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Date :
1Date : 31.12.2018
Need attention
Do’sDon'ts
2
Training Agenda
3
1. ISO/TS 16949 Overview
2. IATF Structure
3. Goal of IATF 16949
4. Relationship to ISO 9001 2015
5. 14 Key changes of IATF 16949 2016
6. Transition timeline of IATF 16949 2016
7. High level structure
8. Relationship to ISO 9001 2015
9. Notable changes in terminology
10. Revival of quality management principle
11. Clause wise addition
12. Clause wise explanation
13. Documented Process – 17 Nos
14. Frequency Requirements / Recommendations
15. Benefits of IATF 16949 2016 Certification
ISO/TS 16949 Overview
4
ISO/TS 16949 Technical Specification for Automotive Quality Management Systems, in conjunction with ISO
9001, defines the quality system requirements for the design/ development, manufacturing, installation
and servicing of automotive- related products. ISO/TS 16949 certification is a mandatory industry
requirement developed by the International Automotive Task Force (IATF) to align automotive quality
systems throughout the world.
ISO/TS 16949 was developed in 1999 by the IATF in conjunction with the ISO quality management
technical committee ISO/TC 176. It is now one of the most widely used international standards in the
automotive industry, aimingto harmonize the different assessment and certification systems in the
global automotive supply chain.
Changes to the Standard
The IATF released the AutomotiveQuality Management
System Standard, IATF 16949, on October 1st, 2016. This new document, along with applicable
automotive customer specific requirements (CSRs) and ISO 9001:2015, defines the fundamental quality
management system requirements for automotive suppliers.
IATF 16949 is not a stand-alone QMS standard andmust be audited in conjunction with ISO
9001:2015 and the CSRs.
IATF (International automotive task force) Structure
5
Goal of IATF 16949 Standard
6
For development of a QMS that:
- Provides for continual improvement
- Emphasizes defect prevention
- Includes specific requirements and tools from the
automotive industry
- 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 an innovative
and customer-oriented document. Common
automotive customer-specific requirements were also
incorporated.
Relationship to ISO 9001:2015
7
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 new 10 clause structure
based on the Annex SL
model
A more comprehensive
approach to controlling
externally provided processes,
products and services
Improved definition of
Interested parties and an
increased focus on
performance and
stakeholders
Concept of Risk based Improved definition of The concept of
thinking throughout the “context of the protecting
the standard organization” Organizational
Changes from ISO/TS16949:2009 to IATF16949
8
IATF16949 requires complete conformance to all ISO 9001:2015
requirements and identifies the supplemental automotive
management system requirements (which are extensive). The
majority of the supplemental requirements are carry over from
ISO/TS 16949:2009. However there have been significant changes
based on the automotive industry direction
14 Key Changes of IATF 16949
9
1. - Risk Analysis consideration are expanded beyond ISO 9001
requirements throughout the standards
2. -Corporate responsibilities Policies such as “whistle blowing, Anti bribery &
code of conduct” are now required
3. - Manufacturing feasibility requirements are enhanced to include capacity
planning and the analysis is now required for any changes to process or
product design
4. -Internal auditor and second party auditor competencies are more
clearly defined and expanded
- to be continued………
14 Key Changes of IATF 16949
10
5. Multiple requirements related throughout the standard related to
managing product with embedded software
6. Additional requirements related to an organization supplier selection
process
7. Requirement added for second party audit as a part of the supplier
management approach
8. Statutory and regulatory conformance evidence requirement added for all
materials/components for country of manufacture and destination
9. Significant expansion of the requirements related to identification and
traceability or products
10. Requirements added for “Temporary change of process controls” to
define and approve in advance, alternate process controls
------- to be continued……….
14 Key Changes of IATF 16949
11
11. Enhanced expectations related to Total Productive Maintenance
12. Several additional inputs to be considered during management reviews
13. Added requirement to have a documented process pertaining to
application of error proofing methodologies
14. Requirement to have a warranty management process for No Trouble
Found (NTF)
Transition Time of IATF 16949
12
High Level Structure – Common Text
13
Annex SL
1. Mandated by ISO’s technical management board
(TMB)
2. High level structure, identical core text &
common terms & code definitions for use in all
management system standards.
3. Purpose : Enhance the consistency &
alignment of different management system
standards.
4. Organization who implement a single system
addressing multiple standard (e.g. QMS, EMS,
ISMS etc) will see the most potential benefits.
High Level Structure
14
Relationship to ISO 9001:2015
15
Notable changes in terminology
16
Revival of quality management principles
17
1. Customer Focus
2. Leadership
3. Engagement of people
4. Process approach
5. Improvement
6. Evidence-based decision making
7. Relationship management
Seven quality management principles are described in ISO
9000
Clause wise additions
18
Clause No. Clause Name ISO 9001
Reqmts
IATF 16949
Introduction 6 0
1 Scope 1 1
2 Normative references 1 1
3 Terms and definitions 1 1
4 Context of the organization 5 4
5 Leadership 5 5
6 Planning 5 4
7 Support 14 15
8 Operation 25 58
9 Performance evaluation 2 12
10 Improvement 4 5
Total--> 69 106
Clause Wise Explanation
19
4 - Context of the Organization
1.– Understanding the Organization & its context - SWOT
2.– Understanding the needs & expectations of the interested parties
3.– Determine the scope of the Quality Management System – Scope, Customer Specific
Requirements
4.– Quality Management System & it’s processes –product safety,
Clause Wise Explanation
20
5 - Leadership
1.– Leadership and Commitment – Corporate responsibility, employee code of conduct, anti-
bribery policy, whistle blowing policy, process efficiency & effectiveness, customer focus
2. – Policy – Communications
3. – Organizational Roles, responsibilities and authorities
Clause Wise Explanation
21
6 - Planning
1.– Action to address risk and opportunities – Risk Analysis, Preventive Action, Contingency Plan
2. – Quality Objectives and planning to achieve them
3. Planning of changes
Clause Wise Explanation
22
7 - Support
1.– Resources – Infrastructure, Plant facility and equipment planning, Environment, MSA,
Calibration, Laboratory requirement, organization knowledge
2.– Competence – On the job training, Internal Auditor competency, second party auditor
competency
3. – Awareness – Employee motivation & empowerment
4. – Communication
5.– Documented Information – QMS, Record retention, Engineering Specification
Clause Wise Explanation
23
8 - Operation
1.– Operational Planning & Control – confidentiality,
2.– Requirements for product and services – customer communication, special characteristics,
manufacturing feasibility,
3.– Design & development of products and services – product design skills, embedded software,
validation, APQP, PPAP
– Control of externally provided processes, product and services – supplier selection, monitoring,
development, second party audits, regulatory requirements, embedded software
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
6.– Release of product and services – layout inspection, acceptance criteria
7.– Control of Non Confirming Outputs – customer concession, rework & repair product,
Clause Wise Explanation
24
9 – Performance Evaluation
1. – Monitoring, measurement, analysis and evaluation –
SPC, Customer Satisfaction
2. – Internal Audit – Programme, Process & Product Audit
3. – Management Review
Clause Wise Explanation
25
10 – Improvement
1.– General
2.– Non conformity & corrective action – Problem Solving, Error-proofing, warranty management
3. – Continual Improvement
DOCUMENTED PROCESS – 17 No’s
26
1.) Management of Product Safety related to Products and manufacturing processes
(4.4.1.2)
2.) Managing Calibration & Verification records (7.1.5.2.1)
3.) Identification of training needs including awareness (7.2.1)
4.) Verify Internal Auditors Competency (7.2.3)
5.) Employee Motivation and Empowerment (7.3.2)
6.) Engineering Change Management (7.5.3.2.2)
7.) Supplier Selection Process (8.4.1.2)
8.) Identify and select type of control for outsourced process (8.4.2.1)
9.) Criteria to Evaluate Supplier Performance (8.4.2.4)
10.) Control of Changes (8.5.6.1)
11.) Control of reworked product (8.7.1.4)
12.) Control of repaired product (8.7.1.5)
13.) Non Confirming Product disposition (8.7.1.7)
14.) Internal Audit Process (9.2.2.1)
15.) Problem Solving (10.2.3)
16.) Error-Proofing (10.2.4)
17.) Continual Improvement (10.3.1)
Frequency Requirement/ Recommendation
27
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 calendar (9.2.2.2)
8.) Manufacturing Process Audit- cover all process in 3 year calendar (9.2.2.3)
Benefits of IATF 16949 certification:
28
1. Increases production efficiency and reduces error rates.
2. Ensures necessary production quality for the automotive industry.
3. Prevents financial losses as a result of high quality of production.
4. enables a company to enter and remain in automotive supplier chain.
5. creates a responsible corporate status
Thank you
……For your Attention
29

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Awareness session on iatf 16949 2016 standard

  • 1. Date : 1Date : 31.12.2018
  • 3. Training Agenda 3 1. ISO/TS 16949 Overview 2. IATF Structure 3. Goal of IATF 16949 4. Relationship to ISO 9001 2015 5. 14 Key changes of IATF 16949 2016 6. Transition timeline of IATF 16949 2016 7. High level structure 8. Relationship to ISO 9001 2015 9. Notable changes in terminology 10. Revival of quality management principle 11. Clause wise addition 12. Clause wise explanation 13. Documented Process – 17 Nos 14. Frequency Requirements / Recommendations 15. Benefits of IATF 16949 2016 Certification
  • 4. ISO/TS 16949 Overview 4 ISO/TS 16949 Technical Specification for Automotive Quality Management Systems, in conjunction with ISO 9001, defines the quality system requirements for the design/ development, manufacturing, installation and servicing of automotive- related products. ISO/TS 16949 certification is a mandatory industry requirement developed by the International Automotive Task Force (IATF) to align automotive quality systems throughout the world. ISO/TS 16949 was developed in 1999 by the IATF in conjunction with the ISO quality management technical committee ISO/TC 176. It is now one of the most widely used international standards in the automotive industry, aimingto harmonize the different assessment and certification systems in the global automotive supply chain. Changes to the Standard The IATF released the AutomotiveQuality Management System Standard, IATF 16949, on October 1st, 2016. This new document, along with applicable automotive customer specific requirements (CSRs) and ISO 9001:2015, defines the fundamental quality management system requirements for automotive suppliers. IATF 16949 is not a stand-alone QMS standard andmust be audited in conjunction with ISO 9001:2015 and the CSRs.
  • 5. IATF (International automotive task force) Structure 5
  • 6. Goal of IATF 16949 Standard 6 For development of a QMS that: - Provides for continual improvement - Emphasizes defect prevention - Includes specific requirements and tools from the automotive industry - 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 an innovative and customer-oriented document. Common automotive customer-specific requirements were also incorporated.
  • 7. Relationship to ISO 9001:2015 7 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 new 10 clause structure based on the Annex SL model A more comprehensive approach to controlling externally provided processes, products and services Improved definition of Interested parties and an increased focus on performance and stakeholders Concept of Risk based Improved definition of The concept of thinking throughout the “context of the protecting the standard organization” Organizational
  • 8. Changes from ISO/TS16949:2009 to IATF16949 8 IATF16949 requires complete conformance to all ISO 9001:2015 requirements and identifies the supplemental automotive management system requirements (which are extensive). The majority of the supplemental requirements are carry over from ISO/TS 16949:2009. However there have been significant changes based on the automotive industry direction
  • 9. 14 Key Changes of IATF 16949 9 1. - Risk Analysis consideration are expanded beyond ISO 9001 requirements throughout the standards 2. -Corporate responsibilities Policies such as “whistle blowing, Anti bribery & code of conduct” are now required 3. - Manufacturing feasibility requirements are enhanced to include capacity planning and the analysis is now required for any changes to process or product design 4. -Internal auditor and second party auditor competencies are more clearly defined and expanded - to be continued………
  • 10. 14 Key Changes of IATF 16949 10 5. Multiple requirements related throughout the standard related to managing product with embedded software 6. Additional requirements related to an organization supplier selection process 7. Requirement added for second party audit as a part of the supplier management approach 8. Statutory and regulatory conformance evidence requirement added for all materials/components for country of manufacture and destination 9. Significant expansion of the requirements related to identification and traceability or products 10. Requirements added for “Temporary change of process controls” to define and approve in advance, alternate process controls ------- to be continued……….
  • 11. 14 Key Changes of IATF 16949 11 11. Enhanced expectations related to Total Productive Maintenance 12. Several additional inputs to be considered during management reviews 13. Added requirement to have a documented process pertaining to application of error proofing methodologies 14. Requirement to have a warranty management process for No Trouble Found (NTF)
  • 12. Transition Time of IATF 16949 12
  • 13. High Level Structure – Common Text 13 Annex SL 1. Mandated by ISO’s technical management board (TMB) 2. High level structure, identical core text & common terms & code definitions for use in all management system standards. 3. Purpose : Enhance the consistency & alignment of different management system standards. 4. Organization who implement a single system addressing multiple standard (e.g. QMS, EMS, ISMS etc) will see the most potential benefits.
  • 15. Relationship to ISO 9001:2015 15
  • 16. Notable changes in terminology 16
  • 17. Revival of quality management principles 17 1. Customer Focus 2. Leadership 3. Engagement of people 4. Process approach 5. Improvement 6. Evidence-based decision making 7. Relationship management Seven quality management principles are described in ISO 9000
  • 18. Clause wise additions 18 Clause No. Clause Name ISO 9001 Reqmts IATF 16949 Introduction 6 0 1 Scope 1 1 2 Normative references 1 1 3 Terms and definitions 1 1 4 Context of the organization 5 4 5 Leadership 5 5 6 Planning 5 4 7 Support 14 15 8 Operation 25 58 9 Performance evaluation 2 12 10 Improvement 4 5 Total--> 69 106
  • 19. Clause Wise Explanation 19 4 - Context of the Organization 1.– Understanding the Organization & its context - SWOT 2.– Understanding the needs & expectations of the interested parties 3.– Determine the scope of the Quality Management System – Scope, Customer Specific Requirements 4.– Quality Management System & it’s processes –product safety,
  • 20. Clause Wise Explanation 20 5 - Leadership 1.– Leadership and Commitment – Corporate responsibility, employee code of conduct, anti- bribery policy, whistle blowing policy, process efficiency & effectiveness, customer focus 2. – Policy – Communications 3. – Organizational Roles, responsibilities and authorities
  • 21. Clause Wise Explanation 21 6 - Planning 1.– Action to address risk and opportunities – Risk Analysis, Preventive Action, Contingency Plan 2. – Quality Objectives and planning to achieve them 3. Planning of changes
  • 22. Clause Wise Explanation 22 7 - Support 1.– Resources – Infrastructure, Plant facility and equipment planning, Environment, MSA, Calibration, Laboratory requirement, organization knowledge 2.– Competence – On the job training, Internal Auditor competency, second party auditor competency 3. – Awareness – Employee motivation & empowerment 4. – Communication 5.– Documented Information – QMS, Record retention, Engineering Specification
  • 23. Clause Wise Explanation 23 8 - Operation 1.– Operational Planning & Control – confidentiality, 2.– Requirements for product and services – customer communication, special characteristics, manufacturing feasibility, 3.– Design & development of products and services – product design skills, embedded software, validation, APQP, PPAP – Control of externally provided processes, product and services – supplier selection, monitoring, development, second party audits, regulatory requirements, embedded software 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 6.– Release of product and services – layout inspection, acceptance criteria 7.– Control of Non Confirming Outputs – customer concession, rework & repair product,
  • 24. Clause Wise Explanation 24 9 – Performance Evaluation 1. – Monitoring, measurement, analysis and evaluation – SPC, Customer Satisfaction 2. – Internal Audit – Programme, Process & Product Audit 3. – Management Review
  • 25. Clause Wise Explanation 25 10 – Improvement 1.– General 2.– Non conformity & corrective action – Problem Solving, Error-proofing, warranty management 3. – Continual Improvement
  • 26. DOCUMENTED PROCESS – 17 No’s 26 1.) Management of Product Safety related to Products and manufacturing processes (4.4.1.2) 2.) Managing Calibration & Verification records (7.1.5.2.1) 3.) Identification of training needs including awareness (7.2.1) 4.) Verify Internal Auditors Competency (7.2.3) 5.) Employee Motivation and Empowerment (7.3.2) 6.) Engineering Change Management (7.5.3.2.2) 7.) Supplier Selection Process (8.4.1.2) 8.) Identify and select type of control for outsourced process (8.4.2.1) 9.) Criteria to Evaluate Supplier Performance (8.4.2.4) 10.) Control of Changes (8.5.6.1) 11.) Control of reworked product (8.7.1.4) 12.) Control of repaired product (8.7.1.5) 13.) Non Confirming Product disposition (8.7.1.7) 14.) Internal Audit Process (9.2.2.1) 15.) Problem Solving (10.2.3) 16.) Error-Proofing (10.2.4) 17.) Continual Improvement (10.3.1)
  • 27. Frequency Requirement/ Recommendation 27 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 calendar (9.2.2.2) 8.) Manufacturing Process Audit- cover all process in 3 year calendar (9.2.2.3)
  • 28. Benefits of IATF 16949 certification: 28 1. Increases production efficiency and reduces error rates. 2. Ensures necessary production quality for the automotive industry. 3. Prevents financial losses as a result of high quality of production. 4. enables a company to enter and remain in automotive supplier chain. 5. creates a responsible corporate status
  • 29. Thank you ……For your Attention 29