Final - Awareness For IATF 16949

Awareness Session for ISO
9001:2015 / IATF 16949:2016
By - Er Arun Kumar Sharma

Founder & CEO
SubMastery Edtech (P) Ltd.
1
Why Me?
➢ I AM
AN ENGINEER TURNED QUALITY
PROFESSIONAL TURNED CORPORATE
TRAINER, FOUNDER OF ‘SUBMASTERY’
COMMUNITY WORKING FOR ENGINEERS
GROWTH
➢ WITH 18 YEARS OF EXPERIENCE, I HAVE

DELIVERED 1200 + LIVE TRAINING IN QMS,
IATF 16949:2016, CORE TOOLS, EMS, OHSAS,
LEAN,ETC FOR 25 K + WORKING ENGINEERS
IN THE AUTOMOTIVE, NON-AUTOMOTIVE &
MANUFACTURING INDUSTRIES
www.submastery.com 2
My Credentials
Qualification - B.E (Mechanical), MBA (Operations)
Total Experience - 18 Years
Training & Consulting Experience - 8 Years
Trainings Delivered - 1200 + Trainings
Working Engineers Trained - 25,000 + no’s
ISO Projects (IATF 16949, ISO 14001 & 45001) - 70 no’s IMS Projects (including 31 IATF 16949:2016 Projects)
Companies Worked for - QSI (ISO Consulting Firm), Imperial Auto, Minda Group, STEPS Training
Professionals Trained - TVS Lucas, Maruti Suzuki, Tata Motors, Valeo, Bajaj Auto, Hero Motorcorp, Sundram
Fasteners, Metal Man Microturners, LGB, ACMA, Minda Group, Tupperware, Talbors, Mahindra CIE, Roop Polymer,
Shriram Foundry, Auto Ignition, Lumax Industries, Sandhar, Munjal Showa,etc.
31 IATF 16949:2016 PROJECTS IMPLEMENTED
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5
Introduction
- First Edition Issued on 1st Oct 2016 (Standard Date, however published 03 rd Oct 2016)
- Developed by the International Automotive Task Force (IATF)
- IATF members include: 10 OEM and 5 Trade Association

- BMW Group, Daimler AG, FCA, Ford Motor Company, General Motors, Jaguar Land Rover (JLR) Limited, Groupe PSA,
Groupe Renault, Geely Group, Volkswagen AG and the vehicle manufacturers respective trade associations – AIAG
(U.S.), ANFIA (Italy), FIEV (France), SMMT (U.K.) and VDA (Germany).
- Includes all the ISO 9001:2015 requirements plus additions required by the automotive
industry
- Replaced ISO/TS 16949:2009
IATF 16949:2016 is not a stand-alone QMS standard and must be audited in conjunction with
ISO 9001:2015 and CSR (Customer Specific Requirements)
Introduction
IATF 16949:2016 only applies only to sites where automotive-related production

and/or service parts are manufactured.(includes assembly, welding, plating, painting,
heat treatment, etc.)
Registration Process -
International Automotive
Task Force Certification Bodies Organization seeking
International Automotive (Registrars) Auditors registration
Oversight Bureau (IAOB)
Goal of IATF 16949:2016 Standard
❖ Provides for continual improvement

❖ Emphasizes defect prevention
❖ Promotes the reduction of variation and waste in the supply chain
Feedback from certification bodies, auditors, suppliers and original equipment

manufacturers (OEMs) was considered during development of the standard, to
make it much practical and customer-oriented standard.
Common automotive customer-specific requirements were also incorporated.
Relationship to ISO 9001:2015
ISO 9001:2015 provided the structure and foundation upon which IATF 16949
expands for the automotive industry. Some of the key changes provided by the ISO
9001:2015 standard are as follows:
A more comprehensive Improved definition of

A new 10 clause structure approach to controlling Interested parties and an
based on the Annex SL externally provided increased focus on
model processes, products and performance and
services stakeholders
Concept of Risk based Improved definition of the The concept of protecting

thinking throughout the “context of the Organizational knowledge
standard organization”
Major Changes in IATF
16949:2016
10
Key Changes in IATF 16949:2016
(w.r.t ISO/TS 16949:2009)
➢ Risk Analysis consideration are expanded beyond ISO 9001 requirements throughout the
standards
➢ Context of the Organization (internal & external issue) added, which need to be
focussed
➢ Process Owner is at the centre stage and Management Representative clause is silent
➢ Corporate responsibilities Policies such as “whistle blowing” are now required
➢ Manufacturing feasibility requirements are enhanced to include capacity planning and
the analysis is now required for any changes to process or product design
➢ Internal auditor and second party auditor competencies are more clearly defined and
expanded
➢ Multiple requirements related throughout the standard related to managing product
with embedded software
(w.r.t ISO/TS 16949:2009)
➢ Additional requirements related to an organization supplier selection process

➢ Requirement added for second party audit as a part of the supplier management
approach
➢ Statutory and regulatory conformance evidence requirement added for all
materials/components for country of manufacture and destination
➢ Significant expansion of the requirements related to identification and traceability or
products
➢ Requirements added for “Temporary change of process controls” to define and
approve in advance, alternate process controls
➢ Enhanced expectations related to Total Productive Maintenance
(w.r.t ISO/TS 16949:2009)
➢ Several additional inputs to be considered during management reviews

➢ Added requirement to have a documented process pertaining to application of error
proofing methodologies
➢ Requirement to have a warranty management process for No Trouble Found (NTF)
High Level Structure – Common Text
Annex SL
➢ High level structure identical core text and common terms and core definitions
to be used in all the management system standards.
➢ Purpose – To enhance the consistency and alignment of different management
system standard towards a common clause structure
➢ For organization – it’ll become easy to integrate different standards
e.g ISO 14001:2015, ISO 45001:2018,etc.
Main Clause
Structure
15
High Level Structure (HLS) - 10 Clause
1.) SCOPE
Easy to Remember-
2.) NORMATIVE REFERENCE
3.) TERMS & DEFINITION SNT CLPS OPI !
4.) CONTEXT OF THE ORGANISATION
5.) LEADERSHIP
6.) PLANNING
7.) SUPPORT
8.) OPERATION
9.) PERFORMANCE EVALUATION
10.) IMPROVEMENT
PDCA Approach in 10 Clauses
Auditable Clauses 4-10, Ensured PDCA Approach in the clauses arrangement itself
PLAN DO CHECK ACT

6. Planning 7. Support 9. Performance 10. Improvement
Evaluation
8. Operation
Input as Clause No. 4 - Context of the Organization

Clause No. 5 Leadership at the center
REFERENCE – Page viii, PDCA Cycle, ISO 9001:2015 Standard
Clause Wise Overview
4 - Context of the Organization
4.1 – Understanding the Organization & its context – E.g SWOT Analysis (strength,
weakness, opportunities, threat)
4.2 – Understanding the needs & expectations of the interested parties
4.3 – Determine the scope of the Quality Management System – Scope, Customer
Specific Requirements
4.4 – Quality Management System & it’s processes – turtle diagram, product safety
5 - Leadership
5.1 – Leadership and Commitment – Corporate responsibility, employee code of

conduct, anti-bribery policy, whistle blowing policy, process efficiency &
effectiveness, customer focus
5.2 – Policy – Communication
5.3 – Organizational Roles, responsibilities and authorities
6 - Planning
6.1 – Action to address risk and opportunities – Risk Analysis, Preventive Action,
Contingency Plan
6.2 – Quality Objectives and planning to achieve them
6.3 – Planning of Changes
7 - Support
7.1 – Resources – Infrastructure, Plant facility and equipment planning,

Environment, MSA, Calibration, Laboratory requirement, organization knowledge
7.2 – Competence – On the job training, Internal Auditor competency, second party
auditor competency
7.3 – Awareness – Employee motivation & empowerment
7.4 – Communication
7.5 – Documented Information – QMS, Record retention, Engineering Specification
8 - Operation
8.1 – Operational Planning & Control – confidentiality
8.2 – Requirements for product and services – customer communication, special

characteristics, manufacturing feasibility,
8.3 – Design & development of products and services – product design skills, embedded
software, validation, APQP, PPAP
8.4 – Control of externally provided processes, product and services – supplier

selection, monitoring, development, second party audits, regulatory requirements,
embedded software
8 - Operation
8.5 – Production & service provision – Control Plan, Work Instruction, Job set-up
verification, Total Productive Maintenance, tooling management, Identification and
traceability, Preservation, temporary change of process control
8.6 – Release of product and services – layout inspection, acceptance criteria
8.7 – Control of Non Confirming Outputs – customer concession, rework & repair,
disposition
9 – Performance Evaluation
9.1 – Monitoring, measurement, analysis and evaluation – SPC, Customer Satisfaction

9.2 – Internal Audit – Programme, Process & Product Audit
9.3 – Management Review
10 – Improvement
10.1 – General
10.2 – Non conformity & corrective action – Problem Solving, Error-proofing, warranty
management
10.3 – Continual Improvement
7 Quality Management Principles
Easy Way to Remember - CLE2 IPR
C - Customer Focus
L – Leadership
E - Engagement of people
E - Evidence-based decision making
I - Improvement
P - Process approach
R - Relationship management
7 Quality Management Principles
Major Linkages with IATF 16949:2016 Clauses
C - Customer Focus – 5.1.2 (customer focus)

L – Leadership – 5 (Leadership)
E - Engagement of people – 7.3.2 (employee motivation & empowerment)
E - Evidence-based decision making – 9.1.3 (analysis & evaluation)
I - Improvement – 10.3 (Continual Improvement)
P - Process approach – 4.4 (QMS & it’s process)
R - Relationship management – 4.2 (Understanding the needs & expectations interested parties)
Mandatory
Documentation Requirements
27
LIST OF MANDATORY DOCUMENTED PROCESS
S. No. Documented Process Clause Number

Documented Process for management of product safety related to Products and
1 4.4.1.2 Product Safety
manufacturing processes
2 Documented Process for Managing Calibration / Verification records 7.1.5.2.1 Calibration / verification records
Documented Process for Identification of training needs including awareness and
3 competency (7.2.1) 7.2.1 Competence - supplement
4 Documented Process to verify Internal auditors competency 7.2.3 Internal auditor competency
5 Documented Process for employee motivation 7.3.2 Employee motivation and empowerment
Documented Process for review, distribution and implementation of customer
6 7.5.3.2.2 Engineering specifications
engineering standards/specification
8.3.1.1 Design and development of products and
7 Documented Process for design & development
services - supplemental
8 Documented Process to identify the special characteristics 8.3.3.3 Special characteristics
9 Documented Supplier Selection Process 8.4.1.2 Supplier selection process

Documented Process to identify and control to verify conformity of externally
10 8.4.2.1 Type and extent of control - supplemental
provided products, processes and services
LIST OF MANDATORY DOCUMENTED PROCESS

Documented Process to ensure the compliance of statutory and regulatory
11 8.4.2.2 Statutory and regulatory requirements
requirements for purchased products, process and services
12 Documented Process and criteria to evaluate supplier performance 8.4.2.4 Supplier monitoring
13 Documented Process to control and reacts to changes in the product realization 8.5.6.1 Control of changes - supplemental
14 Documented Process to manage the use of alternate control methods 8.5.6.1.1 Temporary change of process controls
15 Documented Process control of rework confirmation 8.7.1.4 Control of reworked product
16 Documented Process for control of repair confirmation 8.7.1.5 Control of repaired product
17 Documented Process for disposition of non-confirming product 8.7.1.7 Nonconforming product disposition
18 Documented internal audit process 9.2.2.1 Internal audit programme
19 Documented process for problem solving 10.2.3 Problem solving

Documented process to determine the use of appropriate error-proofing
20 10.2.4 Error-proofing
methodologies
21 Documented Process for continual improvement 10.3.1 Continual improvement- supplemental
LIST OF NON-MANDATORY DOCUMENTED
PROCESS
4.1 Understanding the organization & it's context
Documented Process for determining the context of the organization and Interested
1
Parties 4.2 Understanding the needs and expectations of
interested parties
2 Documented Process for addressing risk & opportunities 6.1 Actions to address risk and opportunities
3 Documented Process for laboratory management 7.5.1.3 Laboratory requirements
4 Documented Process for second-party audits 8.4.2.4.1 Second-party audits
5 Documented Process for Equipment Maintenance 8.5.1.5 Total productive maintenance

8.5.1.6 Management of production tooling and
6 Documented Process for Tooling Management
manufacturing, test, inspection tooling and equipment
Documented Process for verification and acceptance of conformity of externally 8.6.4 Verification and acceptance of conformity of
7
provided products and services externally provided products and services
8 Documented Process for customer satisfaction monitoring 9.1.2 Customer Satisfaction
9 Documented Process for management review 9.3 Management Review
10 Documented Process for warranty management process 10.2.5 Warranty management systems
LIST OF MANDATORY DOCUMENTED INFORMATION -
DOCUMENTS
S.No. Document Name Clause Number

4.3 Determining the scope of the quality management
1 Scope of QMS
system
2 Corporate responsibility policies 5.1.1.1 Corporate responsibility
3 Quality policy 5.2 quality policy

5.3.1 Organizational roles, responsibilities and
4 Roles & responsibilities
authorities - supplemental
5 Quality objectives and action plan for quality objectives 6.2 Quality objectives and planning to achieve them
6 Laboratory scope 7.1.5.3.2 External laboratory
7 Organization knowledge (library, standards, trainings, LMS) 7.1.6 Organizational knowledge
8 List of qualified internal auditors 7.2.3 Internal auditor competency
9 Employee awareness (control plan, fmea, work instruction) 7.3.1 Awareness - supplemental
10 Customer specific requirement matrix 7.5.1.1 Quality Manual
11 Record retention policy 7.5.3.2.1 Record retention
DOCUMENTS
S. No. Document Name Clause Number
12 List of special characteristics 8.3.3.3 Special characteristics
13 Customer designated special characteristics 8.2.3.1.2 Customer-designated special characteristics
14 Control plan 8.5.1.1 Control plan

8.5.1.2 Standardized work - operator instructions and
15 Work Instructions
visual standards
16 Maintenance objectives 8.5.1.5 Total productive maintenance
8.5.1.6 Management of production tooling and
17 Tool design
manufacturing, test, inspection tooling and equipment
18 list of alternate process control / method 8.5.6.1.1 Temporary change of process controls
19 Control plan / drawings, work instruction 8.7.1.4 Control of reworked product
20 Control Plan, work instruction 8.7.1.5 Control of repaired product
21 Internal Audit Plan with scope and critieria 9.2 Internal audit
22 Control Plan, FMEA 10.2.3 Problem solving
RECORDS
S. No. Records Name Clause Number
1 Risk analysis 6.1.2.1 Risk analysis
2 Preventive action 6.1.2.2 Preventive action
3 Contingency plan 6.1.2.3 Contingency plans
4 MSA Study 7.1.5.1.1 Measurement systems analysis
5 Calibration Certificate of Master Equipment 7.1.5.2 Measurement traceability
6 Calibration / verification records of gauges and equipments 7.1.5.2.1 Calibration / verification records
7 Test reports, laboratory personnel competence 7.1.5.3.1 Internal laboratory
8 Training records, education, experience record 7.2 Competence
9 List of qualified internal auditors, Internal trainer competency records 7.2.3 Internal auditor competency
10 Sample inspection reports, test records 7.5.3.2.1 Record retention
11 Engineering change records 7.5.3.2.2 Engineering specifications
RECORDS
S.No. Records Name Clause Number
12 Patrol inspection records, pre-dispatch inspection record 8.1 Operation planning and control
13 Customer complaints 8.2.1 Customer communication
14 Contract review 8.2.3.2 No Tittle

8.2.3.1.1 Review of the requirements for products and
15 Customer deviation
services - supplemental
8.3.2.3 Development of products with embedded
16 software development capability self-assessment record
software
17 Process / engineering change records 8.2.4 Changes to requirements for products and services
18 Design review records 8.3.2 Design and development planning
19 Design review records 8.3.3 Design and development inputs
20 Design review records 8.3.3.1 Product input
21 Manufacturing process input review 8.3.3.2 Manufacturing process input
22 Design review, verification & validation records 8.3.4 Design and development controls
RECORDS
S. No. Records Name Clause Number
23 Part submission warrant / product approval record 8.3.4.4 Product approval process
24 Design review records 8.3.5 Design and development outputs
25 Manufacturing process output review 8.3.5.2 Manufacturing process output
26 Engineering change records 8.3.6 Design and development changes

Customer deviation, revision level of hardware / software in change records (for
27 8.3.6.1 Design and development changes - supplemental
embedded software only)
8.4 Control of external provided processes, products and
28 Supplier audit / evaluation report
services / 8.4.1 General
8.4.2.3.1 Automotive product-related software or
29 Software development capability self-assessment record
automotive products with embedded software
30 Second-party audit report 8.4.2.4.1 Second-party audits
31 Job setup records 8.5.1.3 Verification of job set-ups

Traceability records (Invoice, Pre-dispatch inspection records, production and quality
32 8.5.2.1 Identification and traceability- supplemental
records)
8.5.3 Property belonging to customers or external
33 Customer property record and status
providers
RECORDS
34 Process / engineering change records 8.5.6 Control of changes
35 Process / engineering change records 8.5.6.1 Control of changes - supplemental
36 Records of conformity of product and services with acceptance criteria 8.6 Release of products and services
37 Layout inspection and functional testing records 8.6.2 Layout inspection and functional testing
8.6.4 Verification and acceptance of conformity of
38 Second party auditor report, third party audit report
externally provided products and services
39 Customer deviation 8.7.1.1 Customer authorization for concession
40 Rework record 8.7.1.4 Control of reworked product
41 Customer deviation 8.7.1.5 Control of repaired product
42 Repair record 8.7.1.5 Control of repaired product
43 Customer notification 8.7.1.6 Customer notification
44 Nonconformity records with action plan 8.7.2 Control of nonconforming outputs
RECORDS
9.1.1.1 Monitoring and measurement of manufacturing

45 SPC study, process change records
processes
46 Internal audit Plan Vs Actual, Internal audit reports 9.2 Internal audit
47 MRM minutes of meeting 9.3.3 Management review outputs
48 Action plan when customer performance targets not met 9.3.3.1 Management review outputs - supplemental
49 Nonconformity records with action plan 10.2 Nonconformity and corrective action
50 Error-proofing testing records 10.2.4 Error-proofing
Frequency Requirements/ Recommendation
1. Contingency Plan review minimum annually (6.1.2.3)

2. Quality Objective review with annual targets (6.2.2.1)
3. Internal auditor competency – minimum number of audits per year (7.2.3)
4. PPAP record retention – till product active + one calendar year if not specified by
customer (7.5.3.2)
5. Engineering specification review within 10 working day of receipt of change
(7.5.3.2.2)
6. Acceptance criteria for attribute data sampling is zero defects (8.6.6)
7. QMS Audit – cover all process in 3 year audit cycle (9.2.2.2)
8. Manufacturing Process Audit- cover all process in 3 year calendar (9.2.2.3)
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Awareness Session for ISO

9001:2015 / IATF 16949:2016

By - Er Arun Kumar Sharma

➢ WITH 18 YEARS OF EXPERIENCE, I HAVE

Qualification - B.E (Mechanical), MBA (Operations)

Total Experience - 18 Years

Training & Consulting Experience - 8 Years

Trainings Delivered - 1200 + Trainings

Working Engineers Trained - 25,000 + no’s

- Developed by the International Automotive Task Force (IATF)

- IATF members include: 10 OEM and 5 Trade Association

- Replaced ISO/TS 16949:2009

IATF 16949:2016 only applies only to sites where automotive-related production

❖ Provides for continual improvement

Feedback from certification bodies, auditors, suppliers and original equipment

Common automotive customer-specific requirements were also incorporated.

A more comprehensive Improved definition of

Concept of Risk based Improved definition of the The concept of protecting

➢ Additional requirements related to an organization supplier selection process

➢ Several additional inputs to be considered during management reviews

PLAN DO CHECK ACT

Input as Clause No. 4 - Context of the Organization

REFERENCE – Page viii, PDCA Cycle, ISO 9001:2015 Standard

4 - Context of the Organization

4.2 – Understanding the needs & expectations of the interested parties

5.1 – Leadership and Commitment – Corporate responsibility, employee code of

5.2 – Policy – Communication

5.3 – Organizational Roles, responsibilities and authorities

6.2 – Quality Objectives and planning to achieve them

6.3 – Planning of Changes

7.1 – Resources – Infrastructure, Plant facility and equipment planning,

7.3 – Awareness – Employee motivation & empowerment

7.5 – Documented Information – QMS, Record retention, Engineering Specification

8.2 – Requirements for product and services – customer communication, special

8.4 – Control of externally provided processes, product and services – supplier

8.6 – Release of product and services – layout inspection, acceptance criteria

9.1 – Monitoring, measurement, analysis and evaluation – SPC, Customer Satisfaction

Easy Way to Remember - CLE2 IPR

Major Linkages with IATF 16949:2016 Clauses

C - Customer Focus – 5.1.2 (customer focus)

S. No. Documented Process Clause Number

9 Documented Supplier Selection Process 8.4.1.2 Supplier selection process

S. No. Documented Process Clause Number

15 Documented Process control of rework confirmation 8.7.1.4 Control of reworked product

18 Documented internal audit process 9.2.2.1 Internal audit programme

19 Documented process for problem solving 10.2.3 Problem solving

3 Documented Process for laboratory management 7.5.1.3 Laboratory requirements

4 Documented Process for second-party audits 8.4.2.4.1 Second-party audits

5 Documented Process for Equipment Maintenance 8.5.1.5 Total productive maintenance

9 Documented Process for management review 9.3 Management Review

S.No. Document Name Clause Number

3 Quality policy 5.2 quality policy

6 Laboratory scope 7.1.5.3.2 External laboratory

7 Organization knowledge (library, standards, trainings, LMS) 7.1.6 Organizational knowledge

8 List of qualified internal auditors 7.2.3 Internal auditor competency

10 Customer specific requirement matrix 7.5.1.1 Quality Manual

11 Record retention policy 7.5.3.2.1 Record retention

12 List of special characteristics 8.3.3.3 Special characteristics