By Tripp Martin

30 Exploring ISO/TS 16949:2002

Editors note: The following article is an excerpt
from a new AIAG document under develop-
ment. The new document (working title,
ISO/TS 16949:2002 Implementation
Guideline) should be available through AIAG
rst quarter 2003.
T
he long awaited release of ISO/TS
16949:2002, coupled with the Daimler-
Chrysler requirement for its supply
base to be third-party certied by July 1,
2004, has sparked interest in understand-
ing the revised Technical Specication.
Automotive suppliers are asking:
I What is new in ISO/TS 16949:2002?
I What is different from both QS-9000
Third Edition and ISO/TS 16949:1999?
I How should I modify my systems to
meet the new requirements?
I What opportunity does ISO/TS
16949:2002 present for my quality man-
agement system?
One of the strengths of the new tech-
nical specification is that it is aligned
with the process-based approach of ISO
9001:2000, said Joe Bransky, IATF mem-
ber. The process approach is enhanced
in an automotive context. This enhance-
ment reects consistency with the way auto-
motive organizations operate.
The focus on product realization and
the process approach is the way we do busi-
ness. We think there was legitimacy to
the complaint that the quality system audit
was too oriented to procedures based on an
element-by element assessment, Bransky
continued. What we have in the auto-
motive single process approach is an
approach that sets up an audit trail based
on the line of sight from the agreed upon
customer requirements to the operator
instructions, and back to what was deliv-
ered to the customer. Its a better correla-
tion with the way a manufacturing product
business operates.
Branskys comments give us some
starting points from which to begin our
examination of ISO/TS 16949:2002.
I It is based upon ISO 9001:2000.
I It is focused upon product realization
and the process approach.
I It seeks a line of sight through the
organization that focuses upon the customer.
Based upon
ISO 9001:2000,
not ISO 9001:1994
ISO 9001:1987 (the original issue of the
standard) was aimed at all businesses, from
large corporations to the one- or two-
person company. The 1994 revision added
significant requirements that were com-
patible with manufacturing companies, but
did not really fit service organizations.
Furthermore, ISO 9001:1994 became so
complex and documentation-oriented that
the small company was overburdened in its
compliance efforts. For many organizations,
ISO 9001:1994 required effort that was not
value-added.
ISO 9001:2000 returns the standard
model to one that is exible enough to t
all sizes and types of organizations.
Signicantly more freedom in several areas
encourages adoption of and certication to
the standard.
A number of new and different things
in ISO/TS 16949:2002 come from this
change of the base ISO document. A sum-
mary of the major changes in ISO
9001:2000 from ISO 9001:1994 includes:
I Greater focus on the customer and
customer satisfaction
I New focus on the process approach
vs. the elemental approach
I Clarification of requirements for
continual improvement
I Greater emphasis on the role of top
management
I Measurable quality objectives
I New requirements for data collection
and analysis
I Reduced emphasis on documented
procedures
I Shift in emphasis from training to
providing competent people
I Modication in the purpose of inter-
nal audits
Lets briey review these changes:
(1) Greater focus on the customer and
customer satisfaction. The heart of what
the organization does is identied in ISO
9001:2000 as Clause 7, Product Realization.
This begins and ends with the customer.
Clause 8, Measurement, Analysis and
Improvement, requires measure of customer
satisfaction.
(2) A new focus on the process
approach vs. the elemental approach.
Most signicant in ISO 9001:2000 is the
change from the 20 elements of the 1994
version to the five clauses of the Process
Model.
(3) Clarification of requirements
for continual improvement. Continual
improvement was viewed as a natural out-
come of implementing an ISO 9001:1994
compliant quality management system.
A helpful guide to understanding the new
Technical Specications revisions and changes.
Whats New (and Different!)
in ISO/TS 16949:2002
QS-9000 brought this requirement into
sharper focus. ISO 9001:2000 continues
this evolution and addresses continual
improvement requirements and actions in
Clauses 5.3, 5.4.1, 5.6, 8.2, 8.4, 8.5.2, and
8.5.3.
(4) Greater emphasis upon the role of
top management. The descriptive phrase
management with executive responsibil-
ity (used in the 1994 version) has become
an elastic term. ISO 9001:2000 changes this
phrase to top management, which is
dened in ISO 9000:2000 as a person or
group of people who directs and controls
an organization (3.3.1) at the highest level.
The 2000 version species what actions top
management must perform and what can
be delegated to others.
(5) Measurable quality objectives. ISO
9001:2000 introduces a new feature called
quality objectives. Quality objectives are
based upon the quality policy and imple-
mented at relevant functions and levels
within the organization. Clause 5.4.2
requires that the quality management
system is planned so that its effectiveness
can be measured and compared with the
quality objectives.
(6) New requirements for data col-
lection and analysis. ISO 9001:2000 has
added requirements for data to be collect-
ed and analyzed and the analyses used as
the basis for decisions. This approach is
already part of the automotive industry.
(7) Reduced emphasis on documented
procedures. ISO 9001:1987 did not require
much documentation. The requirement
was for a system by which actions were
accomplished. ISO 9001:1994 increased
the requirements for documented proce-
dures. The 2000 revision reduces this
requirement to six documented procedures:
I Control of documents;
I Control of records;
I Planning and conducting internal
audits;
I Addressing nonconforming products;
I Corrective action; and
I Preventive action.
Now, the requirement is for a process
that can be audited. This change in docu-
mentation emphasis provides one of the
great opportunities for organizations imple-
menting ISO 9001:2000-based quality
management systems.
Exploring ISO/TS 16949:2002 31
Some New Language
A note on a language change in ISO/TS 16949:2002: The ISO 9001:1994
language used to refer to the supply chain has been revised. The new
Implementation Guide from AIAG will use the revised language, so these
changes need to be highlighted:
ISO 9001:1994 Language ISO 9001:2000 Revised Language
Customer Customer
Supplier Organization
Subcontractor Supplier
(8) Shift in emphasis from training to
providing competent people. ISO 9001:1994
focused on how to qualify people to per-
form their work. Often, the focus was the
initial step of hiring. ISO 9001:2000 broad-
ens this focus to how the organization pro-
vides competent people that do work. Instead
of a gate through which only qualified
people enter, ISO 9001:2000 requires a
competent workforce while work is being
performed.
(9) Modication in the purpose of inter-
nal audits. There are three significant
changes in Clause 8.2.2 from Element
4.17.1. First, the quality management sys-
tem must be audited to the requirements of
ISO 9001:2000, not just the planned
arrangements of the organization. Second,
the internal audit is to ensure that the
quality management system (QMS) is
effectively implemented by the top man-
agement. ISO 9001:1994 required that the
internal auditor determine the effective-
ness of the QMS. This is clearly the role
of top management in the management
review. The internal audit checks the QMS
implementation, and the results go to the
management review. The third change is
that the auditors can now audit in the area
in which they workthey may not audit
their own specic work. This gives much
greater freedom to very small companies.
In ISO/TS 16949:2002, the IATF adopt-
ed a concept called Customer Oriented
Processes (COPs). COPs are referred to in
the Checklist to ISO/TS 16949:2002, where
it is stated, The IATF expects ISO/TS
16949:2002 auditors to audit based upon
the Customer Oriented Processes (COP).
The COP is a model that was introduced
by ISO 9001:2000 and refers to the fact that
any organization needs customer input to
comply to specied and expected needs of
the customer (output) in order to achieve
customer satisfaction. This is accomplished
by value adding processes of product real-
ization and appropriate support processes,
both enabled by management processes and
provided resources.
. . . the Automotive Process Approach to
auditing for ISO/TS 16949:2002 must not
be driven by a clause or a section driven
checklist. Instead, the checklist shall be a tool
to verify the completeness of the audit, which
means that the auditor shall audit all appli-
cable requirements to an identied COP.
What Else is
New and Different?
Lets highlight several of the more sig-
nicant items that are new or different in
ISO/TS 16949:2002:
(1) Clause 8.2.1.1 One of the key
clauses of ISO/TS 16949:2002 is 8.2.1.1
Customer Satisfaction Supplemental,
which reads, Customer satisfaction with
the organization shall be monitored through
continual evaluation of performance of the
realization processes. Performance indica-
tors shall be based on objective data and
include, but not be limited to:
I Delivered part quality performance;
I Customer disruptions including eld
returns;
I Delivery schedule performance (includ-
ing incidents of premium freight); and
I Customer notications related to qual-
ity or delivery issues.
The organization shall monitor the
performance of manufacturing processes to
demonstrate compliance with customer
requirements for product quality and
efficiency of the process.
Customer satisfaction is a key concept
in ISO/TS 16949:2002 and is used by audi-
tors (internal and third party) to evaluate
the organizations performance. The four
Product Realization and
the Process Approach
The process model in Figure 1 captures
the two key points made by Bransky earli-
er in this article. First, the organization exists
to meet a customer need with a product
of some kind. Instead of the QMS being
set upon a pedestal or an internal vision
being the driver of the QMS, the process
model claries that the QMS must be con-
cerned, first and foremost, with meeting
customer needs.
Additionally, companies do not operate
in a certain number of silos of activity (e.g.,
20). Companies must operate dynamical-
ly to meet their customers needs. The
process model is not a number of vertical
silos with some other number of horizontal
multidisciplinary activities. Rather, it is
circular, with business processes beginning
and ending with the customer.
Line of Sight Through
the Organization and
COPs
Line of sight refers to the idea that the
product produced, the product realization
process and the management processes under-
lying it all should be based upon customer
requirements. Another way of stating this
is that all activities should be value-added,
where the customer denes value.
32 Exploring ISO/TS 16949:2002
Figure 1. Model of a Process-Based Quality Management System
areas of objective data are related to the key
metrics existing on the Web sites of
DaimlerChrysler, Ford Motor Company and
General Motors. Acceptable performance
on these Web sites is customer satisfaction,
and, per sub-clause 5.6.1.1, demonstrates
customer satisfaction with product supplied.
(2) Clauses 4.2 & 7.5.1.2 Documen-
tation Requirements. Each organization
should examine its own documentation
structure for opportunities such as:
I Reducing the size and complexity of
the quality manual. A compliant quality
manual needs to have only three areas
covered and can be quite short. The areas
are (1) the QMS scope, (2) a reference to
the procedures and (3) a description of the
interactions between the QMS processes.
I Eliminating non-value added docu-
mentation. Many QS-9000-compliant com-
panies have built documentation night-
mares. The organizations have been asking
for relief from the document everything
syndrome, and that relief is here with
ISO/TS 16949:2002. It requires seven doc-
umented procedures and a laboratory doc-
ument. While there are additional require-
ments, the principal requirement is that you
have a process. It need not be documented
in most cases. You can run your shop oor
similar to how you run your office. In par-
ticular, work instructions appear pervasive.
The ISO/TS 16949:2002 requirement is
not that every task has a work instruction;
rather, it is the employee that must have
a work instruction, and even then, only the
employee in the product realization process.
I Be careful on how you word the
Quality Policy and Quality Objectives.
These are not to be visionary statements,
but attainable goals with measures.
(3) Clause 7.3 Design and
Development Planning. Compared with
Element 4.4 in the 1994-based documents,
the major change in this area is the sepa-
ration of the product from the process by
which you manufacture the product. Under
QS-9000, you could exclude all of Element
4.4 (Design Control). This registered the
site at the ISO 9002 level. Manufacturing
processes were then planned and reviewed
under Element 4.2, under APQP.
ISO/TS 16949:2002 allows scope exclu-
sion of product design, but requires all of
Clause 7.3 be applied to the manufactur-
ing process. This brings a much stronger
focus upon the manufacturing process than
was present in QS-9000.
(4) Clause 7.4.1.2 Supplier Quality
Management System Development. Since
QS-9000 Sanctioned Interpretation C9
received so much attention stemming from
its apparent requirement that all suppliers
be third-party registered to an ISO standard-
based requirements document (ISO 9001/
9002, QS-9000, ISO/TS 16949:1999), organ-
izations would naturally turn to the area of
supplier development to understand what
requirements exist for ISO/TS 16949:2002.
The debate is beginning over the mean-
ing of the three sentences in this clause.
In particular, the meaning of the third
sentence is generating debate. Clause 7.4.1.2
states, The organization shall perform
supplier quality management system devel-
opment with the goal of supplier conform-
ity with this Technical Specification.
Conformity with ISO 9001:2000 is the rst
step in achieving this goal.
NOTE: The prioritization of suppliers
for development depends upon, for exam-
ple, the suppliers quality performance and
the importance of the product supplied.
Unless otherwise specied by the cus-
tomer, suppliers to the organization shall be
third-party registered to ISO 9001:2000 by
an accredited third-party certication body.
The intent of this clause is that the organ-
ization should implement a supplier devel-
opment program, and it recommends con-
formity to ISO 9001:2000 as the rst step.
This conformity should be demonstrated by
third-party registration to ISO 9001:2000.
The sentence also states that customer
approval may be otained by the use of an
alternative program, such as second-party
reviews. Cleary, the third sentence should
not be interpreted as requiring all suppli-
ers to be registered prior to an organizations
registration to ISO/TS 16949:2002. Addi-
tionally, the lack of a time requirement in
the third sentence should be understood
as giving the organization the exibility to
focus rst on the subsuppliers most impor-
tant to customer satisfaction.
Tripp Martin is director of quality for sintered
valve train and transmission products and North
American engine bearings for Federal-Mogul
Corporation.
Exploring ISO/TS 16949:2002 33