QUALITY MANAGEMENT SYSTEM SIMPLIFIED

By
Kanwal Jit Singh, Proprietor,
Surbhi Financial Technologies
Pune, India 411027
Contact: ks@surbhi.co.in
Phone +91 98204 44331

INTRODUCTION

More than 1 million organizations across the globe have been certified to ISO
9001, according to the survey of ISO.i The survey methodology covers only
the certificates issued by certification bodies that have been accredited
under the IAF umbrella. There are other certification bodies that are
accredited outside the IAF umbrella. Hence the number is larger.

The focus of this paper is to highlight how the ISO 9001: 2008 QMS process
can add value to your organization. This is a critical aspect of the standard
which in the opinion of the author is appreciated by a minority of the
organisations certified to the standard by a third party certification body.

UNDERSTANDING QUALITY

To understand quality, let us take the example of the ubiquitous pen that all
of us use every day.

There are different kinds of pen ranging from fountain pens to ball pens,
gel pens with their own variants, with brands as diverse as Mont Blanc to
Cross at the high end to Reynolds, Flair at the lower end of the spectrum.

The functional use of a pen is to place an imprint on paper that lasts for a
significant amount of time, preferably through the life of the paper. The
questions are

1. What is the product whose quality we are interested in

understanding?
2. What are the aspects of this quality that interests us and its relevance
for the business model for the organisation producing the pens?

This examination will be in the context of ISO 9000 family of standards,

since that is the principal focus of this article.

First what is the product?

According to ISO 9000:2005 - 3.4.2], a PRODUCT is the output of a process.

And a PROCESS is defined as [ISO 9000:2005 3.4.1] as a set of
interrelated or interacting activities which transforms inputs into outputs.

This implies that the outputs of different processes are different products for
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the purposes of ISO 9000 family of standards.

Coming back to the example of pens it will be easily realised that the
processes for producing different kinds of pens are different hence the
roller ball point pen is a different product from a gel pen is a different
product from a fountain pen. For the reader interested in these aspects of
pens, please visit Wikipedia and see pages

http://en.wikipedia.org/wiki/Ballpoint_pen
http://en.wikipedia.org/wiki/Gel_pen
;http://en.wikipedia.org/wiki/Rollerball_pen
http://en.wikipedia.org/wiki/Fountain_pen

Although the functional use of each of these types of pens is the same
leaving an imprint on paper, however they differ in two different
characteristics the ink and the ink delivery mechanism. Consequently
there would be different processes to produce the different inks and the ink
delivery processes. Even within the same category such as fountain pen a
Mont Blanc pen is significantly different from an ordinary fountain pen since
many features of a Mont Blanc pen are not available in the ordinary
fountain pen. Therefore there would different processes that would be used
to produce these pens. Thus by the definition in ISO 9000 family of
standards these are different products.

Thus comparing their quality is not a feasible as their characteristics are

different as quality can be compared of similar products and not different
products. Oranges have to be compared with oranges they cannot be
compared to apples.

CHARACTERISTIC [ISO 9000:2005 3.5.1] is the distinguishing feature of

the intended product. According to the note a characteristic can be
inherent or assigned, can be qualitative or quantitative.

A QUALITY CHARACTERISTIC [ISO 9000:2005 - 3.5.2] is the inherent

characteristic of a product, process or system related to a requirement. The
note to the clause clarifies that inherent means existing in the product,
especially as a permanent characteristic and characteristics assigned to a
product such as price is not a quality characteristic. Similarly beauty is an
assigned characteristic, although artistic value is inherent.

There are various classes of characteristics, the standard clarifies these

are given in table 1.

Table 1: Classes of Characteristics ISO 9000:2005

Sr Class Sub Class of Characteristics

1. Physical Mechanical, Electrical, Chemical or Biological
2. Sensory Related to smell, touch, taste, sight or hearing
3. Behavioural Courtesy, Honesty, Veracity
4. Temporal Punctuality, Reliability, Availability
5. Ergonomic Physiological Characteristics,
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Related to human safety

6. Functional Speed, etc.
REQUIREMENT [ISO 9000:2005 3.1.2] is defined as need or expectation
that is stated, generally implied or obligatory.

Generally implied according to the standard means that it is customary or

a common practice for the product to have certain characteristics embedded
in the product. This understanding should be common to the organisation,
its customers and other interested parties associated with the product or
service under reference. This implies that the customer may not really state
such a requirement, as the customer understands it to be an essential
feature of the product. Illustratively, any hardware such as a mobile, tablet,
digital camera, computing system including a desktop or laptop would
require certain operating software and certain other feature software, and at
the least DOS operating system.

However, this definition is loaded in the sense that an organisation may be

operating in several areas, and what is generally implied in one location may
be different from the generally implied in another location for example, a
cola in certain areas means Coca Cola or Coke, while in other locations it
means Pepsi Cola or Pepsi.

Obligatory requirements are those that are derived from statutory and
regulatory requirements. The statutory and regulatory requirements that are
applicable to the product due to its characteristics that impact quality and
not the other statutory and regulatory requirements illustratively,
production tax or excise tax, sales tax or value added tax are not covered by
this definition of the standard. However, requirements applicable to the end
of life disposal to the product are covered by the product, as also safety of
the product requirements.

ISO 9000:2005 Clause 3.12.1 states that no deviation from requirements

can be permitted if the same are mentioned in a document containing
criterion for claiming compliance.

Therefore it is important to deal with specified requirements that is those

requirements that have been documented. [ISO 9000: 2005 Note to 3.1.2].
Consequently, the quality of a product is essentially the product meeting the
specified requirements of the customer and other interested parties.

Some Concerns

An issue would arise if the requirements of all the interested parties have
not been translated to specified requirements, then is the product of an
acceptable quality?

Since the product is the output of a process, by definition and a process

cannot be controlled completely there is a statistical randomness that is
embedded in the process. Consequently the quality characteristics of the
product also have an embedded randomness by definition.
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That brings us to the next question, what is quality?

QUALITY [ISO 9000:2005 3.1.1] is the degree to which a set of inherent
characteristics of the intended productii fulfils the requirements. The second
note clarifies that the inherent means existing in something, especially as a
permanent characteristic, not something that is impressionistic and
therefore assigned to it. Something being more beautiful than the other is
not a characteristic of the product, since beauty lies in the eyes of the
beholder not something intrinsic to the product but to the user or viewer.

Quality is therefore the reflected in the distribution of the effects of

randomness around the mean value representing the measurable quantity
of the requirement as inherent in the product, when the entire production is
assessed for that characteristic. This can be represented by a distribution
around the mean. Generally the distribution is represented by the bell
shaped curve for each measurable quantity of the quality characteristic, as
shown in Figure 1.

Thus if 99.8% of the products meet the customer requirements, then the
organisation is working to 6 performance levels. To achieve this we
implement a Quality Management System.

QUALITY MANAGEMENT SYSTEM [ISO 9000:2005 3.2.3] directs and

controls an organisation with regard to quality.

The QUALITY POLICY [ISO 9000:2005 3.2.4] defines the overall intention
and direction of an organisation with respect to quality. This is formally
expressed by the top management of the organisation. The QUALITY
OBJECTIVES [ISO 9000: 2005 - 3.2.5] give effect to the Quality policy in
measurable terms.
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The Quality Objectives are then translated to the quality objectives of every
process, so that the desired results are exhibited in the products emanating
from the processes and then cumulatively in the product that is handed over
to the customer. The quality of the product will generate customer
satisfaction.

What is the objective of a QMS?

Thus the objective of a Quality Management System is to achieve

consistency in the product meeting the requirements of the customer and
other interested parties.

With the promulgation of legislative requirements related to RoHS

(Restriction of Hazardous Substances), the end of life disposal aspects are
becoming an integral part of the requirements of the regulatory aspects
related to certain products.

The wastes are also outputs of the process, but are not the intended outputs
of the processes. The aspects related to wastes are the subject of
Environmental Management System.

The QMS objective is achieved through documentation. Documentation has

two functions essentially from a QMS perspective. These are

1. To provide guidance to consistently produce products meeting the

requirements of customers and other interested parties these are
called written PROCEDURES [ISO 9000: 2005 3.4.5] and WORK
INSTRUCTIONS. The procedures define the way to carry out a process,
while work instructions define the way to carry out specific activities
in a process.
2. Records provide evidence of the products consistently meeting the
customer requirements and that of the other interested parties.

Thus the documentation plus design validation through consistent feedback

from customers through complaints provides a pathway for consistently
producing products meeting requirements of the customer and other
interested parties.

What is Continuous Improvement?

Let us go back to the bell shaped curve in figure 1. This is called the normal
distribution, with the mean or average = 0. That is the average of the
values obtained from the Quality Control for a particular requirement is
deducted from each value in the data to arrive at the distribution around
the mean ( ) . The standard deviation () is the variations around the mean
( ) hence by shifting the mean (by deducting any value the average in our
case - from all the values observed) the variation around the average does
not change. This is by definition of the standard deviation.

In the case of improvement, the standard deviation would reduce that is

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the variations from the average value have been reduced as we have better
compliance hence the curve becomes thinner as shown in the figure 2
below.
Figure 2: Continuous Improvement.

0.6

0.5

Std Dev = 1.5

Average = 0
0.4

0.3

0.2

0.1

0
0

4
-3.6
-3.2
-2.8
-2.4

-1.6
-1.2
-0.8
-0.4

0.4
0.8
1.2
1.6

2.4
2.8
3.2
3.6
-4

-2

0.6

Std Dev = 0.75

0.5

Average = 0
0.4

0.3

0.2

0.1

0
0

4
-3.6
-3.2
-2.8
-2.4

-1.6
-1.2
-0.8
-0.4

3.2
-4

-2

0.4
0.8
1.2
1.6

2.4
2.8

3.6

How is this achieved will be covered in the next chapter.

i http://www.iso.org/iso/iso_survey_executive-summary.pdf
ii Although wastes are also outputs of processes, they are not the intended output of the
specific processes introduced by the organization to produce the product with the
defined intended use also called the intended product. Quality Assurance according
to Note 3 to 3.4.2 is focused on the intended product. Quality Assurance is part of
quality management [3.2.11] focused on providing confidence that quality
requirements will be fulfilled.
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