"Taking the Mystery Out of ISO"
[Column #37, 1/98]
I'm sure many of you read the editorial in this publication a few months ago slamming the ISO 9000 quality management system. The article stirred up many responses from other readers with varying opinions. Having gone through nearly two years of work toward ISO registration-which has finally come to fruition-I thought it would be helpful to give my take on this issue and clear up some of the confusion about the requirements of registration and the benefits it provides.
The International Organization for Standardization (ISO) was founded in 1946. The ISO 9000 series, which covers documentation related to quality management standards, was introduced around the world in 1987. As the name indicates and unlike most quality management systems, ISO 9000 provides an internationally recognized seal of approval for a company's quality system. Certification is prevalent in companies doing overseas business because many European and Asian companies require it-therefore, to supply these companies, they have no choice. Conversely, this trend has trickled into many U.S. companies that now require their vendors be ISO registered and foreign companies wanting to do business with them must maintain registration. For any company seeking overseas vendors, ISO registration provides a quick means of weeding out potential suppliers. ISO 9000 registration has filtered into nearly every industry and is here to stay.
The most fundamental misconception about ISO is that these seemingly powerful and intimidating "ISO people" encroach on your business and tell you exactly how everything needs to be done-verbatim. The truth is, the ISO quality management system adopted by any business is merely a product of what that company decides it should be. ISO registration requires a company to say what they do, do what they say, and prove it. The assumption is that the company knows best how to run its business-ISO registrars merely serve as watchdogs to ensure the company adheres to the documented system and maintains constant internal monitoring for improvements. Any company can adapt its quality system to comply with ISO standards by simply doing the appropriate research and molding their system accordingly. For companies that already maintain effective, well-documented quality systems, obtaining ISO registration is relatively simple.
This brings me to another common misconception. Many people believe that becoming ISO registered is incredibly expensive and requires paying ISO consultants big bucks to come in and tell company management how to run their business. Beyond the auditing and registration costs, it doesn't have to cost any more than the time necessary to find out the requirements, document the existing system, and address any areas of ISO 9000 that may not currently exist in the system. No outside party is required to do the initial legwork-which is the toughest (and most time-consuming) part of becoming registered.
ISO registration requires every level of the company to examine each of the 20 elements of ISO 9000. They must then document every procedure and work instruction in detail and ensure company personnel are trained accordingly (this includes documentation proving individuals have been trained to operate particular machinery or perform particular tasks). Once the company has implemented the system, an independent ISO registrar can perform an optional preassessment to see if everything necessary to attain ISO registration is in place and to provide direction in areas that still need work. The final step toward registration occurs when auditors return to perform the official registration audit. After registration has been awarded, auditors return either annually or semiannually to ensure the company is adhering to its documented quality system. (The certificate of registration is good for three years; however, auditors perform a complete check of the system prior to the three-year expiration date.) Registrars focus on three things in particular: internal audits (checking that everything is documented), corrective and preventive action (initiating complaints internally or externally), and vendor analysis (assessing supplier performance). They address any problems and recommend changes to solve them. They also recommend changes when they feel there is a lack of documented work instructions for a particular area. For example, because we stated on-time delivery as a critical issue in our quality system, our registrars required detailed work instructions for our scheduling department and a documented system for preventive maintenance on our machinery.
For those of us in this crisis-driven industry, I don't need to emphasize the amount of time we spend fighting fires. Perhaps one of the greatest benefits of ISO is its proactive approach to doing business. (I know that's a difficult concept for many of us in the printing and finishing industry.) The standards that companies develop during this process are not based on reacting to mistakes but rather avoiding them altogether. Why waste resources making bad product? Any company considering ISO registration should ask themselves these three things: How well is the company policing itself through internal audits? How well does the company fix problems and ensure they don't recur (using corrective and preventive action)? How well does the company weed out bad suppliers through vendor analysis?
ISO registration means every single product that goes out the door has been consistently produced according to the standards defined by that company. Such a guarantee is an immense responsibility and one that customers will expect the producing company to live by. At Bindagraphics, we have found that although our procedures and work instructions do not eliminate human error, the audit systems it has in place catch mistakes quickly. More importantly, the corrective action system addresses problems as they occur. Not only does ISO 9000 minimize mistakes that get out the door, it allows us to flag many of our customers' mistakes before we run their jobs. The preinspection stage of our process requires us to document anything that could cause problems downstream. Problematic material then goes through an approval process that allows the customer opportunity for input. At Bindagraphics, we have found these requirements have reduced our spoilages and reworks significantly. It's been great to see that trend change direction!
Customers that use ISO-registered suppliers benefit from the assurance that registrars are in place to ensure compliance to the system. This is what sets ISO-registered companies apart from those claiming to have Total Quality Management (TQM) systems. These companies have no independent party monitoring their quality system. Be wary of companies that say they are ISO 9000 compliant-this, too, is an unverifiable claim.
ISO requires a tremendous amount of time and coordination on the part of nearly every person in the company. After almost two years, it has become a way of life for us. It is not simply a set of quality standards the company has adopted. Rather, it is a part of the company culture and the only acceptable means of doing business.