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”
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”
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