Costs for Achieving ISO Certification Process
The International Standards Organization (ISO) develops standards which will be applied to the conduct of corporate business. These standards are developed by Technical Committees serving under the ISO’s governance. Once voted upon, and approved by enough countries within the international community, companies may request an audit of their firms so as to determine if they’re compliant to the quality . Understanding a number of the history behind the ISO Standards applicable to medical device firms also will be helpful in appreciating the necessity for this study. This research study will evaluate the perceived benefits of ISO Certification for little to medium sized, privately held, for profit, us based medical device firms.
The past decade has caused a dramatic increase within the number of ISO certified corporations. This trend seems to possess started in Europe and has been slowly spreading to the us .
A study completed by Guler, Guillen, and Macpherson (2002) indicates that between 1993 and 1998 the amount of ISO 9000 increased from 46,511 to 271,847 within the thirty-four countries researched. For this same period, within the us , they concluded that the expansion rate was even more dramatic, with a rise from 2,059 to just about 25,000 Certification. Initially, very large global corporations within the us began to hunt ISO certification; however, just before the beginning of the twenty first century, a movement began in earnest among small and medium sized firms to realize ISO Certification, as well. This process has continued to realize momentum over the course of the primary few years of this century.
Few are the businesses which will spend funds that aren’t essential to the business or its future; therefore, there must be some significant benefits perceived by firms browsing the ISO certification process. so as to know this issue, one must first recognize that a corporation encounters a considerable cost to travel through the ISO Certification process. A recent study found that costs for achieving ISO certification average $187,000 in 1996 with the prices for little firms decreasing to $50,000.
Normally, small and medium sized privately held firms are even more sensitive to those costs and wouldn’t undertake this sort of project without believing it had been a key factor for the success of their businesses. one among the many initial results was that 80% of all firms surveyed were either already ISO registered or getting to be. Therefore, if these firms are starting to embrace ISO, there must be some perceived benefits. What are these benefits? This research study will explore this subject and reveal more facts so as to determine if this trend will continue.