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1 A Project Report On Study of ISO 9001:2000 Quality Management System By By By By Ketan J. Chaudhari (M.B.A Ketan J. Chaudhari (M.B.A Ketan J. Chaudhari (M.B.A Ketan J. Chaudhari (M.B.A. II II II II – System System System Systems s s s & Marketing) & Marketing) & Marketing) & Marketing)

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A Project Report On

Study of ISO 9001:2000 Quality Management System

ByByByBy Ketan J. Chaudhari (M.B.AKetan J. Chaudhari (M.B.AKetan J. Chaudhari (M.B.AKetan J. Chaudhari (M.B.A.... II II II II –––– SystemSystemSystemSystems s s s & Marketing)& Marketing)& Marketing)& Marketing)

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Executive Summary

Gone are the days when the customers had to rely only upon few software solution

providers to make their business digital. They have to accept theses solutions without

considering the quality factor. Today, the ever-growing software industry, increasing global

competition and expanding market has reversed the situation. Now the customers are the kings

and they have a lot of options to choose from. Considering this fact, today any software

company not considering the ‘Quality’ factor in it’s product realization process would definitely

find it difficult to survive.

Not surprisingly, the ‘Software Quality’ buzzword is being ruling over the industry since

last two decades. Everyone in the industry is trying to make their profile heavy with various

quality certificates. Look for a software company, and you will find a small tag, ‘An XYZ

certified Company’. And the stunt is not only to attract the costumers, but ensuring quality

products and services in the long run.

Any quality consideration should start from understanding the fundamentals. This report

presents a thorough study of Software Quality concepts in the ISO 9001:2000 context. ISO

9001:2000 is the most acquired standard today. In fact, the quality movement in any company

starts with this certification.

The report starts with the company profile of National Informatics Center, which is

implementing ISO 9001:2000 compliance practices, followed by the basics of quality in

software context. Then it explains the ISO standards and the ISO 9000 family. The quality

management principles, on which each of quality certification process is based on, are cited in

the report. The report focuses on ISO 9001:2000 standards, its structure and specially the fourth

clause, Quality Management System. The actual summer project work in NIC, Pune is a

practical case in this context, including various ISO 9001:2000 QMS compliance assignments

on their current project, RojgarMitra. Report gives the details of the project and related work

done during the period. Due to the organization’s security issues, actual documents couldn’t be

revealed in the report. But all the structures of the documentation are explained. The report ends

with findings and conclusion.

The Annexure gives important relevant information like the popular quality models other

than ISO, the actual structure and contents of ISO 9001:2000 standard (fourth clause in detail)

and finally ISO 9001:2000 certified software firms in India.

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Quality Concepts

In his book, Quality is Free, Philip Crosby explains this common misconception by

stating, “The first erroneous assumption is that quality means goodness or luxury or shininess or

weight.”

When we ask for something and say it should be of ‘good quality’, we expect that the

other person interprets the word ‘quality’ the same way as us. If we do not understand what

would be considered as good quality, we cannot aim for it or insure that we produce it. Any

organization that wants to deliver quality products and services therefore needs to understand

what would be considered as quality by its customers.

So what is quality? Quality essentially lies ‘in the eyes of he beholder’. What may be

high quality for one customer may not be high quality for another. A customer will consider a

product or service as ‘high quality ‘ if it meets (or exceeds) what she wants from the product or

service.

Standard definitions quality recognize the customer’s perspective very clearly. IEEE

defines quality in its IEEE Std 610.12-1990 as:

• The degree to which a system, component or process meets specified requirements,

• The degree to which a system, component or process meets customer or user needs or

expectations.

Another formal definition of quality is found in ISO 9000:2000. this standard defines

quality as the ‘degree to which a set of inherent characteristics fulfils requirements.’

It should be noted that regardless of how sophisticated the features of a product, if the

product does not meet the requirements of customers, they would not consider it good quality.

Customers who consider our product and services as being of ‘good quality’ will be

satisfied customers – they would buy from us, maybe make repeated purchases and also speak

well of us and thus encourage other customers to buy from us. They may even be willing to pay

more for our products and services. Good quality thus leads to increase in business.

Software professionals who want to create product and services that are of good quality,

therefore have to understand customer requirements and try to conform to them.

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Quality of Design

Design is done to meet the customer’s needs and expectations and the implementation of

the design should be achievable within required framework of cost and schedule. Design has to

capture the requirements, and is therefore always within the context of customer requirements.

Quality of Design (QoD) is concerned with how good the design is. It is the value

inherent in the design. QoD is an area that is addressed early in the life cycle of a product. Work

subsequent to design aims at realizing the design. It refers to the level of excellence the product

is intended to posses.

Juran, the quality guru, saw quality of design as a component of overall quality, which he

defined as “ fitness for use’. QoD includes market research to understand what features are

indeed. It includes the product concept and the design specifications.

Quality of Conformance

Quality of Conformance (QoC) is a term used to express how well the product built

conforms to the design specifications. A good design is pointless if the product does not

conform to the design specifications. QoC has to be insured all though the process that builds the

product. Essentially, QoC is about meeting the promise made in the design specifications.

In his book, Software Engineering, a Practitioner’s Guide, Pressman says that “quality

of design refers to the characteristics that designers specify for an item” while “quality of

conformance is the degree to which the design specifications are followed during

manufacturing”.

For example, a software product’s design quality is seen in terms like simplicity and

structure of the architecture, its consistency and understandability. The same requirements can

probably catered to by multiple designs. However, design quality impacts aspects like

maintainability, testability, flexibility, portability, reusability and interoperability. So, to build a

good product, we need a good design and then we need a process that builds the product that

conforms to the design.

Besides insuring that the design is of good quality, we need to ensure that the product

conforms to the specifications. A good design can result in a good product only if it is followed

by “quality of conformance” while building the product. Just focusing on quality of design is not

sufficient to produce products of good quality.

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Quality Control

Producers capture customer requirements in the form of specifications. Products meeting

these specifications provide customers what they need. How can we know whether the product

meets specifications? We can check this – that is check the product against specifications and

see whether there are any defects. If defects are detected they will have to be rectified before the

product is shipped to customers.

Such checks on products are called ‘quality control’. It involves:

• Checking the product against the specifications to detect defects and

• Rectifying detected defects (and maybe checking again) before shipping the product.

IEEE Std 610.12-1990 provides alternate definitions for quality control as:

• Set of activities designed to evaluate the quality of developed or manufactured products

and

• The process of verifying one’s own work or that of a co-worker

Essentially, the focus of quality control is checking that the product that reaches the

customer has no defects, by detecting and rectifying defects in the product. The word invokes an

image of an inspector at a gate checking whether the product can be passed on to the customer or

not.

Quality Assurance

It’s a more compressive approach to quality. Here the thrust includes preventing defects.

Right from the initial stage, the focus is on building the product right.

While quality control checks the product towards the end before shipment, quality

assurance encompasses the entire process used to create the product. The idea is to use a process

that prevents defects, not just to detect and correct defects.

A formal definition of quality assurance from IEEE Std 610.12-1990 is:

• A planned and systematic pattern of all actions necessary to provide adequate confidence

that an item or product conforms to established technical requirements and

• A set of activities designed to evaluate the process by which products are developed and

manufactured.

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Quality assurance includes planning to incorporate quality, and using a process geared to

produce quality.

Defects are present in the products because:

• They are introduced while creating the products and

• Some defects pass undetected through the production process and reach the customer.

While quality control addresses the second point, quality assurance addresses both. In

that sense, quality assurance includes quality control mechanisms as one of the means of

assuring quality. More importantly, it tries to prevent defects from entering the product in the

first place.

Cost of Quality

Often both operational staff and management think of quality as an ‘overhead’. They see

any type of quality control or quality assurance activity as something that increases costs, and

are therefore reluctant to include these in their production process.

In a very powerful statement that refutes this, Philip Crosby points out that ‘quality is

free’ in a book of the same name. he says that there is a cost of poor quality – “ the cost of

quality is the expense of doing things wrong”. Crosby explains how creating products of high

quality is less expensive than creating products of poor quality.

When quality is poor possible failure costs are:

• Internal failure – costs of failures that are detected before the product is shipped

• External failures – costs of failures that occur or may occur after the product is shipped

Failure implies that work will need to be done to repair the product. The later the defect is

detected, the higher the cost to fix it. What may be a small detect to rectify if detected on the

drawing board may require major scrapping and rework if detected after construction.

External failures occur after the product reaches customers. Costs related to external

failures include handling customer complaints. Irate customers need prompt service. Help lines

are needed. Product warranties may be involved. Product need to be returned, corrected and

shipped again. They may even need to be withdrawn from customers who have not yet had a

complaint if a defect found implies that there is a risk to other customers.

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External failures are also very costly because they are visible to the existing and potential

customers and result in poor publicity, loss of goodwill and reputation. Customers may have

suffered losses because of the failure and may even demand or sue for compensation.

To improve quality, the costs that are incurred are:

• Prevention costs (related to quality assurance activities) and

• Appraisal costs (related to quality control activities).

We can prevent defects by putting in place processes that reduce the probability of

defects getting into the product. Quality planning, proper training of persons, setting up

appropriate processes, standards, templates, using suitable tools, having design reviews – all

these help to prevent defects. These are also called costs related to quality assurance activities.

Essentially, if we invest in trying to reduce the defects introduced (through quality

assurance activities) and in catching them early when they are cheaper to fix (through various

quality control activities), we can save on failure costs later.

Quality Movement

After World War II, industry in Japan faced major problems since their products were of

poor quality. Japan recognized the need to improve quality and to introduce statistical quality

control concepts. William Edwards Deming was a statistician who had been teaching statistical

quality control in America. Deming was a statistician who has been teaching statistical quality

control in America. Deming was invited to Japan to teach statistical quality control and his

teachings were appreciated and adopted by the Japanese industry. Deming is one of the gurus

credited with the turnaround of industry in Japan. Japan, which started with a reputation for

shoddy quality, was transformed into a country synonymous with good quality to the extent that

American industry fell behind it and started losing market share.

Quality Gurus

• William Edwards Deming

Deming summarized his philosophy in what he called the ‘System of Profound Knowledge’.

This consists of four parts:

o Appreciation of a system

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o Knowledge about variation

o Theory of knowledge and

o psychology

1. Organization use systems to perform their work. These systems have multiple components

that interface with each other to work as a whole. For systems to be effective, they (including the

interactions between the components) have to be understood well. All involved parties –

managers, workers, customers and other stakeholders – have to understand the system.

According to Deming, it is the management’s job to optimize the systems and apply solutions

that look at the system as a whole rather than look at it in parts.

2. Knowledge about variation is the second part of the system of profound knowledge and is

concerned with an understanding of statistical theory as it applies to variation. Any operation

involves a multiple of factors and complex interactions between them. Variations occur due to

individual components. The combined variation can be statistically predicted. There are two

causes of variations:

o Common causes of variation that are due to natural factors present in the process

o Special causes of variation that occur due to assignable causes.

Assignable causes result in unnatural variations that are quite different from the random

variations caused by common causes of variations. Such assignable causes are easier to detect

and economical to remove. On the other hand, natural variations are inherent in any stable

system and can only be reduced by changing the technology of the process.

Understanding that variation is inherent, and that there is a need to seek variation due to

special cauases and remove them, is necessary for proper improvement. Control charts are used

for identification of special cause variations.

3. The third part of the philosophy is the theory of knowledge, which is an understanding of

cause-and-effect relationships that can be used for prediction. Managers need to learn and apply

this theory. Theory of knowledge explains things and encourages questions and testing of the

theory.

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4. Psychology, that is, understanding behavior of people is the fourth part of the system of

profound knowledge. People are different and leaders need to understand these differences to be

able to optimally use the abilities of the various people involved. People cannot be treated as

interchangeable parts. Concepts of dignity and understanding the need for self-esteem and

respect are essential for proper leadership of people.

• Joseph Juran

For achieving quality, Juran focused on three aspects, which he termed as the ‘Quality

Trilogy’. Quality Trilogy is a registered trademark of his institute, the Juran Institute. The three

aspects are:

o Quality planning – this sets up the quality goals,

o Quality control – the process used to meet quality goals during operations and

o Quality improvement – the quality improvement process includes various quality

improvement projects, each starting from an improvement need and then changing

things to improve and to control the improvement.

Juran found that most companies pay too much importance to quality control and are

weaker in quality planning and quality improvement. He felt that quality planning and quality

improvement should be considered important. Quality needs to be pursued at all levels. The

organization’s mission should be overall product quality. Individual departments should also try

to achieve high quality. Quality programs need to be supported by accounting of quality costs so

that there is focus on quality problems. All functions should work together to achieve quality

and there is need for company-wide quality management.

• Philip Crosby

Crosby saw ‘zero defect’ as a performance standard that focused on preventing defects

Rather than finding and fixing them. He listed the basic elements of improvements as top

management determination about achieving quality, education of everyone to understand the

absolutes of quality, and implementation of quality by everyone.

The major quality movements like Total Quality Management (TQM) and Six Sigma are

based on similar underlying principles.

While developing software systems, the life cycle phases are supported by a set of life

cycle support activities that span the entire life cycle. Following diagram shows the place of

software quality assurance in the SDLC.

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Fig. 1: Life Cycle Phases and Support Activities

Assuring Quality in Software Organization

Following guidelines can be suggested for assuring quality in any software organization:

• A Process Approach is Necessary

Watts Humphrey (considered as the father of the Capability Maturity Model) suggested a

process-centric approach for software in his seminal book titled Managing the Software Process.

In this book, he mentions the myth of super-programmers as one of the reason why the

importance of an effectively managed software process was not recognized. In the earlier days,

there was a belief that a bunch of talented programmers working together to build software

ensured success. Many software professional believed that a very few, first class programmers

working on a project is better than having a ‘typical’ software team. These ‘super-programmers’

shall intuitively turn out better software. In real life, very few persons seem to have the caliber

apparently required of such super-programmers. But wishful management often ignored the need

to improve their software processes and hoped that recruiting top-of-the-class software engineers

from hotshot campuses would do the trick.

It became obvious that the only way to tackle the problems being faced by the industry

was to make the ‘process’ of software development more robust. This would reduce the

REQT. DESIGN CONSTRUCTION TESTING DEVELOPMENT OPERATION &

ANALYSIS MAINTENANCE

PROJECT PLANNING & MONITORING

SOFTWARE CONFIGURATION MANAGEMENT

REVIEWS, VERIFICATION & VALIDATION

SOFTWARE QUALITY ASSURANCE

SOFTWARE MEASUREMENT & MTRICES

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dependence on super programmers and guarantee success of the project and the software

product, independent of the individuals developing the software. Humphrey insists that “the

quality of a software system is governed by the quality of the process used to develop and

evolve it”.

• Software Project Management Should Provide Direction and Visibility

To build quality into a software product, we need to use a suitable process. We also need

To plan and monitor quality all through the process. This is especially important in software

since software products are essentially ‘invisible’ and therefore need checking. Planning and

monitoring is done as part of software project management.

In their book, Software Project Management, Hughes and Cotterell state, “One way of

perceiving software project management is as the process of making visible that which is

invisible.” They further explains the characteristics of a software project as:

o Invisibility – progress is not immediately visible in a software project,

o Complexity – software products contain more complexity than other engineered

artifacts and

o Flexibility – because of the perceived ease of changing software, it is expected that

software will changed to accommodate other components. So, software systems are

likely to be subjected to high degree of change.

All these need to be handled by defining the processes the project will follow and

management of the software project.

Since project management is the function that manages both time and resources to

achieve results, it is the function that can ‘make or break’ quality. An approach for quality has to

therefore ensure that project management incorporates whatever is needed for building quality

and checking for quality. Quality assurance has to be an integral part of software project and this

is ensured through project management activities.

• Process Capability and Maturity must be Understood

There needs to be some ways of assessing how good a process is. In this context,

Carnegie Mellon University’s (CMU) Software Capability Maturity Model explains two

relevant concepts – process capability and maturity levels. Further information on SW-CMM is

included in given in Annexure.

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• Process Improvement should be Continual

Processes are used to produce software. To improve quality we need to improve the

processes that create the products. Process improvement is one of the three focus areas of

Juran’s Quality Trilogy and also recommended as a continuous thrust area by Deming.

Process improvement steps are best explained by the simple but popular model from

Shewhart, known as Shewhart Cycle, shown in the figure. This cycle is also called Deming

Cycle by its Japanese users, named after Deming who took it to Japan.

Act Plan

Check Do

Fig. 2: Shewhart’s Cycle

The Shewhart Cycle consists of four cyclic steps:

o Plan

o Do

o Check (or Study) and

o Act

It is also called the PDCA Cycle. Essentially it is a feedback loop. First, an improvement

is identified and a plan is made to achieve it. Work is then done according to this plan. The

effect of work done is checked (studied) using various measurements/observations. These tell us

whether the improvement has been achieved. Action is taken based on the checking done and

whatever has been learnt.

Process improvement is continuous. Typically, a number of small but successful

improvements are preferred to one large cycle. Small successful improvement projects

encourage the persons and convince them about making improvements. There is a less chance

for failure and the resulting loss of motivation.

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Quality and Process Models

Quality models help organization put their software development and management

processes in place. They provide a framework for organizations for their quality journey. Quality

models are process based – they assume that quality can be assured by establishing and

implementing good processes. Models specify what the policies and processes of an

organization should achieve. Certification and assessment schemes compare the processes of an

organization against the requirements of these models. These models are being increasingly

adopted by organizations that now believe in a ‘process-centric’ approach to execute successful

projects and build usable software products. The assumption is that by having better processes

and ensuring they are used, quality of a process output can be assured. These models aim to

improve process capability so that organizations move to higher maturity levels.

Quality models provide guidance to organizations for process improvement by giving:

o Process areas to address,

o Objectives for various process areas and

o Indication of the possible sequence/priority

Assessments/certification to defined quality models are means of obtaining the current

status of an organization with respect to quality model. Trained and authorized persons carry out

assessment using defined methodologies. Assessment results are input for deciding how an

organization can further improve processes. They also help cuctomers and other external persons

in making decision such as whether the organization should be used as a supplier or whether it is

worth investing in.

There are many standards available for a software organization to adopt. Some of them

are given below. This report presents ISO standard in depth. Other standards are also explained

in the Annexure.

o ISO 9001:2000

o Software Capability Maturity Model from CMU

o People Capability Maturity Model from CMU

o Capability Maturity Model Integrated (CMMI) from CMU

o ISO/IEC TR 15504 (and the SPICE project)

o BOOTSTRAP and

o TRILLIUM

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ISO 9000 Family of Standards

The ISO 9000:2000 family of standards are owned and published by International

Organization for Standardization (ISO), based in GENEVA. ISO is a worldwide federation of

the national standards bodies of about 140 countries. The short name of ISO is not an acronym

of International Organization of Standards – it is derived from the Greek word ‘isos’ which

means ‘equal’. This short name of the organization is the same in all countries, and avoids

having different acronyms in different countries.

The organization (ISO) was created when delegates of over 25 countries met after the

World War and decided that there was need for a new international organization to facilitate

international coordination and unification of industrial standards. ISO, a non-governmental

organization, created as a result and began functioning in 1947. ISO published its first standard

in 1951. since then, ISO has been developing voluntary technical standards for almost all sectors

of business, industry and technology. Most of the standards developed by ISO are discipline-

specific and technical.

Standards from ISO:

ISO standards represent international agreement. They take into account the views of all

interests such as government, professional bodies, researchers, manufacturers, academics,

vendors, users and consumer groups, based on their voluntary participation. The resulting

standards are international standards that are market-driven.

A defined process is used for developing the standards. This process ensures adequate

representation and participation. The high level steps of the process are given below to show

how ISO insures that the standards it publishes are global solutions and useful to industries

across countries.

• An industry sector that feels the need for a standard communicates it to a national

standards body, and this national body proposes it to ISO. If this need is recognized and

formally agreed to, the technical scope of the future standard is defined by working

groups comprising technical experts from interested countries.

• When agreement is reached on the technical scope defined, the second of work starts.

ISO calls this the ‘consensus-building phase’.

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• The final phase involves formal approval of the standard as per defined acceptance

criteria. After receiving formal acceptance, ISO publishes the agreed text as an ISO

International Standard.

ISO also has a general rule that all standards it publishes need to be reviewed ( and

revised if necessary) at intervals of not more than five years (revisions may be necessary earlier).

Periodic revisions ensure that standards are not rendered out-of-date because of factors like

technological advances, new requirements of safety and quality and new methods and materials

that may now be available. Feedback on a standard gets incorporated to create an improved and

up-to-date standard.

ISO published over 12000 international standards, mainly in the technical field. These

standards represent international agreements and facilitate international exchange of goods and

services. They are principally of concern to engineers and technical specialists.

In 1987, ISO published its first version of the ISO 9000 family of standards. This

differed from other ISO standards since it was a generic standard for quality and was of interest

to the business community. Today, this family of standards is the best known and most used of

al the standards published by ISO. It has been implemented in several thousand businesses as it

provides a framework for quality management and quality assurance.

What are the ISO standards?

The concern of ISO 9000 is “management of quality”. The concern is about how an

organization should do its work, and not on the specifications of the product. The standards are

process-centric – not a product standard. They are concerned with how the organization defines

and manages its processes. The basis of the standard is the recognition that processes affect

quality and managing processes can assure quality.

ISO 9000 is a generic standard. The standard can be applied to any organization

regardless of its size or the industry it belongs to. It applies to small and large organizations. The

organization could be producing any product or service and could be part of the public or

government or private sector.

The purpose of the standards is not to prescribe what the organization should do or how

it should be done, it is to specify the requirements from the organisation’s quality management

system. Organizations are free to define their processes in the way best suited to their business

and operational environments. To conform to the ISO 9000 standards, the organization’s quality

management system has to have the essential features specified in the standard.

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The ISO 9000 Family of Standards

The ISO 9000 family of standards as published in 2000 consists of four standards in

9000 series. These are:

ISO 9000:2000 Quality Management systems – Fundamentals and Vocabulary

ISO 9001:2000 Quality Management Systems – Requirements

ISO 9004:2000 Quality Management Systems – Guidelines for performance

improvement

ISO 19011 Guidelines on Quality and/or Environmental Management Systems

Auditing

Table1 : ISO 9000 Family of Standards Published in 2000

1. ISO 9000:2000 defines the fundamental terms and definitions and enables users to

understand ISO 9001:2000 and ISO 9004:2000. The definitions are arranged by category and

their inter-relationships have been explained. ISO 9000:2000 is a starting point and ensures

that there is no misunderstanding in the use of ISO 9001:2000 and ISO 9004:2000.

2. ISO 9001:2000 is the standard to which organizations can be assessed and certified. This

standard can be used by organizations to assess their ability to meet customer requirements

and to therefore achieve customer satisfaction. It is the standard that is used by third party

assessors for certification. In the year 2000 release, this is the only standard to which

certification is possible.

3. ISO 9004:2000 is a guideline for organizations that want to derive greater benefits from

quality. ISO 9004:2000 provides guidance for continual improvement of the quality

management system, aimed at sustained customer satisfaction and providing benefit to all

parties.

4. ISO 19011, currently under development and available as a draft standard, provides guidance

on the principles of auditing, the management of audit programs, the conduct of audits and

the competence of auditors. It addresses both quality management system audits and

environmental management audits.

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The other documents of the ISO 9000 series are tabulated below:

ISO 10005:1995 Quality Management – Guidelines for quality plans

ISO 10006:1997 Quality Management – Guidelines for quality in project management

ISO 10007:1995 Quality Management – Guidelines for configuration management

ISO/DIS 10012 Quality assurance requirements for measuring equipment – Part

1:Metrological confirmation system for measuring equipment

ISO 10012-2:1997 Quality assurance for measuring equipment – Part 2: Guidelines for

control of measurement of processes

ISO 10013:1995 Guidelines for developing quality manuals

ISO/TR 10014:1998 Guidelines for managing the economics of quality

ISO 10015:1999 Quality management – guidelines for training

ISO/TS 16949:1999 Quality systems – Automotive suppliers – Particular requirements for

the application of ISO 9001:1994

Table 2: Documents of ISO 9000 Series

Relevance of ISO 9000-3

ISO 9000-3 provides "guidance" on implementing an ISO 9001 compliant set of

processes (collectively referred as a "quality system" or as a "quality management system").

ISO 9000-3 is an international guideline. Guidance is for software development, supply

and maintenance environments. The guideline is primarily written for "custom" (contract

driven) software markets. It can easily be adapted for other market needs such as commercial-

off-the-shelf (COTS), internal software development, etc..

ISO 9000-3 virtually mirrors the provision of ISO 9001--it does not add to, or otherwise

change, the requirements of ISO 9001.

ISO 9000-3 is not intended to be used as an internal/external audit tool. Its intent is to

guide software organizations with their ISO 9001 implementation and process change efforts: in

short, software organizations are audited against ISO 9001 (not ISO 9000-3).

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An example of the type of guidance provided by ISO 9000-3 is shown in the following table.

ISO 9001:1994 says: 4.2.3 Quality planning

The supplier shall define and document how the

requirements for quality will be met. Quality planning

shall be consistent with all other requirements of a

supplier's quality system and shall be documented in a

format to suit the supplier's method of operation. The

supplier shall give consideration to...

Related

ISO 9000-3:1997

guidance includes:

Quality planning should address the following items, as

appropriate:

a) quality requirements, expressed in measurable terms,

where appropriate;

b) the life cycle model to be used for software

development;

c) defined criteria for starting and ending each project

phase;

d) identification of types of reviews, tests and other

verification and validation activities to be carried out;

e) identification of configuration management

procedures to be carried out;

.

.

.

Table 3: ISO 9000 - 3

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Quality Management Principles

There are eight quality management principles that form the foundation of ISO

9001:2000 and ISO 9004:2000. These principles can be used by the top management of any

organization that wants to improve performance. While these principles are not part of the

‘requirements’ of the standard (they do not have to be explicitly conformed to), they are the

basis for the ISO 9001 standard.

The eight quality management principles are:

• Customer focus

• Leadership

• Involvement of people

• Process approach

• System approach to management

• Continual improvement

• Factual approach to decision making

• Mutually beneficial supplier relationships

1. Customer Focus

Essentially, the organization tries to meet its business goals related to revenue,

profit, market share and brand image. For this, the organization typically provides

products and services to its customers. For successfully doing so, the customer has to be

the organization’s focus. Customer focus has been recognized as core to quality

movements such as TQM and Six Sigma.

In software projects, programmers are often concerned with using the latest

features in tools and learning a new technology, without considering whether the latest

feature or technology will help the customers in the long term. Designers are often

concerned about creating an elegant design, rather than looking at usability of the

product. All the work within in any organization should focus on customer.

The organization’s objectives should be linked to customer needs and

expectations. Also, the awareness of customer needs and expectations should be spread

throughout the organization, even to those functions and individuals that do not directly

deal with the customers. Some of the ways to focus on customers are:

• Measurement of customer satisfaction.

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• Customer Relationship Management

• Ensuring that the whole staff has the knowledge and skills needed to satisfy

customers. E.g. there may be need for special communication and human

relations skills for persons directly interacting with customers (like customer

relationship officers, Marketing managers). Programmers and designers may

need to undergo training in usability.

2. Leadership

Leadership is what drives the organization. It requires organizational leadership

to establish an environment where all the people within the organization feel involved

and work together to achieve the organization’s objectives.

Philip Crosby gives The Absolutes of Leadership in his book as

i) a clear agenda

ii) a personal philosophy

iii) enduring relationships

iv) worldliness

People are the most important resources in software organizations. Leadership

should establish trust and eliminate fear so that they can work to their full potential and

can share ideas that could help the organization to improve. An open environment

encourages fearless participation and creative thinking and makes people feel more

involved. Problems and conflicts can be resolved faster and grievance can be sorted out.

3. Involvement of People

Narayan Murthy, the head of Infosys, Banglore, is one of the leaders of the

software industry in India. He expresses his understanding of the worth of people in a

crisp statement: “My assets walk out of the door every evening.” With top management

approach of this type, it is not surprising that Infosys has become an industry leader.

People who feel involved in work bring more commitment and energy to work.

They come up with suggestions for improvements in processes and products, and provide

leadership with information that can help formulate better strategies.

Quality approaches typically have various mechanisms for increasing people

involvement in process improvement. Quality Circles, Suggestion System, Cross-

functional teams and small group activities are examples of such mechanisms.

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4. Process Approach

Watts Humphrey, considered the pioneer of the software process movement, has

Said, “ The quality of a software system is highly influenced by the quality of the process

used to develop and maintain it.” Process approach is the most important aspect of any

modern business. As shown in figure, a process is the glue that ties people, procedures,

tools and equipment together.

Procedures

People

Tools and Technology

Figure 3 : The Process Perspective

All quality models focus on the process approach since this is necessary to assure

quality as the products are being built.

5. System Approach to Management

Process approach is necessary, but the processes should not be isolated processes

– they should work together as a system. Their interfaces and interdependencies should

be understood and the structure of the processes should follow a ‘system’ approach. To

design the organizational processes, we should start top-down from the organization’s

objectives and design a set of integrated processes that are harmonized. There should be

Measurements &

feedback for process

improvement

Process

High quality software

on time, within budget

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consistency in the roles and responsibilities. Organizational capabilities and resource

constraints should be taken into account.

Any system approach is based on the understanding that the whole can be more

than the sum of its parts. Conversely, if processes are designed independent of each

other, they could have overlaps and inconsistencies leading to gaps. We may have some

functions and covered by any process, while some may be covered in different ways in

more than one process. Quality models therefore describe the quality management

system as a system of processes.

6. Continual Improvement

Organizations never operate in static environments. There is competition for

customers, changes in suppliers, changes in the work environment, shifts in technology

and changes in the skills and aspirations of employees. Expectations of customers also

increase with improved products and services. Organizations need to keep coming with

better products and services and use resources more efficiently to be able to grow, and

sometimes to just survive. Organizational capabilities can be improved if the

organization follows the principle of continual improvement.

Often organizations have numerous smaller goals on the path to improvement.

The Japanese philosophy of Kaizen, which is oriented towards progressing in small

steps, is an important concept in process improvement. Here, small group activities and

suggestion systems are used for initiating improvements that result in small increments

in quality. Over time, a steady change towards better quality can be seen.

Another important concept in process improvement is process maturity. SW-

CMM can be used to check process maturity at a very broad level for a software

organization. Moving from a maturity level to higher is a measure of process

improvement.

7. Factual Approach to Decision Making

Any decisions such as policy and strategy or setting goals and targets needs a

basis – an understanding of what current status is, and what can be expected in the

future. By measurements and analysis of data we have the factual basis needed to decide.

Take a simple case of deciding how much to quote for a software development

contract. To quote a feasible price we need a realistic estimate of what the development

will cost. This can be done using the data:

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- how much did similar projects cost in the past

- what is the amount of work to be done

- what is the productivity that cab be achieved

- number of employees those may involve

- their salaries etc.

As opposed to this, a quotation based solely on partial knowledge of the

marketing person could put the organization at risk of losses. Various methods are

available for collection and analysis of data:

i) In software projects, an important type of data is defect data. Analysis of this

provides insights on why problems occur and how they can be removed.

Decisions on the types of changes to be made in the process are based on this

analysis. Defect data on subsequent projects can be used to check whether the

changes are effective.

ii) Basili’s Goal-Question-Metric approach is useful for measurement program

because it identifies measures relevant to the goal. It looks at each goal, and then

further identifies which questions need to be answered to check for achieving the

goal. It then identifies the metrics needed to answer the questions. This top-down

approach helps organizations to arrive at a set of relevant measurements.

iii) Statistical process control using control charts is one technique used to check

whether a process is operating within the desired range. It is very powerful

technique and is recognized as the main factor in the progress Japan made in

quality.

iv) Data analysis can be done can be done by Root Cause Analysis such as

brainstorming and fish-bone analysis.

8. Mutually Beneficial Supplier relationship

Organizations and their suppliers share a interdependent relationship. This

principle recognizes that organizations and suppliers can work together in spirit of trust

and cooperation to create a ‘win-win’ situation.

If the suppliers are in sync with the organization, and a very good relationship has

been established, costs and resources are optimized for both the suppliers and the

organization and there is more flexibility in responding to market.

The use of subcontractor is often considered in software organizations to handle

situations where the existing manpower is insufficient or lacks the required skills.

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Subcontracting is tricky in software because of the problems of judjing the quality of the

subcontracted work and the problems of communicating the work to be done. With an

open relationship with the subcontractor, the chances of producing quality software

improve. In addition to establishing sufficient processes and checkpoints for monitoring

work, a relationship that is based on openness and a perception of sharing the work can

reduce the defects substantially. The subcontractor can feel free to seek clarifications in

the requirements, joint reviews are possible and the subcontractor can also share

problems being faced. Resources from both sides can jointly try to ensure that the work

goes smoothly and that problems are resolved.

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Structure of ISo 9001:2000

The ISO 9001 approach

The ISO 9001:2000 standard is based on eight quality management principles described

in the last section. It identifies the supply chain as

Supplier Organization Customer

1. Basically we assume that ‘organization’ refers to the organization that is attempting to

improve quality through application of standard and its underlying principles, while

using input from ‘suppliers’. The products and services we make are for the ‘customer’.

2. The ‘customer’ could be a consumer, client, end-user, retailer, beneficiary or purchaser.

3. ISO 9001:2000 uses the term ‘product’ to encompass both product and services.

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4. The term ‘organization’ includes the people, the facilities available to them and the

organizational structure within which they work – that is, the responsibilities, authorities

and relationships between them.

5. ‘Suppliers’ are entities that supply products to the organization. E.g. suppliers of a

software organization include hardware and software vendors, service providers for

communication services, and subcontractors being used for outsourced development

work like testing or even design and coding.

6. All three – supplier, organization, and customer are parties interested in the performance

of the organization. They are ‘stakeholders’ and affected by the performance. In addition,

there are other entities that have an interest in the performance- such as owners and

shareholders, employees, financial institutions that have loaned funds, the society within

which the organization functions and environmental bodies. ISO 9001:2000 refers to

these other stakeholders as ‘interested parties’.

7. ISO 9001:2000 recognizes ‘value adding activities’ as the chain that starts from

receiving customer requirements to delivery of the products to the customer. This

conversion of the requirements to the products is rendered by ‘product realization’.

Structure of ISO 9001:2000

ISO 9001:2000 is the year 2000 version of the ISO 9001 standard and has five main

clauses against which conformance is checked. These specify the requirements for a quality

management system of an organization ( as shown in figure). The five clauses are:

• Quality Management System specifies that there needs to be a quality management

system. It specifies the requirements for establishing the quality management system and

the documentation requirements, including the way documents will be controlled,

• Management Responsibility covers aspects like management commitment, customer

focus, quality policy, planning, responsibility, authority and communication and

management review. Essentially, through this clause, the standard ensures that

management is committed to and drives quality by establishing policy and objectives, by

focusing on quality and by planning for quality.

Product Realization

Measurement

Analysis and

Improvement

Customer Customer

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Fig. 4: Structure of the ISO 9001:2000 Standard

• Resource management specifies that the organization has to determine and provide the

resources needed for implementing the quality management system effectively and

achieving customer satisfaction.

• Product realization the process that converts input requirements into products and

services and achieve customer satisfaction. In a software organization, this would include

processes for software development and project management, tools, methodologies etc.

• Measurement, analysis and improvement cover measurement, analysis and improvement.

Measurement and analysis are required to check product conformity and conformity to

the quality management system. They also enable continuous improvement of the

effectiveness of the quality management system.

Following diagram represents the process linkage that covers the clauses.

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Fig. 5

Is ISO 9001 relevant to software?

Today, software customers are clearly going global and are demanding quality. Given

the stakes involved, it is important for software organizations to understand all the rules for self-

improvement and for doing business in the international marketplace. The ISO 9001 standard

has become a basic part of these rules.

How does ISO 9001 apply to software?

ISO 9001 is an international "quality management system" standard--a standard used to

assess an organization's management approach regarding quality.

ISO 9001's focus is directed internally at an organization's processes and methods and externally

at managing (controlling, assuring,...) the quality of products and services delivered.

When viewing the key factors affecting the outcome of software development (shown below in

figure ), ISO 9001's focus is on all factors except "technology".

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Figure 6 : Delivering Quality Software - macro process

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Quality Management System

Introduction

The ISO 9000 standards of the year 2000 can be used by organizations to design and

implement a quality management system that helps to achieve quality. ISO 9001:2000 also

specifies the requirements that a quality management system should meet to be able to achieve

quality effectively and to continually improve quality.

QMS requirements in ISO 9001:2000 are given in Annexure.

Approach to the QMS

1. Establishing the quality policy

The needs and expectations of customers and other stakeholders are determined. This

data helps the top management establish the quality policy of the organization, enabling it to

be clear about its intentions and direction with respect to quality. The aspect of establishing a

quality policy is dealt with in more detail in the next chapter.

2. Setting the quality objective

The quality objectives are set for various functions and levels. The documented Quality

policy and quality objectives form part of the QMS.

3. Determining the system of processes required to fulfill the quality objectives

The processes and responsibilities required to achieve these objectives have to be

identified and defined. The relationships between the processes are identified. Resources are

required for achieving the quality objectives are identified and provided. Measures that can

be used to measure effectiveness of processes are determined.

The QMS includes the identified processes and their interrelationships. It also includes

the definition of the processes in sufficient detail to implement them. The process definitions

supported by procedures, work instructions, forms, templates, guidelines, records, etc. we

discuss this aspect later in more detail.

4. Implementing the QMS and continually improving it

Checking it for effectiveness and improving the processes is the last step. We therefore

need a process for establishing, maintaining and improving the QMS itself. This process is,

along with other processes, a part of the QMS.

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Why document the QMS?

The ISO 9001:2000 standard requires a documented QMS. According to the standard,

the QMS should be established, documented, implemented and maintained, and its effectiveness

must be continually improved. The QMS documentation requirements have been specified in the

standard as a separate sub-clause.

The standard’s requirement that the QMS should be documented is often viewed

negatively, the general impression being that the standard’s approach is bureaucratic and

documentation centric. However, this is not so and the revised standard has in fact simplified its

documentation requirements further, providing organizations a non-prescriptive way of defining

a QMS suited to their particular situation.

Let us examine why there is need for documenting the QMS.

If an organization consists of a single person, she can have knowledge of all the

procedures required. As the number of persons in the organization increase, there is need to

communicate with each other on what is to be done and how, so as to establish a common way

of performing all required work and reducing confusion and duplication of work.

Communication is also required to share the organization’s vision, policy and objectives. If there

is gap in communication, the work and hence the organization suffers. This could be because of

something not being communicated, or because there was some misunderstanding. Also, if a

person leaves, the knowledge held by that person in lost.

Documentation is a way of converting tacit knowledge to explicit knowledge so that

people can share the knowledge and work together effectively. If a procedure is not documented,

only persons who know it can perform it. A new person will need to be trained fully for it. If

there is only one person knowing the procedure and she is not available, the procedure cannot be

performed.

For an organization keen to build quality product, it makes sense to ensure that everyone

understands all processes (that are required to deliver quality products) unambiguously and

uniformly. This makes the processes repeatable. This can be achieved by having QMS

documentation.

QMS documentation should aim at providing a system that assures quality. The

components of such a documented QMS required by ISO 9001:2000 are:

• The quality policy and objectives,

• A quality Manual that specifies the QMS,

• All documented procedures that are required explicitly by ISO 9001:2000,

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• All documents required for effective planning, operation and control of processes and

• All records required by ISO 9001:2000.

We can see that the existence and implementation of a documented QMS as above is

helpful in many ways:

• It forms a clear and unambiguous way of communicating the policies, objectives and

processes to the entire organization,

• By ensuring that all persons follow documented procedures, we can have a uniform

implementation of the procedures. Consistency can be ensured. By using a documented

QMS, we ensure that the process are repeatable,

• Process documentation enables understanding what is being done and how and this can

be reviewed and kept up-to-date,

• Process documentation can be used to audit whether work is indeed being done the way

it should be, and to detect gaps and rectify them,

• By knowing what is being done and measuring how effective it is, we can identify how

to make improvements in the process,

• It makes the organization less dependent on persons as everyone Cn share the defined

and documented processes and

• Records, a part of the documentation required in a QMS, form objective evidence of the

QMS implementation.

The standard, while discussing the value of documentation, says, “Documentation

enables communication of intent and consistency of action”.

We emphasize that a documented QMS is not a formality to meet the requirements of

ISO 9001:2000 (or any other standard) – it is a part of implementing and continually

improving a QMS. The documented QMS is not a tome to be locked away in some obscure

corner of the organization’s library. Instead, it is a representation of the behavior the

organization has established to achieve quality.

Also note that ‘document’ does not mean printed document. It could reside on some

other media or a combination of media such as magnetic, electronic or optical computer disc,

photographs, etc. Software organizations often prefer using electronic media and keep their

QMS as files accessible over their intranet for ease of the persons who may refer to it.

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Contents and Structure of the QMS

The term ‘Quality Manual’ is used for the document that contains the description of the

QMS. The idea of the quality manual is to provide a perspective to the entire QMS. For anyone

trying to understand the QMS and starting point is the Quality manual. From this, the person

should be able to reach any other documentation that is required, such as some detailed process

document, some procedure or work instruction or some checklist.

The components of the QMS documentation are often explained as a ‘hierarchy’ or a

documentation pyramid. This is shown in Figure. The components of the QMS typically include

a Quality Manual, processes, procedures, forms, checklists, standards, guidelines, templates and

records.

Quality Manual Processes & Procedures Forms, Checklists, Standards, Templates, Guidelines Records

Figure 7: QMS Structure

The typical contents of the Quality Manual of a software organization are:

• The scope of the QMS

• The quality policy and quality objectives,

• The process architecture that includes a high level process description and the

interaction between the processes of the QMS,

• Reference to the procedures that constitute the QMS and

• A table depicting how the various requirements of ISO 9001:2000 are met.

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Item Description Example

Process Activities required for transforming input

to output. The activities typically have

interrelations and interactions.

The process used for performing a peer

review

Procedure The sequence of steps to be performed for

an activity/process

The sequence of steps for each part of a

review – pre-review meeting, during the

review, post-review follow-up

Form A blank document such as a blank table,

that is to be filled in one or more steps

while performing some process.

The review findings form that needs to be

filled in during the review meeting.

Checklist A list of items that is used while

performing an activity to ensure that all

items have been considered.

The checklist used during review meeting

for reviewing a particular type of artifact

(e.g. code review checklist).

Standard A mandatory set of requirements that has

to be conformed to while performing an

activity, or by a product being built.

Coding standard that the programmers are

expected to use while coding and

reviewers check for conformance while

reviewing code.

Guidelines A set of suggestions to be used to perform

a process better. It is not mandatory.

Suggested conduct during review

meetings ( e.g. do not make personal

remarks, focus on the product, do not

discuss solutions.

Templates A blank format, possibly with some

embedded guidelines for understanding

the format to be used while preparing a

document.

A project planning format that is used for

creating the project plan ( see the

Annexure )

Record An artifact created as a result of some

activities that provide evidence that the

activity was performed, and may contain

data that can be analyzed for more

information later. A record could be a

form that is filled up while performing

some activity

A review record created during a review

record created during a review, which

provides evidence that the review was

performed. An audit report is another

example of a record.

Table 4: Components of a QMS

While defining their QMS, organizations should choose a structure that is suitable. E.g.

• A small organization with simple operations may have a small QMS and may choose to

pull all of it in a single document,

• A geographically dispersed organization may have separate manuals for each location,

each such manual set containing location specific QMS information,

• A large organization may choose to have one top level Quality Manual which points to

detailed process definitions that are placed in separate manuals. There may be separate

process manuals for each department (e.g. purchase, administration, software

development). Alternatively, there could be separate manuals for each type of business

(banking customers, retail sales customers etc.)

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QMS Processes of a Software Organization

The central activities in software organizations are ‘product realization’ activities – the

technical software engineering activities required to build the project and the management

activities that support these. These are:

1. Life cycle processes such as analysis, design, coding, testing and maintenance – the

phases and activities within the phases depend on a life cycle model selected and

2. Project support processes such as project planning, monitoring and control, software

configuration management, reviews and audits, risk management and software

subcontract management.

These various processes are all interrelated and all interdependencies have to be

recognized in any documentation. Here are some examples:

• The output of any requirements analysis process is the signed-off requirements

specifications and this forms the input for the design process,

• The SCM process is used in each life cycle process for controlling the configuration. The

requirements analysis phase uses the check-in activity of SCM to check in the signed-off

requirements specification and establish a configuration baseline and

• The software planning process includes an activity of selecting a suitable life cycle

model for a project and this determines other processes in the project and any tailoring

within these processes.

Besides the product realization processes, the organization needs processes that ensure

that the management is actively participating in quality related activities, and processes to ensure

that there are enough measurements and analysis of measurements so that the effectiveness of

processes can be checked and they can be continually improved. There may also be some other

support activities that are very important for assuring product quality. Here are some examples:

• A process that ensures that the management sets appropriate quality objectives for

projects in terms of defect density, reliability, etc,

• Processes to collect and analyze data that can help in estimating software size and effort

better,

• Processes to ensure that purchased hardware and software meet specifications,

• Processes to ensure that the system administration provides support at the required level

in upkeep of the network and

• Process to define and manage the QMS

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Figure gives a list of processes for a typical software development and maintenance

Organization.

Process Area Associated Procedures

QMS Management Periodic QMS review

Defining and maintaining the QMS

Measuring process performance

Measuring customer satisfaction

Control of records

Corrective and preventive actions

Management reviews

Quality Assurance Periodic internal audits

Project Software quality assurance

Requirements/Contract Management Setting up the contract

Contract review

Handling amendments to contract

Project Management Estimation

Project planning

Project tracking

Milestone Review

Project closure

Defect prevention

Software Configuration Management SCM Planning

Creating SCM infrastructure

Creating baselines

Changing baseline items

Performing releases

Life Cycle Activities Requirements Analysis

High Level Design

Detailed Design

Construction

Integrated testing

System testing

Acceptance testing

Maintenance

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Work Product Review Plan for reviews

Conduct review

Track defect to closure

Purchasing Purchase requisition

Purchase evaluation

Placing the purchase order

Receipt and inspection of purchased goods

Sub-Contracting Identifying the need for sub-contracted items

Sub-contractor evaluation

Sub-contractor monitoring

Acceptance testing of sub-contracted items

Training Identifying training needs

Preparing training plan and calendar

Conducting training

Evaluating effectiveness of training

Table 5 : A Sample List of Processes and Procedures of a Software Organization

Following figure shows a process template that can be used for process definition.

Heading Description

Process Name The process name

Revision history A tabulation of the release made for the process definition and the

changes incorporated in each release

Purpose & Scope A brief statement of why the process is required, and what it applies to

(e.g. which type of project)

Responsibility The role with the overall responsibility for performing the process

Brief description

List of procedures

A brief description of what the process does

The procedures that constitute the process

Procedure-1 Detail

Name The name of procedure-1

Entry Criteria The criteria that trigger the procedure

Input The documents required for performing the procedure

Steps The steps that will be followed in the procedure, along with the

responsibility for the step. The other processes, templates, checklists,

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etc. which the step requires will be referred from the step.

Outputs The output documents generated by the procedure

Exit Criteria The criteria used to decide whether the procedure can be considered as

complete

Procedure-2 Detail

Procedure-3 Detail

……………..

Records &

Retention

The records generated during the process, the retention period and the

person responsible for the retention

Table 6 : A Process Definition Template

Process definitions typically need to contain or refer to other documents that are required

for implementing the process – procedures, forms, checklists, templates, guidelines and

standards.

The process (and procedure) definition is not just a set of text pages. Use of process

maps, organizational charts, flowcharts, decision trees and tables and lists can make the

document easier to understand and use. Flowcharts are particularly useful for documenting some

types of procedures. Persons performing the documentation should strive to make the document

readable and interesting.

The ISO 9001:2000 standard explicitly requires documented procedures to cover the

following:

• Control of documents

• Control of records

• Internal audit

• Control of non-conformity

• Corrective action and

• Prevention action

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Defining and Maintaining the QMS

The overall responsibility for establishing and maintaining the QMS typically lies with

the person heading the quality initiative in the organization. This person should have the relevant

authority and follow the management mandate to be able to perform/coordinate all required

activities. She should report directly to the top management and not be under any operational

pressure. This person is usually the ‘management representative’ – a role described in the

standard.

In many software organizations, the Head of Quality is management representative and is

responsible for the QMS of the organization. The quality group in these organizations typically

consists of two sub-groups:

1. The Process Engineering Group (or Software Engineering Process Group or SEPG) that

is responsible for defining and modifying processes and

2. The Quality Assurance Group (SQAG) that is responsible for supporting the

implementation and verifying the compliance to the defined processes through audits and

process reviews.

The typical process to define and modify the QMS is depicted in Fig. and is described below.

Figure 8: key elements of Process Definition and Modification

Structure of QMS (Process Architecture)

Identify Processes to Define/Modify

Understand Impact on Other

Processes

Prioritize the Definition/

Modification Define/Modify the

Processes

Perform Pilot Implementation

(If required)

Roll-out the new Processes

Review the QMS

Accept Change requests to

QMS

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Software organizations are increasing using intranet for making the QMS available

within the organization. The QMS documents may be created as a set of hyper-linked

documents. Users should be able to understand the structure of the QMS documentation and

reach the relevant sections easily.

When the QMS is implemented for the first time, an organization-wide orientation and

training is required.

Any change to the documentation must be controlled. Control needs to ensure:

• The person modifying the QMS document uses the correct version as the starting point,

• An impact analysis is done before making any change to any QMS document,

• The changes are made and reviewed,

• If necessary, the changed processes are piloted,

• Any required approval is sought and

• The changed document is then deemed to be the latest version which will be available to

anyone asking the document.

Control of Records

A special type of document that ISO 9001:2000 requires is a ‘record’. The standard

defines record as “document stating results achieved or providing evidenceof activities

performed”.

Records are particularly important because:

• They represent evidence that an activity was performed,

• They tell us how the activity was performed,

• The data in the records are used to track actions,

• The data in the records are used for analysis and provide input for continual

improvement through preventive and corrective action and

• This can be used for future decisions.

For example, the results of the unit test are documented in a record called ‘unit test

results’. The results:

• Provide an evidence that the unit testing was done,

• Give us the information on who did the testing, how long it took, how many defects were

found and when it was done,

• Contain the list of defects that need to be fixed and maybe re-tested for and

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• Data from multiple unit test results can be analyzed to see patterns of various types of

defects – this can be used to identify preventive action.

Figure contains the typical list of records relevant for a software organization.

Area Typical Records

QMS Documentation • QMS Change Requests

• QMS Review and Approvals

• QMS Release Notes

Management Review • Agenda

• Reports and Presentations made during Management review

• Minutes of Meeting

Education, Skills, Training

• Competence/skills database

• Training Needs

• Training Nomination

• Training Calendar

• Training Attendance

• Training Feedback

• Training Effectiveness Evaluation

Internal Audits • Audit Schedule

• Audit Interview Notes

• Audit Checklists Used

• Audit Non-Compliance & Observations

• Audit Report

Requirements/Contracting • Review of contract/requirements

• Estimation

Project Planning • Estimation

• Project Initiation Note

• Project Allocation Note

• Review and Approval of Project Plan

• Approval of Process Deviations

Project Monitoring • Project Status Report

• Project Milestone review Reports

• Project review Minutes of Meeting

• Time sheets/Time logs

Change Management/SCM

• Change request

• CCB minutes of meeting

• Check-in/Check-out details

• Back up records

• Release notes

• Configuration Item Lists

Life Cycle Activities • Review of Requirements Specification Document

• Review of Design document

• Review of Detailed Design

• Review of Test Plans

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• Review of Code

• Test records

• Defect Logs

• Maintenance requests

Purchasing • Vendor database

• Purchase requisition

• Purchase evaluation/ subcontractor evaluation

• Purchase order/subcontract agreement

• Delivery Note

• Acceptance Note

• Audit Result on Supplier Processes

Others • Process performance measurements

• Customer Satisfaction survey

• Customer complaints

• List of customer supplied items

• Defect analysis

• Results of pilot projects for processes

• Preventive and corrective action

• Internal system admin calls

• General admin calls

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Findings and Conclusion

Before a decade or two, the ultimate goal of any organization was to maximize profit.

But now, in this age of cut-throat competition, every businessman has understood the

importance of customer satisfaction. As it is obvious that a customer won’t be satisfied till his

expectations from the product are completely satisfied. Here comes the concept of quality. From

the in depth study of Software Quality and the ISO 9001:2000 Quality management system, we

come to know that an organization can not manufacture Quality Products exclusively. Because

from every customer’s point of view, quality is different. So the ISO 9001 says that if you want

to satisfy your customer, you have to incorporate the quality policy throughout the organization,

applying it to the processes those are carried out to develop the product.

In the last two decades, customers of the software industry have become more

demanding and no longer accept delayed projects, products with glitches or cost overruns. While

awarding software projects to software organizations, one of the questions that customers ask

themselves is ‘will this supplier deliver the software that meets the requirements with minimal

defects, on time and without cost overruns?’ The customer therefore needs some kind of

‘assurance’ that the system used by the supplier is capable of executing software projects

successfully. Many customers look for suppliers with ISO 9001 certification to give themselves

this assurance.

There is a lot of apprehension among software organizations and professionals that ISO

9001 is bureaucratic and documentation heavy. Often, while implementing ISO 9001, the

documentation of the QMS becomes a major project in its own right and seems an isolated and

useless exercise. Also the documented QMS is large, ponderous and detailed, and is impractical

and scarcely used. One of the aims of the year 2000 revision of the standard was to make the

amount and detail of the documentation more relevant to the result of the organization’s process

activities. The revision aims at simplification of documentation to a level relevant for addressing

the needs of each organization (depending on their size, business, etc) and is less prescriptive.

We can see these changes and the ease of documentation in the QMS designed by NIC.

The whole focus of this project work was on Software Quality and the Documentation

which is mostly ignored in many organizations. Probably that is why ISO 9001 has become a

must a ‘must have’ certification standard in the industry, especially in the software industry,

with more than 200 Indian software organizations being already certified to 1994 version of the

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ISO 9001 standard and they are now moving to the revised ISO 9001:2000. Further, many

software giants are going for other quality models like Six Sigma, CMM, P-CMM, CMMI etc.

Whatever model you select, the basic rule is same for all,

“ To become market leader, you have to provide quality product and for that you have to

discipline your business processes.”

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Annexure A : Other Quality Models

1. SW-CMM

Software Capability Maturity Model from Software Engineering Institute, Carnegie

Mellon University is a detailed model for software organizations. SW-CMM is based on the

concept of process maturity and levels of maturity. It is a staged model, that is it uses defined

capability maturity levels to assess the current standings of an organization. The model defines

level of progressively more mature process capabilities.

Figure depicts the five maturity levels and table shows the Key Process Areas for each of

the levels. The SW-CMM defines the requirements of each KPA in a way suitable to software

organization. So it is a useful reference while implementing ISO 9001.

Figure : The Software CMM Model

Initial (1) Unpredictable and poorly controlled

Repeatable (2) Can repeat previously mastered tasks

Defined (3) Process characterized, fairly well understood

Managed (4) Process Measured and controlled

Optimizing (5) Focus on process improvement

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Level Key Process Areas

1 – Initial

2 – Repeatable

Requirements management

Software project planning

Software project tracking and oversight

Software subcontract management

Software quality assurance

Software configuration management

3 – Defined

Organization process focus

Organization process definition

Training program

Integrated software management

Software product engineering

Intergroup coordination

Peer reviews

4 – Managed

Software quality management

Quantitative process management

5 – Optimizing

Defect prevention Technology change management

Process change management

Figure: The KPA across various maturity level of the SW-CMM

2. The People CMM

People Capability Maturity Model from CMU, is aimed at providing the management

and development of human assets of an organization through work-force practices. Following

table shows the maturity levels and KPAs.

Level Key Process Areas

1 - Initial

2 – Managed

Staffing

Communication & Coordination Work Environment

Performance Management Training and development

Compensation

3 – Defined

Competency Analysis

Workforce planning Competency Development

Career Development

Competency-Based practices

Workgroup management

Participatory culture

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4 – Predictable

Competency integration

Empowered workgroups

Competency-based assets

Quantitative performance management

Organizational capability management

Mentoring

5 – Optimizing

Continuous capability improvement

Organizational performance alignment

Continuous workforce innovation

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Annexure B

ISO 9001

Third edition

2000-12-15

Quality management systems — Requirements

1 Scope 1.1 General

1.2 Application

2 Normative reference

3 Terms and definitions

4 Quality Management System

4.1 General requirements

The organization shall establish, document, implement and maintain a quality

management system and continually improve its effectiveness in accordance with the requirements of this International Standard. The organization shall

a) identify the processes needed for the quality management system and their application throughout the organization (see 1.2),

b) determine the sequence and interaction of these processes, c) determine criteria and methods needed to ensure that both the operation and control of these

processes are effective,

d) ensure the availability of resources and information necessary to support the operation and

monitoring of these processes,

e) monitor, measure and analyze these processes, and

f) implement actions necessary to achieve planned results and continual improvement of these

processes.

These processes shall be managed by the organization in accordance with the

requirements of this International Standard. Where an organization chooses to outsource any

process that affects product conformity with requirements, the organization shall ensure control

over such processes. Control of such outsourced processes shall be identified within the quality

management system.

NOTE Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and

measurement.

4.2 Documentation requirements

4.2.1 General

The quality management system documentation shall include a) documented statements of a quality policy and quality objectives,

b) a quality manual,

c) documented procedures required by this International Standard,

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d) documents needed by the organization to ensure the effective planning, operation and control of its processes, and

e) records required by this International Standard (see 4.2.4).

NOTE 1 Where the term “documented procedure” appears within this International

Standard, this means that the procedure is established, documented, implemented and

maintained.

NOTE 2 The extent of the quality management system documentation can differ from

one organization to another due to

a) the size of organization and type of activities,

b) the complexity of processes and their interactions, and

c) the competence of personnel.

NOTE 3 The documentation can be in any form or type of medium.

4.2.2 Quality manual

The organization shall establish and maintain a quality manual that includes a) the scope of the quality management system, including details of and justification for any

exclusions (see 1.2), b) the documented procedures established for the quality management system, or reference to

them, and c) a description of the interaction between the processes of the quality management system.

4.2.3 Control of documents

Documents required by the quality management system shall be controlled. Records are

a special type of document and shall be controlled according to the requirements given in 4.2.4.

A documented procedure shall be established to define the controls needed

a) to approve documents for adequacy prior to issue,

b) to review and update as necessary and re-approve documents,

c) to ensure that changes and the current revision status of documents are identified,

d) to ensure that relevant versions of applicable documents are available at points of use,

e) to ensure that documents remain legible and readily identifiable,

f) to ensure that documents of external origin are identified and their distribution controlled, and

g) to prevent the unintended use of obsolete documents, and to apply suitable identification to

them if they are retained for any purpose.

4.2.4 Control of records Records shall be established and maintained to provide evidence of conformity to

requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established

to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.

5 Management responsibility

5.1 Management commitment

Top management shall provide evidence of its commitment to the development and

implementation of the quality management system and continually improving its effectiveness

by

a) communicating to the organization the importance of meeting customer as well as statutory

and regulatory requirements,

b) establishing the quality policy,

c) ensuring that quality objectives are established,

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d) conducting management reviews, and e) ensuring the availability of resources.

5.2 Customer focus

Top management shall ensure that customer requirements are determined and are met

with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1).

5.3 Quality policy

Top management shall ensure that the quality policy

a) is appropriate to the purpose of the organization,

b) includes a commitment to comply with requirements and continually improve the

effectiveness of the quality management system,

c) provides a framework for establishing and reviewing quality objectives,

d) is communicated and understood within the organization, and

e) is reviewed for continuing suitability.

5.4 Planning

5.4.1 Quality objectives

Top management shall ensure that quality objectives, including those needed to meet requirements for product [see 7.1 a)], are established at relevant functions and levels within the

organization. The quality objectives shall be measurable and consistent with the quality policy.

5.4.2 Quality management system planning

Top management shall ensure that a) the planning of the quality management system is

carried out in order to meet the requirements given in 4.1, as well as the quality objectives, and

b) the integrity of the quality management system is maintained when changes to the quality

management system are planned and implemented.

5.5 Responsibility, authority and communication

5.5.1 Responsibility and authority

Top management shall ensure that responsibilities and authorities are defined and

communicated within the organization.

5.5.2 Management representative

Top management shall appoint a member of management who, irrespective of other

responsibilities, shall have responsibility and authority that includes a) ensuring that processes needed for the quality management system are established,

implemented and maintained, b) reporting to top management on the performance of the quality management system and any

need for improvement, and c) ensuring the promotion of awareness of customer requirements throughout the organization.

NOTE The responsibility of a management representative can include liaison with external parties on matters relating to the quality management system.

5.5.3 Internal communication

Top management shall ensure that appropriate communication processes are established

within the organization and that communication takes place regarding the effectiveness of the

quality management system.

5.6 Management review

5.6.1 General

Top management shall review the organization's quality management system, at planned

intervals, to ensure its continuing suitability, adequacy and effectiveness. This review shall

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include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives. Records from

management reviews shall be maintained (see 4.2.4).

5.6.2 Review input

The input to management review shall include information on

a) results of audits,

b) customer feedback,

c) process performance and product conformity,

d) status of preventive and corrective actions,

e) follow-up actions from previous management reviews,

f) changes that could affect the quality management system, and

g) recommendations for improvement.

5.6.3 Review output The output from the management review shall include any decisions and actions related to

a) improvement of the effectiveness of the quality management system and its processes, b) improvement of product related to customer requirements, and

c) resource needs.

6 Resource management

6.1 Provision of resources

6.2 Human resources

6.2.1 General

6.2.2 Competence, awareness and training

6.3 Infrastructure

6.4 Work environment

7 Product realization

7.1 Planning of product realization

7.2 Customer-related processes

7.2.1 Determination of requirements related to the product

7.2.2 Review of requirements related to the product

7.2.3 Customer communication

7.3 Design and development

7.3.1 Design and development planning

7.3.2 Design and development inputs

7.3.3 Design and development outputs

7.3.4 Design and development review

7.3.5 Design and development verification

7.3.6 Design and development validation

7.3.7 Control of design and development changes

7.4 Purchasing

7.4.1 Purchasing process

7.4.2 Purchasing information

7.4.3 Verification of purchased product

7.5 Production and service provision

7.5.1 Control of production and service provision

7.5.2 Validation of processes for production and service provision

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7.5.3 Identification and traceability

7.5.4 Customer property

7.5.5 Preservation of product

7.6 Control of monitoring and measuring devices

8 Measurement, analysis and improvement

8.1 General

8.2 Monitoring and measurement

8.2.1 Customer satisfaction

8.2.2 Internal audit

8.2.3 Monitoring and measurement of processes

8.2.4 Monitoring and measurement of product

8.3 Control of nonconforming product

8.4 Analysis of data

8.5 Improvement

8.5.1 Continual improvement

8.5.2 Corrective action

8.5.3 Preventive action

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Annexure C :

ISO 9001 Certified Software Companies in India

Aditi Technologies Pvt Ltd

Aptech Ltd

Aspire Systems (India) Pvt. Ltd.

Bells Softech Limited

Bharti Telesoft Ltd.

Birlasoft Limited

Blue Star Infotech Ltd

BPL Telecom Ltd.

Cognizant Technology Solutions India Pvt. Ltd.

Convergys India Services Pvt Ltd

Datamatics Ltd.

Datamatics Technologies Ltd

Eclipse Systems Pvt. Ltd.

EDS - Electronic Data Systems (India) Pvt Ltd

GE Capital Services India

Geometric Software Solutions Company Ltd

HCL Technologies Ltd

Hexaware Technologies Limited

Honeywell Technology Solutions Lab Pvt Ltd

IBM Global Services India Pvt Ltd

iGATE Global Solutions Ltd

Information Technology Park Ltd

ITC Infotech India Ltd

Kanbay Software (India) Pvt Ltd

KPIT Cummins Infosystems Ltd

LG Soft India Pvt. Ltd.

Mahindra - British Telecom Ltd

Mphasis BFL Ltd.

Neilsoft Limited

NIIT Technologies Ltd

Patni Computer Systems Ltd

Pentamedia Graphics Ltd

Philips Software Centre Pvt. Ltd

Polaris Software Lab Ltd

PSI Data Systems Ltd.

Rolta India Ltd.

Samsung Electronics India Software

Operations (SISO)

SAP India Pvt. Ltd.

Satyam Computer Services Ltd

Tasaa Netcom Private Limited

Tata Consultancy Services Ltd

Tata Technologies Limited

Wipro Technologies (Wipro Ltd)

Zenith Software Limited

Zensar Technologies Limited

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Bibliography

Books References

• Software Engineering A Practitioner’s Approach, by Roger S. Pressman, McGraw-Hill

International Edition

• ISO 9001:2000 for Software Organization, By Swapna Kisore and Rajesh Naik, Tata

McGraw-Hill Publishing Company Limited

• ISO 9001 Interpreted for Software Organizations, By R. A. Radice, Paradoxicon

Publishing

Web References

• http://www.iso.org

• www.swquality.com

• www.nasscom.org

• http://www.mah.nic.in

• www.isixsigma.com

• http://www.sei.cmu.edu