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BUILDING SUCCESS WORLDWIDE
F ALL
2000
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The Impact of ISO Web-Based
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9001:2000 on QS- Software for
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Inside:
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9000 and TS Quality Systems
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789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
Training Update
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Management
16949 Part One
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789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
By Chad Kymal, President Omnex, Changes to ISO Based Standards
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789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
Dave Watkins, President OMEC, By Roger W. Black, President
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Omnex News Around
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Omnex Systems
Joe Macko, President AQSR
the World
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789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
(This is the first in
We are facing some of the big789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
The changes in ISO a Series. Part II gest changes in ISO history with the
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appear in the ISO 9000 series of standards. ISO
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9001:2000 will be captured will
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next
Omnex Navi789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
9001:2000 is redefining Quality Sys789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
in
TS-16949
which,
for
all
gator)
tems to Quality Management Sys789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
tems. The focus will change from
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practical purposes, will be789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
The
Final
product quality to business and pro789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
come
the
fourth
edition
of
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Draft Standard of
cess improvement, from documen789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
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ISO
9001:2000
has
tation to continuous improvement
QS-9000.
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recently been re- and from specifications to cus789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
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leased. By year-end
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tomer satisfaction. These changes
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the
International
Standard
will
have
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should impact the quality systems of
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been
adopted
and
released
and
the
roll
most organizations, and especially
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out
will
be
in
full
spate.
Many
comchange the needs for software in a
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panies already certified to ISO positive way. At the same time soft789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
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9000:1994 will begin their transition ware is changing, the economy and
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to the 2000 standard. The technical technology has changed.
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committee 176 will finally have com789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
pleted the Promethean task of achiev- The Global Economy and the
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ing a global consensus on Quality Internet
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Management Systems, leading the
Transportation and business
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world
to
make
the
leap
from
the
old
needs are taking personnel to the far
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standard to the new one. But, while this reaches of the world.
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789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
(continued on page 2)
(continued on page 3)
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OMNEX

Navigator
5

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Web Software (continued from page 1)
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The QMS ISO/QS architecture
New markets are being formed from
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The pieces of the quality information puzzle
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Marakesh to Borneo. With products reaching these
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can
be
nicely
tied together in a systematic approach.
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far corners of the world, naturally revenue, infor1234567890123456789012345678901212345678901234567890123456789012123456789012345678901234567890
This not only lends organization to the data but almation, data, and management systems have to fol1234567890123456789012345678901212345678901234567890123456789012123456789012345678901234567890
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lows the information to be shared with other applilow. Some of the biggest challenges for companies
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cations. Omnex Systems has put toare having glo1234567890123456789012345678901212345678901234567890123456789012123456789012345678901234567890
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a system of its quality software
bal markets and
Our office exchanges infor- gether
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to
accomplish
this goal. The system
global suppliers.
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mation
daily
with
our
remote
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is diagramed below showing the
New product de1234567890123456789012345678901212345678901234567890123456789012123456789012345678901234567890
with Document Pro; the
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velopment and
office in Chennai, India just interactivity
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document management tool prosupply chain
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as
easily
as
if
it
was
in
duced by Omnex Systems. This bemanagement is1234567890123456789012345678901212345678901234567890123456789012123456789012345678901234567890
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comes the centerpiece of the system
sues are com1234567890123456789012345678901212345678901234567890123456789012123456789012345678901234567890
Downtown Detroit.
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controlling all of the documentation
plex and critical.
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and allowing approval and document
How do you
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control using the existing customer installed mail
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manage 1000 suppliers in over 50 different mar1234567890123456789012345678901212345678901234567890123456789012123456789012345678901234567890
system.
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kets? How do you route and receive information
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How does this work? The Quality or busi1234567890123456789012345678901212345678901234567890123456789012123456789012345678901234567890
that is complex and information rich?
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Omnex is working with a global OEM who
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(continued next page)
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is in the midst of a car launch. In the middle of
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Advance Product Quality Planning (APQP) train1234567890123456789012345678901212345678901234567890123456789012123456789012345678901234567890
1234567890123456789012345678901212345678901234567890123456789012123456789012345678901234567890
ing in this South American country we found that
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prototype, PPAP or launch deadlines had not been
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communicated to the supply base. Luckily for us,
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Web and PC technology has really been a big help.
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Why the Web makes sense
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Software and information are easily acces1234567890123456789012345678901212345678901234567890123456789012123456789012345678901234567890
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sible. If you have a PC and access to the web, then
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the data are instantaneously available. The soft1234567890123456789012345678901212345678901234567890123456789012123456789012345678901234567890
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ware is available from any corner of the world
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without additional installations just by using your
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browser. Just e-mail the system administrator and
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get an e-mail with a user ID mailed back. Presto,
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you are ready to go.
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With carefully defined software, process,
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gage, warranty, failure mode, Cpk information can
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be readily available up or down several links in
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the supply chain- customer to supplier to supplier
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to supplier. Also, if data needs to be accessed in
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Dayton, information from Sydney can be seconds
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or minutes away. Our office exchanges informa1234567890123456789012345678901212345678901234567890123456789012123456789012345678901234567890
tion daily with our remote office in Chennai, India
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just as easily as if it was in Downtown Detroit.
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Web Software (continued )
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ness documentation of policies, procedures, work
and the auditing information and audit planning
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instructions, and forms/checklists and the document
would be accessible with Audit Pro.
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control process is housed in Document Pro. From
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Roger Black is the President of Omnex Systems, LLC.
789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
Document Pro the user navigates to AQuA Pro for
He is a graduate of Western Michigan University with a
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manufacturing and design information process
789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
Bachelor of Science degree in Automotive Engineering.
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flow, PFMEA/DFMEA, testing data, warranty data,
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His experience includes numerous management posi789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
PPAP etc. If the data is on Key Measurables, man789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
tions in Quality and Information Technology and as789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
agement
review,
continuous
improvement,
or
Key
signments selecting advanced technology for Informa789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
process
Measurables
then
they
would
navigate
to
tion Systems.
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789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
BOSS.
If
the
company
wants
to
understand
busi789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
FOR MORE INFORMATION ON
789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
ness process documentation such as purchasing
OMNEX SYSTEMS:
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789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
process, marketing process or the hiring process as
www.omnexsystems.com
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required by ISO 9001:2000, then they would go to
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EMAIL: info@omnex.com
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Process Pro. Lastly, all the gaging information on
789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
OR CALL: (734) 761-4940
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calibration
and
MSA
would
be
held
in
MSA
Pro
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Impact of ISO 9001:2000 (continued from page 1)
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major shift in standards is taking place, automotive nical Specification will be handled under the Inter789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
sector companies aligned with ISO/QS-9000 or ISO/ national Automotive Oversight Bureau (IAOB), a
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TS 16949 will be left wondering about the implica- newly created accreditation body.
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(Note: if some or all of this is news to the
tions of this change and its potential impact on them.
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789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
reader, then it is
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789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
time to attend a
In a nutshell, QS-9000 regis789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
No Change to QS-9000 But
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class on ISO/TS
Major Changes to ISO/TS 16949
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tered
companies
need
to
be789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
16949, see page 6.)
As it stands, after the In789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
come very interested in ISO
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Because it
ternational Standard (IS) is re789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
is a Technical
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9001:2000 and TS-16949
leased in the 4th Quarter of 2000,
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Specification (TS),
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registered companies will have
very soon. These standards
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the version of ISO/
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three years to make the transition
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are
in
your
future.
TS 16949 based on
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to ISO 9001:2000. The Interna789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
ISO 9001:2000
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tional Automotive Task Force
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will require ISO
(IATF) has announced that there will be no change
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789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
approval; as a result, it will probably not be released
to QS-9000. While the Big Three have indicated
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until the end of 2001 or beginning of 2002. Of
interest in retaining the rights to the 1994 ISO stan789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
course, we can probably expect the Draft Standard
dard, the seemingly obvious implication is that QS789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
to be released considerably sooner than thatper789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
9000 will become less and less relevant as compa789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
haps even as early as the 1st quarter of 2001.
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nies
adopt
the
process
model
and
migrate
away
from
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In a nutshell, QS-9000 registered companies
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the 20 element model. As a result, the old standard
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need to become very interested in ISO 9001:2000
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should succumb to a natural death during this three789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
and TS 16949 very soon. These standards are in your
year period. The changes in ISO 9001:2000 will be
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789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
future.
captured in TS 16949 which, for all practical pur789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
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The current TS 16949 will be affected sigposes, will become the fourth edition of QS-9000.
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nificantly by the revised TS 16949 Part One of
Despite the integration of the European stan789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
this series discusses the impact of ISO 9001:2000,
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dards, 90 to 95% of ISO/TS 16949 is derived from
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in terms of both structure and the process model.
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QS-9000 content. Accreditation for this new Tech789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
(continued on page 4)
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1234567890123456789012345678901212345678901234567890123456789012123456789012345678901234567890
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Impact of ISO 9001:2000 (continued from page 3)
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For QS/TS companies, Omnex recommends one
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1234567890123456789012345678901212345678901234567890123456789012123456789012345678901234567890
of two methodologies for QMS implementation
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in the transition to ISO/TS 16949: Second Edition.
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Part One discusses the Process Review method1234567890123456789012345678901212345678901234567890123456789012123456789012345678901234567890
ology.
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ISO 9001:2000 Structure
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The ISO 9001:2000 structure is based on
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five
principal
components rather than the 20 ele1234567890123456789012345678901212345678901234567890123456789012123456789012345678901234567890
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ments in TS 16949/QS-9000. This fundamental
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change will significantly affect the documentation
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structure of a companys Quality Management Sys1234567890123456789012345678901212345678901234567890123456789012123456789012345678901234567890
1234567890123456789012345678901212345678901234567890123456789012123456789012345678901234567890
tem. (Although ISO 9001:2000 is quite flexible in
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its approach to documentation, Omnex does not
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expect TS 16949 2nd Edition to be quite as toler1234567890123456789012345678901212345678901234567890123456789012123456789012345678901234567890
1234567890123456789012345678901212345678901234567890123456789012123456789012345678901234567890
ant.)
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At a minimum, the traditional policy-based
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Quality Manual will need to be rewritten and re1234567890123456789012345678901212345678901234567890123456789012123456789012345678901234567890
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oriented; however, the key changes to TS 16949:
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2nd Edition will involve the process mapping and
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the process orientation required by the ISO
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9001:2000 standard.
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Process Model and Measurement of Processes
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In all probability, TS 16949 2nd Edition will
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not prescribe element-based procedures. As a result,
Figure 1: Process Map
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organizations that have structured their procedures in
and TS 16949 organizations.
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alignment with the QS-9000 elements can expect some
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Most well-managed automotive companies
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major document rework ahead. The next edition of
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will recognize the need to document these processes.
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TS 16949 will require companies to document their
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Omnex recommends that companies use Process Re1234567890123456789012345678901212345678901234567890123456789012123456789012345678901234567890
Product Realization Process, i.e. the process of creat1234567890123456789012345678901212345678901234567890123456789012123456789012345678901234567890
view, a methodology that uses Advance Quality Plan1234567890123456789012345678901212345678901234567890123456789012123456789012345678901234567890
ing and producing new products, from concept to de1234567890123456789012345678901212345678901234567890123456789012123456789012345678901234567890
ning tools to improve and control non-manufacturing
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livery to the customer. In addition, support processes
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processes. Process Review employs a Process Flow
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that affect the capability of the product realization pro1234567890123456789012345678901212345678901234567890123456789012123456789012345678901234567890
(PF), Process Failure Modes and Effects Analysis
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cess (e.g. Procurement, Staffing), QMS processes (e.g.
(PFMEA), and Control Plan (CP) and Improvement
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Internal Audit, Corrective Action, Document Control)
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Plan for all the processes identified by the organiza1234567890123456789012345678901212345678901234567890123456789012123456789012345678901234567890
and Business processes (e.g. Marketing, Advertising)
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tion. Of course, the key to effectively employing this
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will need to be identified. (See Figure 1 on this page)
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approach involves efficiently adapting these tools for
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Even though procedurally documenting all of
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service process flows, something Omnex has done for
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these processes may not be required, evidence will be
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several years in a wide variety of non-manufacturing
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required to verify that the control of these processes
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industries. These process flows also effectively docu1234567890123456789012345678901212345678901234567890123456789012123456789012345678901234567890
is effective. In addition, organizations will need to
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ment the process and serve as procedures. (See Figure
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have processes which ensure the availability of re2 on page 7)
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sources and information to support the functioning
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These approaches to documentation, measure1234567890123456789012345678901212345678901234567890123456789012123456789012345678901234567890
of these processes. The standard will also require that
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ment,
monitoring,
and improvement of processes do
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all processes be measured, monitored and improved.
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not have to wait for TS 16949 2nd Edition. Automotive
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This is a major new expectation, even for QS-9000
1234567890123456789012345678901212345678901234567890123456789012123456789012345678901234567890
(continued on page 7)
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O M N E X
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BUILDING SUCCESS WORLDWIDE
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Training Schedule is subject to course load requirements; dates may vary. Please contact Omnex for
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the most current information and a copy of our catalog outlining our full course offering.
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Training
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Learn the best techniques for
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February 5 & 19, 2001
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Training

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Impact of ISO 9001:2000 (continued from page 4)
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companies should start employing them immediately
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as effective ways to enhance competitive capability
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and improve the bottom line. After all, that should be
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why an organization does any of this!
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Chad Kymal is President, consultant, and trainer for Omnex. He is
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on the Malcolm Baldrige Board of Examiners and has a BSME from
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General Motors Institute, and has an MS degree in Industrial Op789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
erations Engineering and an MBA from the University of Michigan.
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David Watkins is President of OMEC and a senior trainer/consult789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
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ant. He has a wide range of international experience focused on
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enhancing his clients ability to create value for customers and stock789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
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holders and integrating quality and management systems to enhance
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performance
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Joe Macko is President of AQSR International and former Vice Presi789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
dent of Magna, Inc. He has more than 25 years experience in the
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Figure 2: Sample Procedure
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automotive and manufacturing industries. For more information
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about AQSR, visit www.aqsr.com.
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Mexico Office Celebrates Anniversary
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Omnex News Around the World
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Omnexs Mexico office celebrated its first anniversary in opera789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
tion this October. We congratulate Melesio Rosales, our office
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Manager, and Jose Rosales, our sales representative.
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First ISO 9001:2000 FDIS in Asia
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Omnexs India operation enjoyed a successful implementation of
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the ISO 9001:2000 at Skycell, a cellular service provider. The
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company was audited by Underwriters Laboratories Registrar on
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September 11th and 12th. According to the UL Registrar, this is
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one of the few companies around the world which has been certi789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
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fied with zero Corrective Action Requests (CARs).
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Omnex Opens Offices in California
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Omnex Systems and AQSR recently opened an office in the Sili789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
con Valley. The Silicon Valley office will be the West Coast con789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
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tact for companies that require on-site or open enrollment training
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seminars. The West Coast office is located with MEPCOM, the
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Dave Watkins, President of Omnex Management and Engi789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
organization that oversees the semiconductor trade associations
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neering Consultants (OMEC), presented a paper on The
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MEPTEC (MicroElectronics Packaging and Test Engineering
Past and Future of Automotive Quality Management Sys789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
Council) and SAC (Semiconductor Assembly Council) in Moun789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
tems to the Auto Trend 2000 Conference in Shanghai.
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tain View, California.
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Semi-conductor Quality
Omnex links up with Delphi and TRW
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Omnex works with the best companies in the world including ST
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Omnex Management and Engineering Consultants, LLC,
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Microelectronics, Philips, Texas Instruments, and Sony Semi-conalong with its partners in Global Learning Center, LLC, has
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ductor. Omnex is advising and leading the way in teaching quality
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been awarded a contract by Delphi Automotive Systems to
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in the semi-conductor industry. Chad Kymal, Omnex President
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participate in the development and operation of the Delphi
presented a course Integration of ISO 9001:2000 and TS 16949
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Global University. As part of GLC, OMEC will be running
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to the semi-conductor industry in the SAC conference at New Or789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
the supplier training website and will be providing training
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leans in June of this year. He is also presenting a course titled
to Delphi employees and suppliers worldwide through the
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The Revised Quality System Checklist-SAC-STD-007: Integrat789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
auspices of the University. TRW has also awarded a con789012345678901234567890121234567890123456789012345678901212345678901234567890123456789012123
ing ISO\TS 16949, ISO 9004 and the Semi-conductor Suppletract to Omnex for Global Training in TS 16949, ISO
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mentabout how to audit these standards. Best in Class reports
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9000:2000 and in supplier development.
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will be made available on the Omnex website.
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Call today for your free demo
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734-761-4940
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info@omnex.com
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www.omnexsystems.com
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BULK RATE
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3025 Boardwalk
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PAID
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Ann Arbor, MI 48108
Ann Arbor, MI
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Tel: (734) 761-4940
Permit #502
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Fax: (734) 761-4966
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e-mail: info@omnex.com
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www.omnex.com
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