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ASQ NEQC 60th Conference, Springfield, Massachusetts

Automotive QMS for

Meeting Today’s

Challenges

Baskar Kotte

Quality System Enhancement

Phone: 770-518-9967

[email protected]

www.enhancequalty.com

October 22, 2014

Session 22B

mailto:[email protected]

http://www.enhancequalty.com/

ASQ NEQC 60th Conference, Springfield, Massachusetts 2

Focus

►How Many Certifications Involved?

►Components of TS 16949: 2009

►Automotive Tier 2 Supplier Impact

►US Based Automotive Manufacturers and Non US Based

Manufacturers

►Who is Influencing the TS 1649?

October 22, 2014


Focus Cont’d.

►Can IATF and IAOB be Successful in Keeping ISO 9001:2008

as Base Standard?

►How Many of the Tier 2 Suppliers Drop ISO 9001:2008?

►IAOB/IATF Position on Tier 2 for ISO 9001:2015

►QMS Quality Management Principles

►ISO/DIS 9001:2014 Common Structure

►Summary

October 22, 2014


ISO 9001:2015 Impact on TS 16949

►Entire Present Structure to be Changed to Meet JTCG

Developed High Level Structure

►10 Element Structure: Only 3 Titles come from ISO 9001:2008

►Common Text: For all Management System Standards

October 22, 2014


ISO 9001:2015 Impact on TS 16949 Cont’d.

►Common Terms: 22 Terms Identified as Common to all

Standards

►New Concept Introduced: Risk-Based Thinking

►Radical Face-lift to ISO/TS 16949:2009 if IAOB Decides to

Adapt ISO 9001:2015

October 22, 2014


How Many Certifications Involved?

►There are at Least 50,000 TS 16949 Certifications (Tier 1)

►There are at Least 100,000 Tier 2 with ISO 9001:2008

Certifications

►There are at Least 1.2 Million ISO 9001:2008 Accredited

Certificates in the World

►Some Portion of this 1.2 Million are Issued to Tier 3

Automotive Suppliers

►All these Certificate Holders to be Prepared for Upcoming

ISO 9001:2015? Or Not?

October 22, 2014


Components of TS 16949:2009

►ISO 9001:2008

►Plus International Automotive Requirements

►Plus Application of Automotive Core Tools

►Plus Automotive Customer Specific Requirements

October 22, 2014


Automotive Tier 2 Supplier Impact

►Must Transition to ISO 9001:2015 by 2018

►All Transition Guidelines as Stipulated by International

Accreditation Forum (IAF) are to be Followed

►Documented System is to be Modified Unless Otherwise

Directed by IAOB Through their Tier 1 Customers

October 22, 2014


US Based Automotive Manufacturers and

Non US Based Manufacturers

►GM, Ford and Chrysler Require Tier 1 Suppliers Certified for

TS 16949 and Play a Critical Role in Managing all Interested

Parties

►Toyota, Nissan, Honda, Hyundai BMW, Mercedes etc. are Not

Requiring their Tier 1 Suppliers Certified for TS 16949

►US Based and Non US Based Automotive Manufacturers

Embrace or Not Embrace ISO 9001:2015?

►What if US Based Automotive Manufacturers who are Active

with IAOB Do Not Embrace ISO 9001:2015?

October 22, 2014


Who is Influencing the TS 16949?

►International Automotive Oversight Bureau (IAOB)

►Automotive Industry Action Group (AIAG)

►What are They Saying about Embracing ISO 9001:2015?

October 22, 2014


Can IATF and IAOB be Successful in

Keeping ISO 9001:2008 as Base Standard?

►IATF/IAOB Expressed Several Concerns about ISO

9001:2015 and Related Annex SL, JTCG Common Structure,

ISO Guide 83

►Dropped Requirements

►Unnecessary Additional Requirements

►Introduction of Risk Based Thinking in Place of Preventive

Action

October 22, 2014


Can IATF and IAOB Keep ISO 9001:2008 as

Base Standard – Cont’d.

►Inadequate Process Approach Emphasis and Application in

the High Level Common Structure

►Confusion Related to Documented Information

►Unnecessary Cost Related to Transition

►IATF/IAOB Requested ISO for Permission to use ISO

9001:2008 in ISO/TS 19649

October 22, 2014


How Many of the Tier 2 Suppliers Drop

ISO 9001:2008?

►Can IATF/IAOB Succeed Retaining ISO 9001:2008 in TS 16949

►Can Tier 2 Retain ISO 9001:2008 and Continue Surveillance

Audits from 3rd Party Registrars? ..... Not Really

►This Leaves IATF/IAOB to Decide How They Want Tier 2

Supplier Development Section.... Now it Requires to Work

Toward Achieving ISO 9001

►If NO Decision is made, there is a Potential for a Lot of

Certificates Dropping

October 22, 2014


IAOB/IATF Position on Tier 2 for ISO

9001:2015

►IATF/IAOB has a Tough Challenge to Face

►Obtain Special Permission from ISO to use ISO 9001:2008...

Possible?

►Tier 2 Supplier Control will be in a Limbo

►Many Sanctioned Interpretations Needed from IATF to Clarify

this Dramatic Decision of not Supporting or Embracing

ISO 9001:2015

October 22, 2014


Quality Management Principles Quote from ISO/DIS 9001:2014 Annex B

►Customer Focus

a. Statement: The primary focus of quality management

is to meet customer requirements and to strive to

exceed customer expectations.

b. Rationale: Sustained success is achieved when an

organization attracts and retains the confidence of

customers and other interested parties on whom it

depends. Every aspect of customer interaction

provides an opportunity to create more value for the

customer. Understanding current and future needs of

customers and other interested parties contributes to

sustained success of an organization.

October 22, 2014


Quality Management Principles Cont’d.

►Leadership

a. Statement: Leaders at all levels establish unity of

purpose and direction and create conditions in which

people are engaged in achieving the quality

objectives of the organization.

b. Rationale: Creation of unity of purpose, direction and

engagement enable an organization to align its

strategies, policies, processes and resources to

achieve its objectives.

October 22, 2014



►Engagement of People

a. Statement: It is essential for the organization that all

people are competent, empowered and engaged in

delivering value.

Competent, empowered and engaged people

throughout the organization enhance its capability to

create value.

b. Rationale: To manage an organization effectively and

efficiently, it is important to involve all people at all

levels and to respect them as individuals. Recognition,

empowerment and enhancement of skills and

knowledge facilitate the engagement of people in

achieving the objectives of the organization.

October 22, 2014



►Process Approach

a. Statement: Consistent and predictable results are

achieved more effectively and efficiently when

activities are understood and managed as interrelated

processes that function as a coherent system.

b. Rationale: The quality management system is

composed of interrelated processes.

Understanding how results are produced by this

system, including all its processes, resources, controls

and interactions, allows the organization to optimize

its performance.

October 22, 2014



►Improvement

a. Statement: Successful organizations have an

ongoing focus on improvement.

b. Rationale: Improvement is essential for an

organization to maintain current levels of

performance, to react to changes in its internal and

external conditions and to create new opportunities.

October 22, 2014



►Evidence-based Decision Making

a. Statement: Decisions based on the analysis and

evaluation of data and information are more likely to

produce desired results.

b. Rationale: Decision-making can be a complex

process, and it always involves some uncertainty. It

often involves multiple types and sources of inputs, as

well as their interpretation, which can be subjective. It

is important to understand cause and effect

relationships and potential unintended consequences.

Facts, evidence and data analysis lead to greater

objectivity and confidence in decisions made.

October 22, 2014



►Relationship Management

a. Statement: For sustained success, organizations

manage their relationships with interested parties,

such as suppliers.

b. Rationale: Interested parties influence the

performance of an organization. Sustained success is

more likely to be achieved when an organization

manages relationships with its interested parties to

optimize their impact on its performance.

Relationship management with its supplier and

partner network is often of particular importance.

October 22, 2014


ISO/DIS 9001:2014 Common Structure

►1. Scope

►2. Normative References

►3.Terms and Definitions

October 22, 2014


ISO/DIS 9001:2014 Common Structure Cont’d.

►4. Context of the Organization

a. Understanding the Organization and its Context

b. Understanding the Needs and Expectations of

Interested Parties

c. Determining the Scope of the Quality Management

System

d. Quality Management System and its Processes

October 22, 2014



►5. Leadership

a. Leadership and Commitment

b. Quality Policy

c. Organizational Roles, Responsibilities and Authorities

October 22, 2014



►6. Planning for the Quality Management System

a. Actions to Address Risks and Opportunities

b. Quality Objectives and Planning to Achieve Them

c. Planning of Changes

October 22, 2014



►7.Support

a. Resources

b. Competence

c. Awareness

d. Communication

e. Documented Information

October 22, 2014



►8. Operation

a. Operational Planning and Control

b. Determination of Requirements for Products and

Services

c. Design and Development of Products and Services

d. Control of Externally Provided Products and Services

e. Production and Service provision

f. Release of Products and Services

g. Control of Nonconforming Process Outputs, Products

and Services

October 22, 2014



►9. Performance Evaluation

a. Monitoring, Measurement, Analysis and Evaluation

b. Internal Audit

c. Management Review

October 22, 2014



►9. Improvement

a. General

b. Nonconformity and Corrective Action

c. Continual Improvement

October 22, 2014


►Radical Structural Changes to TS 16949 if IATF/IAOB

Decides to Adapt ISO 9001:2015

►IATF/IAOB Expressed Concerns of Unnecessary Cost in

Training/Consulting/Auditing

►IATF Submitted for Special Permission to use ISO 9001:2008

as a Part of TS 16949

►If Allowed, IATF has a Challenge to direct the Tier 2 Supplier

Development Process for Meeting QMS Requirements

►Potential Drop of ISO 9001:2008 Certificates

►ISO/DIS 9001:2015 QMPs and Structure

October 22, 2014

Summary


Thank You

October 22, 2014

Questions ?


Baskar Kotte

President and CEO

Quality Systems Enhancement

1790 Woodstock Road

Roswell, GA 30075

Phone: 770-518-9967

Fax: 770-518-9968

[email protected]

www.enhancequalty.com

October 22, 2014

mailto:[email protected]

http://www.enhancequalty.com/

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