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The ISO 9000 standards detail 20 requirements for an organization’s quality management system in the following sphere:

1. Management responsibility
2. Quality Systems
3. Contract review
4. Design control
5. Documentation and data control
6. Purchasing
7. Control of customer supplied product
8. Product identification and traceability
9. Process control
10. Control of inspection, measuring and test equipment
11. Inspection and testing
12. Inspection and test status
13. Control of non conforming product
14. Corrective actions
15. Preventive action
16. Handling, storage, packaging, preservation and delivery
17. Control of quality records
18. Internal quality audits
19. Training
20. Servicing
21. Statistical techniques

These 20 crucial elements in the overall ISO 9000 standard explains the procedures a company has to follow in order to show that it is completing all its procedures as per the ISO 9000 rules. Each of these elements should clearly and completely documented.

The organization to prove conformity has to integrate these twenty elements at the night time and under the right circumstances to yield an overall system. This is usually called a quality system, but many refer to it as a way of doing business, or a management system. Let’s discuss some key interactions of the system, followed by an example of how the various elements work together to form an overall quality system.

For example consider the case of an ore mine, an iron smelting plant, a steel refinery, and finally product manufacturer of simple scalpels.  Clearly, each of these entities must consider purchasing (clause 4.6 Purchasing) and each of these entities must consider placing orders (clause 4.3 Contract Review). Looking at the supply chain, an iron smelting plant will place an order with the ore mine. The plant is involved with purchasing while the ore mine is involved with contract review (P.O. review). Clearly, the closer the contract review conforms to the purchasing, the lesser the confusion or problems will arise in the transaction. Now, when the iron smelting plant interfaces with a steel refinery, the iron smelting plant is playing the role of contract review and the steel refinery is playing the purchasing role. This principle continues all the way to the final manufacturer of scalpels. Purchasing and contract review are two sides to the same process.

Now, let us go through one example that involves several elements at the same time.

A fairly new client with a crisis contacted a consultant. The client was a new start – up organization that had a total of three people. The company (client) manufactured a fairly sophisticated medical device, which required one batch of product to be manufactured in a period of about one week. Apparently, the batch record was reviewed and it was noted that …..to be continued……

Advance Innovation Group is with a superficial experience of 15 years in the training and consulting. Nowadays, it has become a one of the best ISO 9001 certification program service provider. It tends to provide unique ideas for the standardization in the working process of an organization.

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