ISO 9001 Clause Description

1. Management responsibility
ISO 9001 requires that the quality policy be defined, documented, understood, implemented, and maintained; that responsibilities and authorities for all personnel specifying, achieving, and monitoring quality be defined; and that in-house verification resources be defined, trained, and funded. A designated manager ensures that the quality program is implemented and maintained.

2. Quality system
ISO 9001 requires that a documented quality system, including procedures and instructions, be established.

3. Contract review
ISO 9001 requires that contracts be reviewed to determine whether the requirements are adequately de. ned, agree with the bid, and can be implemented.

4. Design control
ISO 9001 requires that procedures to control and verify the design be established. This includes planning design activities, identifyinginputs and outputs, verifying the design, and controlling designchanges.

5. Document control ISO 9001 requires that the distribution and modi. cation of documents be controlled.

6. Purchasing ISO 9001 requires that purchased products conform to their specified requirements. This includes the assessment of potential subcontractors and veri. cation of purchased products.

7. Purchaser-supplied product
ISO 9001 requires that any purchaser-supplied material be veri. ed and maintained.

8. Product identification and traceability
ISO 9001 requires that the product be identified and traceable during all stages of production, delivery, and installation.

9. Process control
ISO 9001 requires that production processes be de. ned and planned. This includes carrying out production under controlled conditions, according to documented instructions. Special processes that cannot be fully veri. ed after the fact are continuously monitored and controlled.

10. Inspection and testing
ISO 9001 requires that incoming materials be inspected or verified before use and that process inspection and testing be performed. Final inspection and testing are performed before the release of finished product. Records of inspection and testing are kept.

11. Inspection, measuring, and test equipment
ISO 9001 requires that equipment used to demonstrate conformance be controlled, calibrated, and maintained. When test hardware or software is used, it is checked before use and rechecked at prescribed intervals.

12. Inspection and test status
ISO 9001 requires that the status of inspections and tests be maintained for items as they progress through various processing steps.

13. Control of nonconforming product
ISO 9001 requires that nonconforming product be controlled to prevent inadvertent use or installation.

14. Corrective action
ISO 9001 requires that the causes of nonconforming product be identified. Potential causes of nonconforming product are eliminated; procedures are changed resulting from corrective action.

15. Handling, storage, packaging, and delivery
ISO 9001 requires that procedures for handling, storage, packaging, and delivery be established and maintained.

16. Quality records
ISO 9001 requires that quality records be collected, maintained, and dispositioned.

17. Internal quality audits
ISO 9001 requires that audits be planned and performed. The results of audits are communicated to management, and any deficiencies found are corrected.

18. Training
ISO 9001 requires that training needs be identi. ed and that training be provided, as selected tasks may require qualified personnel. Records of training are maintained.

19. Servicing
ISO 9001 requires that servicing activities be performed as speci. ed.

20. Statistical techniques
ISO 9001 states that, where appropriate, adequate statistical techniques are identi. ed and used to verify the acceptability of process capability and product characteristics.