International standard headed for shore
By Richard A. Matthews
MYTH: “The new ISO cleanroom standards will not affect me. They are someone else`s problem.”
REALITY: ISO cleanroom standards will affect everyone directly or remotely connected to cleanrooms.
No matter what your relationship to the cleanroom community, if you fit one of the categories listed below, you will be affected by the new ISO cleanroom standards.
Cleanroom components supplier
Cleanroom consumables supplier
Cleanroom equipment vendor
Supplier of process materials and components
End-user or customer for products produced in a cleanroom
The ISO cleanroom standards will be known by their identifying number series, ISO 14644 and ISO 14698. The first of these, 14644-1, is being officially published this month with 10 other documents to be promulgated over the succeeding 12 months. There will be 11 documents affecting all aspects of clean space use from inception through daily operation.
We live in a global economy driven by global quality needs. These new standards provide the needed universal quality levels for cleanroom use anywhere in our world, even on the spacecraft leaving our world.
When you realize, for example, that more than 40 percent of the medical devices produced in the United States are exported and that more than 25 percent of the FDA`s inspections are done outside the United States, you have a better understanding of the globalization of clean space.
Look around your home or work environment, even your automobile, and determine how many of the items were produced outside your home country. Or look at your employer`s customer locations. All of us are impacted by the global economy.
The direct impact of the ISO-14644 and ISO-14698 standards will hit first and hardest in the European Union (EU) and secondly to those doing business in or with EU countries and businesses. The reason is paramount; for 6 months after formal publication of an ISO standard, the member nations of the EU are required to “sunset” or rescind their own national standards in favor of the ISO standards. As such, the ISO standards will have the force of law in Europe. For example, the ISO 14644-1 “Classification of Air Cleanliness” standard becomes mandatory in the EU in November 1999.
If you do business either in Europe or with EU-based vendors and customers, you will be directly affected.
If you are an ISO 9000 certified organization, you are required to use appropriate ISO standards as part of your certification. Therefore, the ISO 14644 and ISO 14698 standards will apply to your certification as they are published and as you are re-certified. That is another form of direct impact.
In the United States, the Insstitute of Environmental Sciences and Technology (IEST) will have to decide what to do about US Federal Standard 209E after the first two ISO standards are published (14644-1 and 14644-2). Fed-Std-209E equals only about 5 – 7 percent of what will be in all the new ISO cleanroom standards. These first two (14644-1 and 14644-2) replace what is in Fed-Std-209E. Bear in mind that the use of Fed-Std-209E is obligatory only for organizations doing work for the United States government. It is a voluntary standard for non-government commercial trade as a reference only per agreement between buyer and seller. This is significantly different from what will be happening in Europe and to businesses trading in Europe.
Some people think the ISO standards are just another form of recommended practices (RPs), similar to those produced by the IEST and other organizations and are usually used as references per agreement between buyer and seller. This assumption is incorrect because ISO standards are directly impacted by ISO 9000 (and ISO 14000) certification criteria. Yet to be determined are the reactions of national regulatory authorities to the new ISO cleanroom standards.
Yes, you will be impacted, and that impact hits this month, May 1999. You are about to be hit with a tsunami. Work done over the past 5.5 years by the ISO Technical Committee on cleanrooms and other associated controlled environments (ISO/TC209) is in its final stages. More than 1,000 volunteers in 34 countries have labored over the creation of 11 standards, creating more than 400 pages covering all aspects of clean space from inception to daily use. Ignore this work at your own peril. The ISO/TC209 tsunami wave is about to hit your shore.
Copies of these ISO standards are available from:
940 East Northwest Highway
Mount Prospect, IL 60056
Richard A. Matthews is founder of Filtration Technology Inc. (Greensboro, NC), a licensed cleanroom general contractor and a manufacturer and distributor of industrial filter equipment. He is chairman of the International Organization for Standardization Technical Committee ISO/TC 209 “Cleanrooms and associated clean environments.” He is past president of the Institute of Environmental Sciences and Technology, and is vice chairman of the standing committee of the International Confederation of Contamination Control Societies. He is also president of Micron Video International, a producer of training programs for cleanroom personnel. He is on the CleanRooms Editorial Advisory Board.