The ISO Approach to Quality Assurance System

ISO 9000 describes the elements of a quality assurance in general terms. These elements include the organizational structure, procedures, processes, and resources needed to implement quality planning, quality control, quality assurance, and quality improvement. However, ISO 9000 does not describe how an organization should implement these quality system elements.

Consequently, the challenge lies in designing and implementing a quality assurance system that meets the standard and fits the company's products, services, and culture.

The ISO 9001 standard

ISO 9001 is the quality assurance standard that applies to software engineering. The standard contains 20 requirements that must be present for an effective quality assurance system. Because the ISO 9001 standard is applicable in all engineering disciplines, a special set of ISO guidelines have been developed to help interpret the standard for use in the software process.

The 20 requirements delineated by ISO9001 address the following topic.

1. Management responsibility

2. Quality system

Contract review

1. Design control

2. Document and data control

3. Purchasing

4. Control of customer supplied product

5. Product identification and tractability

6. Process control

7. Inspection and testing

8. Control of inspection, measuring, and test equipment

9. Inspection and test status

10. Control of non confirming product

11. Corrective and preventive action

12. Handling, storage, packing, preservation, and delivery

13. Control of quality records

14. Internal quality audits

15. Training

16. Servicing

17. Statistical techniques

In order for a software organization to become registered to ISO 9001, it must establish policies and procedure to address each of the requirement noted above and then be able to demonstrate that these policies and procedures are being followed.

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