THE 20 ELEMENTS OF ISO 9001

1. Management Responsibility. Management sets the company quality policy and implements it by providing resources, personnel and training.
2. Quality System. A Quality System comprised of a Quality Manual and supporting procedures is created and maintained.
3. Contract Review. Contracts reflect the customers' needs and expectations. Products and services provided must comply with those requirements.
4. Design Control. Engineering drawings and design changes are carefully documented to ensure that changes have been fully coordinated and approved internally, and when appropriate, by the customer.
5. Document Control. The creation and modification of documents supporting the Quality System is strictly controlled by ISO 9001 procedures.
6. Purchasing. Purchasing procedures describe supplier requirements and the system for ensuring compliance to these standards.
7. Handling of Purchaser Supplied Product. Procedures detail methods of handling and safekeeping of product supplied by the customer.
8. Product Identification and Traceability. Methods of tracking date and lot codes of product and raw materials from start to finish guarantee traceability.
9. Process Control. Work instructions, quality plans and workmanship standards verify that each job is being done correctly.
10. Inspection and Testing. Inspection and testing at receiving, in-process and final inspection areas ensures quality. Test and inspection records are preserved as part of the quality system.
11. Inspection, Measuring and Test Equipment. Instruments and measuring tools are calibrated regularly and records maintained.
12. Inspection and Test Status. Only inspected materials may be used or processed further. Inspected product is always identified.
13. Control of Nonconforming Product. Materials or products that fail to meet specifications are rejected and separated from normal production. Only the proper authorities may decide if rejected material will be used as is, reworked or returned to the supplier.
14. Corrective Action. The corrective action system focuses on identifying the root cause of quality concerns and any corrective action required.
15. Handling, Storage, Packaging and Delivery. Procedures outline practices that protect products from damage during manufacturing and shipping.
16. Quality Records. Quality records provide an audit trail for internal and external auditors.
17. Internal Quality Audits. Specially trained teams verify that the Quality System is working by evaluating the same 20 elements required by the external auditors, on an on-going basis.
18. Training. Training records are maintained for every employee showing their levels of expertise.
19. Servicing. Where servicing is specified in the contract, procedures are established to verify that servicing meets the indicated requirements.
20. Statistical Techniques. Control charts, graphs and other methods of analysis determine how well a process is working and facilitate continuous improvement.