JAY ISO 9000

ISO
9000
Quality Management Systems
Jay shah
2

Before
Advanced Industrial Pharmacy
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EXPECTED
QUALITY
by the Customer
PLANNED
QUALITY
by the Company
PRODUCED
QUALITY
by the Company
PERCEIVED
QUALITY
by the Customer
Measurement of the
Performance of the Company
Measurement of the
Client’s satisfaction
TQM CONCEPT
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• Customer focus
• Leadership
• Empowerment
• Process approach
• Systemic approach
• Continuous improvement
• Decisions based on facts
• Relationship with suppliers mutually
beneficiary
• Customer focus
• Leadership
• Empowerment
• Process approach
• Systemic approach
• Continuous improvement
• Decisions based on facts
• Relationship with suppliers mutually
beneficiary
The 8 principles of TQM …
5

Quality Control Quality Management
Past Future
Detect faults Prevent errors
Look for guilty persons Look for defaults in the processes
Accuse Help, Moderate, Facilitate
Punish Motivate
Micro-management Systematic and systemic management
Quality Control Quality Management
Past Future
Detect faults Prevent errors
Look for guilty persons Look for defaults in the processes
Accuse Help, Moderate, Facilitate
Punish Motivate
Micro-management Systematic and systemic management
Transition towards TQM
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Deming’s wheel
(P.D.C.A.)
Deming’s wheel
(P.D.C.A.)
PLAN D
O
ACT CHECK
Continuous
Improvement
Continuous improvement
7

Quality Improvement …
Up to what extent???
Confusion
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ISO 9000 – A WAY TO TQM
!!!
Destination ……
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In The Early Days..
 The quality movement can trace its roots back to middle
Europe, where craftsmen began organizing into unions
called guilds in the late 13th century.
 This model was followed until the early 19th
century
when factories came to be and there was more emphasis
on product inspection.
 In the early 20th
century manufacturers began to include
quality processes in quality practices.
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The Beginning….
In 1946, delegates from 25 countries met in
““GENEVAGENEVA”(Switzerland)”(Switzerland) and decided to create a new
international organization, of which the object would be
"to facilitate the international coordination and unification
of industrial standards".
The new organization, ISO, officially began
operations on 23 February 1947.
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 I S OI S O

 International Standard OrganizationInternational Standard Organization
 In Greek ISO means “In Greek ISO means “EQUALEQUAL” & is called as” & is called as
 ““International Organization of StandardInternational Organization of Standard””
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WHAT IS ISO 9000?
 They provide a framework for quality system
development in all types of industries including service
organizations.
 It is just purely a management system that will help to
run business in a more organized and systematic manner
which will lead organisation to a more consistent in
quality of the service that it deliver to customers.
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1)1) 14 Industrialized Countries from EUROPE,
2) The US (ANSI),
3) British Common Wealth.
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180 technical committees (TCs)
620 active sub committees (SCs)
 The actual standards preparation is done by ISO
Technical committees (ISO/TCs).
 TCs are assisted by member country Technical Action
Group (TAG).
15

There are 158 National members out of the 195 total
countries in the World :
 ISO has three membership category, they are:
1) Member bodies
2) Correspondent Member
3) Subscribers Member
16

████ member bodiesmember bodies
████ correspondent memberscorrespondent members
████ subscriber memberssubscriber members
████ other places with an ISO 3166-1other places with an ISO 3166-1
code who aren't members of ISOcode who aren't members of ISO
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ISO 9000
Quality Management
Quality System
Elements
Quality
Assurance
Models
ISO 9001 ISO 9002 ISO 9003ISO 9004-1.-2,-3
ISO 9000 : SERIES OF STANDARDS
The Structure Of ISO 9000 Standards
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 ISO 9000-1 : Guidelines for selection and use
 ISO 9000-2 : Generic guideline for the application of
ISO 9001, ISO 9002, ISO 9003
 ISO 9000-3 : Guideline for the application of ISO
9001 to development, supply, and
maintenance of software
 ISO 9000-4 : Guide to dependability program
management
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ISO 9001 - Quality Assurance in design/ development,
production, installation and servicing
ISO 9002 - Quality Assurance in production and
installation
ISO 9003 - Quality Assurance in final inspection and
test
ISO 9004 - Quality management and quality system
elements
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List of Quality System Requirements
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Quality system Requirements
 Management Responsibility
 Quality System
 Contract Review
 Design Control
 Document and Data Control
 Purchasing
 Control of Customer Supplied Product
 Product identification and Traceability
 Process Control
 Inspection and Testing
 Control Inspection, Measuring, and Test Equipment
 Inspection and Test Status
 Control of Non Conforming Product
 Corrective and Preventive Action
 Handling, Storage, Packaging, Preservative, and Delivery
 Control of Quality Record
 Internal Quality Audits
 Training
 Servicing
 Statistical Techniques
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World wide equivalents of ISO 9000 Standards
COUNTRY ISO 9000 Standard Nomenclature
Australia AS 3900
Brazil NB 9000
Canada Z 299
Denmark DS/ISO 9000
France NF EN 29000
Germany DIN ISO 9000
India IS 14000
Japan JIS Z 9900
Mexico NOM – CC 2
United State Q 9000
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 IS:14000:1990 (ISO 9000:1994)
 IS:14001:1990 (ISO 9001:1994)
 IS:14002:1990 (ISO 9002:1994)
 IS:14003:1990 (ISO 9003:1994)
 IS:14004:1990 (ISO 9004:1994)
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ISO 9001 : 1994
ISO 9001 : 2000
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Principles of ISO 9000 Standard
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Based on eight
quality
management
principles
Based on eight
quality
management
principles
LeadershipLeadership
Process
approach
Process
approach
Involvement
of people
Involvement
of people
System
approach to
Management
System
approach to
ManagementContinual
improvement
Continual
improvement
Factual
approach to
decision
making
Factual
approach to
decision
making
Mutual
beneficial
supplier
relationship
Mutual
beneficial
supplier
relationship
Customer
focus
Customer
focus
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A) Principle : 1 Customer focusA) Principle : 1 Customer focus
1) Organization depends1) Organization depends
on their customers.on their customers.
2) Should understand the2) Should understand the
customerscustomers need,need,
requirement,requirement,
expectation.expectation.
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Benefits :
1) Increased revenue & market share.
2) Improve customer satisfaction.
Application:
1) Research work.
2) Understanding the customers
needs, expectation, satisfaction..
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B) Principle : 2 LeadershipB) Principle : 2 Leadership
1) Leaders establish unity of
purpose & direction of
Organization.
2) Should create &
maintained the internal
environment.
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BenefitsBenefits ::
1) People will motivated towards Organization’s goals.
2) Activities are evaluated.
ApplicationApplication::
1) Clear vision of the Organization’s Future.
2) Setting challenging goals & targets.
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People at all levels are
the essence of an
Organization & their
abilities are used for the
Organization’s benefit.
C) Principle : 3 Involvement of peopleC) Principle : 3 Involvement of people
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BenefitsBenefits ::
1) Motivated, committed, Involved People within the Organization.) Motivated, committed, Involved People within the Organization.
2) Innovation & creativity.2) Innovation & creativity.
Application:
1) People accepting the ownership of problems.
2) People freely sharing knowledge & experience.
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D) Principle:4 Process approachD) Principle:4 Process approach
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Benefits :
1) Lower cost & shorter cycle Times.
2) Improved, consistent, & predictable results.
Application:
1) Systematically defining the activities.
2) Identifying the interfaces of key activities.
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Identification, understanding,
managing interrelated
process as a system
contributes to the
Organization’s effectiveness
& efficiency in achieving its
objectives.
E) Principle : 5 System approach to managementE) Principle : 5 System approach to management
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11) Structuring a system to achieve the Organization’s objectives.
2) Continually improving the system through measurement & evaluation.
Benefits :
1) Ability to focus the effort on the key processes.
2) Providing confidence to interested parties as consistency,
effectiveness & efficiency of the Organization.
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F) Principle :6 Continual improvementF) Principle :6 Continual improvement
Overall performance
should be a
permanent objective
of the Organization .
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Benefits :
1) Increase the performance due to the improvement of the Organizational
capabilities.
2) Flexibility to react quickly to the opportunities.
Application:
1) Providing training to the people for the continual Improvement.
2) Establishing the Goals for continual Improvement.
3) Recognizing & acknowledging improvement.
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G) Principle :7 Factual approach to decision makingG) Principle :7 Factual approach to decision making
Effective decisions are
based on the analysis of
data & information.
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BenefitsBenefits ::
1) Informed decisions.1) Informed decisions.
2) Increased ability to demonstrate the effectiveness of the past decisions.2) Increased ability to demonstrate the effectiveness of the past decisions.
3) Increased ability to review.3) Increased ability to review.
1) Analyzing data & information using valid method.1) Analyzing data & information using valid method.
2) Making decision & action based on analysis.2) Making decision & action based on analysis.
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Mutually beneficial
relationship between the
Organization & supplier
enhances the ability of
both to create value.
42

Benefits :
1) Optimizing of cost & resources.
2) Flexibility & speed will increase in the market.
Application:
1) Identifying & selecting key suppliers.
2) Clear & open communication.
3) Sharing information & future plans.
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Application
Surveillance
Audit
Documentation Review
Pre - Assessment
Registration Audit
Registration Decision
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DOCUMENTATION REQUIREMENTSDOCUMENTATION REQUIREMENTS
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Quality Management System DocumentationQuality Management System Documentation
Quality
Manual
Quality
Manual Quality
System
Procedures
Quality
System
Procedures Work
Instructions
Work
Instructions
FormsForms
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1) Quality Manual
 Quality Policy
 Objectives
 Overview
 Responsibilities
 Requirements Policy/Responsibility
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2) Quality System Procedures
 A set of procedures which detail how the
requirements of the quality manual are to be
implemented
 Detailed procedures which define how the
processes are to be performed and controlled
 Specifying who is responsible for what
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3) Work Instructions
 Detailed instructions for the performance of specific tasks
 Such instructions may cover
-Materials
-Processes
-Verification
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4) Forms
Records that provide proof that specified
activities were carried out
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Quality Management System
Standard
ISO 9000
Quality Manual
Quality System Procedures
Work Instructions
Forms
LEVEL 1
LEVEL 2
LEVEL 3
LEVEL 4
Policy Statement, Commitment,
Organization, Responsibilities
Company Practices, Interfaces
Written Instructions
to Control Tasks
Quality
Records
Sales Design Purchasing Manufacturing Accounts Personnel After SalesAdvanced Industrial Pharmacy
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ISO CertificateISO Certificate
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1) Continuous improvement
2) Marketing strategy
3) To meet Customer
requirement
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11) Improved system
documentation
2) Fewer customers
audits
3) Improve customers
relationship
4) Improved quality
awareness
54

Example Very Near
To You !!!!!
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BAPUJI MBA COLLEGEBAPUJI MBA COLLEGE
56Advanced Industrial Pharmacy

After Registration..
Life is not like this
because….
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Naroola G. Conell RM. How to achieve ISO 9000 Registration
Economically and Effectively. New York 1996. Marcel Dekker, Inc.
Stamatis DH. Understanding ISO 9000 and implementing the
basics to quality. New York 1995. Marcel Dekker, Inc.
Rastogi PN.Total quality management theory & practice. AICTE
Continuing Education Program .March 1989;Code No : 298.
61

Krishnan NS. Total quality management 1.AICTE
Continuing Education Program .December 1996 ; Code No
: 623.
Bali PL. Total quality management . AICTE Continuing
Education Program .June 1997 ; Code No : 541.
Google.com
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JAY ISO 9000

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