What's in the name

Greek word " ISOS " mean

" Uniform "

Quality

" Quality is conformance to specification "

British defence industries quality assurance
panel

" Quality is conformance to requirement "

Philip Crosby

" Quality is fitness for use "

Dr. Joe Juran
Quality

"Quality is a predictable degree of uniformity

and dependability, at low cost and suited to the
market"
Dr. Edward Deming

"Quality is meeting the (stated) requirements of

the customer - now and in the future "
Mike Robinson
Quality

"Quality is the totality of features

and characteristics of a product or service
that bear on its ability to satisfy stated or implied
needs“

British standard 4778 & ISO 8402

Quality Management System

Quality Management System

Quality Assurance

Quality Control
ISO & ISO 9001

 International Organization for Standardization -

worldwide federation of national standards
bodies
 ISO technical committees – prepare International
Standards
 ISO 9001 was prepared by Technical Committee
ISO/TC 176, Quality management and quality
assurance, Subcommittee SC 2, Quality systems
 Third edition ISO 9001:2000 supersedes the
second edition (ISO 9001:1994)
 This edition stresses more on enhancing
customer satisfaction
What is ISO 9001:2000?

ISO 9001:2000 is an international

standard for implementing a
quality management system
Why Use ISO 9001:2000?

ISO 9001:2000 sets out how

a company can establish an
effective quality management
system to meet its
stakeholders’ needs
IS0 9000:2000 Series of
Standards
ISO 9000:2000 - Fundamentals and Vocabulary
 Provides an introduction to Quality
Management Systems (QMS) and vocabulary
ISO 9001:2000 - Requirements
 Specifies requirements for a QMS where
capability to provide product that meets
customer and regulatory requirements needs to
be demonstrated
ISO 9004:2000 - Guidelines for Performance
Improvement
 Provides guidance on using an established QMS
to further enhance customer satisfaction and
product/service quality
Eight 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 relationship
Process Approach
(main theme)

Process - an activity using resources, and managed

in order to enable the transformation of inputs
into outputs
ISO 9001 promotes process approach to improve
effectiveness of QMS to enhance customer
satisfaction by meeting customer requirements
For an organization to function effectively, it has to
identify and manage numerous linked activities
The application of a system of processes within an
organization, together with the identification and
interactions of these processes, and their
management, can be referred to as the “process
approach”.
Process Approach
(main theme)

It provides better control over linkage between the

processes & system of processes, as well as over
their combination and interaction.
This approach emphasizes;
understanding and meeting requirements
need to consider processes in terms of added value
obtaining results of process performance and effectiveness
continual improvement of processes based on objective
measurement

Customers play a significant role in defining

requirements
Monitoring of customer satisfaction – very important
Purpose of ISO 9001

 Conventional standards are often applied to

specific products or operations. ISO 9001 is
applied throughout an organization
 Reduce buyers' quality costs through
confidence and assurance in suppliers' quality
practices
 Compliance with ISO 9001 standard provide a
means for contractual agreement between the
buyer and the supplier
 ISO 9001 standards define the minimum
requirements a supplier must meet to assure
its customers that they are receiving high
quality products
ISO 9001

 ISO 9001:2000 is much more project

driven
 Top management has greater
accountability
 The organization is required to measure
business performance against objectives
 If implemented correctly, it will help the
organization to:
 Be more competitive
 Improve cycle times
 Reduce costs
 Improve morale
4 Quality Management
System

 To meet the requirements;

 Document
 Implement
 Maintain
 Continually improve effectiveness
4 Quality Management
System

4.1 General requirements

 Processes, interaction, improvement
4.2 Documentation requirements
 General
 Quality manual
 Control of document
 Control of records
5 Management Responsibility

5.1 Management commitment

5.2 Customer focus
5.3 Quality policy
5.4 Planning
 Objectives
 Management system
5 Management Responsibility

5.5 Responsibility, authority and

communication
 Top management emphasis
 Management representative
 Includes promotion of customer

requirements throughout the organization

 Internal communication
5.6 Management review
 Lists of inputs and outputs
 Recommendation for improvement
 Action items expected
 Records
6 Resource Management

6.1 Provision of resources to improve

processes and enhance customer
satisfaction
6.2 Human resource
 Determine competence
 Provide training or other action
 Evaluate effectiveness of action
6.3 Infrastructure
 Buildings, workspace, utilities
 Process equipment
 Support services
6.4 Work environment
 Manage conditions of environment to
achieve product requirement conformance
7 Product Realization

7.1 Plan and develop the processes

 Include product objectives, relevant processes
and resource, appropriate test and validation
7.2 Customer related processes
 Customer requirement - stated and implied
 Statutory and regulatory
 Product requirements and changes
 Organization ability
 Communication with customers
7.3 Design and development
 Planning, inputs, outputs, systematic reviews,
verification and validation, control of changes
7 Product Realization

7.4 Purchasing
 Supplier evaluation and selection
 Relevant purchasing information
 Verification of purchased product
7.5 Production and service provision
 Controlled conditions including product
characteristics, work instructions, suitable
equipment, measuring devices, and system
 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
7 Product Realization

7.6 Control of monitoring and

measuring devices
 Calibrated where necessary
 Adjusted and readjusted
 Identifies status
 Safeguarded from invalid adjustment
 Protected from damage or deterioration
8 Measurement, Analysis,
and Improvement
8.1 General
 Plan and implement
 Measurement and monitoring processes
 To demonstrate product conformity, system
conformity and continually improve the QMS
8.2 Monitoring and measurement
 Customer satisfaction
 Perception of fulfillment
 Internal planned audit, etc.
 Auditors independent of their own work
 Processes
 Demonstrate achievement of planned results
 Product
 Monitor and measure characteristics
 Conformity with acceptance criteria
 Waivers / concessions
8 Measurement, Analysis,
and Improvement

8.3 Control of nonconforming product

 Elimination, concession, preclude intended
use
8.4 Analysis of data
 Customer satisfaction
 Product and process requirements and
trends
 Suppliers
8.5 Improvement
 Continually improve effectiveness
of the system
 Corrective action
 Preventive action
Documentation requirements

The QMS documentation shall include:

 Documented statements of a quality policy and
quality objectives
 A quality manual
 Documented procedures required by ISO 9001
 Documents needed by the organization to
ensure the effective planning, operation and
control of its processes
 Records required by ISO 9001
Documented procedure means that the
procedure is;
 Established
 Documented
 Implemented
 Maintained
Documentation requirements

The extent of the QMS documentation

can differ from one organization to
another due to;
 Size of organization
 Type of activities
 Complexity of processes and their interactions
 Competence of personnel
The documentation can be in any form
or type of medium
Quality manual

It shall include;
 Scope of the QMS
 Documented procedures established for the QMS
 Description of the interaction between the
processes of the QMS
Control of documents
Documents shall be controlled
A documented procedure shall be
established to define the controls
needed;
 Approve documents for adequacy prior to issue
 Review and update as necessary and re-approve
 Ensure that changes and the current revision
status of documents are identified
 Ensure that relevant versions of applicable
documents are available at points of use
 Ensure that documents remain legible and readily
identifiable
 Ensure that documents of external origin are
identified and their distribution controlled
 Prevent the unintended use of obsolete documents,
and to apply suitable identification to them if they
are retained for any purpose
Control of records
 Shall be established & maintained to provide
evidence of conformity to requirements
 For effective operation of the QMS
 Shall remain legible, readily identifiable and
retrievable
 A documented procedure shall be established
to define the controls needed for;
 Identification
 Storage
 Protection
 Retrieval
 Retention time
 Disposition of records
THANK YOU!