The first cleanroom standard, U.S. Federal Standard 209E(FS209E), was introduced in 1963 by the U.S. government. Because FS209E was strictly a U.S.-mandated standard, industries elsewhere had to either adopt or modify the U.S. standard or create new ones.
In response to this challenge, standardization bodies such as the European Committee for Standardization (CEN) and the Institute of Environmental Science and Technology (IEST) developed additional environmental requirements applicable to cleanrooms. It wasn’t until 1996, however, that a new set of environmental standards was born: ISO 14000. Set forth by the International Organization for Standardization (ISO), the ISO 14000 standards clearly define the global requirements for establishing an Environmental Management System (EMS).
The keystone of cleanroom technology in the ISO 14000 series, ISO 14644-1, became mandatory in the European Union on November 1, 1999. Since then, other parts of the world have adopted ISO 14644-1 as their baseline cleanroom (or “clean space”) classification document. All organizations that have earned ISO 9000 certification (the quality counterpart of ISO 14000) are required to use ISO 14644-1 to define their clean space. ISO 14001, the actual standard against which the EMS audit is conducted, provides a compatible management system framework for dealing with the specialized environmental concerns in the management of cleanrooms and other clean manufacturing spaces.
ISO 14000’s Popularity Grows
According to the ISO, as of 2000 there were a total of 22,897 organizations around the world that had earned ISO 14000 certification—8,791 more than the previous year. In the U.S. alone, certification has increased from 636 in 1999 to 1042 in 2000. The Global Environment & Technology Foundation predicts that by year-end 2002 there will be at least 150,000 companies compliant to ISO 14001 (the actual standard in the ISO 14000 system).
Companies have many reasons to establish an ISO 14000 EMS. The most convincing is the promise of increased sales and profits in competitive global markets.
Incentives. The U.S. adoption of EMS was bolstered by the onset of business-driven mandates and government programs. In April 2000, the president issued an executive order mandating that each federal agency implement an EMS at “all appropriate agency facilities based on facility size, complexity, and the environmental aspects of facility operations no later than December 2005” (EO 13148, April 22, 2000). Previously, automotive companies had issued mandates for vendors to conform to the ISO 14001 standard in 2002 and 2003. As a result, ISO 14000 compliance, once voluntary, has not only become a basic business requirement for many U.S. companies, but may be the key to sustainable development as well as help to limit limit liability—and perhaps fines—should they be found to be out of compliance with other environmental regulations.
Improved corporate image. Establishing a strong image helps firms meet their customers’ expectations. The result is a stronger competitive edge, which leads to increased sales and profitability. In countries outside of the U.S., especially, companies look for the certification as a requirement for accepting bids. Without the ISO designation, doing business in the world market is virtually impossible.
Continuous improvement. The ISO 9000 Quality Management System (QMS) proved its value to U.S. manufacturers as a bottom-line improvement tool, strengthening the ability to reduce failure rates and cut production costs. The management system principles of ISO 9000 were incorporated into the ISO 14000 EMS standards as proven concepts. The ISO 14000 standards can be used under a variety of contexts from a country-wide requirement, to manufacturing operations, to a specific customer requirement of a supplier, to regulatory settlement. Most frequently, however, it is used to internally gain control, create efficiencies, and increase profitability.
Cost reductions. By establishing an ISO 14000 EMS, companies can experience significant cost reductions throughout their operations. For example, cost reductions are realized in the ability to decrease waste, improve energy consumption, develop better waste disposal methods, and prevent liability fines. An efficient operation is a profitable one. Data support that companies registered to ISO 14001 have identified cost savings as one of their first and foremost important improvements.
Applying ISO 14000 to Cleanrooms
ISO 14000 is comprised of two separate documents, ISO 14001 and ISO 14004. ISO 14001 is the actual specification standard that provides the basis for third-party EMS registration. ISO 14001 may also be used for internal self-declaration purposes. ISO 14004 is intended to be an implementation guideline and internal management tool, not for use by registrars as a specification standard.
The elements of the ISO 14000 EMS apply to cleanroom operations such as the following:
- Environmental control
- Air cleanliness (based on specific classifications)
- Environmental testing, evaluation, and monitoring methods
- Design and construction of cleanrooms
- Operation of cleanroom facilities
- Terms and definitions used in cleanroom technology
- Minienvironments and isolators
- Biocontamination control in cleanrooms
- Measurement methods for cleaning or disinfecting inert surfaces
- Molecular contamination control
The following are helpful strategies for completing the ISO 14000 EMS implementation efficiently and cost-effectively:
Get solid commitment from top management. The first step is to convince the management team to finance the ISO 14000 certification. The best way to do this is, of course, to convince them of the certification’s return on investment. First, prepare a presentation that identifies the firm’s environmental management strengths and weaknesses, and compare this to the quantifiable improvements that will result after ISO 14000.
The presentation should also include the estimated annual environmental costs before and after certification, as well as a list of environmental performance improvement objectives. Again, remember to focus on benefits that improve the bottom line, which will most likely attract management’s attention.
Develop a streamlined process for evaluating environmental aspects/impacts. “Aspects” are the elements of any activities, products, or services that interact with the environment. “Impacts” are the positive or negative environmental changes that result from the environmental aspects. Extracting the relevant information contained in existing programs helps to simplify the aspect/impact analysis.
To perform an environmental aspect/impact analysis, the organization should determine the magnitude of the environmental impacts, rated by the following:
- Controllability (administrative and engineering controls)
- Resource use
- Biophysical considerations, such as air emissions
- Generation of a hazardous or non-hazardous waste
- Noise or odor issues
- Legal and other requirements
- Business considerations, such as capital investments
- Interest parties/community environmental concerns
- Past history (internal audits and environmental reports)
- Support infrastructure, such as existing training, procedures, calibration, monitoring and measuring requirements
Many organizations have existing programs and/or procedures which contain useful information about the environmental aspects and impacts, such as process flow diagrams, environmental site assessments, regulatory compliance audits, process safety analysis, risk assessments, environmental impact assessments, industry-specific standards such as Good Manufacturing Practices (GMPs), customer environmental assessment, and reports. Look beyond activities that are covered by laws and regulations. Typically, many of a cleanroom’s aspects and impacts may be addressed by regulatory requirements. Thus, the organization’s compliance program will yield valuable information (permits, audit reports, and monitoring records).
Consider hiring an outside consultant. Without proper guidance from a qualified EMS expert, ISO 14000 certification can be a long, trying process. Hiring a consultant or consulting team can help ensure that the certification process is well planned and smoothly implemented. The consultant of team will direct the audit, help the firm interpret the environmental standards for its business, set realistic environmental objectives and a timeline for achieving those objectives, expedite procedures and processes, and correctly manage training, documentation, communication, and projects.
Select an internationally recognized registrar. To qualify for international recognition, the registrar must be approved by an official accredited registrar. Otherwise, any “certification” performed by the registrar may hold little or no value. The outside consulting team is a helpful resource for deciding which registrar to hire.
Establish a timeline and adhere to it. An ISO 14000 EMS implementation takes a great deal of commitment, financial support, and effort to complete successfully. Ask yourself, your management, and your colleagues:
- How committed is your organization to making the changes needed for ISO 14001 compliance?
- Does your organization have sufficient funding and resources to dedicate to the project?
- How accessible are personnel for training?
Once the decision has been made to pursue certification, it’s important to establish a realistic timeline for completing the project. Depending upon a number of variables, an efficient implementation will typically take between 6 and 10 months.
Build on your organization’s existing framework. If your organization has an ISO 9000 Quality Management System (QMS) in place, most of the expense of implementing an EMS has already been invested—and much of the labor has already been done.
It is clear that ISO 14000 has found its niche in U.S. cleanrooms. The cost of implementing an ISO 14000 EMS is declining, competition is rising, and the need to free up resources abounds. Beyond the numerous benefits of achieving certification, many organization fine the profit potential of completing certification is significant.