Introduction of IS/ISO 9000:2000

Quality Management Systems [QMS]

Presented by,
JAYAVARATHAN B
SARAVANAN J
THANGAVEL S

Founders of ISO, London 1946

 PRESENTATION OUTLINE
• Introduction
• ISO, its evolution and need
• Structure of ISO9000 standards
– Contents of ISO 9001:2000 standard
• Factors leading to ISO 9000:2000
• ISO 9000:2000 quality management principles
• Recent up gradation
• Benefits of ISO
• Summary
 INTRODUCTION
• Quality becomes a major focus of businesses throughout the
world and various organizations developed standards and
guidelines such as quality management, quality control, quality
assurance and quality system
• Meeting standards is a requirement for international
competitiveness
• Apply to all types of business (electronics, chemicals, healthcare,
Food, Energy efficiency & Renewable, banking and transportation)
 …INTRODUCTION

• In the year 1987,composed of representative from national

standards bodies of 91 nations, adopted a series of written
quality standards, to standardize quality requirement of
European countries within the common market and those
who wishing to do business with those countries These
standards, were revised in 1994, and again (significantly)in
the year 2000
• These standards have been adopted in united states by ANSI
with endorsement and co-operation of ASQ
• Currently, we have members from 162 countries and 3,368
technical bodies to take care of standard development
 Standards
• What is ISO?
• Before that, we should know what is standard?
• Standards are documented agreements containing
technical specifications or other precise criteria to be
used consistently as to ensure that rules, guidelines,
materials, products, processes and services are fit for
their purpose
 Ex: In smart card , optical thickness - 0.76 mm.
 Paper size, symbols for automobile controls, ISO international
codes for country names, currencies and languages ,OSI ....etc;
 ISO
Who makes up ISO?

General
Assembly

Policy
Technical
Development Council
Management Board
Committees

Technical Advisory
Groups

Technical Committees
Technical Committees
Technical Committees
Technical Committees
 ISO

• ISO [International organization for

standardization] is a non-governmental
organization established in 1946 in Geneva,
Switzerland
EVOLUTION OF ISO 9000
 NEED FOR ISO
• Main factors are "Quality and Standardization"
around the world
• Worldwide progress in trade liberalization
– Interpenetration of sectors
– Worldwide communications systems
– Global standards needs for emerging technologies
– Developing countries
 ISO 9000 OBJECTIVES
It defines quality system standards
To meet five objectives
1. Achieve, maintain and seek to continuously improve
product quality [including services] in relationship to
requirements
2. Improve the quality of operations
3. Provide confidence to internal management
4. Provide confidence to customers
5. Provide confidence that quality system requirements
are fulfilled
 STRUCTURE OF ISO 9000 STANDARDS

• The ISO 9000:2000 standards focus on developing,

documenting and implementing procedures
– to ensure consistently of operations
– and performance in production and service delivery
processes, with the aim of continual improvement and also
supported by fundamental principles of total quality
• It is a series of standards that are "generic rather than
specific"
• It can be applied to all type of organizations, large or small
scale industry, public, private,...
• ISO standards are developed through consensus, applied
industry wide and it is voluntary
 STRUCTURE OF ISO 9000 STANDARDS
The standard consists of 3 documents

• ISO 9000 (Fundamentals & Vocabulary)

• ISO 9001 (Quality Management Systems – set of 4 minimum

Requirements)
– Management Responsibility
– Resource Management
– Product Realization
– Measurement analysis & improvement
 …STRUCTURE OF ISO 9000 STANDARDS
• ISO 9004: 2000
Quality Management Systems – Guidelines for
performance improvements
Relates to organizations who wish to improve beyond
the scope of ISO 9001
Has an element of self evaluation and this standard does
not stand for certification
 CONTENTS OF ISO 9001:2000 STANDARD

1. Management responsibilities
• Management commitment
• Customer focus
• Quality policy
• Planning
• Responsibility, authority and communication
• Management review
 Management responsibility
1. Management To develop, implement and continuous improvement of
commitment QMS
(Top Management) a.Communicate the need to meet customer, legal and
regulatory requirements
b.Establishing quality policy
c.Ensure that quality objectives are established
d.Conducting management review
e.Ensuring the availability of resources
2. Customer focus Top management should ensure that customer
requirements are determined and met with the aim of
enhancing customer satisfaction
3. Quality policy Appropriate for organization’s purpose or mission
Commitment to comply with requirements and
continually improve the effectiveness of QMS
4. Planning Quality objectives
Finishing department scrap will be reduced from 4 per
cent to 3 per cent and the first line supervisor is
responsible
 …Management responsibility
5. Responsibility, Responsibility and Authority
Authority and Defined
Communication Communicated within the organization
Management representative
Internal communication
6. Management At planned intervals
review 1.To ensure its continuous suitability, adequacy and
effectiveness
2.Assess the opportunities for improvement
3.Need for change in QMS if any
4.Records from reviews shall be maintained
Review input
1.Results of audit
2.Customer feedback
3.Process performance and product conformity
4.Status of corrective and preventive performance
5.Follow-up actions from previous management reviews
6.Recommendations for improvement
Review output
 …CONTENTS OF ISO 9001:2000 STANDARD

2.Resource management

Provision for resources

• People
• Infrastructure
• Work environment
• Information
• Suppliers
• Natural resources
• Financial resources
 …Resource management
Human resources
• Education, training, skills and experience – conformity to
product requirements
– Necessary level of Competence and awareness should be decided
to meet conformance
– Where applicable, provide training
– Awareness of the relevance and importance of their activities and
how they contribute to the objectives
– Maintain records
– Training effectiveness should be assessed
– Competence requirement should be given in the job description by
function or specific position
 …Resource management
Infrastructure requirements
• Buildings
• Workspace and associated utilities
• Process equipment (hardware and software)
• Supporting services (Transport, communication services)
Working environment
• Physical, environmental and other factors like noise,
temperature, humidity. Lighting and weather
 …CONTENTS OF ISO 9001:2000 STANDARD

3. Product realization
– Planning of product
– Processes of interested parties (customer)
– Design and development
• Design and development planning
• Inputs
• Outputs
• Review
• Verification
• Validation
• Control
– Purchasing process
– Production and Service provision
– Control of measuring and monitoring facilities
 CONTENTS OF ISO 9001:2000 STANDARD

4. Measurement, analysis and improvement

– General instructions
– Monitoring and Measurement
• Customer satisfaction
• Internal audit
• Process
• Product and service
– Control of non-conforming product
– Analysis of data
– Improvement
• Continuous improvement
• Corrective action
• Preventive action
ISO 9001:2000 STANDARD
 Implementation
1 Top management commitment 8 Review the present system

2 Appoint the Management 9 Write the documents

representative
3 Awareness 10 Install the new system

4 Appoint Implementation team 11 Internal audit

5 Training 12 Management review

6 Time schedule 13 Pre assessment

7 Select Element owner 14 Registration

 Factors Leading to ISO 9000:2000

• In ISO 9001:1994 series consists of 20 fundamental

elements of basic quality system that includes:
– Management responsibility
– Quality system
– Contract review
– Design control
– Document and data control
– Purchasing
– Customer supplied product
– Product identification and traceability
– Process control
– Inspection and testing
– Inspection, measuring and test equipment
 …Factors Leading to ISO 9000:2000

– Inspection and test status

– Control of nonconforming product
– Corrective and preventive action
– Handling storage, packaging, preservation and delivery
– Quality records
– Internal quality audits
– Training
– Servicing
– Statistical techniques
 …Factors Leading to ISO 9000:2000
• In the year 1994, ISO 9001:1994 was introduced
• 3 big automotive industry[ General Motors, Chrysler and
Ford] were not satisfied with this standard.
• QS 9000 is an industry standard of American automotive
industry, which was prepared in 1994 by the joint efforts of
automakers General Motors, Chrysler and Ford (The Big
Three) and released under the auspices of AIAG (Automotive
Industry Action Group)
• The standard is divided into three sections:
1. ISO 9001 plus some automotive requirements
2. "Additional Requirements" and contains system
requirements that have been adopted by all three
automakers - General Motors, Chrysler and Ford.
3. "Customer Specific Section"
 …Factors Leading to ISO 9000:2000

• Later, QS 9000 was significantly revised in 1998,

– but its main drawback is that it was built on the
foundation of ISO 9001:1994, which is why most car
manufacturers and suppliers in the automotive industry
are moving to the newer standard ISO/TS 16949
– QS 9000 is based on ISO 9000 and includes all ISO
requirements
– But it included additional requirements such as
• continuous improvement
• Manufacturing capability
• Production part approval process
 ISO 9000:2000
Quality management principles
ISO 9000: 2000 is a response to widespread dissatisfaction that
resulted from old standards

1. Customer focus
– Needs and requirements
1. Leadership
– Direction of the organization, unity of purpose
1. Involvement of people
– Human resource focus
1. Process approach
– activities and related resources are managed as a process
 ISO 9000:2000
Quality management principles
5. System approach to management
– Managing interrelated process as system leading to
efficiency of the organization
5. Continual improvement
6. Factual approach to decision making
– Decision making is based on the analysis of data and
information
5. Mutually beneficial supplier relationships
– Organization and suppliers are interdependent and
mutually beneficial relationship enhances the ability of
both to create value
Process Approach
Quality Management System
 ISO 9001 has been updated
• ISO 9001 Quality Management Systems : been revised
• The ISO 9000 family addresses various aspects of quality
management and contains some of ISO’s best known
standards
– The standards provide guidance and tools for companies and
organizations who want to ensure that their products and
services consistently meet customer’s requirements, and that
quality is consistently improved.
• Standards in the ISO 9000 family include:
– ISO 9001:2015 - sets out the requirements of a quality
management system
– ISO 9000:2005 - covers the basic concepts and language
– ISO 9004:2009 - focuses on how to make a quality management
system more efficient and effective
– ISO 19011:2011 - sets out guidance on internal and external
audits of quality management systems.
ISO 9001 : 2015 Stages
 ISO 9001 revised?
• All ISO standards are reviewed every five years to
establish if a revision is required to keep it current and
relevant for the marketplace
• ISO 9001:2015 is designed to respond to the latest
trends and be compatible with other management
systems such as ISO 14001
• The new version follows a new, higher level structure to
make it easier to use in conjunction with other
management system standards, with increased
importance given to risk
 BENEFITS
• Enhanced product quality and reliability at a reasonable
price
• Improved health, safety and environmental protection,
and reduction of waste
• Greater compatibility and interoperability of goods and
services
• Simplification for improved usability
• Reduction in the number of models, and thus reduction
in costs
• Increased distribution efficiency, and ease of
maintenance
 Summary

• ISO International Standards provide practical

tools for tackling many of today’s global
challenges, from managing global water
resources to improving the safety of the food
we eat