QUALITY SYSTEMS

The International Organisation for

Standardisation (ISO) was founded in 1946
in Geneva, Switzerland
Its mandate is to promote the development
of international standards to facilitate the
exchange of goods and services worldwide.
Recognising 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 organisations 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 service 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.
These standards were revised for 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 three

main standards

ISO 9000-2000 (Quality Management Systems-

Fundamentals and vocabulary)

Provides fundamentals of quality management systems

and specifies quality management terms and
definitions.
ISO 9001-2000(Quality Management Systems
Requirements)
Specifies requirements for a quality management
system where an organisation needs to demonstrate its
capability to meet customer requirements for products
and/or services and assessment of that capability by
internal and external parties.

ISO 9004-2000(Quality Management Systems-Guidance

for performance improvement)
Provides guidance on quality management systems as a
means for continual improvement of processes that
contribute to the satisfaction of an organisation'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 organisation. They aim at
continually improving performance over long term,
by focusing on customers while addressing the needs
of all stakeholders.

As per the ISO, the following eight quality

management principles can facilitate any
organisation in creating quality work culture and
successful implementation of quality management.
1. Customer-focused Organisation
Organizations depend on their customers.
Customer-focused organisations 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 responds to customer needs.
• Produce and deliver the product as per the design.
• Enhance after-sales service and handle complaints
quickly.
• Measure customer satisfaction.
• Improve quality to delight the customer.
2. Leadership
Senior leaders of an organisation 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 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 organisation performance
and employee recognition, the leaders serve as role
models who reinforce values and expectations and build
leadership and initiative.
3. Involvement of People

Involvement of the people is one way of improving

quality and productivity. Involving people at all levels
enables their abilities to be used for the benefit of the
organisation.

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 tasks in the organisation.

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
organisation.

6. Continuous Improvement

A permanent objective of the organisation 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 organisation and its suppliers to

create value is enhanced by mutually beneficial
relationships.

The main purposes of quality management systems

can be summarised 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 9000 series has five international standards on
quality management:
ISO 9000
This provides guidelines on selection and use of
quality management and quality assurance
standards.

ISO 9001

It has 20 elements covering design, development,

production, installation and servicing

This is applicable for the industries which are doing

their own design and development, production,
installation and servicing.
ISO 9002

It has 18 elements covering production and

installation. It is the same as ISO 9001 without the
first two tasks, viz., design and development. This is
applicable for the units excluding R & D functions.

ISO 9003

It has 12 elements covering final inspection and

testing for laboratories and ware houses etc.

ISO 9004

This provides guidelines o interpret the quality

management and quality assurance. This also has
suggestions which are mandatory.
BENEFITS of ISO 9000 series
ISO 9000 series provides several tangible and
intangible benefits which are listed below:
– This gives competitive advantage in the global market.
– Consistency in quality, since ISO helps in detecting non-
conformity early which makes it possible to take
corrective actions.
– Documentation of quality procedures adds clarity to
quality systems.
– ISO 9000 ensures adequate and regular quality training
for all members of the organization.
– ISO helps the customers to have cost effective purchase
procedure.
– The customers while making purchase from companies
with ISO certificate, need not spend much on inspection
and testing. This will reduce the quality cost and lead
time.
– This will help in increasing productivity.
– This will aid to improved morale and involvement of
workers.
– The level of job satisfaction would be more.
ISO 9001

ISO 9001 is used where a contract between two

parties requires the demonstration of a supplier’s
capability to deign and supply products.

The requirements specified are aimed primarily at

preventing nonconformity at all stages from design
through to servicing.

It is applicable in contractual situations when the

contract specially requires design effort and the
product requirements are stated principally in
performance or they need to be established and
confidence in product conformance can be attained
by adequate demonstration of certain capabilities of
supplier in design, development, production,
installation and servicing.
 ISO 9001 lists out the different aspects relating to:
1. Management Responsibilities.
2. Quality Systems
3. Product Identification and Traceability.
4. Inspection Status
5. Inspection and testing
6. Inspection measuring and test equipments
7. Control of Non-conforming products
8. Handling, Storage, Packaging and Delivery
9. Document Control
10.Quality Records
11.Training
12.Statistical Techniques
13.Internal Auditing
14.Contract Review
15.Purchasing
16.Process control
17.Purchaser supplied Product
18.Corrective action
19.Design Control
20.Servicing
ISO 9002
ISO 9002 is used when a contract between
two parties requires demonstration of a
supplier‘s capability to control the process
that determine the acceptability of product
specified.

The requirements specified aim at

preventing non-conformity during
production and implementing the means to
prevent recurrence.
ISO 9002 has following points:
1. Management Responsibilities.
2. Quality Systems
3. Product Identification and Traceability.
4. Inspection Status
5. Inspection and testing
6. Inspection measuring and test equipments
7. Control of Non-conforming products
8. Handling, Storage, Packaging and Delivery
9. Document Control
10.Quality Records
11.Training
12.Statistical Techniques
13.Internal Auditing
14.Contract Review
15.Purchasing
16.Process control
17.Purchaser supplied Product
18.Corrective action
ISO 9003

ISO 9003 is used when a contract between two

parties requires demonstration of a supplier’s
capability to detect and control the disposition of any
product non-conformity during final inspection and
test.

It is applicable in contractual situations when the

conformance of the product to specified
requirements can be shown with adequate
confidence providing that certain suppliers
capabilities for inspection and tests conducted on the
product supplied can be satisfactorily demonstrated
on completion.
 ISO 9003 lists out the different aspects relating to:
1. Management Responsibilities.
2. Quality Systems
3. Product Identification and Traceability.
4. Inspection Status
5. Inspection and testing
6. Inspection measuring and test equipments
7. Control of Non-conforming products
8. Handling, Storage, Packaging and Delivery
9. Document Control
10.Quality Records
11.Training
12.Statistical Techniques
ISO 9004
ISO 9004 is used when selection of
appropriate elements contained in this
standard and extent to which these
elements are adopted and applied by a
company depends upon factors such as size
of company, market being served, nature of
product, production processes and customer
needs.

ISO 9004 lists out the different aspects

relating to:
Terminology
Management Responsibility for Quality
– Quality Policy
– Quality Objectives
– Quality Systems
– Quality system Principles
Economics

Quality related cost considerations

– Quality in marketing
– Quality in design and specification
– Quality in procurement
– Quality in production
– Control of production
– Product Verification

Control of measuring and test equipment

– Non conformity
– Corrective action
– Handling & post production functions
Quality documentation & records
Personnel
Product Safety and liability
Use of statistical methods
System for handling of customer complaints
Quality Reporting & reviews
 EIGHT STEPS TO ISO 9000 CERTIFICATION
1. Evaluation of existing quality procedures against the
requirements of the ISO 9001-9003 standards.

2. Identification of corrective action needed to conform with

ISO 9000 series standards

3. Preparation of a certifiable quality management system

4. Definition, documentation and implementation of new

procedure.

5. Preparation of Quality manuals

6. Pre-assessment meeting with registrar to analyse quality

manuals

7. Actual assessment visits

8. Certification/Registration.
ISO 14000
The ISO 14000 document is titled 'Environmental
Management System-General Guidelines on
Principles, Systems and Supporting Techniques '.

It outlines system elements, with advice on how to

initiate, implement, improve and sustain the system.

By following its guidelines and the core elements of

the EMS specification-ISO 1400l-your organisation
will have a framework to balance and integrate
environmental and economic interests.
Doing so will improve your competitive advantage.
ISO 14000 stipulates a set of 10 management
principles for organisations considering an
environmental management system.
These are:

1. Recognize that environmental management is one of

the topmost priorities of any organisation.

2. Establish and maintain communications with

interested parties- both internal and external.

3. Determine legislative requirements and

environmental aspects associated with your
activities, products and services.

4. Get everyone in the organisation to commit to

environmental protection and clearly assign
responsibilities and accountability.

5. Promote environmental planning throughout the life

cycle of the product and the process.

6. Establish a management discipline for achieving
targeted performance.

7. Provide the right resources and sufficient training

to achieve performance targets.

8. Evaluate performance against policy,

environmental objectives and targets, and make
improvements wherever possible.

9. Establish a process to review, monitor and audit

the environmental management system to identify
opportunities for improving performance.

10. Encourage vendors to also establish

environmental management systems.
Benefits of an Environmental Management System

What does ISO 14000 say regarding the benefits to an

organization if the latter implements an effective
environmental management system?

Corporations and organizations can

1. Protect human health and environment from the

potential impacts of their activities, products and
services.

2. Assist in maintaining and improving the quality of

the environment.

3. Meet customers' environmental expectations.

4. Maintain good public and community relations.

5. Satisfy investor criteria and improve access to

capital.
6. provide insurance at a reasonable cost.

7. gain an enhanced image and market share.

8. satisfy vendor certification criteria.

9. improve cost control.

10. limit liabilities.

11. provide resource conservation.

12. provide effective technology development and

transfer.

13. provide confidence to interested parties (and

shareholders) that
(a) policies, objectives and targets are met,
(b) emphasis is on prevention first,
(c) reasonable care and regulatory compliance regularly
occur, and
(d) system design includes continual improvement.
ISO 14000 series
ISO 14000
Environmental management systems. General
guidelines on principles, systems and supporting
techniques.

ISO 14001
Environmental management systems. Specifications
with guidance for use.

ISO 14004
Environmental management systems. General
guidelines on principles, systems and supporting
techniques.

ISO 14010
Guidelines for environmental auditing. General
principles of environmental auditing.
ISO 14011
Guidelines for environmental auditing. Audit
procedures-Part I: auditing of environmental
management systems.

ISO 14012
Guidelines for environmental auditing. Qualification
criteria for environmental auditors.

ISO 14013
Guidelines for environmental auditing. Management
of environmental management system audit
programmes.

ISO 14014
Guidelines for initial environmental reviews.
ISO 14015
Guidelines for environmental site assessments.

ISO 14020
Environmental labelling. Principles of all
environmental labelling.

ISO 14021
Environmental labelling. Self-declaration,
environmental claims-terms and definitions.

ISO 14022
Environmental labelling. Symbols.

ISO 14023
Environmental labelling. Testing and verification
methodologies.
ISO 14024
Environmental labelling. Practitioner programmes,
guiding principles, practices and certification
procedures of multiple criteria.

ISO 14030
Environmental performance evaluation.

ISO 14031
Evaluation of the environmental performance of the
management system and its relationship to the
environment.

ISO 14040
Environmental management-life-cycle assessment
principles and guidelines.

ISO 14041
Environmental management-life-cycle assessment.
Goal definition/scope and inventory analysis.
ISO 14042
Environmental management-life-cycle assessment.
Impact assessment.

ISO 14043
Environmental management-life-cycle assessment.
Improvement assessment (or evaluation and
interpretation).

ISO 14050
Terms and definitions.

ISO 14060
Guidelines for the inclusion of environmental aspects
in product standards.