ISO 9000

Dr. Pravin Kumar

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 QUALITY EDUCATION:
Customer Satisfaction
Whole
Organization
Involvement

Quality
Service 2
 Quality management
ISO 9001 is for quality management.
 Quality refers to all those features of a product (or service)
which are required by the customer.
 Quality management means what the organization does to
 ensure that its products or services satisfy the customer's
quality requirements and
 comply with any regulations applicable to those products or
services.
 Quality management also means what the organization does to
 enhance customer satisfaction, and
 achieve continual improvement of its performance.
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A BRIEF INTRODUCTION
TO
ISO 9000

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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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QUALITY MANAGEMENT PRINCIPLES

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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 ISO 9000 is about QUALITY

Quality is:
 defined by customer needs
 defined in terms of fitness for purpose
 achieved through continuous improvement
 managed through prevention not detection
 ‘getting it right at the first time’
 measurable

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ISO stands for

I nternational
O rganization for
S tandardization

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 Who created the standards?

 International Organization for Standardization -

Geneva
 ISO tech committee - TC 176 started in 1979
 Standards created in 1987
– To eliminate country to country differences
– To eliminate terminology confusion
– To increase quality awareness
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 HISTORY
• 1946 London - delegates from 25 countries to
facilitate the international coordination and
unification of industrial standards
• 1947 - ISO began to officially function
• 1951 - The first ISO standard was published
• In 1979 to meet growing awareness of quality in
industry BS5750 std were developed
• ISO revised and issued BS5750 in 1987 as ISO
9000 series
• Revised in 1994 and 2000
• ISO9001:2000 is valid till next year. 10
 Certification and registration
 Certification is known in some countries as
registration.
 It means that an independent, external body
has audited an organization's management
system and verified that it conforms to the
requirements specified in the standard (ISO
9001 or ISO 14001).
 ISO does not carry out certification and does
not issue or approve certificates,
 Accreditation
 Accreditation is like certification of the certification body.
 It means the formal approval by a specialized body - an
accreditation body - that a certification body is competent to
carry out ISO 9001:2008 or ISO 14001:2004 certification in
specified business sectors.
 Certificates issued by accredited certification bodies - and
known as accredited certificates - may be perceived on the
market as having increased credibility.
 ISO does not carry out or approve accreditations.
Certification not a requirement
 Certification is not a requirement of ISO
9001 or ISO 14001.
 The organization can implement and benefit
from an ISO 9001 or ISO 14001 system
without having it certified.
 The organization can implement them for the
internal benefits without spending money on
a certification programme.
 Certification is a business
decision
 Certification is a decision to be taken for
business reasons:
 if it is a contractual, regulatory, or market
requirement,
 If it meets customer preferences
 it is part of a risk management programme, or
 if it will motivate staff by setting a clear goal.
 ISO does not certify
 ISO does not carry out ISO 9001 or ISO
14001 certification.
 ISO does not issue certificates.
 ISO does not accredit, approve or control the
certification bodies.
 ISO develops standards and guides to
encourage good practice in accreditation and
certification.
Why is ISO 9000 important?
 European Union directive
– ISO 9000 certification required by suppliers of
“Regulated Products”
 health, safety, and the environment
– EC has strict corporate liability legislation
protecting consumers
 Globalization impact
 Why adopt ISO 9000?

 To comply with customers who require ISO 9000

 To sell in the European Union market
 To compete in domestic markets
 To improve the quality system
 To minimize repetitive auditing by similar and
different customers
 To improve subcontractors’ performance
 The ISO 9000 family
 ISO 9001 is the standard that gives the requirements
for a quality management system.
 ISO 9001:2008 is the latest, improved version.
 It is the only standard in the ISO 9000 family that
can be used for certification.
 There are 16 other standards in the family that can
help an organization on specific aspects such as
performance improvement, auditing, training…
The ISO Survey

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Ten Steps to ISO Registration
10. Registration!

9. Final assessment by registrar

8. Take corrective actions

7. Pre-assessment by registrar

6. Submit quality manual for approval

5. Perform self-analysis audit

4. Select a third-party registrar and apply

3. Develop and implement the quality system

2. Select the appropriate standard

1. Set the registration objective 20

 Six Essential Elements of a
Successful Registration Effort
Senior Management Commitment to the Effort
Appropriate ISO 9000 Training

An Effective Management Review Process

Documentation of the Quality System

An Effective Internal Auditing System

An Effective Corrective Action Process

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 Self-manageable
P-D-C-A
 Plan what you do
 Do what you planned & record what you
did
 Check the results
 Act on the difference

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 ISO 9000 REQUIRES :
PLAN, DO, CHECK & ACT
with CONSISTENCY :

 CUSTOMER SATISFACTION
 MANAGEMENT SUPPORTS
 RESOURCES MANAGEMENT
 PROCESS MANAGEMENT
 RESULTS ANALYSIS
 CONTINUOUS IMPROVEMENT
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THE CONTINUOUS IMPROVEMENT
MECHANISM

UNSATISFACTORY OUTCOME

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THE CONTINUOUS IMPROVEMENT MECHANISM

UNSATISFACTORY OUTCOME

WORK IMPROVEMENT TEAM

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THE CONTINUOUS IMPROVEMENT
MECHANISM

UNSATISFACTORY OUTCOME

WORK IMPROVEMENT TEAM

CAUSE INVESTIGATION

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THE CONTINUOUS IMPROVEMENT
MECHANISM

UNSATISFACTORY OUTCOME

WORK IMPROVEMENT TEAM

CAUSE INVESTIGATION

CORRECTIVE ACTION

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THE CONTINUOUS IMPROVEMENT
MECHANISM

UNSATISFACTORY OUTCOME

WORK IMPROVEMENT TEAM

CAUSE INVESTIGATION

CORRECTIVE ACTION

PREVENTIVE ACTION

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THE CONTINUOUS IMPROVEMENT
MECHANISM

UNSATISFACTORY OUTCOME

WORK IMPROVEMENT TEAM

CAUSE INVESTIGATION

CORRECTIVE ACTION

PREVENTIVE ACTION

REVIEW

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THE CONTINUOUS IMPROVEMENT MECHANISM

UNSATISFACTORY OUTCOME

WORK IMPROVEMENT TEAM

CAUSE INVESTIGATION

CORRECTIVE ACTION

PREVENTIVE ACTION

REVIEW

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THE CONTINUOUS IMPROVEMENT
MECHANISM

UNSATISFACTORY OUTCOME

WORK IMPROVEMENT TEAM

CAUSE INVESTIGATION

CORRECTIVE ACTION

PREVENTIVE ACTION

REVIEW

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THE CONTINUOUS IMPROVEMENT
MECHANISM

UNSATISFACTORY OUTCOME

WORK IMPROVEMENT TEAM

CAUSE INVESTIGATION

CORRECTIVE ACTION

PREVENTIVE ACTION

REVIEW

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 Quality Plan

Quality Manual

Q Procedures

Working Instruction
Reference Document
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STANDARD CONTENT APPLICATION

ISO 9000 Provides definition and All industries including software

concepts. development
Explains how to select other
standards for a given business

ISO 9001 Quality assurance in design, Engineering and construction firms,

development, production, manufacturers that design, develop,
installation and servicing install and service products

ISO 9002 Quality assurance in Companies in the chemical process

production and installation industries that are not involved in
product design or after sales service

ISO 9003 Quality assurance in test and Small shops, divisions within a firm,
inspection equipment distributors that inspect
and test supplied products

ISO 9004 Quality management and All industries

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quality system elements
ISO 9001:2000 Requirements
1.Scope
2. Normative reference
3.Terms and definitions
4.Quality management system
5.Management responsibility
6.Resource management
7.Product realization
8.Measurement, analysis and improvement
 Summary of ISO 9001 Standards
 4.1 Management Responsibility
 4.2 Quality System
 4.3 Contract Review
 4.4 Design Control
 4.5 Document Control
 4.6 Purchasing
 4.7 Purchaser Supplied Product
 4.8 Product Identification & Traceability
 4.9 Process Control
 4.10 Inspection & Testing
 4.11 Inspection , Measuring and Test equipment
 4.12 Inspection and Test Status
 4.13 control of Nonconforming Product
 4.14 Corrective Action
 4.15 Handling ,Storage,Packaging, and Delivery 36
 4.16 Quality Records
 4.17 Internal Quality Audits
 4.18 Training
 4.19 Servicing
 4.20 Statistical Techniques

 Note :- Various sections of the standards are interrelated.

 For example, training is covered in paragraph 4.18. But
training procedures will have an impact on almost every other
category. The same is true for concepts like document control (4.5)
or quality records (4.16)

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Scope:
Thespecifiedrequirementsaregenericandapplic
abletoallorganizations,regardlessoftheirtypean
dsize.

•Normative Reference:

•‘Terms and vocabulary

Supplier, Organization, Customer.
 Quality management system
QUALITY

Quality is the totality of charecteristics of an entity that bear

on its ability to satisfy stated and implied needs

Customer satisfaction,whole organisation involvement

Quality Service
 DOCUMENTATION
I. General
II. Quality manual
III. Control of documents
IV. Control of records
DOCUMENTATION PYRAMID
Management responsibility

Management commitment

Customer focus

Quality policy: vission,mission,commitment

Planning
1. Responsibility and authority
2. Management representative
3. Internal communication

MANAGEMENT REVIEW
1. Review input
2. Review output
 Resource management

 Provision of resources
 Human resources
 Infrastructure
 Work environment
TRAINING
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
 Improvement

Corrective action
Preventive action
Continual improvement
THE CONTINUOUS IMPROVEMENT
MECHANISM
UNSATISFACTORY OUTCOME

WORK IMPROVEMENT TEAM

CAUSE INVESTIGATION

CORRECTIVE ACTION

PREVENTIVE ACTION

REVIEW
 ISO 9002
 This Standard leaves out the design phase of ISO 9001.It
focuses on production and delivery.It is used mainly by
commodity companies, such as chemical or paint producers.

 This standard is applicable in contractual situations when

1. The specified requirements for products are stated in terms of

an established design or specifications;

2. Confidence in product conformance can be attained by

adequate demonstration of a certain supplier’s capabilities in
production and installation.

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 ISO 9003

 This standard is less detailed than the two above. It does not
include a comprehensive quality system, but focuses on
testing and inspection. It is useful for companies like
equipment distributors.

 This standards specify quality system requirement for use

where 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.

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 ISO 9004
 This is not a standard that applies to relations with outside customers, but
suggests internal methods for meeting the quality measurements in the
other standards. It describes methods for approaching areas such as
procurement , corrective action , and the use of statistical process
controls.

 This standards provides guidelines on the technical, administrative and

human factors affecting the quality of products or services, at all stages of
the quality loop system. In this standard, emphasis is laid on the
satisfaction of the customer’s need the establishment of functional
responsibility and the importance of assessing the potential risks and
benefits

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