Monday, July 2, 2012

ISO 9000

                            ISO 9000

ISO 9000, a set of standards & guidelines for a quality assurance management system, represents another body of quality standards. ISO 9000 can be described as “say what you do, do what you say, and prove it. It was established by the International organizations for standardization and has been adopted by the European Communities. ISO 9000 standards defines the required elements of an effective quality management system

 
Although many firms & companies are in the process of pursuing ISO9000 registration, it is interesting to observe that many companies actually fail the audit during the first pass. The number of initial failure ranges from 60% to 70%. It is because of the complexity of the standards and the lack of familiarity with what is actually required.
From the software standpoint, we observed that corrective action & document control are the areas where most nonconformances were incurred. There are 20 elements in the ISO
guidelines. To obtain registration, a formal audit is involved and the outcome has to be positive. Guidelines for the application of the 20 elements to the development, supply, and maintenance of the software are also specified in ISO 9000-3. The 20 elements are as follow:
1. Management responsibility
2. Quality system
3. Contract review
4. Design control
5. Document control
6. Purchasing
7. Purchaser-supplied product
8. Product identification & tractability
9. Process control
10. Inspection & testing
11. Inspection, measuring & test equipment
12. Inspection & test status
13. Control of nonconforming product
14. Corrective action
15. Handling, storage, packaging & delivery
16. Quality records
17. Internal quality audits
18. Training
19. Servicing
20. Statistical techniques

ISO 9000 has a standard set of requirements. From our perspective, what are more interesting to us are the requirements on the software metrics, which are listed under the element of statistical techniques. The requirement addresses both product metrics & process metrics:
1. Product Metrics: Measurements should be used for following purposes:
o To collect data and report metric values on regular basis.
o To identify the current level of performance on each metric.
o To take remedial action if metric level goes worse or exceed established target levels.
o To establish specific improvement goals in terms of metrics.
At minimum, some metrics should be used that represents:
o Reported field failures.
o Defects from customer viewpoint.
Selected metrics should be described such that results are comparable.

Process Metrics:
o Are in-process quality objectives being met?
o Addresses how well development process is being carried out with checkpoints.
o Addresses how effective the development process is at reducing the probability that faults are introduced or go undetected.
Essential Elements of the Successful Registration Efforts
1. Senior Management Commitment to the Effort
2. Appropriate ISO 9000 training
3. An effective management review process
4. Documentation of the quality system
5. An effective internal auditing system
6. An effective corrective action process

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