2. Purpose of Program
Awareness of ISO 9001:2008.
Self Improvement
Improvements in routine working
To improve the health of organization’s
Quality Management System
3. FAQ?
What is ISO?
From where it comes?
How it is helpful for us?
How it works?
What we have to do?
4. Contents Of Program
Background of ISO
ISO Family
Quality Management Principle
Process Approach
ISO 9001:2008 Overview
Detail Of Different Clauses Of ISO
9001:2008
5. What is ISO 9001:2008?
ISO = International Organization for
Standardization
ISO has representation from 162 countries
and has issued many standards
ISO 9001:2008 is a model for a quality
management system.
6. Who created the standard?
International Organization for
Standardization - Geneva
Standards created in 1987
To eliminate country to country differences
To eliminate terminology confusion
To increase quality awareness
7. ISO 9000:2005 Consists of 3 Areas
ISO 9000:2005 Quality Management Systems:
fundamentals and vocabulary
ISO 9001:2008 Quality Management Systems –
Requirements (required for certification)
Management responsibility
Resource management
Product/service realization
Measurement, analysis, improvement
ISO 9004-2009 Quality Management Systems –
Guidelines for performance improvement
8. Generic standards
ISO 9001 is a generic standards.
Generic means that the same standards can
be applied:
to any organization, large or small,
whatever its product or service,
in any sector of activity, and
whether it is a business enterprise, a public
administration, or a government department.
9. Generic standards (cont.)
Generic also signifies that
no matter what the organization's scope of
activity
if it wants to establish a quality
management system, ISO 9001 gives the
essential features
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).
ISO does not carry out certification and
does not issue or approve certificates,
11. 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 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 accreditation.
12. Certification not a requirement
Certification is not a requirement of ISO
9001.
The organization can implement and take
benefit from an ISO 9001 system without
having it certified.
The organization can implement them for the
internal benefits without spending money
on a certification programme.
13. 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
if it will motivate staff by setting a clear goal.
14. 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
15. What is a Quality Management
System?
A Quality Management System is a
web of interconnected processes
that are used to manage a
business.
16. Operating Cycle of ISO.
The Plan – Do – Check – Act (PDCA) cycle is the
operating principle of ISO's management system
standards
Plan – establish objectives and make plans (analyze your
organization's situation, establish your overall objectives
and set your interim targets, and develop plans to
achieve them).
Do – implement your plans (do what you planned to).
Check – measure your results (measure/monitor how far
your actual achievements meet your planned objectives).
Act – correct and improve your plans and how you put
them into practice (correct and learn from your mistakes
to improve your plans in order to achieve better results
next time).
17. ISO 9001:2008
CONTINUAL IMPROVEMENT OF THE QUALITY
CONTINUAL IMPROVEMENT OF THE QUALITY
MANAGEMENT SYSTEM
MANAGEMENT SYSTEM
Management Customers
responsibility
Customers Clause 6 Clause 5
Measurement,
Resource
Resource analysis and Satisfaction
management
management improvement
Clause
8
Product Output
Input
Requirements Product
Product
realization
Clause 7
Value adding activities
Information flow
18. PROCESS REQUIREMENTS
With What? WHO?
(Materials / Equipment) Objectives Special Skills? / Competence?
and
Targets
Process
Inputs Outputs
How? Measure
Process
(Methods / Procedure) Linkages
19. Management Principles
A Quality Management Principle is a
comprehensive and fundamental rule or
belief, for leading and operating an
organization, aimed at continually improving
performance over the long term by focusing
on customers while addressing the needs of
all stakeholders.
20. 8 Management Principles
Principle 1 : Customer Focus
Principle 2 : Leadership
Principle 3 : Involvement Of People
Principle 4 : Process Approach
Principle 5 : System approach to management
Principle 6 : Continual Improvement
Principle 7 : Factual approach to decision making
Principle 8 : Mutually beneficial supplier
relationships
21. Principle 1 : Customer Focus
Organizations depend on their customers &
therefore should understand current & future
customer needs, should meet customer
requirements & strive to exceed customer
expectations
22. Principle 2 : Leadership
Leaders establish unity & direction of the
organization. They should create & maintain
the internal environment in which people can
become fully involved in achieving the
organization's objectives.
23. Principle 3 : Involvement Of
People
People at all levels are the essence of an
organization and their full involvement
enables their abilities to be utilized for the
organization's mutual benefit.
24. Principle 4 : Process Approach
The application of a system of processes within
an organization, together with the identification
and interaction of these processes, and their
management to produce the desired outcome,
can be called “Process Approach”
25. Principle 5 : System approach to
management
Identifying, understanding & managing
interrelated processes as a system
contributes to the organization's
effectiveness & efficiency in achieving its
objectives.
26. Principle 6 : Continual
Improvement
Continual Improvement of the organization's overall
performance should be the primary driver of the
organization’s Quality Management System.
Continuous Continual Improvement
Improvement
27. Principle 7 : Factual approach to
decision making
Effective decisions are based on the analysis
of data & information
28. Principle 8 : Mutually beneficial
supplier relationships
An organization & its suppliers are
interdependent, and a mutually beneficial
relationship enhances the ability of both to
create value
29. Clauses of ISO 9001-2008
1.Scope
2.Normative References
3.Term & Definitions
4.Quality Management System
5.Management Responsibility.
6.Resources Management
7.Product Realization
8.Measurment,Analysis and Improvement
30. SCOPE OF STANDARD
1. Scope
General
Application
2. Normative reference
3. Terms and definition
e.g., Supplier Organization Customer
31. QUALITY MANAGEMENT SYSTEM
REQUIREMENTS
4.1 General requirements
Document, implement, maintain and
continually improve
Identify and determine sequence and
interaction of processes
Determine criteria and methods needed
Ensure availability of resources
Monitor, measure and analyze processes
Implement actions to achieve planned
results
33. QUALITY SYSTEM
DOCUMENTATION STRUCTURE
1st Level Policy and Objectives
Quality Manual What the company wishes to
achieve
2nd Level
Procedures How the company
implements its policy
3rd Level Structured to reflect
Work Instructions process flow of events
Machine instructions
Computer inputs Detailed instructions
Detailed work instructions How to complete
a job or task
4th Level
Technical Data
International standards
Computer operating manuals
Detailed product specifications
34. MANAGEMENT RESPONSIBILITY
5.1 Management commitment
5.2 Customer focus
5.3 Quality policy
Must be documented
Must be used for setting objectives
5.4 Planning
Document objectives- Must be Measurable
Quality management system planning
37. RESOURCE MANAGEMENT
6.1 Provision of resources
6.2 Human resources
General
Competence, awareness and training
6.3 Infrastructure
6.4 Work environment
38. PRODUCT REALIZATION
7.1 Planning of product
realization
7.2 Customer-related processes
Determination of requirements related to the
product
Review of requirements related to the product
Customer communication
39. PRODUCT REALIZATION
7.3 Design and development
Planning, inputs, outputs, systematic
reviews, verification and validation, control
of changes
7.4 Purchasing
Supplier evaluation and selection
Relevant purchasing information
Verification of purchased product
- receiving, source
40. PRODUCT REALIZATION
7.5 Production and service provision
Controlled conditions including product
characteristics, work instructions (as necessary),
suitable equipment, monitoring and measuring
devices, monitoring and measurement, and
release, delivery and post- delivery activities
Validation of processes when no other method
Identification and traceability of product and it’s
status
Care of customer property
Preservation of product
Includes constituent parts
41. PRODUCT REALIZATION
7.6 Control of monitoring and measuring
devices
Calibrated or verified where necessary
Adjusted and re-adjusted as necessary
Identified to enable calibration status
Safeguarded from invalid adjustment
Protected from damage and
deterioration
42. MEASUREMENT, ANALYSIS, AND
IMPROVEMENT
8.1 General
8.2 Monitoring and measurement
Customer satisfaction
Internal audit
Monitoring and measurement of
processes
Monitoring and measurement of product
43. MEASUREMENT, ANALYSIS, AND
IMPROVEMENT
8.3 Control of nonconforming product
8.4 Analysis of data
8.5 Improvement
Continual improvement
Corrective action
Preventive action
