How Much Will ISO Certification Cost You

Posted by Steve Smith on February 1st, 2016

The International Standards Organization (ISO) develops standards that can be applied to the conduct of corporate business. These standards are developed by Technical Committees serving under the ISO's governance. One time voted on, and approved by countries in the international community, companies may request an audit of their firms in order to establish in the event that they are compliant to the standard. Understanding a quantity of the history behind the ISO certification standards applicable to medical device firms will even be helpful in appreciating the necessity for this study. This research study will evaluate the perceived benefits of ISO Certification for small to medium sized, privately held, for profit, United States based medical device firms.

The past decade has brought about a dramatic increase in the number of ISO certified corporations. This trend seems to have started in Europe and has been slowly spreading to the United States.

A study done by Guler, Guillen, and Macpherson (2002) indicates that between 1993 and 1998 the number of ISO 9000 increased from 46,511 to 271,847 in the thirty-four countries researched. For this same period, in the United States, they concluded that the growth rate was even more dramatic, with an increase from two,059 to 25,000 Certification. Initially, giant global corporations in the United States began to seek ISO certification; however, prior to the beginning of the0 first century, a movement began in earnest among small and medium sized firms to gain ISO Certification, as well. This method has continued to gain momentum over the coursework of the first few years of this century.

Few are the companies that will spend money that are not essential to the business or its future; therefore, there has to be some significant benefits perceived by firms going through the ISO certification method. In order to understand this issue, needs to first recognize that a company encounters a substantial cost to go through the ISO Certification method. A recent study found that costs for achieving ISO certification average 7,000 in 1996 with the costs for small firms decreasing to ,000.

Normally, small and medium sized privately held firms are even more sensitive to these costs and would not undertake this type of project without believing it was a key factor for the success of their businesses. of the significant preliminary results was that 80% of all firms surveyed were either already ISO registered or planning to be. Therefore, if these firms are beginning to embrace ISO, there has to be some perceived benefits. What are these benefits? This research study will explore this topic and reveal more facts in order to ascertain if this trend will continue.