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How Can You Move From QS-9000 to TS 16949:2000?

Key Challenges of the QS-9000to TS 16949:2002 Tr ansit ion

By Chad Kymal andDavid Watkins

Publisher’s Note: This article has beenreprinted with permission from TH E

INFORMED OUTLOOK Newsletter, November 2001 issue.

The final draft of ISO Tech-

nical Specification (TS)

16949:2002 is now available.

Although its circulation is limited to a

small group within the international qual-

ity management standards community, it

is a sign that ISO/TS 16949:2002, Qualitymanagement systems—Automotive suppli-

ers—Particular requirements for the applica-tion of ISO 9001:2000, will be soon

released to the larger public. Voting on TS

16949:2002 will conclude in December

2002, with the second edition’s release

expected by March 1, 2002.

What is still missing are the cus-

tomer-specific requirements of the original

equipment manufacturers (OEMs) for the

use of TS 16949:2002. These require-

ments, usually available on an OEM’s web

site and accessible by its suppliers, must be

used by a supplier to achieve quality man-

agement system (QMS) conformance with

TS 16949:2002 so as to satisfy the require-ments of a particular existing or poten-

tial OEM customer (e.g., BMW,

DaimlerChrysler, Fiat, Ford, GM,

Pugeot, Renault, Volkswagen) beyond

what TS 16949 requires. OEMs requir-

ing use of TS 16949 and customer-specific requirements may eventually

include Japanese and South Korean

OEMs.

Most QS-9000-registered suppliers

will transition their quality systems to

TS 16949:2002 by December 15, 2003,

when ISO 9001/2:1994 and TS

16949:1999 certificates of registration

will no longer be recognized. There are

two reasons why most suppliers will

make the transition:

1. Customers will soon be mandating

TS 16949:2002 registration by Decem-

ber 2003 as a contractual requirement

(for the latest on the Big Three’s registra-

tion requirements, see the box below).

2. Suppliers will want an ISO

9001:2000-registered QMS to gain the

improvements in the 2000 edition and

satisfy requirements of nonautomotive

customers.

As we stated in “A Plan for the

Transition From Q S-9000 to TS

16949:2002” (THE OUTLOOK , Au-

gust 2001), the second in our series of guidance articles on preparing for and

making the transition, TS 16949:2002

is more influenced by ISO 9001:2000’s

new structure than any new automo-

tive-based requirements change.

For the most part, the first edition

of TS 16949 has been faithfully mapped

into the ISO 9001:2000 framework to

create TS 16949:2002 (for more infor-

mation, see “The Impact of ISO

9001:2000 on QS-9000 and ISO/TS

16949”, THE OUTLOOK , May 2001,

the first article in this series).

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

What Ar e t he Big Thr ee Requir ing Now ?

Rumors have it that DaimlerChrysler, Ford and GM will require their tier 1

suppliers to become registered to TS 16949, preferably the second edition.

Also, QS-9000 is expected to be extended to 2005 for those suppliers that have

contracts only with domestic US facilities of the Big Three. Suppliers that are

not t ier 1 and do not want the ISO 9001:2000/TS 16949:2002 registration

could technically stay QS-9000-registered for the time being.

In other words, QS-9000 will not be revised to align with ISO 9001:2000.

Also, per the International Accreditation Forum (IAF), all certificates of registra-

tion to ISO 9001/2/3:1994—including sector-specific ones involving QS-9000

(and thus ISO 9001/2:1994) will have to be upgraded to ISO 9001:2000 by

December 15, 2003. 1994-based certificates will not be considered valid after that

date (except by the Big Three, as noted).



2 4 TH E I N FO R M ED O u t l o o k Reprint: November 2001

© 2001 by INFORM & ASQ Web Site: HTTP:/ / WWW .INFORM INTL.CO M

The biggest challenge for QS-9000-

registered companies will be the cus-

tomer focus and process focus contained

in this Technical Specification. What we

consider the most significant changes

that organizations transitioning from

QS-9000 to TS 16949:2002 will face

are contained in 15 clauses and

subclauses of ISO 9001:2000/TS

16949:2002 that are summarized in

Table 1 below.

In this article, we will explore three

Reprinted with permission from

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of these clauses—4.1, Quality Manage-

ment System—General Requirements,

7.3, Design and Development, and 7.4,

Purchasing.

4.1, Quality ManagementSystem—General Requirements

This clause in ISO 9001:2000 and

TS 16949:2002 will require an organi-zation to go beyond Q S-9000 and iden-

tify the processes within its hierarchical

organizational structure. The organiza-

tional structure and the chain of com-

mand follow Fredrick Winslow Taylor’s

theory of “specialization”—what is

known in the automotive industry as

organizational silos or chimneys, as

shown in Figure 1 on page 3.

In TS 16949:2002 terms, products

are “realized” by processes, which would

thus require a QS-9000-registered orga-

nization to identify the “product realiza-tion” processes and the “support”

processes. These processes provide not

just for the product, but are also respon-

sible for satisfying the customer.

Two ISO 9001:1994 paradigms

need to be discarded at this stage. One is

that the organization can exclude pro-

cesses not specified in the requirements

of TS 16949:2002. Clause 1.2, Applica-

tion, in ISO 9001:2000 and TS

16949:2002 is careful to point out that

only processes that do not “affect the

organization’s ability, or responsibility,

to provide product that meets customer

and applicable regulatory requirements”

can be excluded from the QMS’s scope.

A “requirement” is defined in 3.1.2

of ISO 9000:2000, Quality management systems—Fundamentals and vocabulary,

as a “need and expectation”. In other

words, an organizational entity or a

process can only be “scoped out” from

the QMS if it does not affect customer

needs or expectations.

Now, it is questionable if organiza-

tions can scope out research and devel-

opment (R&D) centers or sales offices,because customer needs cannot be met

without them if your organization has

Table 1. The 15 Tr ansit ion Challenges for QS-9000 Or ganizati onsClause/ Subclause Influenced by Challenges

4.1, Quality Management ISO 9001:2000 Requirements for process map (orSystem—General equivalent) and process managementRequirements

5.2, Management ISO 9001:2000 Decision on customers vs. interestedResponsibility— parties. Need for process to gatherCustomer Focus “needs and expectations” of customer/

interested parties

5.4.1, Planning— ISO 9001:2000 & Deployed Objectives addressingQuality Objectives TS 16949:1999 customer expectat ions

5.5.3, Internal ISO 9001:2000 Creation of internal communicationCommunication processes suitable to organization

5.6, Management Review ISO 9001:2000 & Revision of previous managementTS16949:1999 review process (TS adds additional items

to be reviewed)

6.1, Resource Management ISO 9001:2000 Establishment of a resource allocation—Provision of Resources process

6.2, Human Resources ISO 9001:2000 & Provision of job competency, on-the-job(particularly 6.2.2.3 on TS 16949:1999 training and employee motivationempowerment) (6.2.2.3 and 6.2.2.4)

7.0, Product Realization ISO 9001:2000 Documents for “effective control” of allprocesses in process map

7.1.4, Change Control New (actually Minor change for most suppliersFord’s Q-101)

7.3, Design and New Inclusion of design and development of Development processes, not just product (note

required development and use of FMEAs)

7.4, Purchasing New Inclusion of service suppliers in cover-age; ISO 9001:2000 registration of suppliers

8.2.1, Monitoring and ISO 9001:2000 Customer rating for quality and deliveryMeasurement—Customer insufficient; monitoring of “customerSatisfaction perceptions” of quality

8.2.2, Internal Audit TS 16949:1999 Manufacturing process and productaudits

8.2.3, Monitoring and ISO 9001:2000 & Process studies on manufacturing pro-Measurement of Processes TS 16949:1999 cesses. Measurement of all processes in

process map

8.4, Analysis of Data ISO 9001:2000 Increased scope from QS-9000



Volume 6, Number 11 T H E I N FO RM ED O u t l o o k 4 3

INFORM: (703) 680-1436; ASQ: (800) 248-1946 © 2001 by INFORM & ASQ

them. Furthermore, TS 16949 has ex-

panded the applicability of Clause 7.3,

Design and Development, to both prod-

uct and processdesign by including

7.3.2.2, Manufacturing Process Design

Input, and 7.3.3.2, Manufacturing

Process Design Output. No organiza-

tion implementing TS 16949:2002 can

exclude 7.3, Design and Development,because every product and service parts

supplier has production processes that

need to be designed and developed

using the QMS.

The other paradigm is that an orga-

nization does not have to control its

supplier’s processes unless the customer

requires it. The last paragraph of 4.1 in

ISO 9001:2000 and TS 16949:2002

clearly states that, when the organization

“chooses to outsource any process that

affects product conformity with require-

ments, the organization shall ensure

control over such processes.”

Subclause 4.6.2, Evaluation of

Subcontractors, in ISO 9001:1994 and

QS-9000 does require an organization

to exercise control over its suppliers, but

only to meet customer requirements for

subcontractors and to the extent neces-

sary to ensure supplier-provided product

meets specifications relative to the

organization’s product.

With TS 16949:2002, an organiza-

tion will need to include outsourced

processes within its process map and

QMS whenever a supplier can affectthe organization’s product, including

heat treating or plating or any compo-

nent of an assembly manufactured by

that supplier.

A process map is a flowchart that

maps out all the processes and their

elements that define what your organi-

zation does, including all its key activi-

ties and more. When creating a process

map, an organization will need to go

beyond the clauses and subclauses of TS

16949:2002 to truly meet its require-

ments for an effective QMS.Telltale signs to auditors that a

QMS is not truly effective is a process

map that only includes QMS elements

related to the standard being audited

against. Inherently, a “process focus” is

different from a “departmental focus” in

that a process may move through every

department within an organization.

The antithesis of the process ap-

proach promoted by ISO 9001:2000

and TS 16949:2002 is the compliance-

driven approach of many organizations,

which implemented quality system

procedures based solely upon elements

of QS-9000 without any thought to

creating systems that actually support

and enhance the processes within their

operations.

Our organization recommends thatyour organization study four types of

processes for inclusion in the process

map:

q TS 16949 Processes

q Product Realization Processes

q Support Processes

q Business Processes.

TS 16949:2002 processes are those

that inherently fulfill the requirements

of the TS. Product Realization Processes

include product ideation, R&D, mar-

keting, design and development all the

way through to delivery of product and

post-delivery services. Support Processes

aid the overall organization, including

operations such as training, purchasing

and document control. Business Pro-

cesses are those that differentiate your

organization from its competitor and

help fulfill “customer needs and expecta-

tions”. Business Processes are the most

important for the success of a business.

Of course, there is overlap in the four

types of processes, as shown in Figure 2

on page 4.

By definition, Product Realization

and Support Processes are exclusive. Inother words, a process can either be a

support process or a product realization

process, while TS 16949 Processes and

Business Processes can be both product

realization and support processes.

After studying the different pro-

cesses, your organization can create a

process map that identifies its processes.

The process map also can show the “se-

quence and interaction” of these pro-

cesses. Two diagrams presenting completeprocess maps appeared as Figure 1 in

both previous articles in this series.

7.3, Product Realization—Design and Development

The two most significant changes

in Clause 7.3 of TS 16949:2002 are the

exclusion of advanced product quality

planning (APQP) as a requirement and

the inclusion of manufacturing process

design as a new requirement. APQP was

excluded because most OEM representa-

tives to the International AutomotiveTask Force (IATF) do not support the

Big Three’s approach of requiring APQP,

which is expected to become a customer-

specific requirement of DaimlerChrysler

Corporation, Ford and GM.

The inclusion of manufacturing

process design input and output require-

ments (7.3.2.2 and 7.3.3.2) by the IATF

is significant. QS-9000-compliant orga-

nizations will need to carefully study the

requirements in 7.3 for process design

and make the necessary changes to their

APQP process. The real challenge comes

when an organization actually has toimplement these changes. In some QS-

9000-registered organizations, the pro-

Process Variation Output

w w

Figur e 1. Pr ocess Focus: Theor y of “ Specialization”



4 4 T H E I N FO RM ED O u t l o o k Reprint: November 2001


cess-engineering group is only one or

two people who will be responsible for

conformance.

However, QS-9000-registered orga-

nizations should not view this change as

a negative. When the first edition of QS-

9000 was released in August 1994, the

payback to design-responsible organiza-

tions was a systematic design process.Many organizations went from chaotic

product design to systematic design

development. With TS 16949:2002, one

payback will be a systematic process for

manufacturing process design.

What are the challenges of incorpo-

rating manufacturing process design

into a QMS? Although TS 16949:2002

only specifies design input and output

requirements, to satisfy the TS’s require-

ments effectively an organization will, in

actuality, need to carefully create a de-

sign and development plan that covers

all phases of process design, including:

q Manufacturing process design input

q Manufacturing process design out-

put

q Design and development reviews

q Monitoring of process design

q Design and development verification

q Validation of the manufacturing

process.

Organizations can decide whether

to include process failure mode and

effects analysis (PFMEA) as a verifica-

tion process and/or machine runoff as a

validation process. One opportunity isto build Mean Time to Repair (MTTR)

and Mean Time to Failure (MTBF) into

the process design, while another is to

build in the entire Reliability and Main-

tainability (R&M) methodology.

Leading-edge organizations are

already practicing these processes and

methodologies. An organization inter-

ested in the up-front involvement of its

tooling and equipment (TE) suppliers

can use the TE Supplement to QS-9000,

which offers guidelines and specifiesmethodologies for PFMEA, machine

runoff, R&M, MTTR and MTBF for

the entire life cycle of the manufactur-

ing process.

Process design has been elevated to

the same importance as product design

in TS 16949:2002. Now both design

and product have the same type of

expectations for inputs, outputs, verifi-

cation and validation. Tools such as

design FMEA, special characteristics,

Design Verification Plan and Report

(DVP&R) on the product design side

and tools such as process flow, PFMEA

and control plans on the process design

side need to be linked.

This is the “effectiveness in prac-

tice” or the results that can be derived

from implementing good product and

process design practices. Think of it as

preparing to take advantage of the com-

ing economic upturn, when the best-

run operations will win.

Another requirement closely

aligned with Clause 7.3 is TS

16949:2002’s 8.2.3.1, Monitoring and

Measurement of Manufacturing Pro-cesses, which requires all new processes

to be statistically studied. The closest

point of comparison is QS-9000’s Pro-

duction Part Approval Process (PPAP)

manual, which requires processes with

only special characteristics to be studied.

Many organizations will implement this

requirement as the last step of the

“Manufacturing Process Design and

Development” process.

The change in design and

development’s scope with Clause 7.3 toinclude process design will require both

new documentation and subsequent

implementation. But, if implemented

properly, this new requirement will

result in profits for organizations.

7.4, PurchasingThe purchasing requirements have

not changed very much from QS-9000.

Organizations will need to continue

following their purchase order process

(7.4.2, Purchasing Information), sup-

plier development process (7.4.1.2,Supplier Quality Management System

Development) and receiving inspection

process (7.4.3, Verification of Purchased

Product). What has changed is the scope

of supplier development and the new

requirement for supplier development

that involves a registration deadline.

With TS 16949:2002, there will

also be no leeway on what constitutes a

purchased product. NOTE 1 to 7.4.1,

Purchasing Process, defines purchased

products as “all products and services

that affect customer requirements….”

Organizations will be required to care-fully study their supplier lists and add in

all suppliers that affect customer needs

and expectations, per the previously

mentioned ISO 9000:2000 definition of

“requirement”.

As for registration requirements,

7.4.1.2, Supplier Quality Management

System Development, requires an organi-

zation conforming to TS 16949:2002 to

require its suppliers to register “to ISO

9001:2000 by an accredited third-party

certification body.” NOTE 1 to 7.4.1.2

requires that suppliers “comply” with ISO9001:2000 by December 15, 2003—the

IAF’s date for termination of the transition

to ISO 9001:2000. This, of course, is the

first step in the ultimate OEM goal of

driving the manufacturing supply base to

TS 16949, Second Edition.

Although NOTE 2 indicates that a

customer may “mandate alternative

requirements” for subcontractors, this

registration requirement is causing con-

Business andISO/TS 16949

Pr ocesses

Pr oductRealizationPr ocesses

Suppor tPr ocesses

Figur e 2. Relat ionship Among Pr ocesses in a TS 169 49-Based Or ganization



Volume 6, Number 11 T H E I N FO RM ED O u t l o o k 4 5

INFORM: (703) 680-1436; ASQ: (800) 248-1946 © 2001 by INFORM & ASQ

cern among QS-9000-registered organi-

zations, many of which do not feel they

have the clout to impose registration

requirements on their supply base. Our

organization has seen the effects of

quality system requirements on client

supply bases since Ford’s Q-101 and

GM’s Targets for Excellence.

Nevertheless, we encourage yourorganization to move forward as follows:

1. Determine your product and ser-

vice supply base (i.e., expand your key

supplier lists).

2. Determine the criteria and dead-

lines for supplier development require-

ments, including ISO 9001:2000

(December 15, 2003) and TS

16949:2002 (subsequently).

3. Announce the requirements and

criteria to your supply base.

4. Have evidence that you are trying

to comply with TS 16949:2002’s intent.Organizations typically mention all

the exceptions in justifying why they

cannot implement supplier development

(i.e., suppliers are unwilling, too small

or strategic). However, our organization

recommends that its clients formulate

their strategies around the 95% of their

supply base that is likely to cooperate,

rather than around the exceptions. If

you follow this strategy, both your cus-

tomer and your registrar’s auditor(s) are

likely to understand the odd exceptions.

Since no one is indispensable, the odd

exceptions will lose out in the long-term

by failing to adopt an effective way to

manage their operations.

We have just explored 3 of the 15

significant challenges we believe will

face Q S-9000-registered organizations

transitioning to TS 16949:2002. There

is a lot of work ahead for companies

that likely have only a little more than

two years remaining before an OEM

will be expecting registration to this

second edition. Organizations need to

make their plans to transition to the

second edition of TS 16949 today.How much work your organization

has ahead of it depends on the quality of

its Q S-9000-registered quality system.

To help you gain a better understanding

of what the transition will likely involve

for your organization, we have identified

an anonymous organization willing to

serve as a case study for transitioning to

TS 16949:2000.

Case Study of an International Tier1 Supplier

QSTS had a contract with an ac-

credited registrar qualified to conduct

QS-9000 registration assessments, but

the registrar was not on the Interna-tional Automotive Oversight Bureau

(IAOB) list of registrars qualified to

conduct TS 16949 assessments. At the

end of the registrar’s contract for QS-

9000, QSTS decided to switch to a

registrar included on the IAOB list

because it planned to transition to TS

16949:2002, thereby obtaining ISO

9001:2000 registration as well.

QSTS was confident it could very

easily transition to both ISO 9001:2000

and TS 16949, since it had already been

working for more than five years onmeeting excellence standards such as the

Malcolm Baldrige National Quality

Award.

The new registrar’s initial audit

provided for a QMS assessment that

would permit a registration transition

from ISO 9001:1994 and the third

edition of QS-9000 to ISO 9001:2000

and TS 16949:1999. However, the audit

was a wake-up call instead. The assess-

ment of QSTS ended up identifying

several major nonconformances, includ-

ing one that required the organization

to align itself with a “site” since it was

technically a “remote location”, despite

the fact that QSTS had a design center,

sales, purchasing and some senior man-

agement located in the US.

Some of the nonconformances

resulted from the lack of preparation by

the registrar’s auditors. In fact, they had

not completed a document review

(desktop audit) prior to the on-site

audit. The other nonconformances

existed because the organization was not

prepared for conformance to both ISO

9001:2000 and TS 16949:1999.QSTS has a few special circum-

stances that need to be mentioned (even

though they do not excuse legitimate

nonconformances), including that it has

10-15 product lines located in the

United States, while several of the busi-

ness units they report to are located in

Europe. What then is the definition of

“top management”?

After the poor showing on the audit,

QSTS contacted our organization. We

collectively decided that it did not make

sense for them to pursue ISO 9001:2000

and TS 16949:1999, but that they

should instead pursue ISO 9001:2000

and TS 16949:2002, which had justbecome available in final draft form.

The implementation is in its in-

fancy, and the scoping of the implemen-

tation is the first challenge. The second

challenge will be the requirements of

ISO 9001:2000 and TS 16949:2002,

especially Management Review, linkage

of processes and purchasing. This case

study will be expanded in upcoming

articles that will explore the remaining

12 challenges of TS 16949:2002 and

their impact on QSTS.

For now, any organization would bewise to focus on the three clauses of TS

16949:2002 discussed above, since they

are the starting point for effective con-

formance with ISO 9001:2000 and the

second edition of TS 16949. ###

Chad Kymal is Chief Executive Officer of Omnex, Inc., an international consulting,training and software organization specializ-ing in business quality improvement method-ologies. Omnex has worked with hundreds of organizations to meet the requirements of ISO9001/2/3, QS-9000 and ISO/TS 16949worldwide and obtain registration. He assistsorganizations worldwide in his capacity as aconsultant and trainer. Mr. Kymal recentlyserved on the Malcolm Baldrige NationalQuality Award Board of Examiners, has a

BSME from General Motors Institute and hasan MS in Industrial Operations Engineeringand an MBA from the University of Michi-gan. He can be contacted by e-mail([email protected]).For more information,visit www.omnex.com.

David Watkins is President of Omnex, Inc.,

and is a senior trainer/consultant. He has awide range of international experience fo-cused on enhancing the ability of organiza-tions to create value for their customers and stockholders and integrating QMSs and other management systems to enhance perfor-mance. Mr. Watkins can be contacted by e-mail ([email protected]).



6 4 TH E I N FO R M ED O u t l o o k Reprint: November 2001


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