5.

QUALITY MANAGEMENT SYSTEMS

We deal with the following quality systems in this chapter:

1. ISO 9000 Series of Standards

2. QS 9000
3. ISO 14000

QUALITY SYSTEMS

The International Organization for Standardization (ISO) was founded in 1946 in Geneva, Switzerland,
where it is still headquartered. Its mandate is to promote the development of international standards to
facilitate the exchange of goods and services worldwide. Recognizing the importance of quality systems,
the ISO has developed a series of standards, which is popular as ISO 9000.These international standards
were jointly developed by all ISO member countries and are being adopted throughout the world.

The ISO 9000 is a series of standards in quality management systems, which can be adopted by all
types of organizations belonging to the government, public, private or joint sectors, producing and
supplying all kinds of goods, services and software. These standards are generic and not specific to any
particular product. They can be used for managing the quality of output of manufacturing and services
industries.

These standards were published for the first time in 1987.The aim was to effectively document
quality management system requirements which needed to be implemented to attain customer
satisfaction. The implementation of ISO 9000 guides in building quality into products and/or services by
preventing deficiencies during design, production , installation and servicing process instead of making
expensive post-production inspection and warranty claims and reworking.

These standards were revised for the the first time in 1994.Based on actual experiences of several
thousand companies, these standards were revised again. The improved version came in 2000.

The latest version would contain the following 3 main standards given below

Standard Title Scope

ISO 9000 - 2000 Quality Management systems – Provides fundamentals of

Fundamentals and Vocabulary
ISO 9001 - 2000 Quality Management Systems -
Requirements
quality management systems
and specifies quality
management terms and
definitions.
Specifies requirements for a
quality management systems
where an organization needs to
demonstrate its capability to

ISO 9004-2000 Quality Management Systems –
Guidance for performance
improvement
meet customer requirements
for products and /or services
and assessment of that
capability by internal and
external parties.
Provide guidance on quality
management systems as a
means for continual
improvement of processes that
contribute to the satisfaction of
an organization’s customers and
other interested parties.

QUALITY MANAGEMENT PRINCIPLES

The quality management principles are a set of comprehensive and fundamental rules or beliefs for
leading and operating an organization. They aim at continually improving performance over long term,
by focusing on customers while addressing the needs of all stakeholders.

These principles provide an understanding of and guidance on the application of quality

management in an organization. As per the ISO, the following eight quality management principles can
facilitate any organization in creating quality work culture and successful implementation of quality
management.

1. Customer –Focused Organization

Organizations depend on their customers. Therefore, they should understand the current and
future needs of the latter, to meet their requirements and strive to exceed their expectations.
Customer – focused organizations produce products and services that customers need and
provide them satisfaction. This can be achieved by the following actions:

 Identify customer needs.

 Design a product that respond to customer needs.
 Product and deliver the product as per the design.
 Enhance after-sales service and handle complaints quickly
 Measures customer satisfaction
 Improves quality to delight the customer.

2. Leadership

Senior leaders of an organization need to set directions and create customer orientation, clear
and visible quality values and high expectations. Values, directions and expectations must
address all stakeholders. The leaders need to ensure the creation of strategies, systems and
methods for achieving excellence. Strategies and values should help guide all activities and
decisions of the organization. The senior leaders must commit to the development of the entire
 workforce and should encourage participation, learning, innovation and creativity by all
employees. Through their personal roles in planning, communications, review or organization
performance and employee recognition, the leaders serve as role models who reinforce values
and expectation and build leadership and initiative.

3. Involvement of People

It is one way of improving quality and productivity. Involving people at all levels enables their
abilities to be used for the benefit of the organization. This can be done by providing a good
corporate work culture, providing an interesting work system and environment and building the
capability of people to perform assigned task in the organization.

4. Process Approach

A desired result is achieved more efficiently when related resources and activities are managed
as a process.

5. Systems Approach to Management

Identifying, understanding and managing a system of interrelated processes for a given

objective contributes to the effectiveness and efficiency of the organization.

6. Continuous Improvement

A permanent objective of the organization is that it should continuously improve performance

by addressing the needs of all the interested parties.

7. Factual Approach to Decision making

Effective decisions are based on the logical or intuitive analysis of data and information.

8. Mutually Beneficial Supplier Relationship

The ability of the organization and its suppliers to create value is enhanced by mutually
beneficial relationship.

The main purpose of quality management systems can be summarized as below:

 Customer satisfaction/Customer delight by assuring the required minimum level of

consistent quality.
 Satisfying internal customers.
 Assuring the management of doing this at minimum possible total cost of quality
 Maximising output to input ratios of processes
 ‘Prevention is better than cure’ strategy to be implemented
 Improve quality of communication all around.
 Develop competent sub-contractors as partners.
 Make continual improvement an ongoing feature of the company’s culture
ISO 9001-2000 is titled as ‘Quality Management Systems-requirements’.

The tile will no longer include the term ‘Quality assurance’. This is probably because the term, somehow,
connoted the manufacturing system only. The new standard tries to be generally more applicable and
be understood more easily.

The requirements not only address quality assurance of the product or service conformity. The emphasis
has been shifted to the need for an organization to demonstrate its capability to achieve customer
satisfaction.

REQUIREMENTS OF A QUALITY MANAGEMENT SYSTEM

1) General

The system must demonstrate a capability to meet customer requirements for product/services and
should also provide for the assessment of that capability by internal and external parties.

These are not a substitute but complementary requirements to the specified technical
requirements for products and services.

It is NOT the purpose of this standard to imply uniformity of quality management systems in all
organizations.(The design and implementation of an organization’s quality management processes and
practices employed and the level of competence of the people involved in implementation).

It doesn’t intend obliging organizations to change the structure of their existing quality management
system and/or its documentation to exactly match with the structure of the ISO 9001 standard. The
documentation of the organization should be defined in a manner that is most appropriate to its unique
activities.

2) Process Model

Any activity or operation which receives input and converts them to outputs can be considered
as a process.

Organizations need to define and manage numerous interlinked processes.

The system identification and management of the various processes employed in an organization
and interaction between such processes may be referred to as the ‘process approach’ management.

The standard encourages the use of the process approach for the management of the
organization and its processes as a means of identifying and managing opportunities for improvement.

Fig. 5.1 gives a conceptual presentation of the generic quality management system. It is broadly
based on the simple but famous Deming cycle of ‘Plan – Do – Check – Act. Deming propounded the use
of this method of working in all aspects of business. Any activity should be planned before it is done. In
many organizations, planning is not carried out with as much seriousness as it should be. In this situation
there is no guidelines against which to judge the performance. Hence, there is no way of improving the
performance either until the customer shouts or just goes away. Once the plan has been agreed upon,
the entire team should stick to doing activities as per the plan until it is revised for some valid reason.
Sometimes, the plan may have to be revised very often to keep up with the requirements of the
customer. But this is no excuse for not having a plan at all. The activities are being performed and the
results have to be checked or measured for their conformance with the requirements at the end of a
process. Data is recorded and analyzed at appropriate intervals using the right statistical techniques.
Cause-analysis is an important part of analysis. Based on the findings, improvement actions-either
corrective or preventive are decided and carried out again in a planned manner. Such actions should
result in- amending work procedures in the company so that the improvements get into the system.
Thus, it ensures a continually learning organization.

3) Compatibility with other Management Systems

This standard shares common principles with ISO 14001, Environmental Management systems
specification with guidance for use.
It is suggested that common subjects in the two series of standards may be implemented in a
shared manner, without unnecessary duplications or imposition of conflicting requirements.
This standard doesn’t address or include requirements from other management systems, such
as environment management, occupational health and safety management or financial
management. However, this standard doesn’t prevent an organization from developing
integration of like management system subject/areas. This means that companies may simplify
documentation by preparing an integrated management system covering the requirements of
different compatible management systems.
Quality system requirements of this standard need not be established independently of
the existing management system requirements.
 FIG.5.1 PROCESS MODEL

QUALITY MANAGEMENT SYSTEM CONTINUAL

IMPROVEMENTS

Management
responsibility

Customer Customer
Requirements Resources Measurement,
Satisfaction
Management Analysis, Improvement

Input Output

Product
Realization
Product/Service

ISO – 9001:2000
QUALITY MANAGEMENT SYSTEMS – REQUIREMENTS CONTENTS

1. Scope
2. Normative Reference
3. Terms and Definitions
4. Quality Management Systems
4.1 General Requirements
4.2 Documentation Requirements
5. Management Responsibility
5.1 Management commitment
5.2 Customer focus
 5.3 Quality Policy
5.4 Planning (Objectives and QMS Planning)
5.5 Responsibility, Authority and Communication (R & A, MR , Int.Com)
5.6 Management Review (Gen,Input, Output)
6. Resource Management
6.1 Provision of Resources
6.2 Human Resources (General, Competence, Awareness and Training)
6.3 Infrastructure
6.4 Work Environment
7. Product Realization
7.1 Planning of Product Realization
7.2 Customer-related Process (Requirements- Determination & Review, Communication)
7.3 Design and Development
7.4 Purchasing
7.5 Product & Service Provision (Control of production & Service provision, Validation of
Processes, Identification and Traceability, Customer Property, Preservation of Product)
7.6 Control of Monitoring and Measuring Devices
8. Measurement , Analysis & Improvement
8.1 General
8.2 Monitoring & Measurement (Customer Satisfaction, Internal Audit, Processes, Product)
8.3 Control of Non-conforming Products
8.4 Analysis of Data
8.5 Improvement (Continual Improvement, Corrective Action, Preventive Action)

1. Scope

Requirements are specified for a quality management system of an organization, which wants to
demonstrate its capability to consistently provide products or services conforming to specifications or
customer requirements.

The specified requirements are generic and applicable to all organizations, regardless of their type and
size.

2. Normative Reference

Supply chain terminology in this standard:

‘Supplier – organization – Customer’

3. Terms and Definitions

The definitions related to the quality systems given below are based on international standards
ISO 8402:1994 and ISO 9000:2000

Quality: The totality of features and characteristics of a product or services that bear on its
ability to satisfy stated or implied needs.
Quality Policy: The overall directions and intentions of an organization regarding quality that are
expressed in a formal document by the top management. It is a statement which is subjected to
third party quality audit at the time of certification as well as surveillance. The management
needs to have evidence that the various statements in the quality policy are, in fact, being
implemented or at least, there are plans with time frames for the implementation.

Quality Management: That aspect of the overall management functions that determines and
implements the quality policy.

It includes strategic planning, allocation of resources and systematic activities for quality
such as quality planning, operations and evaluation.

Although the achievement of the desired quality requires commitment and participation of
every member of an organization, the responsibility for quality management belongs to the top
management.

Quality Loop; Quality Spiral: The conceptual model of interacting activities that influences
quality in various stages – ranging from the identification of the needs of the customer to the
review of the fulfillment of those needs.

Quality System: The organization structure, responsibilities, procedures and resources for
implementing quality management. The quality system should be only as comprehensive as
needed to meet quality objectives. For contractual mandatory and assessment purposes,
demonstration of the implementation of identified elements in the system may be required.

Quality Assurance: A management system designed to give the maximum confidence that a
given acceptable level of quality is being achieved consistently with minimum total expenditure.
It connotes all those planned and systematic actions necessary to provide adequate confidence
that a product or service will satisfy the given requirement for quality. It must be remembered
that unless the specified requirements fully reflects the needs of the user, quality assurance will
not be effective.QA usually requires a continuing assessment of factors that affect the adequacy
of a design or specifications for the intended applications. It also needs verification and audits of
production, installation and inspection operations.

Providing confidence requires showing evidence.

QA is a management tool within the organization. In a contractual situation, it serves to provide

confidence in the supplier organization.

Quality Control: The operational techniques and activities that are used to fulfil requirements
for quality. These are generally aimed at monitoring a process as well as eliminating the causes
of unsatisfactory performance at the relevant stages of the quality loop in order to provide
economically effective solutions to the management.

Quality Plan: A document setting out the specific quality practices, resources and sequence of
activities relevant to a particular product family, service segment, contract or project.
Quality Audit : A systematic and independent examination to determine whether quality
activities and related results comply with the planned arrangements and whether these
arrangements are implemented effectively and are suitable for achieving the objectives.

An independent examination means audits are carried out by the staff with no direct
responsibility in the areas being audited but, preferably, working in cooperation with the
personnel concerned.

These are sometimes called ‘quality system audit’, ‘process quality audit’, ‘product quality
audit’, ‘service quality audit’ and so on.

The most important purpose of quality audit is to evaluate the need for improvement or
corrective action. This should not be confused with ‘process surveillance’ or ‘inspection’ for
product approval. Quality audits can be conducted for ‘internal’ or ‘external’ purposes.

Quality Surveillance: The continuing monitoring and verification of the status of procedures,
methods,conditions,processes,products and services and analysis of records in relation to
planned objectives to ensure that specified requirements for quality are being met.

This may be carried out on behalf of the customer by a third party or directly by the
customer to ensure that the contractual requirements are being met. It considers factors which
may result in degradation with time.

Quality System Review: A formal evaluation by the top management of the status and adequacy
of a quality system in relation to quality policy, requirements of the international standard
model adopted, if any and the new objectives resulting from changing circumstances.

Design Review: A formal documented comprehensive and systematic examination to evaluate

design requirements and its capability to meet these requirements, to identify problems, if any
and to propose solutions.

Design Review in itself is not a substitute to good designing practices to ensure adequate
design. The capability of a design includes many factors such as fitness for purpose, feasibility,
manufacturability, performance, measurability, reliability, safety, maintainability, environmental
aspects, time scale and life cycle costs.

Participants at each design should include qualified people from a pertinent function
affecting quality.

Inspection: Activities such as measuring, examining, testing, gauging one or more features or
characteristics of a product or services and comparing these with specified requirements to
determine conformity.

Reliability: The ability of a product to perform a required function under stated conditions for a
stated period of time. This term is also used to denote probability of success.
 Traceability: The ability to trace the history, application or location of an item or activity or
similar items or activities by means of recorded identification.

Traceability may mean one of the following:

In a distribution sense, it relates to a product or services in a calibration sense, it relates to

a measuring instrument/equipment of national or international standards, primary standards or
basic physical properties, and in a data- collection sense, it relates to calculations and data
generated throughout the quality loop of a product or services.

4. QUALITY MANAGEMENT SYSTEM

4.1 General Requirements

A company has to establish, document, implement and maintain the quality management
system described in the standard. It has to be committed to carrying out continual
improvement in the effectiveness of this quality management system according to the
measures described in its system.

a) The company has to identify the processes needed for the quality management system
and ensure their application throughout the organization.
b) The company has to determine the sequence and interaction of these processes in the
form of process flow charts wherever possible. This is also called ‘Process Mapping’
c) The company has to determine the criteria and methods needed to ensure that both the
operations and control of these processes are effective.
d) The management has to ensure the availability of resources and the information
necessary to support the operation and monitoring of these processes.
e) The Processes have to be monitored measured and analyzed.