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The New Era of Standards:

An Auditor’s Point of View

Once you understand ISO/TS 16949:2002, you will find that not only
is it more comprehensive than QS-9000, but it also mirrors how
most companies operate.

By Tony Perkins and Brian Keckler

ith the release of ISO/TS 16949: when upgrading from QS-9000 to ISO/TS exclusion permitted for companies regis-

W 2002, many organizations are won-


dering what to do next. This isn’t
just an update to QS-9000, as we have
16949:2002 is, “Do we meet the applica-
bility for ISO/TS 16949:2002 registration?”
Though always the intent of both standards,
tered to ISO/TS 16949:2002 is 7.3, Design
and Development. This is only for compa-
nies that are not design responsible. Design
experienced in the past; it is a completely the International Automotive Task Force and development companies are described
new standard. It is a standard with only (IATF) and the International Automotive as “organization[s] with authority to estab-
eight elements and a lot of new terms like Oversight Bureau (IAOB) have made it lish a new, or change an existing, product
continual, process, realization, focus, compe- clear that the applicability and scope of specification.” A further clarification is that
tence and empowerment. ISO/TS 16949:2002 will be strictly enforced. most companies have a manufacturing
Your first reaction might be one of The applicability of ISO/TS 16949:2002 design process, and this would make them
frustration: “We were just getting used to is first apparent on the cover of the docu- design responsible.
QS-9000 and ISO/TS 16949:2002 doesn’t ment itself, as it is a Technical Specification
look anything like it!” However, rest assured for the automotive industry developed by Making an Upgrade
that once you understand ISO/TS the IATF and the Japanese Automobile The process of going from QS-9000 to
16949:2002, you will find it more com- Manufactures Association (JAMA). On ISO/TS 16949:2002 is called an upgrade.
prehensive than QS-9000. You will also page one of the standard, you will see the Keep in mind that only 48 of the current
find that it mirrors how most companies scope of the Technical Specification reads, 173 QS-9000 registrars have been recog-
operate. “Defines the quality management system nized by the IATF to conduct audits to
In addition, significant improvements requirements for the design and develop- ISO/TS 16949:2002. Consequently, your
in the oversight process will reduce incon- ment, production and, when relevant, instal- current QS-9000 registrar may not be able
sistencies between registrars and auditors. lation and service of automotive-related to upgrade you to ISO/TS 16949:2002.
The bottom line is you will have a man- products.” The applicability of a location Traditionally, when “upgrading,” a suppli-
agement system that will benefit your organ- must meet the definition of a site, which is er would conduct a “gap analysis” to deter-
ization and focus your company on under- described as a “location at which value- mine the differences between the two
standing and meeting your customer’s added manufacturing processes occur.” standards by element and determine any
expectations. This article is an overview on Manufacturing is defined as the “process of additional requirements that must be added
the differences of core principles in the stan- making or fabricating production materi- to the existing system. Alternatively, some
dard of the past and the ISO/TS 16949:2002 als, production or service parts, assemblies, organizations consider re-writing their
requirements today. or heat treating, welding, painting, plating system in its entirety to mirror the new stan-
or other finishing services,” i.e., value-added dard. Many of us went through this process
Know the Rules processes. (Editor’s note: For further clarifi- when going from the second edition of
To understand the differences between cation, please contact your registrar or an IATF QS-9000 to the third edition. Often times,
the standards, start with the rules. One of oversight office.) your registrar would perform the upgrade
the first questions you must ask yourself It is also important to note that the only audit at the next regularly scheduled sur-

24 Exploring ISO/TS 16949:2002


veillance audit. With the differences
between these two standards, you will need
more than a paper exercise to successfully Eight quality management principles
upgrade. have been identified that can be used by
When comparing QS-9000 to ISO/TS
16949:2002, you must consider the quali- top management to lead the organization
ty management systems upon which they toward improved performance.
are based. QS-9000 is based on the element
model of ISO 9000:1994, whereas ISO/TS
16949:2002 is based on the process approach 1) Customer focus
principle of the latest ISO version, ISO Organizations depend on their customers and therefore should
9001:2000. In addition, the eight quality understand current and future customer needs, should meet cus-
management principles (see Figure 1) form tomer requirements and strive to exceed customer expectations.
the basis for the quality management sys-
tem within the latest ISO 9000 family of
standards, including ISO/TS 16949:2002. 2) Leadership
You may feel that you’ve already Leaders establish unity of purpose and direction of the organization.
embraced these ideas. Well, ISO/TS They should create and maintain the internal environment in which
16949:2002 has embedded these principles people can become fully involved in achieving the organization's
into the fabric of the quality management objectives.
system requirements. Through a close exam-
ination of the standard, you will see many 3) Involvement of people
examples of how these governing princi- People at all levels are the essence of an organization and their full
ples have been integrated into the standard, involvement enables their abilities to be used for the organization's
and subsequently, how they will be better benefit.
instilled into the core of your quality man-
agement system by upgrading to the new 4) Process approach
standard. A desired result is achieved more efficiently when activities and
related resources are managed as a process.
Process Approach
The primary element-by-element 5) System approach to management
approach of QS-9000 has been replaced by Identifying, understanding and managing interrelated processes
the process approach. Remember writing a as a system contributes to the organization's effectiveness and
procedure for each QS-9000 element to efficiency in achieving its objectives.
address your compliance for that element?
No more! Such an approach for the ISO/TS 6) Continual improvement
16949:2002 requirements will prove inef- Continual improvement of the organization's overall performance
fective. Who runs their business that way, should be a permanent objective of the organization.
anyway? How many times has a manage-
ment representative brushed the dust off
the quality manual during an audit? 7) Factual approach to decision making
ISO/TS 16949:2002 is much more than Effective decisions are based on the analysis of data and
a business management system; it is information.
the way your business operates. That is,
ISO/TS 16949:2002 asks you to identify 8) Mutually beneficial supplier relationships
the processes (not just production, but sup- An organization and its suppliers are interdependent and a mutually
port processes as well) that make up your beneficial relationship enhances the ability of both to create value.
quality management system and then asks
you to look at the sequence and interaction These eight quality management principles form the basis for the
of the identified processes. This is a change quality management system standards within the ISO 9000 family.
from the checklist method used in the past.
Now, your organization must make an eval-
uation of itself and identify what processes Source: ISO 9000:2000 Quality Management Systems – Fundamentals and Vocabulary
should be incorporated into its manage-
ment system.
Figure 1. Quality Management Principles

Exploring ISO/TS 16949:2002 25


A P

E C D Input E E
X Output E
PROCESS E X
T T
E Input A
A P
E
Output A
R PROCESS A C D R
N N
A P
A A
Output D
L C D Input C Input D
PROCESS C PROCESS D L
Output C
C Input B A P A P
PROCESS B C
U Output B U
C D C D
S A P S
T T
C D InputF F Output F
O Input
O
M Internal PROCESS F Internal M
E Customer Customer
Feedback E
R A P
R
C D

Figure 2. Process Elements

The process approach requires clear and data for analyzing process performance an opportunity to streamline and enhance
understanding of all processes implement- with respect to meeting quality objectives current quality system documentation to
ed within an organization. This includes or product/service input and output char- be consistent with the process approach.
processes for product realization, as well acteristics. Processes are managed to under- In addition to a documented quality poli-
as the other processes of the quality man- stand and meet current and future customer cy, documented quality objectives and a
agement system (QMS). Requirements for needs, as well as to meet customer require- quality manual, the ISO 9001:2000 core
these processes are stated in the following ments while striving to exceed customer requirements of ISO/TS 16949:2002 only
clauses of ISO/TS 16949:2002: expectations. mandates six specific procedures (see Figure
4) Quality management system This may sound foreign at first, but think 3); other documents, as determined by the
5) Management responsibility about how your business really functions. need of your organization for the effective
6) Resource management You will be modifying the quality system control of your processes; and records, which
7) Product realization requirements around the processes of your are considered a special form of documents
8) Measurement, analysis and improve- organization. It should be clicking in your (see section 4.2 of ISO/TS 16949:2002).
ment mind by now that process mapping will Keep in mind that ISO/TS 16949:2002 has
A process consists of one or more activ- be a valuable technique for looking at your documentation requirements, such as those
ities that transform input into output. Inputs organization’s processes. under sub-elements 7.5.1.2 and 7.5.1.3.
and outputs may be products that are If based on a process approach, much of
tangible and/or intangible. To perform activ- Less Paperwork your existing documentation will already
ities within the process, appropriate resources Did we mention less emphasis on doc- be suited to the new standard (perhaps ele-
should be allocated. A measurement umentation? Although not a requirement, ments such as purchasing, those listed in
system can be used to gather information most companies will look at the upgrade as Figure 2 and most work instructions).

26 Exploring ISO/TS 16949:2002


Focus on the Customer
The new requirement focuses attention
Six Mandatory Procedures beyond documentation and simple com-
pliance to the standard and onto under-
✔ 4.2.3 Control of Documents standing your customer-specific require-
ments, customer satisfaction, efficient
✔ 4.2.4 Control of Records handling of customer-oriented processes,
and the performance of your organization.
✔ 8.2.2 Internal Audit As a registrar, we will be not only looking
at implementation, but also at effectiveness
✔ 8.3 Control of Nonconforming Product by assessing the means by which your organ-
ization measures, analyzes and improves the
✔ 8.5.2 Corrective Action conformity of product, quality system and
effectiveness of your own quality manage-
✔ 8.5.3 Preventive Action ment system (see section 8.1 of ISO/TS
16949:2002).
Figure 3. Core Requirements Mandatory Procedures Besides the monitoring and measure-
ment requirements carried over from
QS-9000 that we were all familiar with
Overall, the opportunity to reassess the dened with committing resources to main- (management review, internal audit,
quality system documentation will be a taining quality system documentation that corrective and preventive actions), new
benefit to small and large businesses alike; often times was voluminous, wordy and analysis and measurement aspects of ISO/TS
no doubt, many organizations were bur- cumbersome. 16949:2002 include:

Exploring ISO/TS 16949:2002 27


■ Measurable quality objectives, defined progress towards objectives and actions relat- ments are also high on the list of things that
by top management, at relevant functions ed to customer satisfaction (8.4) an organization’s personnel must be aware
and levels within the organization (5.4) of, as well as how non-conforming products
■ Enhanced requirements for the man- Changes in Requirements affect the customer. Organizations must
agement review process (5.6) Now that we have some of the funda- also demonstrate their ability to motivate
■ Customer satisfaction, including cus- mental differences between the two stan- personnel to achieve goals and objectives,
tomer perception as to whether customer dards out of the way, let’s look at some of the thereby improving the quality management
requirements have been met by the organ- changes in the requirements of the ISO/TS system.
ization, with emphasis on: 16949:2002 standard. A great deal of infor-
– Delivered part quality performance mation is available comparing the elements Summing Up
– Customer disruptions including field of QS-9000 to ISO/TS 16949:2002. In this The overall difference between QS-9000
returns article, we will focus on what we think are and ISO/TS 16949:2002 is the approach
– Delivery schedule performance (includ- four significant changes in the standard that that organizations must use to demonstrate
ing incidents of premium freight) remain unaddressed to this point. compliance to the newer standard.
– Customer notifications related to An increased emphasis on quality plan- Organizations must first be able to demon-
quality or delivery issues (8.2) ning is apparent in ISO/TS 16949:2002. strate that they understand and describe
■ Monitoring and measurement of While APQP has always been the guidance themselves, their customers’ requirements
processes to demonstrate that the quality document of note for automotive quality and all of the processes used to satisfy those
management processes and manufacturing management system standards in North requirements. Furthermore, organizations
processes are achieving desired results (8.2.3 America, ISO/TS 16949:2002 allows for must demonstrate that they are continual-
and 8.2.3.1) flexibility in the approach to quality plan- ly seeking to ascertain their customers’ per-
■ Analysis and use of data, including ning activities. This flexibility, however, is ception of them as an organization and con-
characteristics, process and product trends, based primarily on the customers’ require- tinually set realistic goals to improve upon
ments. The fundamental difference between the level of customer satisfaction by using
QS-9000 and ISO/TS 16949:2002 is sound judgment and good business plan-
the requirement to use design control ning practices. In short, ISO/TS 16949:2002
disciplines for the design of processes, is a far superior standard to QS-9000, due
irrespective of product design responsibili- to the use of the process model and the abil-
ty. This method provides for improved ity to recognize organizations as individual
quality planning in an effort to deploy and unique, not a bunch of clones with ele-
customer-specific requirements throughout ment-based quality management systems.
the product realization process. Together, all these requirements will ben-
As for actual manufacturing/production efit your organization in ways not required
processes, ISO/TS 16949:2002 lends itself by QS-9000. They will provide a basis
to capturing the entire product realization throughout your organization and, in par-
process—from concept to deliverable ticular, for top management to make informed
goods—much more effectively than with decisions based on factual information. This
QS-9000. A typical ISO/TS 16949:2002 information can be used to gain a better
audit of manufacturing processes would understanding of what your customer
begin with a review of the actual plans for requirements are and how you can improve
the product to be produced and a compar- the quality of product you provide to the final
ison of that to tangible results. The most customer. For those companies that have
important audit trails are those that verify experienced a decrease in the initial bene-
that customer-specific requirements fits of QS-9000, this is your opportunity to
addressed during quality planning activi- tune up your existing management system.
ties are being monitored, measured and ana-
lyzed with real data. Tony Perkins is the automotive sector man-
How will this new standard affect your ager and director of marketing for QMI. He
staff? To be sure, ISO/TS 16949:2002 goes has been working in third-party registration and
much further than QS-9000 ever did specializing in automotive for the last six years.
in requiring organizations to specify the Brian Keckler has worked as an auditor since
competency required for all positions in the 1991, auditing in the automotive sector from
organization and to measure the incum- the inception of QS-9000 in 1995. He is a
bents’ performance against established goals certified QMS lead auditor for QS-9000/TE
and objectives. Customer-specific require- Supplement/ISO/TS 16949 (currently 1999).

28 Exploring ISO/TS 16949:2002

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