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A Project Report On

Study of ISO 9001:2000 Quality Management System

ByByByBy KetanKetanKetanKetan J.J.J.J. ChaudhariChaudhariChaudhariChaudhari (M.B.A(M.B.A.(M.B.A(M.B.A IIIIIIII –––– SystemSystemsSystemSystemsss &&&& Marketing)Marketing)Marketing)Marketing)

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.

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.

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.

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.

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

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.

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.

REQT.

DESIGN

CONSTRUCTION

TESTING

DEVELOPMENT

OPERATION &

ANALYSIS

MAINTENANCE

 

PROJECT PLANNING & MONITORING

 
 

SOFTWARE CONFIGURATION MANAGEMENT

 
 

REVIEWS, VERIFICATION & VALIDATION

 
 

SOFTWARE QUALITY ASSURANCE

 
 

SOFTWARE MEASUREMENT & MTRICES

 

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

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.

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

Check

users, named after Deming who took it to Japan. Act Check Plan Do Fig. 2: Shewhart’s
users, named after Deming who took it to Japan. Act Check Plan Do Fig. 2: Shewhart’s
users, named after Deming who took it to Japan. Act Check Plan Do Fig. 2: Shewhart’s
users, named after Deming who took it to Japan. Act Check Plan Do Fig. 2: Shewhart’s

Plan

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.

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’.

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.

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

 
 

Quality

Management

Systems

Guidelines

for

performance

ISO 9004:2000

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.

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).

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

21
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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.

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.

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.

that ties people, procedures, tools and equipment together. High quality software on time, within budget Process

High quality software on time, within budget

Process
Process

Measurements & feedback for process improvement

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

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:

- 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.

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.

Structure of ISo 9001:2000 The ISO 9001 approach The ISO 9001:2000 standard is based on

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

the supply chain as Supplier Organization Customer 1. Basically we assume that ‘organization’ refers to the
the supply chain as Supplier Organization Customer 1. Basically we assume that ‘organization’ refers to the

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.

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.

Customer
Customer
Measurement Analysis and Improvement
Measurement
Analysis and
Improvement
Customer
Customer

29

Product Realization

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.

Fig. 5 Is ISO 9001 relevant to software? Today, software customers are clearly going global

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,

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".

)

the quality of products and services delivered.

Figure 6 : Delivering Quality Software - macro process 32

Figure 6 : Delivering Quality Software - macro process

33

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.

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,

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.

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:
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.

Item

Description

 

Example

Process

Activities required for transforming input

The process used for performing a peer review

to

output. The activities typically have

interrelations and interactions.

   

Procedure

The sequence of steps to be performed for

The sequence of steps for each part of a review – pre-review meeting, during the review, post-review follow-up

an activity/process

 

Form

A blank document such as a blank table,

The review findings form that needs to be filled in during the review meeting.

that is to be filled in one or more steps

while performing some process.

 

Checklist

A

list

of items that is

used while

The checklist used during review meeting for reviewing a particular type of artifact (e.g. code review checklist).

performing an activity to ensure that all items have been considered.

Standard

A

mandatory set of requirements that has

Coding standard that the programmers are expected to use while coding and reviewers check for conformance while reviewing code.

to

be conformed to while performing an

activity, or by a product being built.

Guidelines

A

set of suggestions to be used to perform

Suggested

conduct

during review

a process better. It is not mandatory.

meetings ( e.g. do not make personal remarks, focus on the product, do not discuss solutions.

Templates

A

blank format, possibly with some

A project planning format that is used for creating the project plan ( see the Annexure )

embedded guidelines for understanding

the

format to be used while preparing a

document.

   

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.)

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

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

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

 

A

brief statement of why the process is required, and what it applies to

Purpose & Scope

(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,

 

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 &

The records generated during the process, the retention period and the person responsible for the retention

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

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:

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.

1.

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

Structure of QMS (Process Architecture)

Identify

Processes to

Define/Modify

Architecture) Identify Processes to Define/Modify Review the QMS Understand Impact on Other Processes
Review the QMS
Review the
QMS
Identify Processes to Define/Modify Review the QMS Understand Impact on Other Processes Prioritize the

Understand Impact on Other Processes

Understand Impact on Other Processes Prioritize the Definition/ Modification

Prioritize the

Definition/

Modification

Roll-out the new Processes

Accept Change requests to Define/Modify the QMS Processes Perform Pilot Implementation (If required)
Accept Change
requests to
Define/Modify the
QMS
Processes
Perform Pilot
Implementation
(If required)
QMS Processes Perform Pilot Implementation (If required) Figure 8: key elements of Process Definition and
QMS Processes Perform Pilot Implementation (If required) Figure 8: key elements of Process Definition and

Figure 8: key elements of Process Definition and Modification

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

performed”. Records are particularly important because:

as “document stating results achieved or providing evidenceof activities

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

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

and

Reports

Presentations

made

during

Management

review

Minutes of Meeting

 

Education, Skills,

Competence/skills database

 

Training

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

Change request

 

Management/SCM

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

 

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

48
48

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

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.”

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.

Optimizing (5) Focus on process improvement

Managed (4) Process Measured and controlled
Managed (4)
Process Measured
and controlled
improvement Managed (4) Process Measured and controlled Defined (3) Process characterized, fairly well understood

Defined (3) Process characterized, fairly well understood

Repeatable (2) Can repeat previously mastered tasks

Initial (1) Unpredictable and poorly controlled

Figure : The Software CMM Model

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

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

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,

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,

maintained.

NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to

and

this

means

that

the

procedure

is

established,

documented,

implemented

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,

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

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

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

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

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