BY SAINATH KARI

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ISO 9000 AND 14000 VALIDATION
SUBMITTED BY:
SAINATH KARI SUBMITTED TO:
MR.A.V.S.ASHOK,
ASST.PROFESSOR,
RVR AND JC COLLEGE OF ENGINEERING,
CHOWDAWARAM,
GUNTUR.

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Contents
1.Introduction
2.Principles
3.ISO 9000
4.Objectives
5.Advantages
6.ISO 14000
7.Conclusion

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Definition
ISO 9000 is a series of standards ,
development and published by the
ISO that define , establish and
maintain an effective quality
assurance system for manufacturing
and service industries.

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What is ISO
ISO is a name used for the
International Organization for Standardization
ISO is not an acronym
It was formed in 1947 in Geneva Switzerland.
It is a federation of national standard bodies of
143 countries.

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OBJECTIVES
To Facilitate International Trade Of Goods and
Services.
To obtain competitiveness by obtaining required
quality in a cost effective way.
Promoting a Total Quality Control System(TQC)

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ISO 9000 Series
ISO 8402-Quality Terms
ISO 9000-General terms and fundamentals
ISO 9002-Manufacturing Standards
ISO 9001-Suppliers
ISO 9003-Test houses
ISO 9004-Systems and Elements

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PRINCIPLES OF ISO
1. Customer focus
2. Leadership
3. Involvement of people
4. Process approach
5. System approach to management
6. Continual improvement
7. Factual approach to decision making
8. Mutually beneficial supplier relationships

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PRINCIPLES OF NEW STANDARD
Customer
Mutual focus
beneficial
Leadership
supplier
relationship
Factual Based on
approach to eight quality Involvement
decision management of people
making principles
Continual Process
improvement System approach
approach to
Management

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1.Customer focus
 Organizations depend on their customers and therefore
should understand current and future customer needs,
should meet customer requirements and strive to exceed
customer expectations.
 Key benefits : Increased revenue and market Share
obtained through flexible and fast Responses to market
opportunities.

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2.Leadership
 Leaders establish unity of purpose and direction of the
organization. They should create and maintain the internal
environment in which people can become fully involved in
achieving the organization’s objectives.
 Key benefits : People will understand and be motivated
towards the organization’s goals and objectives.
Activities are evaluated, aligned and implemented in a unified
way.
Miscommunication between levels of an organization will be
minimized.

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3.Involvement of people
 People at all levels are the essence of an organization and their
full involvement enables their abilities to be used for the
organization’s benefit.
 Key benefits : Motivated, committed and involved people
within the organization.
Innovation and creativity in furthering the organization’s
objectives.
People being accountable for their own performance. People
eager to participate in and contribute to continual
improvement.

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4.Process Approach
 A desired result is achieved more efficiently when activities and
related resources are managed as a process.
 Key benefits : Lower costs and shorter cycle times
through effective use of resources.
Improved, consistent and predictable results.
Focused and prioritized improvement opportunities.

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5.System Approach to Management
 Identifying, understanding and managing interrelated
processes as a system contributes to the organization’s
effectiveness and efficiency in achieving its objectives.
 Key benefits : Integration and alignment of the processes that
will best achieve the desired results.
Ability to focus effort on the key processes.
Providing confidence to interested parties as to the consistency,
effectiveness and efficiency of the organization.

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6.Continual Improvement
 Continual improvement of the organization’s overall
performance should be a permanent objective
of the organization.
 Key benefits : Performance advantage through improved
organizational capabilities.
Alignment of improvement activities at all levels to an
organization’s strategic intent.
Flexibility to react quickly to opportunities.

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7.Factual approach to decision making
 Effective decisions are based on the analysis of data and
information.
 Key benefits : Informed decisions.
An increased ability to demonstrate the effectiveness of past
decisions through reference to factual records.
Increased ability to review, challenge and change opinions and
decisions.

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8.Mutually beneficial supplier relationships
 An organization and its suppliers are interdependent and a
mutually beneficial relationship enhances the ability of both to
create value.
 Key benefits : Increased ability to create value for both parties.
Flexibility and speed of joint responses to changing market or
customer needs and expectations.
Optimization of costs and resources.

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ISO 9001:2000 – Model of a process-based quality management system
CONTINUAL IMPROVEMENT OF
THE QUALITY MANAGEMENT SYSTEM
5.MANAGEMENT
RESPONSIBILITY
CUSTOMERS
CUSTOMERS
Satisfaction
QUALITY 8. MEASUREMENT
6. RESOURCE
MANAGEMENT MANAGEMENT ANALYSIS AND
IMPROVEMENT
SYSTEM
7. PRODUCT
Requirements Product Consumption
REALIZATION

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New ISO 9001
Management
Responsibility
General Measurement, General
Resource
requirements management QMS analysis &
improvements
requirements
Product
Realization
Continual Improvement cycle
ISO 9001:2000 explained
18

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ISO 9001:2000
Transition Process
1st visit 2nd visit 3rd visit 4th visit
Review of Review of
Review of Review of
QMS & Measurement
Management Resource
Product , analysis &
responsibility management
realization improvements
2 years

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Challenges in implementing new
standard
Management Support
Encouragement
New ISO
Communication
Other employee Support

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Requirements of ISO 9001-2000
1.Scope
2. Normative reference
3.Terms and definitions
4.Quality management system
5.Management responsibility
6.Resource management
7.Product realisation
8.Measurement, analysis and improvement

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1.Scope:The specified requirements are generic
and applicable to all organizations, regardless of
their type and size.
2.Normative Reference
3.Terms and vocabulary : Supplier, Organization,
Customer.

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Quality management system
QUALITY
Quality is the totality of characteristics of an
entity that bear on its ability to satisfy stated and
implied needs.
Customer satisfaction , whole organization
involvement.
Quality Service

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DOCUMENTATION
I. General
II. Quality manual
III. Control of documents
IV. Control of records

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DOCUMENTATION PYRAMID

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Management responsibility
Management commitment
Customer focus
Quality policy:vission,mission,commitment
Planning

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1. Responsibility and authority
2. Management representative
3. Internal communication
MANAGEMENT REVIEW
1. Review input
2. Review output

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Resource Management
Human resources
Infrastructure
Work environment
Provision of resources

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TRAINING

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Measurement , Analysis, Improvement
It is done
• To demonstrate conformity of product
• To ensure conformity of QMS
• AUDITING : External audit:Auditing by an
external certification body
• Internal audit:By internal staff trained for this
process

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Improvement
UNSATISFACTORY OUTCOME
WORK IMPROVEMENT TEAM
CAUSE INVESTIGATION
CORRECTIVE ACTION
PREVENTIVE ACTION

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Steps to ISO Registration

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ADVANTAGES
• For the customer :- Increase satisfaction
and growth in confidence.
• For the company :- Well defined
organization and responsibilities,
i.e., minimize grey areas and possible
resources wastage.
• Establishment of proper communication
channel

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ISO 14000
• INTRODUCTION : In the present day, environmental
matter is not limited only in one country or specific
area. The environmental impact effects everywhere
and leads to problem all over the world.
• Environmental conservation has become so
complicated that it causes pressure to all business
organizations.
• The International Organization for Standardization
had led to the development of the International
Standard for environmental management system
series (ISO 14000).

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ISO 14000 SERIES
PRODUCT EVALUATION STANDARDS
Environmental Labeling
14020 Basic Principles
Environmental Aspects in 14021 Self Discipline
Product Standards 14022 Symbols
Guide 64 EAPS Guide 14023 Testing
and Verification
14024 Third Party
Life Cycle Assessment
14040 principles Framework
14041 Goals and Definition
14042 Impact Assessment
14043 Improvement Assessment

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• The structure of the standards is as follows:
▫ Environmental Management Systems (EMS)
▫ Environmental ng and Related Environmental Investigations (EA)
▫ Environmental Labeling (EL)
▫ Environmental Performance Evaluation (EPE)
▫ Life Cycle Assessment (LCA)
▫ Terms and Definitions (T&D)
• ISO 14000 Series is the set of standards relating to environmental
management system.
• Generally, the standard used for certification is
▫ ISO 14001 Environmental Management Systems - Specifications
with Guidance for Use.

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ELEMENTS OF ISO 14001
 General Requirements
 Environmental Policy
 Planning
 Implementation & Operation
 Checking & Corrective action
 Management review

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Environmental management system
model
1.Environmental policy
Initially, the organization’s top management should have commitment and
define the policy on EMS which is used for the direction of implementing and
improving its EMS.
2. Planning
In order to achieve environmental policy, at least, the organization should :
Identify the environmental aspects of its activities and specify those which
have significant impacts on the environment.
Establish objectives and targets of its activities having impacts to
environment.
Establish environmental programs for achieving its objectives and targets.

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3. Implementation
•In order to achieve environmental planning, at least, the organization
should :
•Define roles, responsibilities and authorities for facilitating EMS
effectively.
•Communicate to the staffs at each level for the importance of
conformance to the environmental policy; provide appropriate training to
personnel performing the tasks to gain their knowledge and competence.
•Identify potential accidents and emergency situations for preventing and
mitigating the environmental impacts that may be associated with them and
periodically test such procedures where practicable.

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4. Checking and corrective action
To ensure that the organization is performing in accordance with
the stated EMS programmes, at least, the organization should:
 Monitor and measure its operations and activities against the
organization’s plans.
Record the on-going activities of the EMS.
Conduct periodic EMS audits.
5. Management review
The organization’s top management should review and continually
improve its EMS, with the objective of improving its overall
environmental performance.

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Environmental management system model

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CONCLUSION
It can be applied to any type of organization
It help in maintaining an efficient quality system
in an organization
It creates confidence in customer on quality of
product supplied
It act as competitive barrier

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Various logos used in p’industries

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REFERENCES
 http://www.iso.org/iso/en/isoonline.frontpage
 S.Bhaskar, Industrial Management,First
edition,2008,pg.no.29.3-29.10.
 T.Telsang, Production Management, First
edition,2005,pg.no.277-295.
 www.pharmaworld.com

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