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Quality Assurance by D. H. Stamatis

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127
11
Certication to the International Standard
and Customer-Specic 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 signicance 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 noncertied items such as the scope that denes 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 denitions and how they are used throughout
the text of the standard.
Once these informational items are presented, the standard moves into
the certiable elements. This means that the organization must be certied
as adopting and following the requirements as specied 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. Specically, 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 dened, identied, 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 dened.
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 dened and cas-
caded throughout the organization.
Planning: Here the standard focuses on how the organiza-
tion denes the risks and opportunity actions that bring about
improvement or need attention. This is done by making sure that
specic plans and planning changes are identied and incorpo-
rated in the organization. In other words, they become part of
the organizational culture.
Support: Here, the standard addresses the need for dening,
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-
ments 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 signicance is based on
the verication of what has been dened and implemented in the
planning stage. Without verication and validation, the planning
stage is not worth very much. Items recognized as important are
Operational planning and control, that is, operational deni-
tions of requirements
Determination of requirements that satisfy the customer
Design and development of appropriate and applicable
requirements

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