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ISO 9001:2000
Issues To Be Discussed
Whats new with ISO 9001:2000 ?
How will ISO 9001:2000 affect software
development companies ?
How can CMM be integrated with ISO
9001:2000?
New Structure
4.1. Management Responsibility
4.2. Quality System 5. Management Responsibility
4.3. Contract Review 5.1. Management Commitment
4.4. Design Control 5.2. Customer Focus
4.5. Document and Data Control 5.3. Quality Policy
4.6. Purchasing 5.4, Planning
4.7. Control of Customer-supplied Product 5.5. Administration
4.8. Product Identification and Traceability 5.6. Management Review
4.9. Process Control 6. Resource Management
4.10. Inspection and Testing 6.1. Provisions of resources
4.11. Control of Inspection, Measuring and 6.2. Human resources
Test Equipment 6.3. Facilities
4.12. Inspection and Test Status 6.4. Work environment
4.13. Control of Nonconforming Product 7. Product Realization
4.14. Corrective and Preventive Action 7.1. Planning of realization processes
4.15. Handling, Storage, Packing, 7.2. Customer-related processes
Preservation, and Delivery 7.3. Design and/or development
4.16. Control of Quality Records 7.4. Purchasing
4.17. Internal Quality Audits 7.5. Production and service operations
4.18. Training 7.6. Control of measuring and monitoring devices
4.19. Servicing 8. Measurement, Analysis and Improvement
4.20. Statistical Techniques 8.1. Planning
8.2. Measurement and monitoring
8.3. Control of nonconformity
ISO 9001:1994 8.4. Analysis of data
8.5. Improvement
ISO 9001:2000
6 Bilgi Grubu Ltd., 2000
Simplified Terminology
ISO 9001:1994 ISO 9001:2000
Subcontractor Supplier
Supplier Organization
Quality system Process
element
Inspection and Product verification
testing and validation
Clause 6: Resource
Management
Requirements for determining and providing
necessary resources are still valid, however
completely rewritten as a new clause
Emphasis on improvement and customer
satisfaction
New requirements
Evaluating the effectiveness of training
Ensuring that employees are aware of their role
and contributions within the quality system
Clause 8: Measurement,
Analysis and Improvement
All activities related to measurement and
monitoring are gathered under this clause
Requirements related to corrective and preventive
actions, measuring product and processes remain
unchanged
New requirements
Measurement and monitoring activities should be
planned
Customer satisfaction/dissatisfaction should be
measured
Data should be analyzed for identifying improvement
opportunities
Final Remarks
Do we need to be a Level 4 company for ISO
9001:2000 certification ?
Probably not, interpretation of requirements related to
measurement will be important for software development
companies
ISO 9001:2000 is consistent with the practices of
software development companies engaged in
process improvement
ISO 9001:2000 certification will require considerably less
effort, and no major changes in software quality system
that exist in a Level 3 company
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