1. ISO : 9000

2. Quality Management System – ISO:9000
The ISO 9000 family of standards has been developed to assist organizations, of all types & sizes, to implement and operate effective quality management systems.

3. Evolution of ISO 9000 Series
US MIL SPECS
AQAP - 1, 4, 9
DEFENCE STANDARDS (U K)
05 / / / 29 BS
Pt Pt Pt3
Pt Pt Pt6 α

4. Evolution of ISO 9000 Seriesα
NATIONAL STANDARDS
ISO 9000 SERIES1987
ISO
ISO 9004 EN
EN 29000
EN 29004
ISO 900 SERIES 1994
ISO , -2
ISO ,-2,-3
ISO 9000 :2000
ISO 9004 :2000
ISO 9001: 2000
CONTRCTUAL
NON-CONTACTUAL

5. Fundamentals of Quality Management System
The quality management system approach encourages organizations to analyze customer requirements, define the processes that contribute to the achievement of a product which is acceptable to customer, and keep these processes under control.
A quality management system can provide the framework for continual improvement to increase the probability of enhancing customer satisfaction and the satisfaction of other interested parties. It provides confidence to the organization and its customers that it is able to provide products that consistently fulfill requirements.

6. Quality management systems approach
determining the needs & expectations of customers and other interested parties;
establishing the quality policy and quality objectives of the organization;
determining the processes and responsibilities necessary to attain the quality objectives;
determining & providing the resources necessary to attain the quality objectives;
establishing methods to measure the effectiveness and efficiency of each process;

7. Quality management systems approach (contd.)
applying these measures to determine the effectiveness & efficiency of each process;
determining means of preventing non-conformities and eliminating their causes;
establishing & applying a process for continual improvement of the quality management system.

8. Quality Management Principles
Eight management principles form the basis for the quality management system standards within the ISO 9000 family. These are :
Customer focus ,
Leadership,
Involvement of people,
Process approach,
Systems approach to management,
Continual improvement,
Factual approach to decision making,
Mutually beneficial supplier relationships.

9. Model of a process-based quality management system
Continual Improvement of the
QMS
Customers & other interested parties
Customers and other interested parties
Management responsibility
Resource management
Measurement, analysis & improvement
Satisfaction
Output
Input
Product realization
Requirements
Product

10. What does ISO:9001 registration mean ?
ISO : 9001 registration means the certification of company quality systems by third party thru’ the mechanism of registration ;
This is done by having an accreditated independent third party on-site audit of a company’s operations against the requirements of the appropriate standard.
Upon successful completion of this audit, the company will receive a registration certificate that identifies its quality system as being in compliance with ISO : 9001.

11. Summary of ISO : 9001 requirements
Clause No.
Requirements
4.1
4.2
General requirements
Documentation requirements
5.0
Management Responsibility
- Management commitment
- Customer focus
- Quality policy
- Management representative
- Management review

12. Summary of ISO : 9001 requirements
Clause No.
Requirements
6.0
Resource Management
7.0
Product Realization
- Process
- Customer requirements
- Design & Development
- Purchasing
- Production & Service under controlled conditions

13. Summary of ISO : 9001 requirements
Clause No.
Requirements
8.0
Management, Analysis & Improvement
- Customer satisfaction
- Internal Audit
- Control of Non-conforming product
- Analysis of data
- Continual Improvement
- Corrective & Preventive action.