ISO 9001:2015 and IATF 16949:2016

ISO 9001:2015 and IATF 16949:2016

Quality Management Systems

R ARUMUGAM – 9448291557
[email protected]
 ISO 9001:2015 and IATF 16949:2016
TRANSITING FROM ISO/TS 16949:2009 TO

IATF 16949 : 2016

ISO 9001:2015 and IATF 16949:2016
Key Perspectives
 ISO 9001:2015 and IATF 16949:2016
ISO9001:2008- ISO9001: 2015 Fifth
Introduction/ FOURTH EDITION- Edition International
Standard Released
CURRENTLY IN
Evolution of ISO 9000 series PRACTICE

ISO9001:2000-
ISO9001:1994-SECOND THIRD EDITION
EDITION

ISO9001/2/3:1987- BIS ADOPTED THE SAME

FIRST EDITION SERIES IN 1987 AS
IS/ISO9001

BS 5750
FORMATION OF TC/176
IN 1982

QMS is the mother

DEVELOPMENT OF
STANDARDS- 1960 POST of all standards
WAR MILITARY
STANDARDS
4
 ISO 9001:2015 and IATF 16949:2016
Origin of the Standard
IATF 16949:2016

TS 16949:2009
Revision 2015
QS 9000:2006 obsolete

Revised in the year 2002

Revision 2008
Introduction of TS 16949:1999

Non acceptance by Germany, Italy, France

Revision 2000 multiple certification criteria)

Introduction of QS-9000-
1994(Automotive applications)

Non acceptance of ISO 9000

Revision 1994 series by Big-3

Establish of QMS through ISO

9000 series in 1987
 ISO 9001:2015 and IATF 16949:2016
STRUCTURE OF ISO 9001:2015 Vs ISO 9001:2008

Clause Clause Description as per Clause Clause Description as per

No. ISO 9001:2015 No. ISO 9001:2008
1 Scope 1 Scope
2 Normative Reference 2 Normative Reference
3 Terms & Definitions 3 Terms & Definitions
4 Context of the Organization 4 Quality Management System
5 Leadership 5 Management Responsibility
6 Planning 6 Resource Management
7 Support 7 Product Realization
8 Operation 8 Measurement Analysis &
Improvement
9 Performance Evaluation
10 Improvement

6
ISO 9001:2015 and IATF 16949:2016
ISO 9001:2015 and IATF 16949:2016
ISO 9001:2015 and IATF 16949:2016
ISO 9001:2015 and IATF 16949:2016
 ISO 9001:2015 and IATF 16949:2016

KEY CHANGES

RISK BASED THINKING

INTEGRATION OF CUSTOMER SPECIFIC REQUIREMENTS

FIRST AND SECOND PARTY AUDITOR COMPETENCY

PRDUCT SAFETY

MANUFACTURING FEASABILITY

WARRENTY MANAGEMENT

DEVELOPMENT OF PRODUCTS WITH EMBEDDED SOFT WARE

 ISO 9001:2015 and IATF 16949:2016
CHANGES IN ISO 9001:2015 WITH RESPECT TO ISO 9001:2008

Aligning QMS policy and objectives with the strategy of an organization

Minor

Focusing on Organization knowledge management ,Competence, Training

and awareness, Management Review / Internal Audit and Corrective Action

More Emphasis on Leadership, Control of Externally provided processes,

Moderate

products and services / Quality objectives and plans for achieving them /
Performance evaluation / Document management / Production and service
provision / QMS Scope , Greater Focus on Customer
Major

Context of the Organization , Internal Issue External Issue ,

Interested Parties , Risk Based Thinking

12
 ISO 9001:2015 and IATF 16949:2016

Introduction
• IATF 16949 cannot be considered a stand alone QMS standard
but has to be comprehended as a supplement to and used in
conjunction with ISO 9001: 2015.

• IATF 16949 (1st edition) represents an innovative document,

given the strong orientation to the customer, with inclusion of a
number of consolidated previous customer specific
requirements

13
 ISO 9001:2015 and IATF 16949:2016
KEY PERSPECTIVES
ISO 9001 :2015 Requirements are

 To Adapt to a changing world

 To Enhance an organization's ability to satisfy its customers

 To Provide a consistent foundation for the future

 To Reflect the increasingly complex environment in which

organizations operate ensure the new standard reflects the
needs of all interested parties integrate with other
management systems

14
 ISO 9001:2015 and IATF 16949:2016
EMPHASIS (IMPORTANCE)

 Greater Customer focus

 Risk-based thinking by organizations

 Aligning QMS policy and objectives with the Strategy of an

organization

 Greater flexibility with documentation

15
 ISO 9001:2015 and IATF 16949:2016
7 Key Principles
1. Customer Focus
2. Leadership
3. Engagement Of People
4. Process Approach
5. Improvement
6. Evidence Based Decision Making
7. Relationship Management
 ISO 9001:2015 and IATF 16949:2016
0.3 Process Approach
0.3.1 General

17
 ISO 9001:2015 and IATF 16949:2016
0.3.2 Plan-Do-Check-Act cycle

18
ISO 9001:2015 and IATF 16949:2016

19
 ISO 9001:2015 and IATF 16949:2016
Process Approach
What is a process?
Set of interrelated or interacting activities

INPUT
Monitoring and Measuring
activities
PROCEDURE ACTIVITY (Before, During & After
(“Specified way to carryout an
activity or a process”-may be the Process)
documented or not)

Effectiveness of process
OUTPUT
Efficiency of process
(Results achieved (Ability to achieve
vs.. desired results on time )
Resources used)

20
 ISO 9001:2015 and IATF 16949:2016
ISO 9001:2015
RISK BASED THINKING

Objective of ISO 9001:2015

• Risk-based thinking makes preventive action part of strategic
planning

• Risk-based thinking can help to identify opportunities. This can be

considered to be the positive side of risk.

• To provide confidence to in the organization’s ability to

consistently provide customers with conforming Goods and
Services to enhance customer satisfaction
 ISO 9001:2015 and IATF 16949:2016

RISK BASED THINKING

• The concept of “risk” in the context of ISO 9001:2015

relates to the uncertainty of achieving such objectives

• The concept of “opportunity” in the context of ISO 9001:2015

relates to exceeding expectations and going beyond stated
objectives
 ISO 9001:2015 and IATF 16949:2016

1. Scope
10 Main
2. Normative Reference
Clauses
3. Terms and Definitions

Plan:
4. Context of the Organization:
Basic understanding about the Organization, Expectations of the Interested parties, Scope
of QMS, Processes of QMS

5. Leadership:
Commitment by the Top management for QMS implementation, Policy, Customer focus,
Roles, Responsibilities and Authorities

6. Planning for QMS:

Risks & opportunities, Objectives, Changes to QMS
 ISO 9001:2015 and IATF 16949:2016
DO :
7. Support : People, Infrastructure, Process Environment, Monitoring & Measuring
resources, Knowledge, Competence, Awareness, Communication, Documented
information – creation, updating & control

8. Operation :
Planning & Control, Determining the requirements for Products & Services, Design & development,
Control of externally provided products & services, Production & Service provision, Release of Products
& Services, Control of Non-conforming products & services

Check :

9. Performance Evaluation :
Monitoring, Measuring, Analyzing & Evaluating, Internal audit, Management Review

Act :

10. Improvement :
Non-conformity & Corrective action, Continual improvement
 ISO 9001:2015 and IATF 16949:2016
ISO 9001:2015

4. Context of the organization

4.1 Understanding the organization and its context

• Determine external and internal issues

• Monitor and review the information about these issues

Note 1 Issues can include positive and negative factors

Note 2 Understanding the external context and internal context

25
 ISO 9001:2015 and IATF 16949:2016
ISO 9001:2015
4.2 Understanding the needs and expectations of interested
parties
Determine:
• The interested parties that are relevant to the QMS and their
requirements to satisfy customers needs and expectations
• The organization shall monitor and review the information about
these interested parties and their relevant requirements
4.3 Determining the scope of the QMS

4.3.2: Customer-specific requirements

4.4 QMS and its Processes

4.4.1.1 Conformance of products and processes

4.4.1.2 Product safety

26
 ISO 9001:2015 and IATF 16949:2016
ISO 9001:2015

5 Leadership

5.1 Leadership and commitment

5.1.1.1 Corporate responsibility

5.1.1.3 Process owners

5.2 Quality Policy

5.3 Organizational roles, responsibilities and authorities

27
Nathan and Nathan Consultants Pvt. Ltd NNCPL/QMS/ 001
 ISO 9001:2015 and IATF 16949:2016
ISO 9001:2015

6 Planning

6.1 Actions to address risks and opportunities

6.1.2.1 Risk Analysis

6.1.2.3 Contingency plans

6.2 Quality objectives and planning to achieve them

6.3 Planning of changes

 ISO 9001:2015 and IATF 16949:2016
ISO 9001:2015

7 Support

7.1 Resources

7.1.2 People

7.1.3 Infrastructure

7.1.3.1 Plant, facility and equipment planning

7.1.4 Environment for the operation of processes

7.1.5 Monitoring and measuring resources

7.1.5.1.1 Measurement systems analysis

7.1.5.2 Measurement traceability

 ISO 9001:2015 and IATF 16949:2016
ISO 9001:2015

7 Support

7.1.5.3 Laboratory requirements

7.1.6 Organizational knowledge

7.2 Competence

7.2.3 Internal auditor competency

7.2.4 Second- party auditor competency

7.3 Awareness

7.4 Communication

7.5 Documented information

 ISO 9001:2015 and IATF 16949:2016
ISO 9001:2015
8 Operation

8.1 Operational planning and control

8.2 Requirements for products and services

8.3 Design and development of products and services

8.4 Control of externally provided processes, products and

services

8.4.1.2 Supplier selection process

8.4.2 Type and extent of control

8.4.2.3 Supplier QMS development

 ISO 9001:2015 and IATF 16949:2016
ISO 9001:2015

8.4.2.3.1 Automotive product-related software or automotive products

with embedded software

8.4.2.4 Supplier monitoring

8.4.2.4.1 Second party audits

8.5 Production and service provision

8.5.1.4 Verification after shutdown

8.5.1.5 Total productive maintenance

8.5.6.1.1 Temporary change of process controls

8.6 Release of products and services

8.7 Control of Nonconforming outputs

 ISO 9001:2015 and IATF 16949:2016
ISO 9001:2015
9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1.2 Customer satisfaction
9.1.3 Analysis and evaluation
9.2 Internal audit
9.3 Management review
10 Improvement
10.2 Nonconformity and corrective action
10.2.5 Warranty management systems
10.2.6 Customer complaints and field failure test analysis
10.3 Continual improvement
 ISO 9001:2015 and IATF 16949:2016

Major differences in terminology between ISO 9001:2008 and ISO 9001:2015

 ISO 9001:2015 and IATF 16949:2016
Implementation Method
Step 6. Step 1.
Provide evidence Familiarize with
that organization ISO 9001:2015 &
has met the new IATF 16949:2016
requirements

Step 5. Step 2.
Update existing Perform an Organizational
system Gap Analysis with
Focus Area respect to IATF 16949
•Risk Based Thinking Standard
•Implementation of CSR
•First and second party auditor
competency
•Product Safety
•Manufacturing Feasibility
•Warranty Management
•Development of product with
embedded software (if Step 3.
applicable) Step 4. Develop an
Provide training for all Implementation
relevant individuals Plan
 ISO 9001:2015 and IATF 16949:2016
Summary
• High Level Structure
• Products and services
• Process approach
• Risk based Thinking
• Product Safety
• Context of the Organization
• Leadership
• Planning
• Corporate Responsibility
• Customer Specific Requirements
• Change control
• Organizational Knowledge
• Communication
• Supplier Development, Second Party Audits
• Improvement
• Friendly Language
 ISO 9001:2015 and IATF 16949:2016

YOU SHOULD COME

FORWARD Benefits

FOLLOW THE SYSTEM & GET SUCCESS

U
QMS HELPS YOU IN
ACHIEVING DEFINED TARGETS

37