Your Company

Presents a:

Two Hour ISO/TS 16949:2002

Executive Overview
Presented by:

Date:

Outline
TS 16949:2002 Executive
Overview
Quality Management Principles
Process Approach
New/Changed Requirements related to
Management Responsibility

TS 16949 Is . . .
A process approach for:
Implementing an effective quality
management system, and
Enhancing customer satisfaction
through continual improvement

Based on ISO 9001:2000

What does ISO 9000 accomplish?

Gives the organization confidence that
customer requirements are being met;
Gives the customer confidence that products
and services are consistent;
Provides or sustains market entry; and
Helps an organization achieve, sustain,
and improve product/service quality by
managing the processes that create them.
4

Goals for TS 16949

Provide a model for continual improvement in
the automotive supply chain,

emphasizing defect
prevention and reduction of
variation;

Define fundamental quality system

requirements AND customer specific
requirements (i.e. TS 16949 plus) uniquely
applicable to the automotive industry; and
Avoid the need for multiple certification audits.

Why Standardize Quality

Management Systems?
Provides a common basis for doing
business and managing quality, globally;
Allows diverse companies to exchange
products and services with greater
confidence; and
Reduces the need to satisfy multiple
(often contradictory) standards.

ISO 9000 is the Most Successful

Standard in ISO History
Over 500,000 registrations world-wide in over
160 countries from all continents
Over 40 sectors or industry classifications
led by: electrical/optical equipment,
metal products, construction, machinery,
wholesale/retail trade
but growing in acceptance by many others,
including: engineering, information
technology, health/social work, utilities,
transportation, public administration,
education, and other services.
7

Why did the ISO 9001/2:1994

Standards Need Revision?

Bias

Wording/terms biased towards manufacturing

Problems with the 20 element model

Difficult for small businesses to adapt
Flow incompatible with how companies do business
Incompatible with other models (ISO 14000 EMS e.g.)

Not sufficiently forward looking

Does not smoothly facilitate the move from baseline quality
to performance excellence required by evolving user and
customer needs (MBNQA, e.g.).

One World
One Quality System
QS 9000 standards contain loopholes
Too many companies have only sought to meet
minimum requirements and then only by
twisting the intent of the existing standards
There is a growing demand for
performance excellence
QS 9000 is not sufficiently performance oriented
ISO 9001:2000 is process/performance oriented,
but by itself is not yet viewed as a performance
excellence standard for automotive manufacturers
9

The Performance Pyramid

Business Vision

#1

Performance Excellence
Malcolm Baldrige Criteria

Competitive

Performance Improvement
TS 16949

Efficient

Baseline Performance:
ISO 9001:2000

Advantage

Quality Management System

Effective
Quality Management System

10

ISO 9001:2000
Quality Management Principles
Customer Focus
Leadership
Involvement of People
Process Approach
System Approach
Continual Improvement
Factual Approach to Decision Making
Mutually Beneficial Supplier Relationships
11

Customer Focus
Organizations depend on their
customers and therefore should:
understand current and future customer
needs;
meet customer requirements; and
strive to exceed customer expectations.
12

Leadership
Leaders should:
establish unity of purpose and
direction of the organization, and
create and maintain the internal
environment in which people can
become fully involved in
achieving the organizations
objectives.
13

Process Approach
INPUT

ACTIVITY

OUTPUT

Monitor more than process output:

(typically through inspection activities)

Monitor inputs and transformation

activities as well: (i.e. define/control input, develop
controls and mechanisms to manage the activity, and
define/measure output in terms of desired results that are linked
to established the organizations performance and improvement
objectives)

14

What is a Process?
Activity that transforms input into output

Input

Activity

Output

Resources:

Results:

People
Facilities/Equipment
Material
Methods

Products
Services
Performance

15

How is a Process Managed?

Monitor & Measure the Process
make sure the inputs are right, the transformation
activities consistently work, and the desired results
are achieved, then - improve the process as needed

Input

Activity

Right Resources:
Qualified People
Right Facilities/Equipment
Correct Materials
Proven Methods

16

Output

Desired Results:
Quality Products
Quality Services
Customer Satisfaction

How is a Process Measured?

Efficient
No Waste

Input

Effective

Desired Results Achieved

Activity

Output

Right Resources:

Desired Results:

Qualified People
Right Facilities/Equipment
Correct Materials
Proven Methods

Quality Products
Quality Services
Customer Satisfaction

17

System Approach
Identify, understand, and manage
interrelated processes (system)
the output of one process is the
input to one or more subsequent
processes in the system
these interfaces must be managed to ensure
the outputs of a process meet the input
requirements of related process(es) that
follow
18

Benefits of the System

Approach
Clear understanding of processes
and their interactions with other
processes
Better control of linkages
between related processes and
people who perform them
Facilitates continual improvement
19

TS 16949 implements
the PDCA improvement cycle
Plan
Clause 5. Management responsibility - everything
flows from Management who define the requirements for
the system
Clause 6. Resource management - from these
requirements the resources will be identified and
management must ensure they are provided and applied
within the system

Do
Clause 7. Product (and/or service) realization - the
necessary process are established and carried out
20

TS 16949 implements
the PDCA improvement cycle
Check
Clause 8. Measurement, analysis and
improvement - processes and products will be
monitored and measured against policies, objectives and
requirements for the product and results/opportunity for
improvement reported

Act
Clause 8. Measurement, analysis and
improvement - acting upon data reported in the check
cycle, improvement actions can be taken - directly, or as
an output of the Management Review process (Clause
5.6)
21

C
U
S
T
O
M
E
R
R
E
Q
U
I
R
E
M
E
N
T
S

Continual Improvement of the

Quality Management System

Management
Responsibility

Resource
Management

Measurement
Analysis &
Improvement

Product
Realization
Input

Product
Output

The Process-Based Quality

Management System

22

C
U
S
T
O
M
E
R
S
A
T
I
S
F
A
C
T
I
O
N

Involvement of People
People at all levels are the essence of
an organization, and
their full involvement enables . . .
their abilities to be used . . .
for the organizations benefit

23

Continual Improvement
Continual

Continuous

Continual improvement of the organizations overall

performance should be a permanent objective:

improvement activities must planned (take action to

achieve a desired result) and monitored for
effectiveness
24

The QMS Sustains the Gains of

Continual Improvement
Improve Process
through PDCA Cycle

Plan
Act
QMS

25

Results

Do
Check

Measure/Monitor Results Against

Objectives - Improve Process and
Change QMS as Needed to Achieve and
Sustain Desired Results
Improvement
Objective
Baseline Performance

Factual Approach
to Decision Making
Effective decisions are:

based on the analysis of

data and information.

26

Performance Against
Desired Results
Actions are taken when targets/goals
NOT achieved, especially as they may
relate customer targets/goals for:

Zero Defects (PPM)

Capability (Cpk, Ppk)
Efficiency (thruput, scrap, waste)
On-Time Delivery (schedule adherence)
Expediting Costs (premium freight)
27

Mutually Beneficial
Supplier Relationships
An organization and its suppliers
are inter-dependent so:
a mutually beneficial relationship
enhances the ability of both
to create value.

28

TS 16949:2002
Supplier Expectations
ISO 9001:2000 Registration, and
customer approved processes for:

Advanced Product Quality Planning (APQP)

Production Part Approval Process (PPAP)
Process Control (Control Plan, Flow Diagrams, SPC)
Containment Process
Corrective/Preventive Action Process (utilizing 8D or
other disciplined problem solving process)
Targeted Improvement; e.g. quality (PPM), capability
(Cpk/Ppk), schedule (on-time delivery), cost of quality
(scrap, rework, etc), efficiency (productivity/throughput)
29

The ISO 9000:2000 standards

include 3 documents...
ISO 9000:2000
Quality Management Systems Fundamentals and Vocabulary

ISO 9001:2000
Quality Management Systems Requirements

ISO 9004:2000
Quality Management Systems Guidelines for Performance Improvements
30

Role of ISO 9000:2000

Defines quality management
principles
terms and definitions
fundamentals:
- systems approach
- process approach
- continual improvement

ISO 9000:2000 is a normative reference (i.e.

part of the requirements), replaces:
ISO 8402:1994 and ISO 9000-1:1994

31

Role of ISO 9001:2000

Specifies quality system requirements:
for achieving customer satisfaction
applicable to entire enterprise
Note:

permissible exclusions (like design)

must be justified, and are limited to
requirements within Clause 7 Product Realization

ISO 9001:2000 replaces:

ISO 9001/2/3:1994

32

Role of ISO 9004:2000

Provides guidelines for performance
improvement, based on
quality management principles and approaches defined in ISO
9000, and
continual improvement of the quality management system
itself
note:

however, ISO 9004 is NOT intended as a

guideline for implementing or assessing
implementation of ISO 9001 requirements

ISO 9004:2000 replaces:

ISO 9004-1, 9004-2, 9004-3 & 9004-4

33

ISO 9001 and ISO 9004

are the Consistent Pair
Comprised of the following 8 clauses:
1. Scope
2. Normative references

(part of the requirements)

3. Terms and definitions

4. Quality management system
5. Management responsibility
6. Resource management
7. Product

(and/or service)

realization

8. Measurement, analysis & improvement

34

TS 16949 incorporates all

ISO 9000:2000 standards and ...
ISO/TS 16949:2002

Quality Management Systems - particular

requirements for the application of ISO 9001:2000
for automotive production and relevant service part
organizations

Customer Requirements / Guidance

Advanced Product Quality Planning (APQP) & Control Plan
Failure Mode Effects Analysis (FMEA)
Production Part Approval Process (PPAP)
Fundamental Statistical Process Control (SPC)
Measurement Systems Analysis (MSA)
Quality System Assessment (QSA) Checklist
35

Role of TS 16949
Developed as a stand-alone document
Includes ISO 9001:2000 in its entirety
Numerous additional automotive
customer requirements

36

EXERCISE #1

Pick one of the eight quality management principles and list three
of the most important actions you think your organization should
take in applying this principle.
1. __________________________________________________________
2. __________________________________________________________
3. __________________________________________________________

How well does your organization do each of the actions identified

above?
1. __________________________________________________________
2. __________________________________________________________
3. __________________________________________________________

How can top management become more involved in implementing

the principles and requirements associated with TS 16949?
1. __________________________________________________________
2. __________________________________________________________
3. __________________________________________________________

37

TS 16949
in a nutshell
Clause 4.1 Establish a quality management
system and continually improve its
effectiveness
a) identify processes needed for the QMS
b) determine the sequence and interaction of these
processes
c) determine criteria and methods needed to ensure these
processes are effective
d) ensure availability of resources and information need to
support the operation and monitoring of these processes
e) monitor, measure and analyze these processes, and
f) implement actions need to achieved planned results and
continual improvement of these processes

38

Clause 5 - Management responsibility

5.1 Management commitment - top management must
demonstrate commitment to development and
implementation of the quality system and continually
improving its effectiveness through specific activities:
communicate importance of meeting
customer (and regulatory/legal)
requirements
establish quality policy and objectives
conduct management reviews
ensure availability of necessary resources

QS-9000 1998 Cross Reference: 4.1.1

Note: Management must provide evidence of their commitment to (i.e. involvement in)
the QMS and its continual improvement

39

Clause 5 - Management responsibility

5.1.1 Process efficiency top management shall
review the product realization processes and the
support processes to assure their effectiveness and
efficiency.

QS-9000 1998 Cross Reference: None

Note: Management to review product realization processes for effectiveness and
efficiency; organization may also identify key manufacturing oriented processes
and their associated support processes and describe how they are managed to
achieve and improve effectiveness and efficiency. Review cost trends and
benchmarking of key processes.

40

Clause 5 - Management responsibility

5.2 Customer focus - in addition to commitment
to specific activities, top management must:
ensure customer needs and
expectations are determined,
turned into requirements, and
that those requirements are met
customer requirements (identified per Clause 7.2.1) must
be met with the aim of enhancing customer
satisfaction (a perception that must be measured per
Clause 8.2.1)
QS-9000 1998 Cross Reference: 4.3.2
Note: Management must pursue the enhancement of customer satisfaction; typically this
is through appropriate focus on customer oriented processes (see Section 7.2): i.e. those
with significant input from customers, and describe how they are managed to enhance
customer satisfaction.

41

Clause 5 - Management responsibility

5.3 Quality policy - this clause follows on from the
general requirements for top management and requires
them to establish quality policy that:
is appropriate for the organizations purpose,

includes a commitment to meeting requirements

and continually improving the QMS by:
establishing and periodically reviewing the quality policy for
continuing suitability,
establishing and reviewing
measurable quality objectives
for achievement, and
communicating policy and objectives at
appropriate levels throughout the organization
QS-9000 1998 Cross Reference: 4.1.1
Note: Policy must include statement on commitment to continually improve QMS.

42

Clause 5 - Management responsibility

5.4 Planning
5.4.1 Quality objectives.
Must be measurable & consistent with quality policy
Must be established at relevant functions and levels in the
organization
Must include those needed to meet product requirements
(identified per Clause 7.1 a)
QS-9000 1998 Cross Reference: None
Note: Establish quality objectives for relevant functions and levels; objectives to be measurable.

5.4.1.1 Supplemental top management shall define quality

objectives and measurements that shall be included in the
business plan and used to deploy the quality policy
QS-9000 1998 Cross Reference: 4.1.4 & 4.1.5
Note: Business Plan requirements much less prescriptive; a process should be in place to
create, disseminate and monitor quality objectives in Business Plan. The objectives should be
customer focused, stipulated and deployed, measurable, measured, used to facilitate an
effective and efficient review by management and utilized for corrective action and continual
improvement. Quality objectives should address customer expectations and be achievable
within a defined time period.

43

Clause 5 - Management responsibility

5.4 Planning (continued)
5.4.2 Quality management system planning.
Top management must plan to ensure that the
QMS meets the requirements of clause 4.1
The integrity of the QMS must be maintained
when changes are planned and implemented

QS-9000 1998 Cross Reference: 4.2.3.1

Note: Management to plan for changes when changes to the business occur;
preparation of quality plans (see Section 7.1) not specified

44

Sample Policy and Objectives

Quality Policy Statement
Deliver High Quality Products On-Time at Competitive Prices
through Process Management and Continual Improvement

Measurable Objectives

Improve Customer
Satisfaction

(satisfy new customers, achieve higher levels of satisfaction of loyal customers)

Improve Supplier Performance

(through timely supplier corrective action and supplier development activities)

Improve Processes

(through teamwork aimed at reducing scrap, rework, waste, cycle time variation, etc.)

Improve Product Quality

(through teamwork aimed at reducing defects, returns, within spec variation, etc.)

Improve On-Time Delivery

Performance

(through better planning and resource management)

45

Clause 5 - Management responsibility

5.5 Responsibility, authority and
communication
5.5.1 Responsibility and authority.
Responsibilities and authorities must be
defined and communicated with the
organization
Plant Manager
Sales

Design

Production

QS-9000 1998 Cross Reference: 4.1.2

Note: Greater flexibility in how responsibility and authority is documented.

46

Clause 5 - Management responsibility

5.5 Responsibility, authority and communication
5.5.1.1
Responsibility for Quality
Management with responsibility and authority for
corrective action need to be promptly informed of
products and process nonconformities
People responsible for product quality
must have the authority to
stop production for quality problems
All shifts must have people responsible for ensuring
product quality
QS-9000 1998 Cross Reference: 4.1.2.1.a, 4.1.2.2, 4.1.2.5
Note: : Documentation requirements for identifying and recording quality problems
removed; added requirements to: identify responsibility for stoppage of production to
correct quality problems, and to provide accountability across all shifts.

47

Clause 5 - Management responsibility

5.5 Responsibility, authority and communication
(cont.)
5.5.2 Management representative. Top management shall
appoint a member of management to
Ensure QMS processes are established & maintained
Report to top mgmt on QMS performance
Ensure organizational awareness of customer requirements
QS-9000 1998 Cross Reference: 4.1.2.3
Note: Representative to also ensure promotion of awareness of customer requirements.
The management representative can also act as liaison with external parties on
matters related to QMS.

5.5.2.1 Customer Representative. Top management must appoint

someone to ensure that customer requirements are addressed.
QS-9000 1998 Cross Reference: None
Note: Management to designate personnel to ensure customer needs are met by QMS.
The customer rep should participate in decision points related to product release,
engineering release and activities related to customer requirements.

48

Clause 5 - Management responsibility

5.5.3 Internal communication. Top
management must ensure processes are
established to communicate effectiveness of
the QMS.

QS-9000 1998 Cross Reference: None

Note: Management to ensure internal communication processes are created and used to
address QMS effectiveness; also see clause 7.2.3 regarding customer communications

49

Clause 5 - Management responsibility

5.6 Management review
5.6.1 General. Top management must review the suitability,
effectiveness, and adequacy of the QMS at planned intervals; and
must evaluate the need for change, including changes to policy and
objectives.
QS-9000 1998 Cross Reference: 4.1.3, 4.1.3.1
Note: Review expanded to include QMS improvement opportunities and need for changes

5.6.1.1 QMS Performance. Reviews shall include all QMS requirements

and performance trends; monitoring of quality objectives; reporting and
evaluation of cost of quality; and evidence (records) of achievement of
quality objectives and customer satisfaction. Evidence includes quality
objectives specified in the business plan.
QS-9000 1998 Cross Reference: 4.1. 3.1, 4.1.5
Note: Must go beyond company level data; i.e. review evidence of achievement of business
plan quality objectives and customer satisfaction; benchmarking and competitive data
comparisons not specified. Examples of measurement include gap analysis, timeliness, error
rates and corrective action effectiveness. Cost of quality includes both internal and external
costs.

50

Clause 5 - Management responsibility

5.6 Management review
5.6.2 Review input. Specific review inputs are
required including performance trends related to
audit results, customer feedback, product
conformance, process performance, changes that
could affect the QMS, and status of actions taken, as
well as recommendations for improvement.

QS-9000 1998 Cross Reference: None

Note: Specifies information on sources to be included in review. See Clause 7.3.4.1 Monitoring must be included in management review.

5.6.2.1 Supplemental. Review input shall include

analysis of actual and potential field failures and their
impact on quality, safety, and the environment
QS-9000 1998 Cross Reference: 4.14.2.1, 4.14.3
Note: If the products is manufactured or distributed in a number of markets, the organization
must ensure that there is a defined structure and decision process for info on field failures
and/or product returns. Information should be collected in one central location and then
disseminated and acted upon at all affected locations.

51

Clause 5 - Management responsibility

5.6 Management review

5.6.3 Review output. Decisions and

actions as well as resource needs to carry
them out must be documented.

52

QS-9000 1998 Cross Reference: None

Note: Specifies information on sources to be included as outputs.

EXERCISE #2

List your organizations three most significant challenges or

business needs over the next 2-3 years (consider any external
changes that will affect your organization):
1. __________________________________________________________
2. __________________________________________________________
3. __________________________________________________________

What are your organizations goals and objectives?

1. __________________________________________________________
2. __________________________________________________________
3. __________________________________________________________

How can you use TS 16949 to help deal with business needs and
external challenges?
___________________________________________________________
___________________________________________________________
___________________________________________________________

53

Quality System Attributes

Words of wisdom from Victor Schur (Sears):
A Quality System must be S.E.D.A. -- Suitable
- Documented
- Effective
- Auditable
Words of wisdom from Ian Durand (US Technical
Advisory Group to ISO TC 176):
The basis of a quality system is to say what you do, do
what you say, record what you did, check the results,
and act on the difference.

54

Use of Audits to Assess QMS

Effectiveness has shifted
9001:1994
Internal audit

Effectiveness
assessed in
audit report

Management
review

9001:2000/TS 16949
Internal audit
Customer
satisfaction
Other data

55

Management
determines
effectiveness by
analyzing all
available data
and information

Management
review

Customer Oriented Processes

This is a process
O

An interface Organizational/
External environment input (I)

An interface Organizational/
External environment output (O)

Organization
I

Notice how this is a literal

application of the process model.

Check input
against
output.

Continual improvement of the quality

Continual improvement of the quality
management system
management system
Management
responsibility

Customers
Customers

Customers
Customers

Measurement,
analysis and
improvement

Resource
management

Satisfaction

Key
Informationflow
Valueaddingactivities
Requirements

56

Input

Product
realization

Product

Output

The Octopus Model

1
10

7
8

57

Examples of COPs
Finished
Prototype

Product
Specifications
Determined
Production Run
and Optimized

Product
Analyzed and
Request for
Change Issued

Prototype
Delivered

Prototype
Requested

Product
Validation

Warranty
Request

Product
Realization

Warranty

Warranty
Request
Accepted

Customer
Feedback

Performance
Reports

Product Design

Order Accepted

Order / Request

Corrective actions,
Preventive actions,
Continual
Improvement

Market Analysis
Bid Awarded
with
Specifications

Bid / Tender

Bid Proposal
Request for
Quote from
Customer

58

Information
about Product
Line(s)

Sales and
Marketing
Research of
Market

59

60

Exercise # 2
1.

Map what you perceive to be the customer

oriented process (COP) model for your
organization.

2.

Identify support oriented processes (SOPs) in

place to aid in effective implementation of your
organizations COPs.

3.

Identify management oriented processes (MOPs)

in place to aid in achieving management
objectives or requirements of ISO/TS 16949:2002
and related customer requirements documents.

4.

Present your COP/SOP/MOP model to the group

and explain how this structure can aid in helping
the organization establish/implement and
effective continual improvement program.

61

Process Approach
(Managers Define / Auditors Assess)
1. Process Scope and Boundaries
2. Process Flow, including:
2.1 Inputs used to effect process completion
2.2 Events that start process activity
2.3 Activities required to complete the process
2.4 Validation that process is effective
2.5 Events that signal process completion
2.6 Outputs resulting from process completion
3. Process metrics and statistics (to monitor/measure)
4. Process Change Management
5. Tools used to fulfill process requirements
6. Controlled Documents
7. Quality Records
62

Turtle Diagram

63

Turtle Diagram (Guid

Exercise # 3
1.

Map a customer oriented process (COP) using the

deployment flowcharting technique from a pre-determined
start and stop point.

2.

Complete a TURTLE DIAGRAM (or Process Assessment

Worksheet) of this COP (use tool of choice using the form
and instructions included as course handouts).

3.

Identify key process performance measures that are (or

could be) applicable to this COP.

4.

Document (or estimate) current COP performance.

5.

Determine if current performance is acceptable or in need

of improvement. If in need of improvement, establish a
measurable improvement objective for this COP (i.e. can be
tracked and achieved within a specified time frame), a list of
recommended actions to achieve the objectives, and
required resources.

6.

Participate in a (mock) management review meeting

presenting summary results of your COP data analysis,
including fact based justification for recommendations.

65

Where can I obtain more

information?
On the world-wide web:
ISO web site
TC 176 web site
ASQ web site
AIAG website
IsoQual, Inc.website

www.iso.org
www.bsi.org.uk/iso-176-sc2
www.asq.org
www.aiag.org
www.qualitymap.com

Other questions?
IsoQual, Inc. Staff

66

Email: isoqual@bellsouth.net
call (502) 299-6122

or