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11
Certication to the International Standard
and Customer-Specic Requirements
Overview
Every organization worldwide is expected to follow some kind of basic quality
standards. In fact, it has become so critical that the International Organization
for Standardization has developed such a system called ISO 9001. This stan-
dard has been revised several times since the late 1980s and currently we are
at the 2008 revision. It is expected that a new version will be published by late
2015.The standard does not guarantee product quality, but rather establishes
the foundation for a good quality system. Because of this weakness, several
industries have added requirements to make the ISO 9001 system into a prod-
uct-oriented quality system. Examples of this are the ISO/TS 16949 (2009)
(automotive), the AS 9100 (2009) (aerospace), ISO/IEC 17025 (2005) (testing and
calibration), ISO/IEC 9126 (2001, 2003) (software), and many others.
In this chapter, we are going to give an overview of the requirements with-
out very much detail. The reason for the cursory review is that there many
sources (books, articles, blogs, and pamphlets) that the reader may nd help-
ful and as such it will be redundant effort on our part to reiterate what is
already available.
The signicance of the standard, however, for any organization is pro-
foundly important, and we believe that it should be covered here as an over-
view. With the overview, we hope the reader will understand the importance
and rationale of what the standard is all about. The general structure of the
standard follows the Plan, Do, Check, Act (PDCA) model.
It begins with noncertied items such as the scope that denes the bound-
ary of the standard; it is followed by the normative references, which were used
to generate the standards as well as how they relate to the actual text; and the
explanation of key terms and denitions and how they are used throughout
the text of the standard.
Once these informational items are presented, the standard moves into
the certiable elements. This means that the organization must be certied
as adopting and following the requirements as specied in the standard
128 Quality Assurance
through a third-party auditor recognized by the ISO organization. In general
terms, the structure follows the PDCA cycle.
• Plan: In this stage, we see the coverage of the overall quality sys-
tem and how it relates to the individual organization as well as how
management responds to it. Specically, it covers the
• Context of the organization: Here the standard focuses on the big
picture of the organization and its context as well as the needs
and expectations that are necessary for improvement. These are
expected to be appropriately dened, identied, and commu-
nicated throughout the organization. Furthermore, in this rst
item of the PDCA model, the inclusion of both scope and quality
management system/processes are dened.
• Leadership: Here the standard addresses the leadership respon-
sibility and commitment to quality. It focuses on having a policy;
roles, responsibility, and authority are clearly dened and cas-
caded throughout the organization.
• Planning: Here the standard focuses on how the organiza-
tion denes the risks and opportunity actions that bring about
improvement or need attention. This is done by making sure that
specic plans and planning changes are identied and incorpo-
rated in the organization. In other words, they become part of
the organizational culture.
• Support: Here, the standard addresses the need for dening,
developing resources, competence for needed skills, awareness,
and communication programs to make sure appropriate per-
sonnel are notied of the needs of the organization to improve,
and needed documented information exists to support manage-
ment’s commitment to continual improvement.
• Do: It is the stage where the standard is demanding some action to
verify that the planning activities are being carried out as planned.
Therefore, the focus here is on operations.
• Operation: By far the most important element of the PDCA model
is the verication and validation of what is being done and how this
action compares with what was planned. Its signicance is based on
the verication of what has been dened and implemented in the
planning stage. Without verication and validation, the planning
stage is not worth very much. Items recognized as important are
− Operational planning and control, that is, operational deni-
tions of requirements
− Determination of requirements that satisfy the customer
− Design and development of appropriate and applicable
requirements
129Certication to the International Standard
− Control of externally provided products and services (i.e.,
from subsuppliers)
− Production and service provisions, that is, alternative or con-
tingent plans
− Release of products and services, that is, meeting appropriate
milestones on time
− Control nonconforming process outputs, products and ser-
vices, that is, third-party inspection, dening quarantine
space, and disposition practices of the nonconforming item
• Check: In this stage of the PDCA model, the need for measurement
and how effective this measurement is are discussed in measuring
the process, product, or service. Specically, the item of concern is
performance evaluation. This is evaluated by
• Monitoring, measurement analysis, and evaluation, that is,
gauge R&R, ANOVA, etc.
• Conducting internal audit at frequent and predetermined time-
line, that is, layer audits
• Conducting regular management review of quality indicators
and quality improvement, that is, QOS regular reviews, cus-
tomer feedback, warranty issues, etc.
• Act: The nal stage of the model addresses the closure of the con-
tinual improvement process by directly addressing
• Nonconformities and appropriate corrective action
• Continual improvement documentation
• Comparative analysis of before and after corrective actions
implementation
ISO’s Key Elements
So now that we recognize the structure, how can we understand the ele-
ments (clauses) of the standard? In a summary form, one can review the
standard and see the following eight elements interwoven throughout its
context. They are
• Customer focus. Every organization exists because of their cus-
tomers. Therefore, management needs to understand who their
customers are, what they need, what excites (delights) them, and
then aim to meet their needs. The strategy for a successful orga-
nization must be to always try to understand the customer needs,
and provide satisfaction, loyalty, and trust. If the customer is not
130 Quality Assurance
appreciated and does not get the satisfaction that is expected, then
the organization will either go out of business or remain in a sta-
tus quo. A fundamental principle here is to understand the KANO
model and its signicance in customer satisfaction over time. The
parameters of the KANO model must be evaluated on a continual
basis. Those parameters are the basic characteristics (items taken
for granted), performance characteristics (items that meet mini-
mum market requirements), and excitement or delighted charac-
teristics (items that are a surprise or unexpected to the customer).
Here we must emphasize that over time, the surprise or unexpected
items become basic. Also over time, new characteristics become the
new surprise and unexpected characteristics because of customer
behavior changes, competition innovations, or new technology.
• Leadership. Leadership is the engine of any organization.
Management’s leadership guides the organization with the right
strategy, direction, and ultimate success for growth. The manage-
ment’s leadership style molds the culture of the organization via a
clear communication vision and purpose. Without a good leader-
ship, the organization will fail in due time.
• Involvement of people. Every organization depends on people. In
fact, the best asset that any organization has is its people. They
make the difference between excellence and just so-so performance
whether in sales, operations, management, engineering, customer
service, or behind the scenes. It is imperative that in order for the
people to be engaged in continual quality performance, they must
be empowered to do what it takes to complete the task at hand. This
means that they have to be appropriately authorized to carry out the
assigned task but they also have to be responsible (accountable) for
decision making within the boundary of their position.
• A process approach. It is a fact that most business (or organization)
activities are part of one or more processes. Therefore, these pro-
cesses should be viewed as a system rather than individual silos.
The results will be much better because the holistic approach will
examine individual processes but also their interaction.
• A systems approach to management. All businesses are systems,
made up of smaller parts. Therefore, the management should view
their organization as an integrated system and make decisions based
on optimization of the entire organization rather than suboptimiza-
tion (individual department maximization at the expense of some
other department).
• Continual improvement. Improving is essential—a permanent ele-
ment of any organization that wants to do well. The ISO standard is
full of both direct and indirect references to continual improvement
throughout.
131Certication to the International Standard
• A factual approach to decision making. Decisions should be based
on facts and evidence. In other words, organizations must be data
driven. This implies that the data must be dened (operational de-
nitions) in clear terms, must be appropriate, and must be applicable
to the task. Sampling, frequency, and analysis are of paramount
importance for a factual decision.
• Mutually benecial supplier relationships. This implies a win-win
relationship. That is, seeing the supplier/customer relationship as an
interdependent relationship that can provide benets to both parties
by focusing on an effective and efcient managing strategy.
This is a simple summary of whatthe ISO 9001:2008 standard for quality
management system says. To be certied to ISO 9001, you must meet all the
applicable requirements (things you must do or have). Rather than explain-
ing the requirements in detail, I will summarize them. The literature offers
an abundant resource for the explanation and the requirements of the stan-
dard in books and articles as well as the Internet. For a good search, start
with www.amazon.com or www.ASQ.org.
Individual Certifiable Clauses
In the previous section, we summarized some of the key threads of the
standard. Here we will identify each category and give the specic require-
ments of each. We have simplied the language for an easier understanding.
However, it should be pointed out that the standard is very specic in some
words that are used. For example,
• The word shall is a legal term and it means that it must be done.
• The word should implies recommendation.
• The expression such as is used to provide examples.
• The word note is used to provide explanations.
The actual certiable standard by the third party is Sections 4–8 and cov-
ers the following items.
Section 4: General Requirements for the Management System
4.1 Establish a quality management system: Develop it, use it, and
continue to improve it.
4.2 Document your system.
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