ISO 9000: the thing to do?
Everyone is doing it. It has become the latest fad and it is all the rage. Like most things chic, it began in Europe. And even though the North American nonwovens industry may have been slow to embrace it, nonwovens companies are now rapidly joining the rush. With quality and globalization two of the key words for the nonwovens industry today, the International Organization for Standardization (ISO) 9000 certification series has rapidly become a major consideration for almost every nonwovens manufacturing company around the world.
At its most basic, the ISO 9000 series is a set of quality management standards for manufacturing facilities, standards audited by an outside, third party. In and of themselves, the ISO 9000 family is NOT a quality system but a set of standards governing a company's quality management system. The key to ISO certification is the documentation of manufacturing processes and procedures that deal with every potential situation. An ISO credo could read "Say what you do and do what you say," or more specifically "Document what you do (manufacture) and how you do it and do (manufacture) what you document."
Of course an ISO certification is no guarantee of a top-of-the-line product. An ISO certificate states only that a company follows specific written procedures in its manufacturing process, not that the process produces the best possible product. The ISO model refers to management systems and not products made at the site. Variability will be greatly reduced and consistency will increase with the adoption of ISO standards but the products themselves are governed only by internal quality controls.
At present, ISO certification is still a voluntary process and it is not required by any agency or bureau. In Europe, however, not being ISO certified can be a negative mark against a company, as the program has become almost mandatory. In some areas, ISO certification has become a commercial requirement, if not a legal one. For example, the medical products industry in Europe may very soon adopt ISO certification as a requirement for business.
In North America, the ISO program has been slow in gaining acceptance. Currently, there are 500-900 manufacturing sites in the U.S. and Canada that are ISO certified, while in the U.K, where the standards were first introduced, there are more than 15,000. ISO standards are not restricted to Europe and North America, however, and more than 50 countries have already adopted them as their recognized quality management standard, with nine more countries pending.
ISO 9000: The Specifics
From its origins in the British military as a standard for quality assurance, the ISO series was officially issued in 1987 by the Geneva-based International Organization for Standardization, which is made up of 90 national standards organizations from around the globe (such as ASTM in the U.S. and DIN in Germany). The ISO 9000 series has since been adopted by the European Community as the CEN 29000 series, by the U.S. as the ANSI/ASQC (American National Standards Institute/American Society of Quality Control) Q90 series and by many other countries around the globe.
The 9000 series consists of three different models - 9001, 9002 and 9003 - that vary according to the specifics of each qualifying site and the level desired. It is important to note that ISO certification is awarded site by site or unit by unit and is not a company-wide award.
Specifically, the ISO 9000 standard defines the scope of the other documents and provides a cross-reference for the other standards.
ISO 9001 is a guide for company units that design as well as manufacture and supply products, essentially targeting quality control areas in equipment manufacturing.
ISO 9002 is designed for sites that manufacture and supply products but does not include design and research and development criteria. It is a standard for the quality control systems of goods or raw materials made or used in a manufacturing process.
ISO 9003 is a subset of 9002 and deals with final product inspection and testing.
Finally, ISO 9004 provides guidelines on how the quality systems should be implemented and managed.
In general, ISO standards define five key aspects of total quality: policy, management, systems, control and assurance. Table 1 outlines specifically the criteria for the 9001, 9002 and 9003 levels. As can be seen, ISO 9001 is the most comprehensive standard but it does not apply to every company or situation, although some sites have the option to pursue either. Interestingly, a greater percentage of European companies have achieved the tougher ISO 9001 certification than has been done in the U.S.
Table 1 ISO 9000 CRITERIA 9001 9002 9003 1. Management Responsibility x x x 2. Quality System Principles x x x 3. Contract Review x x 4. Design Control x 5. Document Control x x x 6. Purchasing x x 7. Purchaser Supplied Product x x 8. Product Identification & Traceability x x x 9. Process Control x x 10. Inspection and Testing x x x 11. Control of Measurement & Test Equip. x x x 12. Inspection and Test Status x x x 13. Control of Nonconforming Product x x x 14. Corrective Action x x 15. Handling, Storage, Packaging & Delivery x x x 16. Quality Records x x x 17. Internal Quality Audits x x 18. Personnel Training x x x 19. After Sales Servicing x 20. Statistical Techniques x x x
In the end, being ISO certified should simplify the vendor/buyer relationship because the buyer has the guarantee that the vendor will manufacture the product following specific quality management procedures, as checked by an outside auditor. Exact product specifications, however, must be worked out between buyer and vendor.
The Registrars: The Companies
Behind The Certification
Simply ensuring that all 20 criteria for ISO 9001 are in place does not earn a company certification. Awards are presented by outside third party auditors or registrars who are hired to examine the quality management systems. In some cases, a company will also hire an ISO consultant to help them design, implement and document a quality management system in the initial stages.
The majority of companies, however, build upon existing quality systems to create their own total quality management system as required by ISO. Registrars then ensure that the proper procedures exist and are followed, with inspections every six months. It is possible for a site to lose certification; re-certification is required every three years.
Until recently, the U.S. did not have a central body that accredited registrars. Companies seeking certification were required to use registrars accredited in Europe. In December, 1991, however, an agreement between the Registrar Accreditation Board (RAB), a subsidiary of the ASQC, and ANSI resulted in the American National Accreditation Program for Registrars of Quality Systems. This joint effort provides a list of registrars in the U.S. and Canada that meet the appropriate standards of the RAB/ANSI program, enabling them to award ISO certification.
While ISO standards are, in principle, universal, some countries have stricter interpretations of the guidelines (Germany, for example). In some nations, particularly in Western Europe, the demand for registrars far outweighs the supply and facilities are forced to wait for their opportunity. Even within particular countries, different registrars have varying reputations and certification from some registrars is better accepted than from others, especially in the U.S. with regard to European acceptance.
The Supply Side: What
Nonwovens Suppliers Say
Many of the nonwoven raw materials and fiber suppliers have gone through or are in the process of ISO certification. Yet these companies - many of which are huge, multinational suppliers that serve a broad spectrum of industries - are not citing demand from nonwovens producers as the overriding factor in their decision to seek certification. For the most part, the international recognition accorded ISO certification is a prime motivating factor for these suppliers, while only a few mentioned specific requests from nonwovens customers. This trend, however, may soon be changing, as certification among roll goods companies increases (see accompanying sidebar).
The international appeal of being ISO certified was cited most frequently as a motivator. "Air Products believes ISO certification to be a prerequisite for competing effectively in international markets," said Robert Gadomski, vice president, Chemicals Group, Air Products and Chemicals, Allentown, PA. These sentiments were echoed across the board.
"Any paper or nonwovens company that wants to do European business must get certified and will have to push the requirements down to us, their suppliers," agreed Joseph Petska, director of quality management for the Process Chemicals Division, Nalco, Naperville, IL. He added that at present 23 of the company's 37 sites around the world are certified, including facilities in Garyville, LA, Sugar Land, TX and Bedford Park, IL, with the remainder in progress.
Suppliers also discussed other incentives, some of which became clearer as the ISO process began. "We are aiming to eliminate variability and achieve batch to batch consistency," said Richard Ruzzini, market manager-nonwovens, Rohm and Haas, Philadelphia, PA. He noted that four company emulsion (binder) plants (Louisville, K-Y, Hayward, CA, Bayport, TX and Houston, TX) are already ISO 9002 certified, with three more plants scheduled to receive certification later this year. The company plans to have all North American sites finished with the process by mid-1995.
"Our push for ISO certification is customer driven," said Hermann Ortega, vice president and general manager-manufacturing, Chemicals Group, Air Products and Chemicals. The company's Calvert Cityl KY, Paulsboro, NJ and Wichita, KS sites and one near Greenville, SC, are ISO 9002 certified, with eight other North American facilities, in process.
"We are committed to the goal of having our quality systems meet or exceed ISO 9002 requirements across the board," said Ted Lafleur, chairman, ISO 9000 steering committee, Hoechst Celanese, Charlotte, NC. With two Belgium sites and six North American facilities already 9002 registered and eleven more units at six U.S. and Canadian plants in process, the company is well on its way to achieving total registration.
Suppliers noted that ISO certification can be a sales and marketing tool as well, both here and abroad. "I think companies that are not certified or are not in the process are already at a disadvantage and falling behind," said Michael Oberkich, polypropylene product manager, Amoco Chemical, Atlanta, GA. Amoco's olefin and polymers business unit, Chicago, IL, along with its Chocolate Bayou, TX plant and the Cedar Bayou, TX facilities, have all achieved 9002 certification, joining all of the Amoco Fabries Europe sites.
Peter Kaczmarak, senior manager-global quality, BFGoodrich Specialty Polymers and Chemicals Division, Cleveland, OH, agreed. "One of our motivations was the desire to remain competitive and even gain a short term advantage on competitors by getting certified sooner," he said. He noted that every plant in the division is currently responsible for putting together an aggressive plan for achieving certification, with the majority of the sites already 30-40% along in the process.
Mr. Kaczmarak also mentioned that the ISO certification process provides a time for self examination. "The ISO standards provide an excellent opportunity for us to examine our own quality systems and to formalize the commitment to quality," he said.
Mr. Petska, at Nalco, took it one step further. "ISO 9000 helps support in-house quality improvements and is the foundation for one of the Malcolm Baldridge criteria, an award that we will soon be seeking," he said.
"The ISO program fits neatly into our internal motivation programs as part of our TQL (Total Quality Leadership) effort," added. Mr. Ruzzini, Rohm and Haas.
While the motivations may be varied, the costs of the certification process were firmly agreed upon. In strict financial terms, without an ISO consultant, registration costs $10,000-20,000 per site for an auditor, a fairly modest fee. The real cost is in terms of labor. A massive manpower commitment is necessary to achieve certification, with estimates of between two and 12 man-years required for designing and compiling all the required documentation and the implementation of training programs.
Getting certified can be an arduous task and it relates specifically to the quality systems already in place. Good quality systems are not the key to rapid and easy certification, however - proper documentation of all procedures and eventualities is. The hardest part of being ISO certified may even be the effort required to remain certified, as doing everything by the book can sometimes create an overly structured manufacturing environment.
From inception to certification, the ISO process is a one to two year operation. Fast becoming the international quality management system standard, it remains flexible enough to seek improvements - a major review is planned for 1997. With the nonwovens industry striving for globalization, it is becoming increasingly evident that ISO 9000 will be a major part of the effort.