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2
Outline
Introduction
8 Quality Management Principles
ISO 9001:2008 Standard- Overview
Benefits of ISO 9001:2008
3
ISO 9001:2008
Introduction
Introduction
ISO 9001 is for quality management
can be adopted by any kind of
organization
Quality refers to all those features of a
product that are required by
customers Quality management means
what the organization does to:
Enhance customer satisfaction
Achieve continuous improvement of
its performance
4
ISO 9001 : 2008
Requirements are generic,
applied in any organization
regardless of size, type and product
provided
Where any requirement cannot apply
due to the nature of organization then
it can be considered for exclusion 5
6
8 Quality Management
Principles
7
Customer focused organization
Organizations depend on their customers
and therefore should understand current
and future customer needs, meet
customer requirements and strive to
exceed customer expectations.
Principle “1”
8
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
benefit.
Principle “2”
9
Involvment of People
People at all levels are the essence of an
organization and their full involvment enables
their abilities to be used for the organization’s
benefit.
Principle “3”
10
Process Approach
A desired result is achieved more
efficiently when related resources
and activities are managed as a process.
Principle “4”
11
System Approach to Management
Identifying, understanding and managing a
system of interrrelated processes for a given
objective improves the organization’s
effectiveness and efficiency.
Principle “5”
12
Continual Improvement
Continual improvement should be a
permanent objective of the organization.
Principle “6”
13
C
u
s
t
o
m
e
r
R
e
q
u
i
r
e
m
e
n
t
s
Resource
management
Management
responsibility
Measurement,
analysis,
improvement
Product
(and/or service)
realization
C
u
s
t
o
m
e
r
S
a
t
i
s
f
a
c
t
i
o
n
Output Product/
Service
Quality Management System
Continual Improvement
PlanPlan
DoDo CheckCheck
ActAct
14
Factual Approach to Decision
Making Effective decisions are
based on the analysis of data and information.
Principle “7”
15
Mutually Beneficial Supplier Relationships
An organization and its suppliers are
interdependent, & a mutually beneficial
relationship enhances the ability of both to
create value.
Principle “8”
16
ISO 9001:2000
Overview
Structural Content of the Standard
Foreword
Introduction
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
18
1 Scope
1.1 General
1.2 Application
ISO 9001:2008 Quality Management Systems –
Requirements
19
2 Normative Reference
ISO 9000:2008 Quality Management
Systems -Fundamentals and Vocabulary
ISO 9001:2008 Quality Management Systems –
Requirements
20
3 Terms and Definitions
As provided in ISO 9000:2008 Quality
Management Systems - Fundamentals and
Vocabulary
SUPPLIER  ORGANIZATION  CUSTOMER
ISO 9001:2008 Quality Management Systems –
Requirements
21
4 Quality management system
4.1 General requirements
4.2 Documentation Requirements
ISO 9001:2008 Quality Management Systems –
Requirements
22
4.1 Develop Quality Management System (QMS)
Establish your organization's process-based QMS.
Document your organization's process-based QMS.
Implement your organization's process-based QMS.
Maintain your organization's process-based QMS.
Improve your organization's process-based QMS.
ISO 9001:2008 Quality Management Systems –
Requirements
23
Customer’s Record Customer’s Information
stated travel requirements, recorded
requirements other requirements (electronic/paper)
INPUT ACTIVITY OUTPUT
Schematic of Order - Receiving Process
PROCESS 1PROCESS 1
ISO 9001:2008 Quality Management Systems –
Requirements
24
Information Make bookings Confirmation
received from (Phone/ online) record/ statement.
order desk (Call hotel/ car rental/ (electronic/ paper)
airline/ cruise company)
The Sequence and Interaction of all the processes
must be determined by the organization
PROCESS 2PROCESS 2
INPUT ACTIVITY OUTPUT
Schematic of Order - Receiving Process
ISO 9001:2008 Quality Management Systems –
Requirements
25
4.2 Documentation requirements
4.2.1 General
4.2.2 Prepare Quality Manual
4.2.3 Control of documents
4.2.4 Control of records
ISO 9001:2008 Quality Management Systems –
Requirements
26
5 Management responsibility
5.1 Management Commitment
5.2 Customer Focus
5.3 Quality Policy
5.4 Planning
» 5.4.1 Quality objectives
» 5.4.2 Quality management system planning
5.5 Responsibility, Authority and Communication
» 5.5.1 Responsibility and authority
» 5.5.2 Management representative
» 5.5.3 Internal Communication
5.6 Management review
» 5.6.1 General
» 5.6.2 Review input
» 5.6.2 Review output
ISO 9001:2008 Quality Management Systems –
Requirements
27
6 Resource management
6.1 Provision of resources
6.2 Human Resources
» 6.2.1 General
» 6.2.2 Competence, awareness and training
6.3 Infrastructure
6.4 Suitable work environment
ISO 9001:2008 Quality Management Systems –
Requirements
28
7 Product realization
7.1 Planning of product realization
7.2 Customer-related processes
» 7.2.1 Determination of requirements related to the product
» 7.2.2 Review of requirements related to the product
» 7.2.3 Customer communication
7.3 Design and development
» 7.3.1 Design and development planning
» 7.3.2 Design and development inputs
» 7.3.3 Design and development outputs
» 7.3.4 Design and development review
» 7.3.5 Design and development verification
» 7.3.6 Design and development validation
» 7.3.7 Control of design and development changes
ISO 9001:2008 Quality Management Systems –
Requirements
29
7 Product realization (cont’d)
7.4 Purchasing
» 7.4.1 Purchasing process
» 7.4.2 Purchasing information
» 7.4.3 Verification of purchased product
7.5 Production and service provision
» 7.5.1 Control of production and service provision
» 7.5.2 Validation of processes for production and service
provision
» 7.5.3 Identification and traceability
» 7.5.4 Customer property
» 7.5.5 Preservation of product
7.6 Control of monitoring and measuring devices
ISO 9001:2008 Quality Management Systems –
Requirements
30
8 Measurement, analysis and improvement
8.1 General
8.2 Monitoring and measurement
» 8.2.1 Customer satisfaction
» 8.2.2 Internal audit
» 8.2.3 Monitoring and measurement of processes
» 8.2.4 Monitoring and measurement of product
» 7.5.5 Preservation of product
8.3 Control of nonconforming product
8.4 Analysis of data
8.5 Improvement
» 8.5.1 Continual Improvement
» 8.5.2 Corrective action
» 8.5.3 Preventive action
ISO 9001:2008 Quality Management Systems –
Requirements
31
ISO 9001:2008
Benefits
32
Major Benefits
1 Customer Satisfaction
2 Top management commitment/
Leadership
3 Clear understanding of the difference between
ISO 9000 and product/ service standards.
4 Involvement of people in setting the system
5 Gaining competence and expertise in quality
control.
6 Increased consistency, effectiveness,
and efficiency
7 Increased market share
8 Reduced cost
33
Major Benefits (cont’d)
9 Reduced waste (Time,rework,etc)
10 Better Integration between Quality system
and other management systems in the
organization
11 Gained international recognition/confidence
12 Continual improvement
13 Better relation with suppliers
14 Updated facts
15 Wide applicability and basis for various
sectors
16 Preservation of Know How
35
Poor ProductPoor Product
QualityQuality
High ProductHigh Product
QualityQuality
SatisfiedSatisfied
CustomersCustomers
IncreasedIncreased
SalesSales
(Locally & Exports)(Locally & Exports)
ImprovedImproved
EconomyEconomy
HigherHigher
RevenueRevenue
eater possibilityeater possibility
of Investmentof Investment
and Developmentand Development
DissatisfiedDissatisfied
CustomersCustomers
LessLess
RevenueRevenue
Pressure on thePressure on the
government togovernment to
provide employmentprovide employment
opportunitiesopportunities
EconomicEconomic
DepressionDepression
No ImprovementNo Improvement
& decreased& decreased
EmploymentEmployment
DecreasedDecreased
SalesSales
Happy CitizensHappy Citizens
36
Improved Quality
Reduced Waste
Reduced Costs
Less Pressure on the
Economy
Positive Balance of
Trade
(Export >Imports)
37
Thank you!

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ISO the procedure and Benifits

  • 1.
  • 2. 2 Outline Introduction 8 Quality Management Principles ISO 9001:2008 Standard- Overview Benefits of ISO 9001:2008
  • 4. Introduction ISO 9001 is for quality management can be adopted by any kind of organization Quality refers to all those features of a product that are required by customers Quality management means what the organization does to: Enhance customer satisfaction Achieve continuous improvement of its performance 4
  • 5. ISO 9001 : 2008 Requirements are generic, applied in any organization regardless of size, type and product provided Where any requirement cannot apply due to the nature of organization then it can be considered for exclusion 5
  • 7. 7 Customer focused organization Organizations depend on their customers and therefore should understand current and future customer needs, meet customer requirements and strive to exceed customer expectations. Principle “1”
  • 8. 8 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 benefit. Principle “2”
  • 9. 9 Involvment of People People at all levels are the essence of an organization and their full involvment enables their abilities to be used for the organization’s benefit. Principle “3”
  • 10. 10 Process Approach A desired result is achieved more efficiently when related resources and activities are managed as a process. Principle “4”
  • 11. 11 System Approach to Management Identifying, understanding and managing a system of interrrelated processes for a given objective improves the organization’s effectiveness and efficiency. Principle “5”
  • 12. 12 Continual Improvement Continual improvement should be a permanent objective of the organization. Principle “6”
  • 14. 14 Factual Approach to Decision Making Effective decisions are based on the analysis of data and information. Principle “7”
  • 15. 15 Mutually Beneficial Supplier Relationships An organization and its suppliers are interdependent, & a mutually beneficial relationship enhances the ability of both to create value. Principle “8”
  • 17. Structural Content of the Standard Foreword Introduction 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
  • 18. 18 1 Scope 1.1 General 1.2 Application ISO 9001:2008 Quality Management Systems – Requirements
  • 19. 19 2 Normative Reference ISO 9000:2008 Quality Management Systems -Fundamentals and Vocabulary ISO 9001:2008 Quality Management Systems – Requirements
  • 20. 20 3 Terms and Definitions As provided in ISO 9000:2008 Quality Management Systems - Fundamentals and Vocabulary SUPPLIER  ORGANIZATION  CUSTOMER ISO 9001:2008 Quality Management Systems – Requirements
  • 21. 21 4 Quality management system 4.1 General requirements 4.2 Documentation Requirements ISO 9001:2008 Quality Management Systems – Requirements
  • 22. 22 4.1 Develop Quality Management System (QMS) Establish your organization's process-based QMS. Document your organization's process-based QMS. Implement your organization's process-based QMS. Maintain your organization's process-based QMS. Improve your organization's process-based QMS. ISO 9001:2008 Quality Management Systems – Requirements
  • 23. 23 Customer’s Record Customer’s Information stated travel requirements, recorded requirements other requirements (electronic/paper) INPUT ACTIVITY OUTPUT Schematic of Order - Receiving Process PROCESS 1PROCESS 1 ISO 9001:2008 Quality Management Systems – Requirements
  • 24. 24 Information Make bookings Confirmation received from (Phone/ online) record/ statement. order desk (Call hotel/ car rental/ (electronic/ paper) airline/ cruise company) The Sequence and Interaction of all the processes must be determined by the organization PROCESS 2PROCESS 2 INPUT ACTIVITY OUTPUT Schematic of Order - Receiving Process ISO 9001:2008 Quality Management Systems – Requirements
  • 25. 25 4.2 Documentation requirements 4.2.1 General 4.2.2 Prepare Quality Manual 4.2.3 Control of documents 4.2.4 Control of records ISO 9001:2008 Quality Management Systems – Requirements
  • 26. 26 5 Management responsibility 5.1 Management Commitment 5.2 Customer Focus 5.3 Quality Policy 5.4 Planning » 5.4.1 Quality objectives » 5.4.2 Quality management system planning 5.5 Responsibility, Authority and Communication » 5.5.1 Responsibility and authority » 5.5.2 Management representative » 5.5.3 Internal Communication 5.6 Management review » 5.6.1 General » 5.6.2 Review input » 5.6.2 Review output ISO 9001:2008 Quality Management Systems – Requirements
  • 27. 27 6 Resource management 6.1 Provision of resources 6.2 Human Resources » 6.2.1 General » 6.2.2 Competence, awareness and training 6.3 Infrastructure 6.4 Suitable work environment ISO 9001:2008 Quality Management Systems – Requirements
  • 28. 28 7 Product realization 7.1 Planning of product realization 7.2 Customer-related processes » 7.2.1 Determination of requirements related to the product » 7.2.2 Review of requirements related to the product » 7.2.3 Customer communication 7.3 Design and development » 7.3.1 Design and development planning » 7.3.2 Design and development inputs » 7.3.3 Design and development outputs » 7.3.4 Design and development review » 7.3.5 Design and development verification » 7.3.6 Design and development validation » 7.3.7 Control of design and development changes ISO 9001:2008 Quality Management Systems – Requirements
  • 29. 29 7 Product realization (cont’d) 7.4 Purchasing » 7.4.1 Purchasing process » 7.4.2 Purchasing information » 7.4.3 Verification of purchased product 7.5 Production and service provision » 7.5.1 Control of production and service provision » 7.5.2 Validation of processes for production and service provision » 7.5.3 Identification and traceability » 7.5.4 Customer property » 7.5.5 Preservation of product 7.6 Control of monitoring and measuring devices ISO 9001:2008 Quality Management Systems – Requirements
  • 30. 30 8 Measurement, analysis and improvement 8.1 General 8.2 Monitoring and measurement » 8.2.1 Customer satisfaction » 8.2.2 Internal audit » 8.2.3 Monitoring and measurement of processes » 8.2.4 Monitoring and measurement of product » 7.5.5 Preservation of product 8.3 Control of nonconforming product 8.4 Analysis of data 8.5 Improvement » 8.5.1 Continual Improvement » 8.5.2 Corrective action » 8.5.3 Preventive action ISO 9001:2008 Quality Management Systems – Requirements
  • 32. 32 Major Benefits 1 Customer Satisfaction 2 Top management commitment/ Leadership 3 Clear understanding of the difference between ISO 9000 and product/ service standards. 4 Involvement of people in setting the system 5 Gaining competence and expertise in quality control. 6 Increased consistency, effectiveness, and efficiency 7 Increased market share 8 Reduced cost
  • 33. 33 Major Benefits (cont’d) 9 Reduced waste (Time,rework,etc) 10 Better Integration between Quality system and other management systems in the organization 11 Gained international recognition/confidence 12 Continual improvement 13 Better relation with suppliers 14 Updated facts 15 Wide applicability and basis for various sectors 16 Preservation of Know How
  • 34.
  • 35. 35 Poor ProductPoor Product QualityQuality High ProductHigh Product QualityQuality SatisfiedSatisfied CustomersCustomers IncreasedIncreased SalesSales (Locally & Exports)(Locally & Exports) ImprovedImproved EconomyEconomy HigherHigher RevenueRevenue eater possibilityeater possibility of Investmentof Investment and Developmentand Development DissatisfiedDissatisfied CustomersCustomers LessLess RevenueRevenue Pressure on thePressure on the government togovernment to provide employmentprovide employment opportunitiesopportunities EconomicEconomic DepressionDepression No ImprovementNo Improvement & decreased& decreased EmploymentEmployment DecreasedDecreased SalesSales Happy CitizensHappy Citizens
  • 36. 36 Improved Quality Reduced Waste Reduced Costs Less Pressure on the Economy Positive Balance of Trade (Export >Imports)