411705005-IATF-16949-PPT-TRAINING-AWARENESS.pptx

Advik Hi-Tech Pvt. Ltd.
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QMS, ISO 9001:2015 & IATF 16949:2016
Introduction And Awareness
Faculty : Ashish Bhuskat
ashish.bhuskat@advik.co.in
Doing the right things in the right way
Date : 12 Jul. 2018

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 Introduction to Quality Management System (QMS)
 Basics of Quality Management System (QMS)
 Introduction to ISO Organizations for Automotive
 Transition of ISO 9001:2015
 Changes in ISO 9001:2015 Compared to ISO 9001:2008
 Transition of IATF 16949:2016
 Changes in IATF 16949:2016 Compared to ISO 9001:2008
 PDCA Methodology – ISO/TS & IATF
 High Level Structure of ISO 9001:2015
 Specific requirements of ISO 9001:2015
 Specific requirements of IATF 16949: 2016
 ISO 9001:2015 and IATF 16949:2016 Clauses and Requirements
Contents

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What do you know about QMS?

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What do you understand by QMS?
Quality Management System:
A Quality Management System is a collection of -
 Policies,
 Processes
 Procedures
 Plans
 Resources
 Practices
 Responsibilities
 Authorities
To achieve product and services quality
levels, customer satisfaction and
company objectives.

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Quality Control
Quality Assurance
Quality System

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Quality Management Principles
1. Customer Focus
2. Leadership
3. People Involvement
4. Process Approach
5. Systems Approach
6. Continual improvement
7. Factual Approach to Decision Making
8. Mutually Beneficial Supplier Relationships

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Policy,
Vision, Mission,
QM
Procedures
Forms, Formats, Work Instructions, Guidelines,
Standards, Specification, Checklists, Standards,
Training Material, etc.
All Filled up and Completed Documents Stored in
Hard / Soft Format, etc.
Level 1 (L1)
Level 2 (L2)
Level 3 (L3)
Level 4 (L4)
L1
L2
L3
L4

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Introduction of Quality Documentation?
1. Quality Policy (Objectives of the Organization)
2. Vision / Mission (Where we want to see ourselves in future)
3. Quality Manual (Collection of Principles from Standards)
4. Quality Procedures (Set of requirements from functions)
5. Forms / Formats (Structured form if Information)
6. Checklist / Check Sheet (What is the difference?)
7. Standards (What something should be?)
8. Work Instructions (How to perform specific Task Correctly?)
9. Specifications (Statement of precise requirement)
What is a difference between “Procedure” and “Work Instruction” ?
Why everyone is approaching to Standard Operating Procedures (SOP)?

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Why Industries need QMS?
 QMS affects every aspect of an
organization's performance.
 To meet the customer’s
requirements
 Counter meeting organization's
requirements, which ensure
compliance with regulations
 To utilize cost and resources
efficiently
 Creating room for expansion,
growth and profit
 Increasing Brand Value and
Reputation of the Organization

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Process Map /Interaction Matrix
Process Interaction Matrix
• Scope of QMS
• Interaction of
Processes with each
other
• Categorization of
processes into
Management Oriented
Processes (MOP),
Customer Oriented
Processes (COP) and
Support Oriented
Processes (SOP)
• Flow of processes from
Inputs by Customer to
Out to the customer.

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Process Approach

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Customer needs &
Expectations
Customer
Satisfaction
Process
Quality
Policies
Quality
Standards/
Specifications
Quality
Manual
Document
Forms /
Formats
Records
Quality
Procedures
Continuous Improvement
Monitoring & Tracking
Process Approach

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Turtle Diagram

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Development of ISO 9001: 2015

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What’s new in ISO 9001: 2015?

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Process Approach & High Level Structure (HLS)
P
D
C
A
4
6
7
8
9
10
Context of the Organization 4
Leadership 5
Planning 6
Support 7
Operation 8
Performance Evaluation 9
Improvement 10
Leadership
5

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PDCA Methodology

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Three Key Organizations
1. IATF – International Automotive Task Force
2. IAOB - International Automotive Oversight Bureau
3. AIAG – Automotive Industries Action Group
Publishing standards and offering educational conferences and training.
IATF AIAG
Auditing Bodies
Industry-2 Industry-3
IAOB

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Purpose of the IATF Organization
• Develop consensus for international quality system requirements
(automotive)
• Develop policy & procedure for registration
• Provide appropriate training to CBs
• Serve as formal liaison

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IATF Members
Vehicle manufacturers:
8 Subscribers-
• BMW,
• Daimler Chrysler,
• FIAT,
• Ford Motor,
• GM,
• PSA (French Car Mfg.),
• Renault,
• Volkswagen
Industry trade organizations:
AIAG – Automotive Industry Action
Group
ANFIA (Italy)- National Association of
the Automobile Industry (Associazione
Nazionale Fra Industrie Automobilistiche)
FIEV (France)- French Vehicle
Equipment Industries Association
(Fédération des Industries des Equipements
pour Véhicules)
SMMT (UK), VDA (Germany), ZF
(Germany)
Guest members: JAMA - Japan
Automobile Manufacturers
Association

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IAOB - International Automotive Oversight Bureau
ANFIA, IAOB, IATF-FRANCE, SMMT, VDA-QMC
• Implementation of IATF registration scheme and rules via a common process
 Witness audits
 Auditor qualification training and exam
 Monitor CB/auditor performance
• Apply and implement IATF policy and decisions
• Coordinate special projects and work teams
• Develop sanctioned interpretations and recommendations for improvement
• Database management

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Goal of IATF 16949:2016
Goal of the IATF 16949 standard is the development of strong QMS that;
1. Provides for continual improvements
2. Emphasizes defect prevention
3. Promotes reduction of variation and waste throughout the supply chain.
4. Includes specific requirements and tools from the automotive industry (Development of
Quality Management System)

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Comparison Between ISO 9001 :2015 & ISO 9001 :2008

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Differences in Terminologies
ISO 9001:2008 ISO 9001:2015
Products Products and services
Exclusions Not used (See Clause A.5 for clarification of
applicability)
Management representative Process Owners (Similar responsibilities and
authorities are assigned but no requirement for a
single management representative)
Documentation, quality manual, documented
procedures, records
Documented information
Work environment Environment for the operation of processes
Monitoring and measuring equipment Monitoring and measuring resources
Purchased product Externally provided products and services
Supplier External provider

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Comparison in Clauses and Sub-clauses
ISO 9001:2008 ISO 9001:2015 Changes/Remarks
0. Introduction 0. Introduction No Change
1. Scope 1. Scope No Change
2. Normative references 2. Normative references No Change
3. Terms and definitions 3. Terms and definitions
New Definitions are added such as
Aftermarket Part, Accessory Part,
DFA, DFM, DFMA, Escalation, FTA, etc.
4. Quality Management System 4. Context of the organization
Added Communication to External
Parties and Risk Assessment
4.1 General Requirements
4.1 Understanding the organization
and its context
4.2 Documentation Requirements
4.2.1 General
4.2.2 Quality Manual -
4.2.3 Control of Documents 7.5 Documented Information
Records and Documents are now
"Documented Information"
4.2.4 Control of Records 7.5 Documented Information
Records and Documents are now
"Documented Information"

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Changes in Index
5. Management Responsibility 5. Leadership
5.1 Management Commitment
5.2 Customer Focus
5.3 Quality Policy
5.4 Planning 6. Planning
5.4.1 Quality Objectives
5.4.2 Quality Management System Planning
5.5 Responsibility, Authority, and
Communication
5.5.1 Responsibility and Authority
5.5.2 Management Representative
MR not required. Process Owners are
the MRs of their respective functions.
5.5.3 Internal Communications
5.6 Management Review 9.3 Management Review
5.6.1 General
5.6.2 Review Input
5.6.3 Review Output

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Changes in Index
6. Resource Management 7. Support
6.1 Provision of Resources 7.1 Resources
6.2 Human Resources 7.2 Competence
6.2.1 General
6.2.2 Competence, Training, and Awareness 7.2 Competence
6.3 Infrastructure
6.4 Work Environment
7. Product Realization 8. Operation
7.1 Planning of Product Realization
7.2 Customer-Related Processes
7.2.1 Determination of Requirements
Related to the Product
7.2.2 Review of Requirements Related to
the Product
7.2.3 Customer Communication

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Changes in Index
7.3 Design and Development
7.3.1 Design and Development
Planning
7.3.2 Design and Development Inputs
7.3.3 Design and Development Outputs
7.3.4 Design and Development Review
Verification
Validation
7.3.7 Control of Design and
Development Changes
7.4 Purchasing
7.4.1 Purchasing Process
7.4.2 Purchasing Information
7.4.3 Verification of Purchased Product

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Changes in Index
7.5 Production and Service Provision
7.5.1 Control of Production and Service
Provision
7.5.2 Validation of Processes for
Production and Service Provision
7.5.3 Identification and Traceability 8.5.2 Identification and traceability
7.5.4 Customer Property
7.5.5 Preservation of Product 8.5.4 Preservation Production and service
7.6 Control of Monitoring and
Measuring Equipment
8. Measurement, Analysis, and
Improvement
9. Performance evaluation
8.1 General
8.2 Monitoring and Measurement
8.2.1 Customer Satisfaction
8.2.2 Internal Audit 9.2 Internal Audit
8.2.3 Monitoring and Measurement of
Processes
8.2.4 Monitoring and Measurement of
Product

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Changes in Index
8.3 Control of Nonconforming Product
8.4 Analysis of Data
8.5 Improvement 10 Improvement
8.5.1 Continual Improvement 10.3 Continual improvement
8.5.2 Corrective Action
10.2 Nonconformity and corrective
action
8.5.3 Preventive Action
-Replaced by Risk Based Thinking and
Risk Assessments

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What is new in IATF 16949?

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What is new in IATF 16949?

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September 2015:
ISO 9001:2015
Standard Released
April 2016:
IATF Standard
conference to review
draft 16949 standard
October 2016:
Expected publication
of IATF 16949
October 2017:
No further audit to
ISO/TS 16949:2009
September 2018:
Full conformance
with new IATF 16949
2015 2016 2017 March 2017: 2018
Kick off development
Transition of IATF

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Transition of IATF

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Why Transition to IATF 16949 : 2016?
Why transition to new automotive Standard?
1. Increased expectation from stake holders (OEMs, Regulatory bodies…)
2. Development in and emergence of new Manufacturing Technologies
3. Raising the bar

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ROADMAP FOR TRANSITION TO IATF 16949:2016
We are currently certified to
ISO/TS 16949:2009
What should I do?

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Timeframe for transition audit to IATF 16949?

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ISO 9001 Certification Process

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Risk Management

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 To minimize the likelihood of failure during new
program development
 To maximize the potential realization of planned
activities.
 To ensure risk-based thinking is pervasive
throughout the organization
 Top management needs to be actively engaged.
 Risk-based is essential for achieving an effective
quality management system.
 Carrying out preventive action to eliminate
potential nonconformities
 To conform to the requirements of International
Standard, an organization needs to plan and
implement actions to address risks and
opportunities.
Risk Based Thinking

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Our Experience
Our Experience
• A QMS involves more that HARD
measures of quality
• SOFT Measures
- Teamwork
- Empowerment
- Management Approach
- Working environment
- Mindset

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Our Experience
Lessons Learnt
1. Shift in Management Philosophy
2. Culture of Continuous Improvement
3. Training is Key
4. Effective Communications
5. Recognition of Achievements / Motivation
6. Results in Improved Productivity

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Our Experience

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I need more information…. Where should I contact?
1. Certification Bodies
2. Local QMS Coordinator
3. Search through Internet and Media
4. Training Providing Agencies (Omnex, TUV SUD, etc.

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Any Questions?

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