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How Can You Move From QS-9000 to TS 16949:2002?

The Impact of ISO 9001:2000on QS-9000 and ISO/TS 16949

By Chad Kymal andDave Watkins

Publishers Note: This article has beenreprinted with permission from TH E

INFORMED OUTLOOK Newsletter,

May 2001 issue.

Many organizations registered

to ISO 9001/2/3:1994 have

begun planning for the tran-

sition of their quality management sys-

tems (QMSs) toISO 9001:2000,

Quality management systemsRequire-

ments. While this major shift in stan-

dards usage is taking place slowly but

steadily in many industries, suppliers to

the automotive sector have by and large

not begun planning for the transition.

The reason is that automotive suppli-

ers are confused about what is happening

with the third edition ofQuality System

Requirements QS-9000 andISO Technical

Specification (TS) 16949:1999, Quality

systemsAutomotive suppliersParticular

requirements for the application of ISO

9001:1994, in response to the changes to

their base document, ISO 9001.

In large part, this confusion is the

result of concerns about the implications

of this change and its potential impacton them. Automotive suppliers are left

to wonder, Is QS-9000 going away?

Will I have to change my system to

ISO/TS 16949? When will the revision

of TS 16949 come out? The lack of

clear direction from the automotiveoriginal equipment manufacturers

(OEMs) in regard to Q S-9000 and TS

16949 has left the supply base in limbo.

As it stands, organizations registered

to ISO 9001/2/3:1994 and/or any set of

sector-specific requirements based on

ISO 9001:1994, have three years to make

the transition to ISO 9001:2000. Mean-

while, the International Automotive Task

Force (IATF) has announced that there

will be no revisions to EAQF, VDA 6.1,

AVSQ or QS-9000the French, Ger-

man, Italian and US automotive catalogs

to which registration has been required of

suppliers. At the same time, TS

16949:1999, which is considered equiva-

lent to the four catalogs, is on track to be

revised in early 2002.

QS-9000 Will Not Be Revised; TS16949 Deadlines Ahead?

The fact remains that the only OEM

to have clearly stated its future intentions

is Italys Fiat, which reportedly informed

its suppliers in July 2000 that they

should pursue registration to TS 16949

in place of AVSQ (see IATF ProvidesLimited Transition Insight, THE OUT-

LOOK, February 2001). The broadest

hint that all the OEMs may follow suit is

the indication that they will not revise

the four national catalogs but are close to

completing a draft of TS 16949:2002.

This draft will contain the verbatim text

of ISO 9001:2000 and have the same

transition period as ISO 9001.

The seemingly obvious implication

is that QS-9000 will become less and

less relevant as organizations adopt the

process approach model of ISO

9001:2000 and migrate away from the20-clause/element structure of QS-

9000/ISO 9001:1994. As a result, QS-

9000 will probably succumb to a

natural death during this three-year

period. The changes in ISO 9001:2000

will be captured in TS 16949 which, for

all practical purposes, will become the

fourth edition of QS-9000.

Because ISO/TS 16949 is an ISO

document developed with ISO Technical

Committee (TC) 176, the version based

on ISO 9001:2000 will require TC 176

approval. Therefore, even though thedraft of TS 16949:2002 is expected to be

completed by June 2001, it will probably

not be released until the beginning of

2002, so as to permit the participating

member bodies of TC 176 to review and

ballot the TS. While a draft TS might

be released for information only in the

next few months, the final document

will be released in less than a year. By the

third or fourth quarter of 2001, most of

the Big Three are expected to announce

deadlines for their supply bases to make

the transition to TS 16949.

In effect, QS-9000-registered com-

panies should become familiar with ISO

9001:2000 and TS 16949 very soon.

O m n e x , In c .7 3 4 -7 6 1 -4 9 4 0 4 w w w . o m n e x . c o m


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These standards are in the future of

many automotive suppliers, who will

need to devote a lot of effort to making

the transition, although the benefits of

doing it right will benefit their organiza-

tions tremendously and make the effort

worthwhile. To help you prepare for the

coming transition, we will discuss the

impact of ISO 9001:2000, in terms ofboth the structure and the process ap-

proach model, and examine approaches

to QMS implementation in the transi-

tion to TS 16949:2002, with a detailed

examination of what we refer to as the

Process Review methodology.

ISO 9001:2000s Structure and theProcess Approach

ISO 9001:2000s structure is based

on five principal componentssec-

tionsrather than the 20 clauses in ISO

9001:1994the elements in TS16949/Q S-9000. The new structure is

not simply a matter of grouping several

elements together into 1 of 5 sections. It

involves a significant reorganization of

Reprinted with permission from

THE INFORMED OUTLOOK

May 2001 issues

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the requirements that brings together

some requirements from different ele-

ments and breaks up the requirements

in some elements and spreads them

throughout the 5 sections.

Thus, for an organizations QS-9000-

based quality system, the new structure is

not simply a matter of regrouping proce-

dures or putting a matrix in front of theprocedures manual. It is more of a signifi-

cant reorganization or a complete rewrite

of documentation for companies that

wrote their documentation to match the

20 clauses in ISO 9001:1994.

The intent of ISO 9001:2000 was to

streamline an organizations processes,

avoid the previous compartmentalization

of quality system requirements and instill

the cross-functional nature of a QMS.

This fundamental change will signifi-

cantly affect the documentation structure

of an organizations QMS. Although ISO

9001:2000 also provides for greater

flexibility regarding the need for docu-

mented procedures and documentation,

you can expect that TS 16949:2002 will

reestablish some of the documentation

requirements in QS-9000/ISO 9001 to

suit automotive OEM needs.

At a minimum, the traditional

policy-based Q uality Manual will need

to be rewritten and reoriented. Key

changes to TS 16949:2002 are likely to

involve the process mapping and process

orientation required by ISO 9001:2000.

In all probability, the second edition ofTS 16949 will not prescribe element-

based procedures from the first edition.

As a result, organizations that have

structured their procedures to mimic the

QS-9000 elements can expect some

major document rework ahead.

TS 16949:2002 will likely require

companies to document their product

realization process (i.e., the process of

creating and producing new products,

from concept to delivery to the cus-

tomer). This process is larger in scope

than the current Advanced ProductQuality Planning (APQP) process. It

also may require organizations to start

Figur e 1. Pr ocess Map


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with the very act of forming ideas about

a potential product or the product

concept and may end only with the

shipping of that product.

In addition, support processes that

affect the capability of the product

realization process (e.g., procurement,

staffing), Q MS processes (e.g., internal

audit, corrective and preventive action,document control) and business pro-

cesses (e.g., marketing, advertising) will

need to be identified, as shown in Figure

1 on the previous page.

The process map in Figure 1 is an

example of what a manufacturing organi-

zation can develop to show the

sequence and interaction of its

processes. This is a requirement

of both Clause 4.1b, Quality

Management SystemGeneral

Requirements, and Subclause

4.2.2c, Documentation Re-

quirementsQuality Manual.

This map is helpful to under-

standing how the processes in

the organization are related to

each other. An organization

implementing ISO 9001:2000

will need to reorient its docu-

mentation and the QMS to

understand that its business is a

series of interrelated processes.

We see this as a culture

change within a company

the breaking down of the walls

of the hierarchical organizationand gaining of an understand-

ing of the cross-functional

nature of the business.

Documenting ProcessesEven though procedurally

documentingall these processes

is not required, ISO 9001:2000

requires evidence to ensure the

effective planning, operation

and control of its processes

(Subclause 4.2.1b, Documenta-

tion RequirementsGeneral).In addition, organizations will

need to ensure the availability

of resources and information

necessary to support the opera-

tion and monitoring of these

processes (Clause 4.1d, Quality

Management SystemGeneral

Requirements). Clause 4.1e also

requires allprocessesto be mea-

sured, monitored and im-

proved. This is a major new expectation,

even for organizations registered to QS-

9000 or TS 16949.

Most well-managed automotive

suppliers will recognize the need to docu-

ment these processes. Your organization

should consider using Process Review, a

methodology that uses APQP tools to

improve and control nonmanufacturingprocesses. Process Review employs Process

Flow (PF), Process Failure Modes and

Effects Analysis (PFMEA), a Control Plan

and an Improvement Plan for all the

processes identified by the organization.

Of course, the key to effectively employ-

ing this approach involves efficiently

adapting these tools for service process

flows, something that has been done

effectively for several years in a wide vari-

ety of nonmanufacturing industries. These

PFs can also be used to effectively docu-

ment a process and serve as its written

procedures, as shown in the example in

Figure 2 below.Figure 2 shows a sample procedure

that documents a process for corrective and

preventive action. The flowchart shows

each step of the process, who is responsible

and any specific notes on each step. Each

step of the process is investigated for prob-

Figur e 2. Sample Pr ocedur e


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lems using PFMEA and analyzed for pos-

sible measurement, monitoring or other

controls in the control plan.

These approaches to documenta-

tion, measurement, monitoring and

improvement of processes do not have to

wait for TS 16949:2002. Automotive

companies should start employing them

immediately as effective ways to enhancecompetitive capability and improve the

bottom line. After all, that should be why

an organization does any of this!

Customer FocusWhat is the impact of ISO 9001:2000

on TS 16949? Whatever way QS-9000 or

TS 16949:1999 are sliced, neither has the

customer focus of ISO 9001:2000. Cus-

tomer expectations and requirements need

to be ascertained when it comes to product

quality, delivery, lead time, communication,

etc. These expectations must be met andshould be surpassed to improve customer

satisfaction. Does your current system

accomplish this? What process are you

using? The customer focus process pre-

sented in Figure 3 is an effective way to

satisfy ISO 9001:2000 and meet and exceed

the requirements of QS-9000 and TS

16949:1999.

The process illustrated in Figure 3

shows that Customer Need and Expecta-

tion (Clause 5.2, Management Responsi-

bilityCustomer Focus) are driving the

Goal and Objective (Clause 5.4, Plan-

ning) for the organization. The Goal andObjective are then subsequently trans-

lated by what is called a Result Measur-

able into metrics for use in management

review. Key Processes that impact the

Goal and Objective, as shown in Figure

3, are identified and tracked through

Process Measurables. The Key Processes

need to be improved to impact the Goal

and Objective. The Process Measurables

serve the purpose of measuring the pro-

cesses as required by Clause 4.1e.

An example that illustrates the

customer focus process is a typical cus-

tomer expectation of on-time delivery(OTD). An organization translates this

to an objective of 100% of shipments

will be received by all customers on

scheduled day. This is measured by a

result measurable% On Time. The

organization studies the objective and

identifies three key processes that drive

OTD: maintenance, shipping and train-

ing. Process measurables, such as %

Downtime, Shipment Accuracy and

Setup Jobs Filled, are then tracked for

each of the key processes.

What the customer focus process

accomplishes is the translation of a

customer requirement into an objective

that is then converted within the com-

pany into metrics and processes. The

key to overall improvement is the iden-

tification and improvement of processes.

Organizations cannot directly improve

the results, they can only improve pro-

cesses that improve the results.

ISO 9001:2000s Impact and aQS-9000 Action Plan

The overall changes in ISO

9001:2000 present challenges in terms ofthe significant change in the documenta-

tion requirements (as described earlier),

the use of a process approach and the role

of a customer focus on the QMS.

Between now and the end of 2003,

when the ISO 9001:2000 and TS

16949:2002 transition periods will end,

your organization really has only two

options if it is registered to QS-9000:

q Upgrade to TS 16949 and ISO

9001:2000, which will satisfy existing

and future customer requirements

q Lose your registration status. On

December 15, 2003, the members ofthe International Accreditation Forum

(IAF), which includes all accreditation

bodies that accredit QMS registrars and

qualify those competent to audit auto-

motive suppliers and issue QS-9000

registrations, will cease to recognize ISO

9001/2/3:1994 certificates of registra-

tion. Thus, certificates that cite QS-

9000 and any other sector requirements

still based on ISO 9001:1994 will be-

come invalid to the IAF members, the

registrars they have accredited and most

customers. As discussed above, the third

edition of QS-9000 is not going to be

upgraded to ISO 9001:2000, only the

first edition of TS 16949 is, and there

are no indications that any of the OEMs

presently requiring registration to TS

16949 or one of the four national cata-

logs plans to drop that requirement.

Previous experience assisting organi-

zations with implementation of QS-

9000and recent experience with ISO

9001:2000 and TS 16949tells us that

most large corporations will need at least

two years to successfully complete themigration from QS-9000/ISO 9001/

2:1994 to TS 16949. The best advice is

that all QS-9000-registered organizations

start their migration todayand not just

to TS 16949, but with ISO 9001:2000.

This will put them in the position to

make the transition to TS 16949:2002/

ISO 9001:2000 with minimal changes to

the QMS when the TS is published in

2002. The IATF is not expected to make

major changes to TS 16949:1999 beyond

its restructuring to include and flow

with ISO 9001:2000.In a second article on the impact of

ISO 9001:2000, which will appear in

the near future, we will explore the

structure and organization of the re-

quirements in ISO 9001:2000 and show

a practical approach to upgrading a QS-

9000-conforming quality system to

conform to ISO 9001:2000 and TS

16949:1999 with minimal disruption

and reworking of the system and maxi-

Figur e 3. Cust omer Focus


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mum results and benefits from the new

and improved system.

In the meantime, we recommend

that QS-9000-registered organizations

start today in moving the designs of

their systems toward TS 16949 and ISO

9001:2000. There are many savings

your organization can achieve with this

re-focus on improvement. ###

Chad Kymalis Chief Executive Officer

of Omnex, Inc., an international consult-

ing, training and software organization

specializing in business quality improve-

ment methodologies. Omnex has worked

with hundreds of organizations to meet

the requirements of ISO 9001/2/3, QS-

9000 and ISO/TS 16949 worldwide and

obtain registration. He assists organiza-

tions worldwide in his capacity as a

consultant and trainer. Mr. Kymal re-

cently served on the Malcolm BaldrigeNational Quality Award Board of Exam-

iners, has a BSME from General Motors

Institute and has an MS in Industrial

Operations Engineering and an MBA from

the University of Michigan. He can be

contacted by e-mail ([email protected]).

David Watkins is President of Omnex,

Inc., and is a senior trainer/consultant. He

has a wide range of international experi-

ence focused on enhancing the ability of

organizations to create value for their

customers and stockholders and integratingQMSs and other management systems to

enhance performance. Mr. Watkins can be

contacted by e-mail

([email protected]).

OMNEX Inc., along with its affiliates is an interna-

tional consulting, training and software organization,

which from the outset has specialized in business

quality improvement methodologies. Among our family ofcompanies are OMNEX-which provides training, OMNEX

Management and Engineering Consultants for quality systems

implementations and OMNEX Systems, LLC. OMNEX, as a

leader in Quality

Systems consulting, training and software, is uniquely

qualified to assist companies in increasing their market share.

We provide leading Quality focused consulting and training to

the automotive, truck, semiconductor and service industries.

Headquartered in Ann Arbor, Michigan, OMNEX & its affili-

ates also operate in:

q Bangkok, Thailand CON TACT OMNEX:

q Toronto, Canada Call 734/668-1000

q Sao Paulo, Brazil Fax 734-668-9414

q Argentina Email info@omnex

q Mexico Web www.omnex.com

q Venezuela

q Chennai, India

q Shanghai, China

q Malaysia

q Philippines

q Europe

and we have targeted Korea and Japan for future expansions.

The OMNEX MissionThe OMNEX mission has been to transfer our extensive

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OMNEX implements quality improvement methodologies

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not only for manufacturing organizations but also for improv-

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OMNEX in the Competitive WorldThousands of companies worldwide who have aggres-

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OMNEX typically conducts an initial assessment which cul-

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OMNEX ClientsOur automotive clients include Ford Motor Company,

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InfOutlook-TransitionQStoTS_Part01