1. ISO 9001 Quality Management System

2. What is ISO? INTERNATIONAL ORGANIZATION FOR STANDARDIZATION
Established in 1947
Head Office is based in Geneva - Switzerland
Greek Word “isos” which means equal

3. Current ISO Standards ISO 9001:2008 Quality Management System
Environmental Management System
ISO 22000
Food Safety Management System
ISO 27001
Information Security Management System

4. History of ISO 9000 Second world war US military standards NATO
British Standards Institute BS5750
ISO 9000:1987 Vocabulary Standard
Revised in ISO 9000:1994 &
ISO 9001:2000 QMS
ISO 9001:2008 Current

5. Hierarchy / Chain of Monitoring
(ISO) International Organization for Standardization
Worldwide Accreditation Bodies
(Every Country)
Certification Bodies

6. World-wide Accreditation Bodies
UKAS United Kingdom
TGA DAR German
PNAC Pakistan
RvA Netherlands
ANSI RAB America
JAB Japan
COFRAC France

7. ISO 9001 CERTIFICATION BODIES UKAS BVC LRQA ACS Registrars Moody
International

8. Introduction to ISO 9001 QMS
ISO 9001 is the quality management system standard. Which addresses the basic requirements for a quality system.
It is equally applicable to manufacturing, servicing & inspection / testing organizations.

9. Continual improvement of the quality management system
About ISO 9001:2008 Process Model
Continual improvement of the quality management system 5
Management C R
Responsibility u e C q u s u s t i 6 8 o r t
ISO9001/2008 e
Resource
Measurement,
Analysis o m m
Management
Process e e
Model m
Improvement n r e t s r s 7 s
Product/ Service
Product
Realization
& Service
Input
Output

10. ISO 9001:2008 QMS Process requirements
Five Key Activities (Paragraphs)
4. Quality Management System
5. Management Responsibility
6 Resource Management
Please refer process model approach diagram. Slide no 12.
7. Product Realization.
8. Measurement, Analysis, Improvement

11. ISO 9001:2008 4.0 Quality Management System 4.1 Requirements shall
Establish,
Document,
Implement,
Maintain
Continually improve its effectiveness
Note the continuos improvement is a requirement.

12. ISO 9001:2008 5. Management responsibility 5.1 Management Commitment
5.2 Customer focus
5.3 Quality Policy
5.4 Planning
It is no longer say what you do and do what you say, it is more about keeping customer satisfied.
Finally recognition that QMS has to be administered.
5.5 Responsibility, authority and
communication
5.6 Management review

13. ISO 9001:2008 6. Resource Management 6.1 Provision of Resources
6.2 Human resources
6.3 Infrastructure
6.4 Work environment

14. ISO 9001:2008 7. Product Realization
7.1 Planning of product realization
7.2 Customer-related processes
7.3 Design and development
7.4 Purchasing
7.5 Production and service provision
7.6 Control of monitoring & measuring devices.

15. ISO 9001:2008 8.0 Measurement, analysis and improvement 8.1 General
8.2 Monitoring and measurement
8.3 Control of Non conformity product
8.4 Analysis of data
8.5 Improvement

16. Integrated Management System

17. Training courses we can offer during system development & implementation
ISO 9001 QMS Introduction
ISO 9001 QMS Internal Auditing
ISO EMS Introduction
ISO EMS Internal Auditing
Occupational Health & Safety Basic Introduction
Integration of ISO 9001, ISO & OHSAS 18001
ISO Food Safety

18. Benefits of ISO Standardization
Globally Recognized
Improvement in Quality System Efficiency
Controlled Wastages
Better Motivation
World-wide Acceptance
Customer Satisfaction

19. Trained Work Force
Better Working Environment
Defined Roles & Responsibilities
Better Coordination
Environment Friendly
Better Future
Increased Competence & Commitment of Employees as well as Vendors

20. STEPS TO GET YOUR COMPANY ISO CERTIFIED (Summary)
GAP Analysis
Training Session
Defining Quality Policy
Developing & implementing Operating Procedures, Job Descriptions and Work Instructions
Setting Quality Objectives
Training of Internal Auditors
Pre-evaluation of QMS System
Certification Audit
Never Ending Improvement