Driven to Quality Assurance.

Even if you don't do business in Europe, odds are the ISO 9001 standard will touch your business sooner or later. Here's a look at what it's about.

Brace yourself. Here comes the latest in a seemingly endless line of acronyms--ISO. Why should you care? After all, ISO only relates to companies doing business in Europe, right? While it's true the origin for ISO 9000 series standard was Europe, actually England, over 100 nations have adopted the system as "official." So, given the pervasiveness of our global economy, it's a fair assumption that few companies can remain ISO-isolated for long.

ISO 9001 (International Organization for Standardization) is a standard applicable to virtually any business. From order entry to shipping, how a business does what it says it does is certified as complying with ISO standards. The standards are quality measurements that cover virtually all aspects of an enterprise. They were adopted from British standards and are used as a benchmark for accepting goods and services between countries.

Before ISO, each European country had its own standards. If a company did business in France, it was required to meet French standards, Spain required meeting Spanish standards, and so on. It was not a very efficient system, and certainly not conducive to easy trade between EC (European community) members and non-members. So, ISO 9001 became the pan-European standard, assuring EC traders that acceptable quality standards were in place within ISO-certified companies.

Certification is what ISO 9001 does. There are indications that sometime soon only ISO-certified companies will be permitted to do business in Europe. But for now, there is no such requirement in place within any ISO participating country.

Why Should U.S. Companies Care?

It's safe to say, if an American company does or plans to do business in Europe, and especially if ISO 9001 compliance becomes law, the choice is simple--certification or abdication.

But how about the thousands of domestic companies that manage just fine, snug within the friendly confines of our domestic economy? What does ISO 9001 mean for them?

No one, at this point, knows for sure where domestic compliance with ISO certification is headed. The number of certified U.S. companies is in the thousands. Compare that to more than 15,000 certifications in Britain alone. ISO certification has made a start in the U.S., but it's nowhere close to the program's pervasiveness in the EC. It is questionable whether the dissemination of ISO in the United States will cascade down the supplier chain, like SPC (statistical process control) compliance did. Rather than requiring certification as ante in contract negotiations, most primary manufacturers have, so far, only endorsed ISO standards as a good idea. Part of this is because so many of the primes have not yet, themselves, achieved compliance.

But regardless of the what transpires relative to forced or unforced compliance, it is clear that the standard represents an excellent way to apply world-class evaluation to a company's manufacturing processes. And in doing so, companies can reap additional internal benefits from streamlined process control such as cost reduction and better profits, even if the standards are not requisite for the market.

A way to hedge a shop's bet vis-a-vis compliance is suggested by Bill Ruxton, of NTMA (National Tooling and Machining Association). He says what makes the ISO 9001 standard attractive is the process analysis that they make businesses go through. Once the compliance steps are taken, the awarding of actual certification is pretty much a formality.

Some small shops postpone paying the high price of certification, but do all the documentation and procedural modifications needed to comply with ISO 9001 standard. They save spending the dollars for final certification until needed. The key to successfully implementing this strategy, though, is to be sure you do it by the book.

Some of NTMA's members report that contracts mentioning ISO as a specification mostly ask for ISO awareness. There has not yet been much demand for actual certification.

What Is ISO 9001--Really?

The ISO 9001 standard is concerned with certifying that a company has an acceptable system of quality in place. Simply put: A company must be able to document what it does and do what it documents.

ISO 9001 is a process-based standard as opposed to a product-based standard. An example of process-based certification is the Red Cross CPR program. In classes, conducted by trained instructors, people learn how to perform CPR. But certification comes only after applicants can demonstrate the technique and pass a test.

In contrast, product-based certification is what U/L (Underwriters Laboratory) does. U/L tests a product to verify it performs within specifications advertised by the manufacturer.

The ISO 9001 standard is purposefully non-specific. It is not designed as replacements for existing quality systems in a company. Quite the contrary is true. Existing quality systems that work make the ISO certification process easier. All ISO 9001 wants to certify is that processes in place within a company to assure quality are used as the company says they are used.

ISO 9001 looks for linkage between different systems in a company. Some call it gap analysis. Gaps between quality systems (the infamous cracks through which things fall) are closed before ISO certification. For example, in some companies, order entry is one system while shop orders may be another. A gap, or lack of communication between these two systems, can be inefficient, leading to last-minute ordering of materials for producing the order. A seamless connection between the two creates better work flow and allows better production planning. Such connectivity between systems is one major contribution that the ISO 9001 standard can help make in a business.

If ISO 9001 were a manufacturer, its product would be documentation. Documentation is the mechanism through which the ISO 9001 standard is implemented. Yet there is no formal specification for the documentation. Participants in ISO 9001 simply learn to write down everything they do using their own format. For example, if a machine operator takes training to use a new CNC software program, it gets recorded. All this documentation is made into a kind of shop manual that essentially serves as a set of instructions for operating the quality processes in the business.

When all is documented, the certifying people (auditors)come in and compare the documentation to the actual operation. They follow the instruction manual prepared by the applicant company. The auditor may, for example, interview the operator mentioned above to confirm attendance in the programming class.

Depending on the size and complexity of the business, an audit can take several days to complete. The degree of compliance is measured by major and minor violations. A violation occurs when the documentation and the operation do not jibe. Major or minor is judged by how serious the violation is to the process.

After correcting the violations, a certification is awarded. But this is not the end of the line. ISO certification is an on-going process that includes bi-annual compliance audits and full renewal audits every three years.

This Article was Provided by a Driso Consultant.

Driso provide ISO 9001 2000 consultancy, auditing, software, and training Services.
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