20 basic elements of ISO 9000

ISO 9000 standards are published by the ISO. The ISO 9000 series consist of the following quality standards:
- ISO 9000
- ISO 9001
- ISO 9002
- ISO 9003
- ISO 9004

ISO 9000 is an overview for selecting the appropriate standard. ISO 9001 covers the 20 elements of an effective quality management system (QMS), which include design, production, servicing, and installation:
1. Management responsibility
2. Quality system
3. Contract review
4. Design control
5. Document and data control
6. Purchasing
7. Control of customer-supplied product
8. Product identification and traceability
9. Process control
10. Inspection and testing
11. Control of inspection measuring and test equipment
12. Inspection and test status
13. Control of a nonconforming product
14. Corrective and preventive action
15. Handling, storage, packaging, preservation, and delivery
16. Control of quality records
17. Internal quality audits
18. Training
19. Servicing
20. Statistical techniques

ISO 9002 addresses all elements of a QMS except design. ISO 9003 focuses on final inspection and testing. ISO 9004 provides implementation guidance and can be used to expand and improve an organization's quality system. If ISO 9004 is in place, an organization can achieve the ISO 9001 standard. The ISO 9000 series was first published in 1987 and is currently under review. Under the revision, ISO 9002 and ISO 9003 will be incorporated into a new ISO 9001. The new version of ISO 9001 will include the following:
- All types of products and services
- A single standard with flexibility of use
- A more generic approach to conform to different types of industries
- Alignment with other standards
- Consistent terms, phrases, and definitions