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What Was the Initial Momentum Behind the ISO 9000 Series?

The story starts back in 1957 with the Treaty of Rome, which serves as the European Community’s (EC) founding charter. Since this time, Europe has endeavored to create a single economic community. This is a system that strives to break down trade barriers and allow free trade between the European states in much the same way trade is established between the states of the U.S.

For almost 30 years after the Treaty of Rome was signed, the process of European economic unification was continuously stifled and put off. Finally, in 1986, the Treaty of Rome was amended for the first time by the Single European Act. The Single European Act has four major objectives:

1. Completion of the single European trade bloc by the end of 1992,

2. Greater EC research and development,

3. Progress made toward a single European currency, and

4. Overall environmental and working condition improvements.

The EC member states are Belgium, Britain, Denmark, France, Germany, Greece, Holland, Ireland, Italy, Luxembourg, Portugal, and Spain. The EFTA member states include Austria, Finland, Iceland, Norway, Sweden and Switzerland.

Since its implementation, the trading bloc of the European Community has been the free world’s largest single trading bloc, 33 percent larger than the United States. Because of the EC’s sheer size, the international standards that gauge a company’s quality become extremely important to comply with, especially if U.S. companies want to continue successfully selling product in Europe.

What is ISO?

ISO is an acronym for the International Organization for Standardization based in Geneva Swit­zer­land. The ISO is like our own ANSI (or American National Standards Institute). Unlike ANSI, the ISO is made up of national member bodies. One of those bodies happens to be our own ANSI. Therefore, as ANSI is a national standards institute, ISO is international. This is an important concept to remember because, just as ANSI develops regulations that American in­dustries use to conduct local business, the ISO develops standards that International industries use to conduct international business.

What is the ISO 9000 Series?

The ISO has created many standards. The 9000 series is a set of standards created by ISO Technical Committee (ISO/TC) 176 that deal with a company’s quality assurance system. The ISO has set aside the 9000 and 10000 series of numbers for ISO/TC 176’s use in the development of future international quality standards. So keep your eyes open!

Companies obtain certification only to the 9001, 9002, or 9003. The 9002 and 9003 are substandards of the 9001. This means that everything that is in the 9003 is in the 9002 and all that is in the 9002 is in the 9001. Refer to Essay III in this section for a more detailed comparison between standards.

What is The Importance of the 9000 Series?

Even without considering the market benefits of the EC’s open door policy toward companies certified to the ISO standards, the 9000 series outlines the basic requirements for any company desiring to achieve an effective quality system. Because of this, the ISO standards have become such a world recognized program that most countries have adopted them either directly or by the formation of similar standards. In the United States, the American National Standards Institute (ANSI) and the American Society for Quality Control (ASQC) have adopted the Q90 series that parallels the ISO 9000 series in American English (verses British English).

The ISO 9000 series stresses the point that the improvement of a company’s quality system is the only way to achieve and maintain quality products and services. The series identifies the performance of an organization as being related to its quality. Therefore, it is vital to constantly improve quality to achieve and sustain genuine economic performance.

The market’s acceptance of the 9000 series can easily be felt as many current and prospective customers are now requiring their suppliers to be certified to the standards. As more suppliers are certified they are requiring their suppliers to be certified as well. It’s a tidal wave!

How is the 9000 Series Changing U.S. Industry?

The traditional American quality system is limited to the production floor. When one used to speak of quality, they were usually talking about product quality. Well, not any longer. With the philosophy that the 9000 series has adopted, quality now covers every component of the company’s business. Some of the areas where the 9001 must be implemented are:

• Research & Development

• Sales and Marketing

• Document Control

• Purchasing

• Material

• Training

• Servicing

Logic follows that in order to maintain a continuous repeatable process, some sort of documentation would be required. In fact, the very first sentence of the first section of 9001, 2, and 3’s Quality System Requirements requires documentation. Further documentation is either required, recom­mended, or desired in almost every other element of all the international standards.

What is an ISO Quality System?

For ISO, a quality system is the documented method a company uses to ensure the level of quality of the company’s product or service.

If you decide to bake a pie, using a recipe is a good idea. A documented quality system for con­ducting a business is nothing less than a necessity. A documented quality system sets a standard for consistent quality. A quality system that is certified to an international quality standard, such as the ISO 9001, will also help to boost a company’s qual­ity reputation.

A documented quality system consists of three major tiers of instructional and directional documentation. The first tier of a company’s quality documentation is usually the quality manual that makes policy statements about the system. The second tier of documentation is the quality implemen­tation procedures (QIP’s) which give general directions for the quality system’s implementation. The third tier of documentation acts similarly to QIP’s except they provide implementation instructions for a more specific function.

All three tiers of the documented quality system are instructions of how a company performs its day-to-day operations. The documentation not only controls functions such as inspection and testing, but also includes the areas of management responsibility, employee training, corrective action, and purchasing, to name a few.

Examples of Quality Document Tiers...

The following is an example of the instructional process of quality documentation.

1. First tier documentation (quality manual) will say: “The company will have manufac­turing procedures.” Certifying agencies and customers would normally make this re­quirement on the company.
   
   Besides its obvious benefits, one important reason that a company has a quality manual is because of quality standards like the ISO 9001. Many customers these days require some sort of evidence that a supplier is capable of producing a consistent product or service of high quality. Certification to a standard (like the ISO 9001) by an external agency can provide evidence to a customer of a company’s strong commitment to quality.
2. Second tier documentation (QIP’s) will then say: “The company manufacturing procedures will have this kind and that kind of information.” Any information or instructions that would be common to more than one manufacturing procedure can be included in the directing QIP. This is a commonsense rule that will cut down on repetitiveness within the manufacturing procedures.
3. Third tier documentation (manufacturing procedures in this example) will then say: “This product line will follow the following flow” and “Inspection will take place at these points.”
   
   The most frightening aspect of a tiered system is that most people believe that because a document has three tiers, an instruction must be repeated three times. This is a complete falsehood. Just follow this simple rule: If instructions printed in one tier are adequate for the repeated performance of a task or continuous function, then no additional instruction, in any other tier, is necessary. The hardest part is determining adequacy.