1. ISO 9000 Introduction
Imran Hussain

2. Why have a Quality Standard?

3. Customer
contract
Supplier
subcontract
Vendor
Subcontractor

4. Motivation for ISO 9000 Helps in selection of suppliers and vendors
Places onus of proving quality on supplier
Controls
Processes
Procedures
Quality records

5. What’s the difference between TQM and ISO 9000?

6. Benefits to customers and _____ ?

7. Benefits of ISO 9000
Customers and users will benefit by receiving the products that are:
Conforming to the requirements
Dependable and reliable
Available when needed
Maintainable

8. Benefits to employees?

9. Benefits of ISO 9000 People in the organization will benefit by:
Better working conditions
Increased job satisfaction
Improved health and safety
Improved morale
Improved stability of employment

10. Benefits to owners and investors?

11. Benefits of ISO 9000 Owners and investors will benefit by:
Increased return on investment
Improved operational results
Increased market share
Increased profits

12. Benefits to suppliers and partners?

13. Benefits of ISO 9000 Suppliers and partners will benefit by: Stability
Growth
Partnership and mutual understanding

14. Benefits to society?

15. Benefits of ISO 9000 Society will benefit by:
Fulfillment of legal and regulatory requirements
Improved health and safety
Reduced environmental impact
Increased security

16. Does ISO have anything to do with Quality Management?

17. ISO 9000 and Quality Management (QM)
ISO standards based on the following QM principles:
Customer focus
Leadership
Involvement of people
Process approach
System approach to management
Continual improvement
Factual approach to decision making
Mutually beneficial supplier relationships

18. ISO 9000 and SQA Group Responsibility lies with management SQA group
implements standards
Monitors effectiveness in organization

19. Responsibilities of SQA Group
Perform audits
Promote awareness
Communicate Quality System to staff
Support implementation of ISO 9000
Perform customer satisfaction surveys
Facilitate improvement following customer feedback
Review project quality at milestones
Act as partner in quality project

20. Responsibilities of SQA Group
Facilitate improvement and defect prevention activities
Monitor and verify process compliance
Monitor effectiveness of processes
Monitor institutionalisation of processes
Chair organization quality reviews
Facilitate external audits
Test planning, execution, reporting and recommendation
Test lab management
Support a metrics culture

21. ISO 9000 History and Background
BS 5750 (forerunner to ISO 9000)
ISO 9000: 1987
ISO 9000: 1994
ISO 9000: 2000

22. ISO 9000: 1994 Family of standards
Applicable to manufacturing organizations, servicing organizations and software organizations
Different flavours
ISO 9001 (full product lifecycle) - superset
ISO 9002 (production, installation, servicing)
ISO 9004 (inspection and testing)

23. Quality Management System Documentation
Quality Manual
Quality System Procedures
Work Instructions
Forms

24. Quality Manual Quality Policy Objectives Overview Organisation
Responsibilities
Requirements Policy/Responsibility/Procedure Reference

25. Quality System Procedures
A set of procedures which detail how the requirements of the quality manual are to be implemented
Detailed procedures which define how the processes are to be performed and controlled
Specifying who is responsible for what

26. Work Instructions
Detailed instructions for the performance of specific tasks
Such instructions may cover
Materials
Processes
Verification

27. Forms
Records that provide proof that specified activities were carried out
A.k.a. quality records

28. Quality Management System
Standard
ISO 9000
Quality Manual
Policy Statement, Commitment, Organisation, Responsibilities
LEVEL 1
Quality System Procedures
Company Practices, Interfaces
LEVEL 2
Work Instructions
Written Instructions to Control Tasks
LEVEL 3
Forms
Quality Records
LEVEL 4
Sales
Design
Purchasing
Manufacturing
Accounts
Personnel
After Sales

29. Documenting Procedures
Say what you do
Do what you say
And where necessary
Show what you did

30. ISO 9000: 1994 Clauses Management Responsibility Quality System
Contract Review
Design Control
Document Control
Purchasing
Purchaser Supplied Product
Product Identification and Traceability
Process Control
Inspection and Testing

31. ISO 9000: 1994 Clauses Inspection Measuring and Test Equipment
Inspection and Test Status
Control of Non-Conforming Product
Corrective Action
Handling, Storage, Packaging and Delivery
Quality Records
Internal Quality Audits
Training
Servicing
Statistical Techniques

32. References
Software Quality Management and ISO 9001, by Michael Jenner, Ch. 1, 2
A Practical Approach to Software Quality, by Gerard O’Regan, Ch. 3