10. Quality and Related Concepts
11. Total Quality Management and Other Quality
If we go with the dictionary meaning of quality, then quality means “standard of
something when compared with one that already exists, or degree of excellence of
Quality is something that motivates organisations not only to achieve the minimum
excellence mark but also to improve it continuously. Quality of any product depends
upon the stakeholders, i.e. their demands and expectations from the products. Here,
stakeholder means everyone who has an interest in the product directly or indirectly.
Customers comprise a large group of stakeholders. Other stakeholders are investors,
Quality of any product can be assured by three ways:
i. By setting guidelines which are compulsory for an organisation to follow.
ii. By setting up an effective quality control system in the organisation that will
iii. By developing a culture in the organisation of improving the quality.
This unit deals with the same concept of quality and different quality management
systems developed for ensuring quality. Different ISO series have also been discussed
The quality in the pharmaceutical industry is a very important topic. The government
regulatory agencies, drug manufacturers, customers and other stakeholders all joined
together to give or to have a quality product. Every agency or stakeholders define
quality differently. Everyone has its meaning of quality.
According to ASQC (American Society for Quality Control) quality can be defined
as the totality of features and characteristics of a product that bears on its ability to
satisfy the stated or implied needs.
ISO, an international body for formulating standards, has defined quality as: “Degree
to which a set of inherent characteristics fulfils requirements”.
According to ICH quality is the degree to which a set of inherent properties of a
product, system or process fulfils requirements.
Quality and Related Concepts 151
There are many ways to define quality like:
a. “It delivers the properties described on the label and is not contaminated”
d. “Meeting or exceeding customer expectations”
We can summarise these definitions of quality as:
i. User-based: “In the eyes of beholder/what user expects.”
ii. Manufacturing-based: “Right at the first time”
iii. Product-based: “Precise as per specifications”
There are eight dimensions which decide either the product is a quality product or
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