I read your July editorial ("Eliminate ISO 9000?," July 2002, p. 6) and being busy attending an ISO technical committee meeting in Malaysia, I did not have time to reply. My company is actively involved in the ISO process as a manufacturer and distributor of condoms. We have one of the largest facilities in the world and are an ISO 9000 registered company. To be successful in our industry, a manufacturer must be compliant with ISO 4074, ISO 13485 and the ISO 9000 quality system. Therefore, I am pleased to have the opportunity to respond as part of what should be a "not so silent" majority.
Regardless of whether or not a company should be ISO compliant, any company should have as the underpinning of all quality programs the fact that quality is a journey, not a destination. The ISO 9000 quality standard is only a description of a vehicle that can make the quality journey. Granted, it is one heavily loaded with options, but it is still only the vehicle that takes a company on the quality journey. Because it is a vehicle, ISO is only the mode of transportation for the journey and is not the destination itself.
As a medical manufacturer, European Union requirements, and even our own government's purchase standards, mandate an ISO 9000 quality compliant system. The FDA regulation for medical devices is actually based on ISO 9001: 1994, with some edits, and the FDA itself has assessed its own systems to ISO 9001: 2000 and found itself to be substantially compliant. This could also be a prelude to adoption of ISO 9001:2000 as a consensus standard.
In operating in a heavily regulated environment, the standard complaint about ISO of "too much paperwork" is not realistic, because ISO requires no more paperwork than the government regulations already specify. ISO instead provides a framework for an organization's paperwork and the common structure that is understood by both the company and its regulators.
Some of the push to closely examine the need to remain ISO compliant and ISO's value, may be the result of the standards change that is fast approaching. Everyone who is currently certified to ISO 9001:1994 will have to be ISO 9001:2000 certified before December 2003, or face the loss of ISO certification. It is easier to start spin control as a positive decision and say "we decided to eliminate ISO" rather than "we are not compliant with the current standard."
This review could also be the result of customers who do not understand what an ISO 9000 quality system is. Most assume that ISO means quality. It only means that the company has established a framework; it does not mean that they have been traveling on a quality journey. A company's ISO quality system is only as good as the company who enforces it and the notified body who oversees it. In my experience, customers do not remember that ISO is measured each time an employee follows the procedure.
With more consultants, prepackaged systems and promises of "certification in less than 90 days" to shake a stick at, the value of ISO may also be made to seem insignificant. We have had discussions with customers comparing our ANSI-certified notified-body registered certificate with one that is not ANSI certified or registered. Both companies can make the claim of "ISO certified" but only the ANSI-certified company would be compliant with ISO requirements. Therefore, for those companies registered with ANSI and certified to the accepted standard, it is a tool and quality language of international trade. It allows a uniform comparison of manufacturers and an independent audit of the quality system. For buyers and sellers geographically far apart, this is an acceptable method of quality audit and documentation.
In our organization, we have used ISO certification as a method to teach basic quality requirements and to motivate a diverse group of employees. Our employees understand that we are ISO certified and have been for more than 10 years. They also understand when they deviate from procedure that this is a nonconformance and is dealt with according to established policy. It provides a method for discovering mistakes, correcting them and taking appropriate action to see that they are not repeated.
ISO is not, as some assume, regimentation, but consistency. Consistency is always prized. It is the reason McDonald's is very successful; customers always know what to expect, regardless of the restaurant's location. For our organization, ISO has provided that same consistency and it assists our quality professionals in keeping our employees focused on the quality journey. As for the assertion that ISO may actually do a disservice to the quality system, for our organization it has assisted us in ensuring that we are FDA compliant, that we meet customer specifications and are able to continue to export products to more than 85 companies. Without ISO, we would be less efficient in ensuring that we meet regulatory requirements, and would be unable to meet regulatory requirements in more than 30 countries.
Our company remains on the quality journey, continually looking at the sites and paying attention to signposts pointing to profitability and success along the way. While our quality professionals continue to look for ways to modernize and economize our ISO quality vehicle, we are going to continue to drive on toward success.
Lillie Thomas, M.S.
Vice President of Quality and Regulatory Compliance
Custom Services International Inc.