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2.
Elaborate the concept of International
Standards. Also explain the following terms
a. ISO 9001:2008
b. ISO 9004:2009
c. ISO 90003:2004: Software Quality Management
d.
ISO 13485:2003: Medical Devices Quality
Management
International Standards
The ISO is related to quality management systems and responsible for the
development of international standards, which are based on the
requirements of customers. The ISO develops these standards keeping in
mind the requirements of the industry.
The main reason behind establishing the ISO standards is to ensure
the safety and reliability of products and services. This consequently raises
the levels of productivity and reduces the chances of errors. By
standardising, the ISO also aims at opening new avenues for
international trade for developing nations and helps them in gaining access
to new
steps
of
continuous
quality
Steps in CQI
CQI is a systematic approach and involves a number of steps, as shown in
below figure:
5.
Define different aspects of the design and
development of a product.
Different Aspects of the Design and Development of a Product
Let us study all these aspects in detail in the subsequent sections.
1. Architecture and modularity of the product
The physical layout of a product is known as its architecture. It is usually
divided into various clusters of components. The architecture of a product is
composed by defining the relationships between various functions of
the variety of components.
There are two approaches to define the architecture of a product. These are
as follows:
a. Knowledge Management
Knowledge Management (KM) is a process of identifying, representing, and
adapting perceptions and experiences from various dimensions. The
following are some of the popular definitions of KM: According to Karl Erik
Sveiby, Knowledge management is the art of creating value by
leveraging the intangible assets.
In the words of The Gartner Group, Knowledge management is a discipline
that promotes an integrated approach to identifying, managing, and sharing
all of an enterprises information assets. These information assets may