFMEA and control plan
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7.3 - Awareness
Persons doing work under the organization’s control shall be aware of:
a) the quality policy;
b) relevant quality objectives;
c) their contribution to the effectiveness of the QMS, including the benefits of
improved quality performance;
d) the implications of not conforming with the quality management system
requirements.
7.3.1 Awareness – supplemental

Maintain documented information that demonstrates
All employees to be aware of -
o their impact on product quality
o the importance of their activities in achieving, maintaining, and improving quality,
o including customer requirements and the risk involved for the customer with non-
conforming product.
7.3.2 Employee motivation and empowerment
Maintain documented process to motivate employee to achieve quality objective, continual
improvement, promotes innovation
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7.4 - Communication
The organization shall determine the internal and external communications relevant
to the QMS including:
a) on what it will communicate;
b) when to communicate;
c) with whom to communicate;
d) how to communicate..
Replaces internal communication section 5.5.3 of older version and includes external
communication also
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7.5 – Documented Information
7.5.1 General
The organization’s quality management system shall include
a) documented information required by this International Standard;
b) documented information determined by the organization as being necessary for
the effectiveness of the QMS
NOTE: The extent of documented information for a QMS can differ from one
organization to another due to:
a) the size of organization and its type of activities, processes, products and services;
b) the complexity of processes and their interactions;
c) the competence of persons.

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o Replaces the requirement from older version of 4.2.1 and 4.2.2 quality manual
o Does not mention the requirement of quality manual
o Flexibility in choosing appropriate documentation
o The term documented information covers both documents and records
7.5.1.1 Quality management system documentation

o Have a quality manual,.
Quality manual to include:
 the scope of the quality management system and justification for any exclusions;
 documented processes or reference to them;
 the organization’s processes and their sequence and interaction (inputs and outputs),
including type and extent of control of any outsourced processes;
 a document (i.e. , matrix) indicating where within the organization’s quality
management system their customer-specific requirements are addressed.
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7.5.2 Creating and updating

When creating and updating documented information the organization shall ensure
appropriate:
a) identification and description (e.g. a title, date, author, or reference number);
b) format (e.g. language, software version, graphics) and media (e.g. paper, electronic);
c) review and approval for suitability and adequacy.
Does not require a documented process

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TPIPL
7.5.3 Control of documented Information

it is available and suitable for use, where and when it is needed;
and is adequately protected (e.g. from loss of confidentiality, improper use, or loss of
integrity).
7.5.3.2 For the control of documented information

distribution, access, retrieval and use;
b) storage and preservation, including preservation of legibility;
c) control of changes (e.g. version control);
d) retention and disposition.
Documented information of external origin determined by the organization shall be identified as
appropriate, and controlled.

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TPIPL
• 7.5.3.2.1 Record retention

– Define, document, and implement a record retention policy.
– Consider statutory, regulatory, organizational, and customer requirements.
– Production part approvals, tooling records, product and process design records, purchase
orders ,contracts ad amendments shall be retained for the length of time that the product is
active for production and service requirements, plus one calendar year
• 7.5.3.2.2 Engineering specifications

– Document process describing the review, distribution, and implementation of all customer
engineering standards/specifications and related revisions based on customer schedules,
as required.
– Retain a record of the date on which each change is implemented in production.
– Implementation shall include updated documents.
– Review should be completed within 10 working days
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Clause 8 – Operation
8.1 Operation planning and control
8.2 Requirement of product and services
8.3 Design and development of product and services
8.4 Control of externally provided processes, products and services
8.5 Production and service provisioning
8.6 Release of product and services
8.7 Control of non conforming output

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TPIPL
8.1 – Operation planning and control
The organization shall plan, implement and control the processes, must consider
clause 4.4 and 6.1
a) determining requirements for the product and services;
b) establishing criteria for the processes and for the acceptance of products and
services;
c) determining the resources needed to achieve conformity to product and service
requirements;
d) implementing control of the processes in accordance with the criteria;
e) retaining documented information
The organization shall control planned changes and review the consequences of
unintended changes, taking action to mitigate any adverse effects, as necessary.
The organization shall ensure that outsourced processes are controlled

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8.1 – Operation planning and control
8.1.1 Operational planning and control – supplemental

Consider -
o customer product requirements and technical specifications;
o logistics requirements;
o manufacturing feasibility;
o project planning (refer to ISO 9001, Section 8.3.2);
o acceptance criteria.
8.1.2 Confidentiality
Maintain confidentiality of customer contracted product or project under development
including product related information
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8.2 – Determination of requirements for products and

services
8.2.1 Customer communication
The organization shall establish the processes for communicating with customers in
relation to:
a) information relating to products and services;
b) enquiries, contracts or order handling, including changes;
c) obtaining customer views, feedback and perceptions, including customer
complaints;
d) the handling or treatment of customer property, if applicable;
e) specific requirements for contingency actions, when relevant.
Additional requirement related to customer property and contingency plan
8.2.1 Customer communication - Supplemental

Communication in a language, format agreed with customer including data 72
8.2 – Determination of requirements for products and
services
8.2.2 Determination of requirements related to products and services
The organization shall establish, implement and maintain a process to determine the requirements for
the products and services to be offered to potential customers.
The organization shall define product and service requirements including
a) those considered necessary by the organisation, and
b) applicable statutory and regulatory requirements,
Shall meet the requirements for claims for the products and services it offers.
Additional requirement related to customer property and contingency plan
8.2.2.1 Determining the requirements for products and services – supplemental

Include recycling, environmental impact, and characteristics identified as a result of the
organization’s knowledge of the product and manufacturing processes.
Include all applicable government, safety, and environmental regulations related to acquisition,
storage, handling, recycling, elimination, or disposal of material
73
8.2 – Determination of requirements for products

and services
8.2.3 Review of requirements related to products and services

The organization shall review,
o requirements for delivery and post-delivery activities;
o requirements not stated by the customer, but necessary for the customers'
o additional statutory and regulatory requirements applicable
o contract or order requirements differing from those previously expressed
o review shall be conducted prior to the organization’s commitment to supply products and services
o the customer requirements shall be confirmed by the organization before acceptance
o relevant personnel must be made aware of changes in requirement whenever it occur
No changes in the requirement

74
8.2 – Determination of requirements for products
and services
• 8.2.3.1.1 Review of the requirements for products and services –
supplemental
– Retain documented evidence of a customer-authorized waiver for a formal review.
• 8.2.3.1.2 Customer-designated special characteristics
– The organization shall conform to customer requirements for designation, approval
documentation, and control of special characteristics.
• 8.2.3.1.3 Organization manufacturing feasibility
– Have multidisciplinary approach
– Conduct this feasibility analysis for new and for any changed manufacturing process
or product design.
– Additionally, validate through production runs, benchmarking studies, or other
appropriate methods, their ability to make product to specifications at the required
rate.
• 8.2.3.2 Retain documented information of review and any new requirement of product or
services
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8.3 Design and development of products and services
8.3.1 General
the organization shall establish, implement and maintain a design and development process and
development of processes for production and services provision
For service organisation , process for service delivery
8.3.1.1 Design and development of products and services – supplemental

o Requirements apply to product and manufacturing process design and development
o Focus on error prevention rather than detection.
o Document the design and development process.

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TPIPL
8.3.2 Design and development planning

the organization shall consider:
a) the nature, duration and complexity of the design and development activities;
b) applicable design and development reviews at different stages
c) the required design and development verification and validation;
d) the responsibilities and authorities involved in the design and development process;
e) the need to control interfaces between individuals and parties involved in the design and
development process;
f) the need for involvement of customer and user groups in the design and development process;
g) documented information to confirm that design and development requirements have been met.
77
8.3.2.1 Design and development planning – supplemental

Includes all affected stakeholders in -
Project management (APQP);
DFM and DFA, FMEAs
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
Organisation to ensure personnel with product design responsibility are competent
8.3.2.3 Development of products with embedded software
Use a process for quality assurance for their products with internally developed embedded
software
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8.3.3 Design and development Inputs

the organization shall determine:
a) Requirements including, functional and performance requirements
b) applicable statutory and regulatory requirements
c) standards or codes of practice
d) internal and external resource
e) potential consequences of failure due to the nature of the products and services
f) level of control expected
Inputs shall be adequate for design and development purposes, complete, and unambiguous.
Conflicts among inputs shall be resolved.
79
• 8.3.3.1 Product design input

– Input requirements as a result of contract review
– product specifications and special characteristics, identification, traceability, and
packaging;
– consideration of design alternatives;
– assessment of risks from the feasibility analysis;
– targets for conformity to product requirements including preservation, reliability,
durability, serviceability, health, safety, environmental, development timing, and costs;
– applicable statutory and regulatory requirements of the customer-identified country of
destination
– Experiences, competitive product analysis (benchmarking), supplier feedback, internal
input, field data, and other relevant sources for current and future projects of a similar
nature.
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• 8.3.3.2 Manufacturing process design input

– Include
• Special characteristics, target of productivity, process capability, timing, cost, new materials;
• product handling and ergonomic requirements; and
• design for manufacturing and design for assembly.
• use of error-proofing methods to a degree appropriate to the magnitude of the problem(s)
and commensurate with the risks encountered.
• 8.3.3.3 Special characteristics
– Use a multidisciplinary approach to identify special characteristics,
• determined by the customer and the risk analysis
– 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;
– Compliance with customer-specified definitions and symbols
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8.3 Design and development of products and

services
8.3.4 Design and development controls
controls applied to the design and development process shall ensure :
a) results to be achieved are clearly defined
b) design and development reviews are conducted as planned
c) Verification (output meets the input requirement) and
d) Validation (processes are meeting the requirement)
• 8.3.4.1 Monitoring
– Measurement at specified stage of design and development of product or process shall be defined,
analysed, and reported in MRM, where possible include risk, cost, lead time, critical path etc.
• 8.3.4.2 Design and development validation
– Consider customer requirements, statutory and regulatory norms, including planning timing in alignment
with customer-timing
• 8.3.4.3 Prototype programme
– When required by customer, where possible use production tooling, process, supplier
• 8.3.4.4 Product approval process
– Earlier 7.3.6.3 including - obtain documented product approval prior to shipment, if required by the
customer
– NOTE Product approval should be subsequent to the verification of the manufacturing process.
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8.3 Design and development of products and
services
8.3.5 Design and development outputs
Design and development output should :
a) meet the input requirements for design and development
b) Be adequate for the subsequent processes
c) Include monitoring and measuring requirements, and acceptance criteria
d) are fit for intended purpose for safe and proper use
8.3.5.1 Design and development outputs – supplemental

Include FMEA, reliability test, Special characteristics, result of DFMA, DFSS, GD&T,
Additionally includes -
results of product design error-proofing, such as DFSS, DFMA, and FTA
Service part requirements;
Packaging and labeling requirements for shipping.
8.3.5.2 Manufacturing process design output
Specification, drawing, Special characteristics, tools, equipment, PFD, CP, WI, PFMEA, process
approval and acceptance criteria, etc..
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8.3.6 Design and development changes

Organisation shall review, control and identify changes made to design inputs and design
outputs during the design and development of products and services or subsequently, to the extent
that there is no adverse impact on conformity to requirements.
Documented information on design and development changes shall be retained
Explicitly mention responsibility and authority

Inclusion of code of practice
Parties involved
Underline risk based approach
8.3.6.1 Design and development changes – supplemental

• Evaluate all design changes after initial product approval
• Validate against customer requirements and approved internally, prior to production
implementation.
• If required by the customer, obtain documented approval, or a documented waiver, from the
customer prior to production implementation.
• For products with embedded software, document the revision level
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8.4 Control of externally provided products and
services
8.4.1 General
shall ensure that externally provided processes, products, and services conform to specified
requirements.
The organization shall apply the specified requirements for the control for
a) products and services are provided by external providers for incorporation into the organization’s
own products and services;
b) products and services are provided directly to the customer(s) by external providers on behalf of
the organization;
c) to outsource process or function.
d) The organization shall establish and apply criteria for the evaluation, selection, monitoring of
performance and re-evaluation
e) The organization shall retain appropriate documented information of the results

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TPIPL
8.4 Control of externally provided products and

services
• For supplier (external providers), IATF includes –
• 8.4.1.1 General – supplemental
– Include all products and services that affect customer requirements – subassenby,
sequencing, shorting, rework and calibration
• 8.4.1.2 Supplier selection process
– Document supplier selection process and include:
– an assessment of the selected supplier’s risk to product conformity and uninterrupted
supply , quality and delivery performance, multidisciplinary decision making,
assessment of software development capability where applicable.
• 8.4.1.3 Customer-directed sources (also known as “Directed-Buy)
– When specified by the customer, purchase products, materials, or services from
customer-directed sources.
– All requirements of Section 8.4 (except the requirements in IATF 16949, Section
8.4.1.2) are applicable
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8.4 Control of externally provided products and services
8.4.2 Type and extent of control of external provision

shall consider:
a) the potential impact of the externally provided processes, products and services on the
organization’s ability to consistently meet customer and applicable statutory and regulatory
requirements;
b) the perceived effectiveness of the controls applied by the external provider
c) Externally provided product or services remains within the scope of organisation
8.4.2.1 Type and extent of control – supplemental

Have documented process to identify outsourced processes and to select the types and extent
of controls
Include the criteria and actions to escalate or reduce the types and extent of controls and
development activities.
8.4.2.2 Statutory and regulatory requirements
Similar to 7.4.1.1 and if customer defines special controls for certain products with statutory and
regulatory requirements, then ensure those controls
87

8.4.2.3 Supplier quality management system development
Steps involved-
o compliance to ISO 9001 through second –party audits;
o certification to ISO 9001 through third-party audits by a recognized C.B.
o certification to ISO 9001 with compliance to other customer-defined QMS requirements
o certification to ISO 9001 with compliance to IATF 16949 through second-party audits;
o certification to 16949 through third-party audits by an IATF-recognized certification body..
8.4.2.3.1 Automotive product-related software or automotive products with embedded software

8.4.2.4 Supplier monitoring
– Have a documented process and criteria to evaluate supplier performance on -
• delivered product conformity to requirements;
• customer disruptions at the receiving plant, including yard holds and stop ships;
• delivery schedule performance;
• number of occurrences of premium freight.
• If provided by the customer, the organization shall also include the following, as appropriate, in their
supplier performance monitoring:
• special status customer notifications related to quality or delivery issues;
• dealer returns, warranty, field actions, and recalls.
88
• 8.4.2.4.1 Second-party audits
– Include a second-party audit process for the following:
• supplier risk assessment;
• supplier monitoring;
• supplier QMS development;
• product audits;
• process audits.
• 8.4.2.5 Supplier development
– Determine the priority, type, extent, and timing of required supplier development
actions for its active suppliers considering -
• performance issues identified through supplier monitoring
• second-party audit findings
• third-party quality management system certification status;
• risk analysis.
– Implement actions necessary to resolve open (unsatisfactory) performance issues and
pursue opportunities for continual improvement.
89
8.4.3 Information for external providers

The organization shall communicate to external providers the following:
a) approval or release of products and services, methods, processes or equipment;
b) competence of personnel, including necessary qualification;
c) their interactions with the organization's quality management system;
d) the control and monitoring of the external provider’s performance to be applied by the
organization;
e) verification activities that the organization, or its customer, intends to perform at the external
provider’s premises.
f) The organization shall ensure the adequacy of specified requirements prior to their
communication to the external provider.
8.4.3.1 Information for external providers – supplemental

Pass down all applicable statutory and regulatory requirements and special product and process
characteristics to their suppliers
Require the suppliers to cascade all applicable requirements down the supply chain to the point of
manufacture.
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8.5 Production and service provision
8.5.1 Control of production and service provision

Controlled conditions shall include :
a) availability of documented information that defines the characteristics of the products and
services;
b) the availability of documented information that defines the activities to be performed and the
results to be achieved
c) monitoring and measurement activities against set criteria
d) use, and control of suitable infrastructure and process environment
e) availability and use of suitable monitoring and measuring resources
f) Competence and qualification of personnel
g) Validation and revalidation
h) products and services release, delivery and post-delivery activities
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8.5.1.1 Control plan

Same as earlier 7.5.1.1 with additions of -
Family control plans are acceptable for bulk material and similar parts
Review control plans, and update as required –
o when shipped nonconforming product to the customer;
o change occurs affecting product, manufacturing process, measurement, logistics, supply
sources, production volume changes, or risk analysis (FMEA) (see Annex A);
o after a customer complaint and implementation of the associated corrective action, when
applicable;
o at a set frequency based on a risk analysis.
8.5.1.2 Standardised work – operator instructions and visual standards

Ensure that standardised work documents are:
o communicated to and understood by the employees
o legible;
o presented in the language(s) understood by the personnel
o accessible for use at the designated work areas(s).
o include rules for operator safety.
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8.5.1.3 Verification of job set-ups

Earlier 7.5.1.3 with additions of -
o perform first-off/last-off part validation,
o first-off parts should be retained for comparison with last-off parts;
o last-off-parts should be retained for comparison with first-off parts in subsequent runs;
o retain records of process and product approval following set-up and first-off part validations.
8.5.1.4 Verification after shutdown
Define and implement the necessary actions to ensure product compliance with requirements after a
planned or unplanned production shutdown period.
8.5.1.5 Total productive maintenance
o Develop, implement, and maintain a documented total productive maintenance system to include
o Document maintenance objective, for example: OEE (Overall Equipment Effectiveness), MTBF
(Mean Time Between Failure), and MTTR (Mean Time To Repair)
o regular review of maintenance plan and objectives and a documented action plan to address
corrective actions where objectives are not achieved;
o use of preventive maintenance methods;
o use of predictive maintenance methods, as applicable;
o periodic overhaul.
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• 8.5.1.6 Management of production tooling and manufacturing, test, inspection tooling

and equipment
– Organisation to provide resource for tool and gauge design, fabrication and verification activities
for production, service and bulk material.
– Organisation to establish and implement a system for production tooling management, repair,
personnel, storage, tool change, tool design modification document, tool identification etc.
• 8.5.1.7 Production scheduling

– Organisation to ensure production scheduling to meet customer demand, JIT, and is supported
with information of production information at key stages and is assessable.
• 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.
94
8.5.2 Identification and traceability

o shall identify the status of process outputs
o traceability is a requirement, the organization shall control the unique identification of the process
outputs, and retain any documented information necessary to maintain traceability
8.5.2.1 Identification and traceability – supplemental

o The purpose of traceability is to support identification of clear start and stop points for product
received by the customer on in the field that may contain quality and/or safety-related
nonconformities.
o Therefore, the organization shall implement identification and traceability processes
o Define the appropriate traceability system, processes, and methods by product, process, and
manufacturing location . . .
95

8.5.3 Property belonging to customers or external providers
o shall identify, verify, protect and safeguard the customer’s or external provider’s property
o Shall inform to owner in case of incorrectly used, lost, damaged or otherwise found to be
unsuitable for use
8.5.4 Preservation
Should preserve process output by means of identification, handling, packaging, storage,
transmission or transportation, and protection.
8.5.4 Preservation - Supplemental

Preservation shall include identification, handling, contamination, packaging, storage, transportation
and protection
Include material from internal/ external providers
Applies till accepted by customer
Implement FIFO and control obsolete material 96
8.5.5 Post-delivery activities

Shall consider:
o risks associated with the products and services
o nature, use and intended lifetime of the products and services
o customer feedback
o statutory and regulatory requirements
• 8.5.5.1 Feedback of information from service

– Ensure communication of service concerning manufacturing, logistic, handling, engineering and design
activity is established
• 8.5.5.2 Service agreement with customer
– Relevant service centers to comply
– Ensure effectiveness of special purpose tool and measurement equipment
– Competence of personnel
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8.5.6 Control of changes

o shall review and control unplanned changes essential for production or service
o shall retain documented information describing the results of the review of changes, the personnel
authorizing the change, and any necessary actions.

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TPIPL
• 8.5.6.1 Control of changes – supplemental

– Have a documented process to control and react to changes that impact product realization
– Changes should require a production trial run
– When required by the customer,
• notify the customer of any planned product realization changes after the most recent product approval;
• obtain documented approval, prior to implementation of the change;
• complete additional verification or identification requirements, such as production trial run and new
product validation.
• 8.5.6.1.1 Temporary change of process controls

– Document the process that manages the use of alternate control methods.
– Include in this process, based in risk analysis (such as FMEA), severity, and the internal
approvals to be obtained prior to production implementation of the alternate control method.
– Standard work instructions to be available for each alternate process control method.
– Review the operation of alternate process controls on a daily basis
– Implement traceability of all product produced
99
8.6 Release of products and services
The organization shall implement the planned arrangements at appropriate stages to verify that
product and service requirements have been met
The release of products and services to the customer shall not proceed until the planned
arrangements for verification of conformity have been satisfactorily completed, unless otherwise
approved by a relevant authority and, as applicable, by the customer.
Documented information shall provide traceability to the person(s) authorizing release of products
and services for delivery to the customer.
100
8.6.1 Release of products and services – supplemental
Ensure that the planned arrangements to verify that the product and service requirements have
been met encompass 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
For layout inspection and functional verification for each product as specified in control plan.
Result to be available to customer
8.6.3 Appearance items
Organisation to provide – resources including lighting, master for grain, colour, texture, gloss etc.
Ensure competency of person
8.6.4 Verification and acceptance of conformity of externally provided products and services
Shall have a process to receipt and evaluation, inspection testing, second / third party assessment,
part evaluation etc.
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• 8.6.5 Statutory and regulatory conformity

– 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, if provided.
– Confirmation to be prior to release of externally provided products into its production
flow, the organization shall
• 8.6.6 Acceptance criteria
– define acceptance criteria and where appropriate acquire customer approval
– acceptance level to be zero defect for attribute data sampling
102
8.7 Control of nonconforming process outputs, products
and services
a) correction;
b) segregation, containment, return or suspension of provision of products and services;
c) informing the customer;
d) obtaining authorization for: use “as-is’;
e) release, continuation or re-provision of the products and services;
f) acceptance under concession.
g) Where nonconforming process outputs, products and services are corrected, conformity to the
requirements shall be verified.
h) The organization shall retain documented information of actions taken
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and services
8.7.1.1 Customer authorization for concession
New requirements such as –
If sub-components are reused, that sub-component reuse shall be clearly communicated to the
customer
8.7.1.2 Control of nonconforming product – customer-specified process
o Comply with applicable customer-specified controls for nonconforming product(s).
8.7.1.3 Control of suspect product
o Unidentified or suspect product is classified and controlled as nonconforming product.
o Ensure that all appropriate manufacturing personnel receive training for containment of suspect and
nonconforming product.
8.7.1.4 Control of reworked product
o The organization shall utilize risk analysis (such as FMEA) methodology to assess risk in the rework
process prior to a decision to rework product
o Have a documented process for rework confirmation
o Instruction for disassembly or rework, including re-inspection and traceability requirements, shall be
accessible and utilized
o Retain documented information on the disposition of reworked product including quantity,
disposition, disposition date, and applicable traceability information
8.7.1.5 Control of repaired product
o Requirements are same as for reworked product
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and services
8.7.1.4 Control of reworked product

o The organization shall utilize risk analysis (such as FMEA) methodology to assess risk in the
rework process prior to a decision to rework product
o Have a documented process for rework confirmation
o Instruction for disassembly or rework, including re-inspection and traceability requirements, shall
be accessible and utilized
o Retain documented information on the disposition of reworked product including quantity,
disposition, disposition date, and applicable traceability information

Requirements are same as for reworked product

Shall maintain document information that
Describe the non conformity
Describe the action taken
Describe any concession obtained
Identifies the authority deciding the action with respect to the non conformity
105
Clause 9 - Performance evaluation
9.1 Monitoring, measurement,

analysis and evaluation
9.2 Internal audit
9.3 Management review
106
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
The organization shall determine:
a) what needs to be monitored and measured;
b) the methods for monitoring, measurement, analysis and evaluation, as applicable, to ensure
valid results;
c) when the monitoring and measuring shall be performed;
d) when the results from monitoring and measurement shall be analysed and evaluated
e) retain appropriate documented information
f) evaluate the quality performance and the effectiveness of QMS

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TPIPL
• 9.1.1.1 Monitoring and measurement of manufacturing processes

– Organisation shall perform process study on all new manufacturing processes to verify capability
– Shall maintain the manufacturing process capability and performance result as specified by
customer part approval process
– Verify PDF, FMEA and CP is implemented
– Significant change event such as tool change, machine repair etc is recorded
– Shall maintain the record dates of effective dates of process change
• 9.1.1.2 Identification of statistical tools
– Same as earlier 8.1.1 with reference of including the statistical tools in APQP, DFMEA, PFMEA
and control plan
• 9.1.1.3 Applicable statistical concepts
– Same as earlier 8.1.2 with practical approach on applicability of it to users of it (employees
involved in the collection, analysis, and management of statistical data).
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9.1.2 Customer satisfaction

The organization shall :
a) monitor customer perceptions
b) obtain information relating to customer views and opinions
c) methods for obtaining and using this information shall be determined
Note:
a) Method can include customer satisfaction or opinion surveys, customer data on delivered products or
services quality, market-share analysis, compliments, warranty claims and dealer reports.
9.1.2.1 Customer satisfaction – supplemental

o Monitoring through continual evaluation of internal and external performance indicators to ensure
compliance to the product and process specifications and other customer requirements.
o Consider field returns, recalls, and warranty (where applicable);
o Monitoring to include the review of customer performance data including online customer portals
and customer scorecards, where provided.
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9.1 Monitoring, measurement, analysis and

evaluation
9.1.3 Analysis and evaluation
The organization shall evaluate data and information related to:
a) conformity of products and services to requirements
b) customer satisfaction
c) conformity and effectiveness of the quality management system
d) performance of processes
e) performance of external provider
f) need or opportunities for improvements
The results of analysis and evaluation shall also be used to provide inputs to management review
9.1.3.1 Prioritization
Trends in quality and operational performance to be compared with progress toward objectives
And, lead to action to support prioritization of actions for improving customer satisfaction.
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9.2 Internal audit
9.2.1 The organization shall conduct internal audits at planned intervals to check if QMS conforms
to :
a) the organization’s own requirements for its quality management system
b) the requirements of this International Standard
c) is effectively implemented and maintained
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9.2 Internal audit
9.2.1 The organization shall:

a) plan, establish, implement and maintain an audit programme(s) including the frequency,
methods, responsibilities, planning requirements and reporting, which shall take into consideration
the quality objectives, the importance of the processes concerned, customer feedback, changes
impacting on the organisation, and the results of previous audits;
b) define the audit criteria and scope
c) select auditors and conduct audits
d) results of the audits are reported to relevant management
e) take necessary correction and corrective actions without undue delay
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9.2 Internal audit
• 9.2.2.1 Internal audit programme
– Have a documented internal audit process covering quality management system audits,
manufacturing process audits, and product audits.
– The audit programme to be prioritized based upon risk, internal and external performance
trends, and criticality of the process(es).
– The frequency of audits to be reviewed and, where appropriate, adjusted based on occurrence
of process changes, internal and external nonconformities, and/or customer complaints.
– The effectiveness of the audit programme to be reviewed as a part of management review.
• 9.2.2.2 Quality management system audit
– Audit all quality management system processes over each three-year calendar period,
according to an annual programme, using the process approach
– Sample customer-specific quality management system requirements for effective
implementation.
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9.2 Internal audit
• 9.2.2.3 Manufacturing process audit

– Audit all manufacturing processes over each three-year calendar period to determine
their effectiveness and efficiency
– Within each individual audit plan, each manufacturing process to be audited on all
shifts where it occurs, including the appropriate sampling of the shift handover.
– 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
– Audit products using customer-specific required approaches at appropriate stages of
production and delivery
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9.3.1 shall review the organization's quality management system, at planned intervals, to ensure its
continuing suitability, adequacy, and effectiveness
Important consideration:
a) status of actions from previous management reviews
b) changes in external and internal issues
c) nonconformities and corrective actions;
d) monitoring and measurement results;
e) audit results;
f) customer satisfaction;
g) issues concerning external providers and other relevant interested parties;
h) adequacy of resources required for maintaining an effective QMS
i) process performance and conformity
j) effectiveness of actions taken to address risks and opportunities
k) new potential opportunities for continual improvement
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9.3.1.1 Management review – supplemental
Conduct MRM at least annually.
Increase frequency based on risk to compliance with customer requirements
9.3.2.1 Management review inputs – supplemental

Input to management review in addition to earlier are:
o cost of poor quality (cost of internal and external nonconformities);
o measures of process effectiveness;
o measures of process efficiency;
o product conformance;
o review of performance against maintenance objectives;
o warranty performance (where applicable);
o review of customer scorecards (where applicable);
116
9.3.3 Output shall include

a) decisions and actions related to continual improvement opportunities;
b) any need for changes to the QMS including resource needs.
c) shall retain documented information as evidence of the results of management reviews.
9.3.3.1 Management review outputs – supplemental

Top management to document and implement an action plan when customer performance targets
are not met.
117
Clause 10 - Improvement
10.1 General
10.2 Nonconformity and corrective

action
10.3 Continual improvement

118
TPIPL
10.1 General
The organization shall determine and select opportunities for improvement and implement necessary
actions to meet customer requirements and enhance customer satisfaction.
This shall include, as appropriate:
a) improving processes to prevent nonconformities;
b) improving products and services to meet known and predicted requirements;
c) improving quality management system results
Improvement can be effected

a) reactively (e.g. corrective action),
b) incrementally (e.g. continual improvement),
c) by step change (e.g. breakthrough),
d) creatively (e.g. innovation)
e) re-organisation (e.g. transformation).

119
TPIPL
10.2 Nonconformity and corrective action

Reactive action:
o take action to control and correct it;
o deal with the consequences
Evaluation
o reviewing the nonconformity
o determining the causes of the nonconformity
o determining if similar nonconformities exist, or could potentially occur
Implement action
Review the effectiveness of corrective action
Make change in QMS as necessary
Shall retain documented information on reactive and corrective action
Preventive action no more a separate clause

120
TPIPL
• 10.2.3 Problem solving

– Have a 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).
– Where the customer has specific prescribed processes, tools, or systems for problem solving, the
organization to use those.
121
10.3 Continual improvement

o The organization shall continually improve the suitability, adequacy, and effectiveness of QMS
o shall consider the outputs of analysis and evaluation, and the outputs from management
review, to confirm if there are areas of underperformance or opportunities that shall be
addressed as part of continual improvement.
o organization shall select and utilise applicable tools and methodologies for investigation of the
causes of underperformance and for supporting continual improvement
10.3.1 Continual improvement – supplemental

The organization shall have a documented process for continual improvement.
Include -
o identification of the methodology used, objectives, measurement, effectiveness, and
documented information;
o a manufacturing process improvement action plan with emphasis on the reduction of process
variation and waste;
o risk analysis (such as FMEA).
(earlier clauses 8.5.1.1 & 8.5.1.2)
122
• 10.2.4 Error-proofing
– Have a documented process to determine the use of appropriate error-proofing methodologies.
– Document the methods in the process risk analysis (such as PFMEA)
– Test frequencies to be documented in the control plan.
– Include the testing of error-proofing devices for failure or simulated failure.
– Maintain records
– Challenge parts, when used, to be identified, controlled, verified, and calibrated where feasible.
– Error-proofing device failures to have a reaction plan.
• 10.2.5 Warranty management systems
– As applicable, implement a warranty management process.
– Include in the process a method for warranty part analysis, including NTF (no trouble found)
• 10.2.6 Customer complaint and field failure test analysis
– The organization shall perform analysis on customer complaints and field failures, including any
returned parts
123
124

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Training on IATF 16949 : 2016 Quality Management Systems

(QMS), and Audit Concepts

ISO / TS ISO / TS IISO/ TS IATF 16949 :

2015 2016 2017 2018

Transition Period of ISO 9001:2015

Transition Period of IATF 16949:2016

Quality Management Principles

Customer Focus Leadership Engagement of Process Approach

Improvement Evidence Based Relationship

IATF cooperates with ISO 9001

o Risk based thinking

High level structure

Organizations implementing multiple management systems

Quality Management System (4)

Training on ISO 9001 QMS Concepts, Audit Concepts @

Section 2- Normative reference

ISO 9000:2015, Quality Management System – Fundamentals and vocabulary refered

2.1 - Normative and informative references IATF

Inclusion of Annex A – Control Plan, Annex B - Bibliography

Training on ISO 9001 QMS Concepts, Audit Concepts @

3.1 - Terms & Definitions for the automotive industry

4.1Understanding the organisation and

4.2 Understanding the needs and

4.3 Determining the scope of the quality

4.4 Quality management system

Training on ISO 9001 QMS Concepts, Audit Concepts @

 SWOT Analysis – Strength Weakness Opportunity and Threat

Training on ISO 9001 QMS Concepts, Audit Concepts @

 Internal context – Knowledge level, culture, values, organisation performance etc.

Training on ISO 9001 QMS Concepts, Audit Concepts @

4.2 : Needs & Expectations of Interested Parties

 Goes beyond customer

Internal Interested parties: External Interested parties:

 Determine and boundaries and applicability of QMS

4.3.1 : Determining the scope of the quality management

 Only exclusion design and development (clause 8.3)

 No exclusion in manufacturing process design

4.3.2 : Customer Specification Requirement (CSR)

 To be evaluated and included in QMS

Training on ISO 9001 QMS Concepts, Audit Concepts @

4.4.1 : Quality management system

4.4.1.2 : Product safety

 Identify statutory and regulatory product safety requirement

Training on ISO 9001 QMS Concepts, Audit Concepts @

4.4.2 : Quality Management System and its process

a. Maintain documented information to support the operation of processes.

5.1 Leadership and

5.2 Quality policy

5.3 organisation role,

Training on ISO 9001 QMS Concepts, Audit Concepts @

5.1 : Leadership & commitment

o Replaces 5.1 of older version of management commitment

Training on ISO 9001 QMS Concepts, Audit Concepts @

5.1.1 : Leadership & commitment

 take accountability for effectiveness of QMS

Training on ISO 9001 QMS Concepts, Audit Concepts @

• New requirements of IATF

Training on ISO 9001 QMS Concepts, Audit Concepts @

5.1.2 : Customer focus

Training on ISO 9001 QMS Concepts, Audit Concepts @

5.2.1 Establishing the Quality Policy

5.2.2 Communicating the Quality Policy

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